What you need to know about drugs

Mysoline

Mysoline(primidone) – Valeant

THERAPEUTIC CLASS

Pyrimidinedione derivative

INDICATIONS

Alone or with other anticonvulsants in the control of grand mal, psychomotor and focal epileptic seizures. May also control grand mal seizures refractory to other anticonvulsant therapy.

ADULT DOSAGE

Adults: Individualize dose. No Prior Antiepileptic Therapy: Initial: Day 1-3: 100-125mg qhs. Day 4-6: 100-125mg bid. Day 7-9: 100-125mg tid. Day 10-Maint: 250mg tid. Usual Maint: 250mg tid or qid. Max: 500mg qid. With Prior Anticonvulsant Therapy: Initial: 100-125mg qhs. Titrate: Increase gradually to maint dose as other drug is gradually d/c over ≥2 weeks. Max: 2g/day.

PEDIATRIC DOSAGE

Pediatrics: ≥8 yrs: Individualize dose. No Prior Antiepileptic Therapy: Initial: Day 1-3: 100-125mg qhs. Day 4-6: 100-125mg bid. Day 7-9: 100-125mg tid. Day 10-Maint: 250mg tid. Usual Maint: 250mg tid or qid. Max: 500mg qid. With Prior Anticonvulsant Therapy: Initial: 100-125mg qhs. Titrate: Increase gradually to maint dose as other drug is gradually d/c over ≥2 weeks. Max: 2g/day. <8 yrs: Day 1-3: 50mg qhs. Day 4-6: 50mg bid. Day 7-9: 100mg bid. Day 10-Maint: 125-250mg tid. Usual Maint: 125-250mg tid or 10-25mg/kg/day in divided doses.

HOW SUPPLIED

Tab: 50mg*, 250mg* *scored

CONTRAINDICATIONS

Porphyria, phenobarbital hypersensitivity.

WARNINGS/PRECAUTIONS

Avoid abrupt withdrawal; may precipitate status epilepticus. Increased risk of suicidal thoughts or behavior; monitor for emergence or worsening of depression, suicidal thoughts/behavior, or any unusual changes in mood or behavior. Increased incidence of birth defects reported; encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Neonatal hemorrhage reported in newborns; give pregnant women prophylactic vitamin K1 therapy for 1 month prior to, and during, delivery.

ADVERSE REACTIONS

Ataxia, vertigo, granulocytopenia, agranulocytosis, red-cell hypoplasia, aplasia.

PREGNANCY

Safety not known in pregnancy, not for use in nursing.

MECHANISM OF ACTION

Pyrimidinedione derivative; not established. Raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals.

PHARMACOKINETICS

Distribution: Found in breast milk. Metabolism: Phenobarbital, phenylethylmalonamide (metabolites).

ASSESSMENT

Assess for porphyria, hypersensitivity to phenobarbital, prior anticonvulsant therapy, depression, and pregnancy/nursing status.

MONITORING

Monitor for status epilepticus, emergence or worsening of depression, suicidal thoughts/behavior, and any unusual changes in mood or behavior. Monitor CBC, drug serum blood level, and sequential multiple analysis-12 test q6 months.

PATIENT COUNSELING

Counsel patients, their caregivers, and families that the therapy may increase risk of suicidal thoughts and behavior and advise to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Immediately report behaviors of concern to healthcare providers. Encourage pregnant patients to enroll in the NAAED Pregnancy Registry (1-888-233-2334).

ADMINISTRATION/STORAGE

Administration: Oral route. Storage: 20-25oC (68-77oF).


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    Mysoline

    Mysoline

    Generic Name: barbiturate (Oral route, Parenteral route, Rectal route)

    Commonly used brand name(s)

    In the U.S.

    • Butisol Sodium
    • Mebaral
    • Mysoline
    • Seconal

    In Canada

    • Nova Rectal

    Available Dosage Forms:

    • Elixir
    • Tablet
    • Suppository
    • Capsule
    • Enema
    • Suspension
    • Solution

    Uses For Mysoline

    Barbiturates belong to the group of medicines called central nervous system (CNS) depressants (medicines that cause drowsiness). They act on the brain and CNS to produce effects that may be helpful or harmful. This depends on the individual patient’s condition and response and the amount of medicine taken.

    Some of the barbiturates may be used before surgery to relieve anxiety or tension. In addition, some of the barbiturates are used as anticonvulsants to help control seizures in certain disorders or diseases, such as epilepsy. Barbiturates may also be used for other conditions as determined by your doctor.

    The barbiturates have been used to treat insomnia (trouble in sleeping); but if they are used regularly (for example, every day) for insomnia, they are usually not effective for longer than 2 weeks. The barbiturates have also been used to relieve nervousness or restlessness during the daytime. However, the barbiturates have generally been replaced by safer medicines for the treatment of insomnia and daytime nervousness or tension.

    If too much of a barbiturate is used, it may become habit-forming.

    Barbiturates should not be used for anxiety or tension caused by the stress of everyday life.

    These medicines are available only with your doctor’s prescription.

    Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, phenobarbital is used in certain patients with the following medical condition:

    • Hyperbilirubinemia (high amount of bile pigments in the blood that may lead to jaundice)

    Before Using Mysoline

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Unusual excitement may be more likely to occur in children, who are usually more sensitive than adults to the effects of barbiturates.

    Geriatric

    Confusion, mental depression, and unusual excitement may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of barbiturates.

    Pregnancy

    Barbiturates have been shown to increase the chance of birth defects in humans. However, this medicine may be needed in serious diseases or other situations that threaten the mother’s life. Be sure you have discussed this and the following information with your doctor:

    • Taking barbiturates regularly during pregnancy may cause bleeding problems in the newborn infant. In addition, taking barbiturates regularly during the last 3 months of pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects in the baby after birth.
    • One study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby.
    • Barbiturates taken for anesthesia during labor and delivery may reduce the force and frequency of contractions of the uterus; this may prolong labor and delay delivery.
    • Use of barbiturates during labor may cause breathing problems in the newborn infant.

    Breast Feeding

    Barbiturates pass into the breast milk and may cause drowsiness, slow heartbeat, shortness of breath, or troubled breathing in babies of nursing mothers taking this medicine.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

    • Artemether
    • Boceprevir
    • Lurasidone
    • Nifedipine
    • Praziquantel
    • Ranolazine
    • Rilpivirine
    • Voriconazole

    Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abiraterone Acetate
    • Acenocoumarol
    • Adinazolam
    • Alfentanil
    • Alprazolam
    • Amobarbital
    • Anileridine
    • Anisindione
    • Aprobarbital
    • Axitinib
    • Bortezomib
    • Bosutinib
    • Bromazepam
    • Brotizolam
    • Butabarbital
    • Butalbital
    • Cabazitaxel
    • Carisoprodol
    • Chloral Hydrate
    • Chlordiazepoxide
    • Chlorzoxazone
    • Clobazam
    • Clonazepam
    • Clorazepate
    • Cobicistat
    • Codeine
    • Crizotinib
    • Dantrolene
    • Dasatinib
    • Delavirdine
    • Diazepam
    • Dicumarol
    • Dronedarone
    • Elvitegravir
    • Enzalutamide
    • Erlotinib
    • Estazolam
    • Ethchlorvynol
    • Etravirine
    • Everolimus
    • Fentanyl
    • Flunitrazepam
    • Flurazepam
    • Fospropofol
    • Halazepam
    • Hydrocodone
    • Hydromorphone
    • Ifosfamide
    • Imatinib
    • Irinotecan
    • Ivacaftor
    • Ixabepilone
    • Ketazolam
    • Ketorolac
    • Lapatinib
    • Levorphanol
    • Linagliptin
    • Lopinavir
    • Lorazepam
    • Lormetazepam
    • Maraviroc
    • Medazepam
    • Meperidine
    • Mephenesin
    • Mephobarbital
    • Meprobamate
    • Metaxalone
    • Methocarbamol
    • Methohexital
    • Methoxyflurane
    • Midazolam
    • Mifepristone
    • Morphine
    • Morphine Sulfate Liposome
    • Naproxen
    • Nilotinib
    • Nimodipine
    • Nitrazepam
    • Nordazepam
    • Oxazepam
    • Oxycodone
    • Oxymorphone
    • Pentobarbital
    • Phenindione
    • Phenobarbital
    • Phenprocoumon
    • Prazepam
    • Primidone
    • Propoxyphene
    • Quazepam
    • Quetiapine
    • Remifentanil
    • Rivaroxaban
    • Roflumilast
    • Romidepsin
    • Secobarbital
    • Sirolimus
    • Sodium Oxybate
    • Succinylcholine
    • Sufentanil
    • Sunitinib
    • Tacrolimus
    • Tapentadol
    • Temazepam
    • Temsirolimus
    • Teniposide
    • Thiopental
    • Ticagrelor
    • Tolvaptan
    • Triazolam
    • Valproic Acid
    • Vandetanib
    • Vemurafenib
    • Vincristine Sulfate
    • Vincristine Sulfate Liposome
    • Zolpidem

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

    • Alcohol abuse (or history of) or
    • Drug abuse or dependence (or history of)—Dependence on barbiturates may develop.
    • Anemia (severe) or
    • Asthma (history of), emphysema, or other chronic lung disease or
    • Type 2 diabetes mellitus or
    • Hyperactivity (in children) or
    • Mental depression or
    • Overactive thyroid or
    • Porphyria (or history of)—Barbiturates may make the condition worse.
    • Kidney disease or
    • Liver disease—Higher blood levels of barbiturates may result, increasing the chance of side effects.
    • Pain—Barbiturates may cause unexpected excitement or mask important symptoms of more serious problems.
    • Underactive adrenal gland—Barbiturates may interfere with the effects of other medicines needed for this condition.

    Proper Use of barbiturate

    This section provides information on the proper use of a number of products that contain barbiturate. It may not be specific to Mysoline. Please read with care.

    For patients taking the extended-release capsule or tablet form of this medicine:

    • These capsules or tablets are to be swallowed whole. Do not break, crush, or chew before swallowing.

    For patients using the rectal suppository form of this medicine:

    • To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.
    • Wash your hands with soap and water.

    Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much is used, it may become habit-forming (causing mental or physical dependence).

    If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose. To do so may increase the chance of your becoming dependent on the medicine. Instead, check with your doctor.

    If you are taking this medicine for epilepsy, it must be taken every day in regularly spaced doses as ordered by your doctor in order for it to control your seizures. This is necessary to keep a constant amount of medicine in the blood. To help keep the amount constant, do not miss any doses.

    Dosing

    The dose medicines in this class will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For amobarbital
    • For oral dosage form (tablets or capsules):
      • For trouble in sleeping:
        • Adults—65 to 200 milligrams (mg) at bedtime.
        • Children—Dose must be determined by your doctor.
      • For daytime sedation:
        • Adults—50 to 300 mg, taken in smaller doses during the day.
        • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight taken three times a day.
      • For sedation before surgery:
        • Adults—200 mg taken one to two hours before surgery.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, taken before surgery. However, the dose is usually not more than 100 mg.
      • For sedation during labor:
        • Adults—200 to 400 mg every one to three hours if needed. However, the total dose is usually not more than 1000 mg.
    • For injection dosage form:
      • For trouble in sleeping:
        • Adults—65 to 200 mg, injected into a muscle or vein.
        • Children up to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mg per kg (0.9 to 1.4 mg per pound) of body weight, injected into a muscle.
        • Children 6 years of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mg per kg (0.9 to 1.4 mg per pound) of body weight, injected into a muscle, or 65 to 500 mg injected into a vein.
      • For daytime sedation:
        • Adults—30 to 50 mg two or three times a day, injected into a muscle or vein
      • For sedation before surgery:
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight or 65 to 500 mg per dose, injected into a vein.
      • For control of seizures:
        • Adults and children 6 years of age and over—65 to 500 mg per dose, injected into a vein.
        • Children up to 6 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle or vein.
    • For aprobarbital
    • For oral dosage form (elixir):
      • For trouble in sleeping:
        • Adults—40 to 160 milligrams (mg) at bedtime.
        • Children—Dose must be determined by your doctor.
      • For daytime sedation:
        • Adults—40 mg three times a day.
        • Children—Dose must be determined by your doctor.
    • For butabarbital
    • For oral dosage forms (elixir or tablets):
      • For trouble in sleeping:
        • Adults—50 to 100 milligrams (mg) at bedtime.
        • Children—Dose must be determined by your doctor.
      • For daytime sedation:
        • Adults—15 to 30 mg three or four times a day.
        • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day.
      • For sedation before surgery:
        • Adults—50 to 100 mg sixty to ninety minutes before surgery.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight. However, the dose is usually not more than 100 mg.
    • For mephobarbital
    • For oral dosage form (tablets):
      • For daytime sedation:
        • Adults—32 to 100 milligrams (mg) three or four times a day.
        • Children—16 to 32 mg three or four times a day.
      • For control of seizures:
        • Adults—200 to 600 mg a day, taken in smaller doses during the day.
        • Children 5 years of age and over—32 to 64 mg three or four times a day.
        • Children up to 5 years of age—16 to 32 mg three or four times a day.
    • For metharbital
    • For oral dosage form (tablets):
      • For control of seizures:
        • Adults—At first, 100 milligrams (mg) one to three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 800 mg a day.
        • Children—50 mg one to three times a day.
    • For pentobarbital
    • For oral dosage forms (elixir or capsules):
      • For trouble in sleeping:
        • Adults—100 milligrams (mg) at bedtime.
        • Children—Dose must be determined by your doctor.
      • For daytime sedation:
        • Adults—20 mg three or four times a day.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kilogram (kg) (0.9 to 2.7 mg per pound) of body weight per day.
      • For sedation before surgery:
        • Adults—100 mg before surgery.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kilogram (0.9 to 2.7 mg per pound) of body weight, taken before surgery. However, the dose is usually not more than 100 mg.
    • For injection dosage form:
      • For trouble in sleeping:
        • Adults—150 to 200 mg, injected into a muscle. Or, 100 mg injected into a vein, with additional small doses given if needed. However, the dose is usually not more than 500 mg.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, injected into a muscle. Or, 50 mg injected into a vein, with additional small doses given if needed.
      • For sedation before surgery:
        • Adults—150 to 200 mg, injected into a muscle.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, injected into a muscle. However, the dose is usually not more than 100 mg.
      • For control of seizures:
        • Adults—At first, 100 mg injected into a vein. Additional small doses may be given if needed. However, the dose is usually not more than 500 mg.
        • Children—At first, 50 mg injected into a muscle or vein. Additional small doses may be given if needed.
    • For rectal dosage form (suppositories):
      • For trouble in sleeping:
        • Adults—120 to 200 mg inserted into the rectum at bedtime.
        • Children 12 to 14 years of age—60 or 120 mg inserted into the rectum at bedtime.
        • Children 5 to 12 years of age—60 mg inserted into the rectum at bedtime.
        • Children 1 to 4 years of age—30 or 60 mg inserted into the rectum at bedtime.
        • Children 2 months to 1 year of age—30 mg inserted into the rectum at bedtime.
        • Children up to 2 months of age—Dose must be determined by your doctor.
      • For daytime sedation:
        • Adults—30 mg inserted into the rectum two to four times a day.
        • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kg (0.9 mg per pound) of body weight, inserted into the rectum three times a day.
      • For sedation before surgery:
        • Children 12 to 14 years of age—60 or 120 mg inserted into the rectum.
        • Children 5 to 12 years of age—60 mg inserted into the rectum.
        • Children 1 to 4 years of age—30 or 60 mg inserted into the rectum.
        • Children 2 months to 1 year of age—30 mg inserted into the rectum.
        • Children up to 2 months of age—Dose must be determined by your doctor.
    • For phenobarbital
    • For oral dosage forms (elixir, capsules, or tablets):
      • For trouble in sleeping:
        • Adults—100 to 320 milligrams (mg) at bedtime.
        • Children—Dose must be determined by your doctor.
      • For daytime sedation:
        • Adults—30 to 120 mg a day, taken in smaller doses two or three times during the day.
        • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day.
      • For sedation before surgery:
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mg per kg (0.45 to 1.4 mg per pound) of body weight.
      • For control of seizures:
        • Adults—60 to 250 mg a day.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 6 mg per kg (0.45 to 2.7 mg per pound) of body weight a day.
    • For injection dosage form:
      • For trouble in sleeping:
        • Adults—100 to 325 mg, injected into a muscle or vein, or under the skin.
        • Children—Dose must be determined by your doctor.
      • For daytime sedation:
        • Adults—30 to 120 mg a day, injected into a muscle or a vein, or under the skin, in smaller doses two or three times during the day.
        • Children—Dose must be determined by your doctor.
      • For sedation before surgery:
        • Adults—130 to 200 mg, injected into a muscle sixty to ninety minutes before surgery.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mg per kg (0.45 to 1.4 mg per pound) of body weight, injected into a muscle or vein sixty to ninety minutes before surgery.
      • For control of seizures:
        • Adults—100 to 320 mg injected into a vein. The dose may be repeated if needed, but is usually not more than 600 mg a day. However, higher doses may be needed for certain types of continuing seizures.
        • Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 20 mg per kg (4.5 to 9 mg per pound) of body weight, injected into a vein. Later, 1 to 6 mg per kg (0.45 to 2.7 mg per pound) of body weight a day, injected into a vein. Higher doses may be needed for certain types of continuing seizures.
    • For secobarbital
    • For oral dosage form (capsules):
      • For trouble in sleeping:
        • Adults—100 milligrams (mg) at bedtime.
        • Children—Dose must be determined by your doctor.
      • For daytime sedation:
        • Adults—30 to 50 mg three or four times a day.
        • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day.
      • For sedation before surgery:
        • Adults—200 to 300 mg one or two hours before surgery.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight one or two hours before surgery. However, the dose is usually not more than 100 mg.
    • For injection dosage form:
      • For trouble in sleeping:
        • Adults—100 to 200 mg injected into a muscle, or 50 to 250 mg injected into a vein.
        • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle. However, the dose is usually not more than 100 mg.
      • For sedation before dental procedures:
        • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 1.1 to 2.2 mg per kg (0.5 to 1 mg per pound) of body weight, injected into a muscle ten to fifteen minutes before the procedure.
        • Children—Dose must be determined by your dentist.
      • For sedation before a nerve block:
        • Adults—100 to 150 mg, injected into a vein.
      • For sedation before surgery:
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 4 to 5 mg per kg (1.8 to 2.3 mg per pound) of body weight, injected into a muscle.
      • For seizures from tetanus:
        • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 5.5 mg per kg (2.5 mg per pound) of body weight, injected into a muscle or vein. Dose may be repeated every three to four hours if needed.
        • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle or vein.
    • For secobarbital and amobarbital combination
    • For oral dosage form (capsules):
      • For trouble in sleeping:
        • Adults—1 capsule at bedtime.
        • Children—Dose must be determined by your doctor.
      • For sedation before surgery:
        • Adults—1 capsule taken one hour before surgery.
        • Children—Dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Keep out of the reach of children.

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Do not keep outdated medicine or medicine no longer needed.

    Store the suppository form of this medicine in the refrigerator.

    Precautions While Using Mysoline

    If you will be using this medicine regularly for a long time:

    • Your doctor should check your progress at regular visits.
    • Do not stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are using before stopping completely.

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

    Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of the metyrapone test may be affected by this medicine.

    If you have been using this medicine for a long time and you think that you may have become mentally or physically dependent on it, check with your doctor. Some signs of mental or physical dependence on barbiturates are:

    • a strong desire or need to continue taking the medicine.
    • a need to increase the dose to receive the effects of the medicine.
    • withdrawal side effects (for example, anxiety or restlessness, convulsions [seizures], feeling faint, nausea or vomiting, trembling of hands, trouble in sleeping) occurring after the medicine is stopped.

    If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of a barbiturate or taking alcohol or other CNS depressants with the barbiturate may lead to unconsciousness and possibly death. Some signs of an overdose are severe drowsiness, severe confusion, severe weakness, shortness of breath or slow or troubled breathing, slurred speech, staggering, and slow heartbeat.

    This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

    Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking barbiturates. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking barbiturates. If you have any questions about this, check with your health care professional.

    Mysoline Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Rare

    • Bleeding sores on lips
    • chest pain
    • fever
    • muscle or joint pain
    • red, thickened, or scaly skin
    • skin rash or hives
    • sores, ulcers, or white spots in mouth (painful)
    • sore throat and/or fever
    • swelling of eyelids, face, or lips
    • wheezing or tightness in chest

    Check with your doctor as soon as possible if any of the following side effects occur:

    Less common

    • Confusion
    • mental depression
    • unusual excitement

    Rare

    • Hallucinations (seeing, hearing, or feeling things that are not there)
    • unusual bleeding or bruising
    • unusual tiredness or weakness

    With long-term or chronic use

    • Bone pain, tenderness, or aching
    • loss of appetite
    • muscle weakness
    • weight loss (unusual)
    • yellow eyes or skin

    Symptoms of overdose

    • Confusion (severe)
    • decrease in or loss of reflexes
    • drowsiness (severe)
    • fever
    • irritability (continuing)
    • low body temperature
    • poor judgment
    • shortness of breath or slow or troubled breathing
    • slow heartbeat
    • slurred speech
    • staggering
    • trouble in sleeping
    • unusual movements of the eyes
    • weakness (severe)

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Clumsiness or unsteadiness
    • dizziness or lightheadedness
    • drowsiness
    • “hangover” effect

    Less common

    • Anxiety or nervousness
    • constipation
    • feeling faint
    • headache
    • irritability
    • nausea or vomiting
    • nightmares or trouble in sleeping

    Confusion, mental depression, and unusual excitement may be more likely to occur in very ill patients.

    After you stop using this medicine, your body may need time to adjust. If you took this medicine in high doses or for a long time, this may take up to about 15 days. During this period of time check with your doctor if any of the following side effects occur (usually occur within 8 to 16 hours after medicine is stopped):

    • Anxiety or restlessness
    • convulsions (seizures)
    • dizziness or lightheadedness
    • feeling faint
    • hallucinations (seeing, hearing, or feeling things that are not there)
    • muscle twitching
    • nausea or vomiting
    • trembling of hands
    • trouble in sleeping, increased dreaming, or nightmares
    • vision problems
    • weakness

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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    Mysoline

    Mysoline

    Generic Name: primidone (Oral route)

    PRIM-i-done

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • Mysoline

    Available Dosage Forms:

    • Tablet
    • Suspension

    Therapeutic Class: Anticonvulsant

    Pharmacologic Class: Barbiturate, Intermediate Acting

    Uses For Mysoline

    Primidone is used alone or in combination with other medicines, to control seizures (convulsions) in the treatment of epilepsy. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

    This medicine is available only with your doctor’s prescription.

    Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, primidone is used in certain patients with the following medical conditions:

    • Essential tremor.

    Before Using Mysoline

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of primidone in children.

    Geriatric

    No information is available on the relationship of age to the effects of primidone in geriatric patients.

    Unusual excitement or restlessness may occur in elderly patients, who are usually more sensitive than younger adults to these effects of primidone.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Adinazolam
    • Alprazolam
    • Amobarbital
    • Anisindione
    • Aprobarbital
    • Bromazepam
    • Brotizolam
    • Butabarbital
    • Butalbital
    • Carisoprodol
    • Chloral Hydrate
    • Chlordiazepoxide
    • Chlorzoxazone
    • Clobazam
    • Clonazepam
    • Clorazepate
    • Dantrolene
    • Diazepam
    • Dicumarol
    • Estazolam
    • Ethchlorvynol
    • Flunitrazepam
    • Flurazepam
    • Halazepam
    • Ketazolam
    • Lorazepam
    • Lormetazepam
    • Medazepam
    • Mephenesin
    • Mephobarbital
    • Meprobamate
    • Metaxalone
    • Methocarbamol
    • Methohexital
    • Midazolam
    • Nitrazepam
    • Nordazepam
    • Oxazepam
    • Pentobarbital
    • Phenindione
    • Phenobarbital
    • Phenprocoumon
    • Prazepam
    • Primidone
    • Quazepam
    • Quetiapine
    • Secobarbital
    • Sodium Oxybate
    • Temazepam
    • Thiopental
    • Triazolam
    • Valproic Acid

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Betamethasone
    • Cannabis
    • Carbamazepine
    • Cortisone
    • Desogestrel
    • Dexamethasone
    • Dienogest
    • Drospirenone
    • Estradiol Cypionate
    • Estradiol Valerate
    • Ethinyl Estradiol
    • Ethynodiol Diacetate
    • Etonogestrel
    • Ginkgo
    • Hydrocortisone
    • Lamotrigine
    • Leucovorin
    • Levonorgestrel
    • Medroxyprogesterone Acetate
    • Mestranol
    • Methylprednisolone
    • Norelgestromin
    • Norethindrone
    • Norgestimate
    • Norgestrel
    • Prednisolone
    • Prednisone
    • Rufinamide
    • Tiagabine
    • Triamcinolone
    • Warfarin

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Asthma, emphysema, or chronic lung disease—Primidone may cause serious problems in breathing.
    • Depression, history of or
    • Hyperactivity (in children) or
    • Kidney disease or
    • Liver disease—Primidone may make these conditions worse.
    • Porphyria (an enzyme problem)—Should not be used in patients with this condition.

    Proper Use of Mysoline

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    This medicine may be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

    Take primidone everyday in regularly spaced doses as ordered by your doctor. This will provide the proper amount of medicine needed to prevent seizures.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage forms (chewable tablets, suspension, or tablets):
      • For seizures:
        • Adults, teenagers, and children 8 years of age or older—At first, 100 or 125 milligrams (mg) once a day at bedtime. Your doctor may increase your dose if needed. However, the dose is usually not more than 2000 mg a day.
        • Children up to 8 years of age—At first, 50 mg once a day at bedtime. Your doctor may increase your dose if needed.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Precautions While Using Mysoline

    It is very important that your doctor check your progress at regular visits while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

    If you have been taking primidone regularly for several weeks, you should not suddenly stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

    This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child’s doctor right away.

    Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (such as the metyrapone and phentolamine tests) may be affected by this medicine.

    Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

    Primidone may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

    Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking primidone. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking primidone. If you have any questions about this, check with your doctor.

    Mysoline Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Shakiness and unsteady walk
    • unsteadiness, trembling, or other problems with muscle control or coordination

    Less common

    • Unusual excitement or restlessness (especially in children and in the elderly)

    Rare

    • Chills
    • cough or hoarseness
    • fainting spells
    • fever and sore throat
    • fever with or without chills
    • general feeling of tiredness or weakness
    • irregular heartbeat
    • lower back or side pain
    • painful or difficult urination
    • pale skin
    • shortness of breath
    • skin rash
    • sores, ulcers, or white spots on the lips or in the mouth
    • unusual bleeding or bruising
    • unusual tiredness or weakness

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Confusion
    • continuous, uncontrolled rolling eye movements
    • double vision
    • troubled breathing

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Clumsiness or unsteadiness
    • dizziness or lightheadedness
    • feeling of constant movement of self or surroundings
    • sensation of spinning

    Less common

    • Decreased sexual ability
    • drowsiness
    • loss of appetite
    • mood or mental changes
    • nausea or vomiting

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    See also: Mysoline side effects (in more detail)

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    Mysoline

    Mysoline

    Generic Name: Primidone
    Class: Barbiturates

    VA Class: CN400

    Chemical Name: 5-ethyldihydro-5-phenyl-4,6(1H, 5H)-pyrimidinedione

    CAS Number: 125-33-7

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Warning(s)

    REMS:

    FDA approved a REMS for primidone to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

    Introduction

    Anticonvulsant; a structural analog of phenobarbital; related to barbiturate-derivative anticonvulsants.a b c d

    Uses for Mysoline

    Used alone or with other anticonvulsants (e.g., phenytoin, phenobarbital); a c d however, some clinicians do not recommend concurrent use of primidone and phenobarbital because of possible increased sedation.a

    Generalized Seizures

    Prophylactic management of tonic-clonic (grand mal) seizures, particularly those refractory to other anticonvulsant therapy.a c d

    Prophylactic management of other partial seizures (e.g., those with autonomic symptoms), including atonic (also known as akinetic) seizures.a b

    Partial Seizures

    Prophylactic management of partial seizures with complex symptomatology (psychomotor seizures).a c d

    Prophylactic management of other partial seizures, including focal seizures.a b c d

    Mysoline Dosage and Administration

    General

    • Closely monitor patients receiving anticonvulsant therapy for notable changes in behavior that could indicate emergence or worsening of suicidal thoughts or behavior or depression.d g h i (See Suicidality Risk under Cautions.)

    • When primidone therapy is discontinued, withdraw the drug slowly to avoid precipitating seizures or status epilepticus.a b c d
    • When a patient is transferred to primidone from another anticonvulsant, gradually increase primidone dosage over a period of at least 2 weeks while gradually decreasing dosage of the other anticonvulsant, to maintain adequate seizure control.a c

    Administration

    Oral Administration

    Administer orally.a c d

    Dosage

    Adjust dosage carefully according to individual requirements and response.a c d In some cases, determination of blood concentrations of the drug may be needed to achieve optimal dosage adjustment.c d

    May require several weeks of therapy before therapeutic efficacy can be assessed.c d

    Pediatric Patients

    Generalized and Partial Seizures
    Oral

    Anticonvulsant-naive children <8 years of age: Initially, 50 mg at bedtime (days 1–3), increase to 50 mg twice daily (days 4–6), then increase to 100 mg twice daily (days 7–9).a c d Follow with a maintenance dosage of 125–250 mg 3 times daily or 10–25 mg/kg daily given in divided doses.a c d Alternatively, some clinicians recommend 1.25 g/m2 daily in 2–4 divided doses.a

    Anticonvulsant-naive children ≥8 years of age: Initially, 100–125 mg at bedtime (days 1–3), increase to 100–125 mg twice daily (days 4–6), then increase to 100–125 mg 3 times daily (days 7–9).a c d Follow with a maintenance dosage of 250 mg 3 or 4 times daily.a c d Do not exceed 500 mg 4 times daily.a c d

    Children ≥8 years of age receiving other anticonvulsants: Initially, 100–125 mg (primidone) at bedtime; increase dosage (primidone) slowly to maintenance level while gradually decreasing dosage of other anticonvulsant.c d Continue this regimen until satisfactory dosage achieved with the combination, or the other drug is withdrawn.c d If primidone monotherapy is the objective, gradually increase primidone dosage while decreasing dosage of the drug being discontinued over a period of at least 2 weeks.a c d

    Adults

    Generalized and Partial Seizures
    Oral

    Anticonvulsant therapy-naive adults: Initially, 100–125 mg at bedtime (days 1–3), increase to 100–125 mg twice daily (days 4–6), then increase to 100–125 mg 3 times daily (days 7–9).a c d Follow with a maintenance dosage of 250 mg 3 or 4 times daily.a c d Do not exceed 500 mg 4 times daily.a c d

    Adults receiving other anticonvulsants: Initially, 100–125 mg (primidone) at bedtime; increase dosage (primidone) slowly to maintenance level while gradually decreasing dosage of other anticonvulsant.c d Continue this regimen until satisfactory dosage is achieved with the combination, or the other drug is withdrawn.c d If primidone monotherapy is the objective, gradually increase primidone dosage while decreasing dosage of the drug being discontinued over a period of at least 2 weeks.a c d

    Prescribing Limits

    Pediatric Patients

    Generalized and Partial Seizures
    Oral

    Children ≥8 years of age: Maximum 2 g daily given in divided doses (e.g., 500 mg 4 times daily).a c d

    Adults

    Generalized and Partial Seizures
    Oral

    Maximum 2 g daily given in divided doses (e.g., 500 mg 4 times daily).a c d

    Special Populations

    No special population dosage recommendations at this time.c d

    Cautions for Mysoline

    Contraindications

    • Porphyria.c d

    • Known hypersensitivity to phenobarbital.c d

    Warnings/Precautions

    Warnings

    Shares the toxic potentials of the barbiturate-derivative anticonvulsants; observe the usual precautions of anticonvulsant therapy.a

    Suicidality Risk

    Increased risk of suicidality (suicidal ideation or behavior) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%).d g h i j Increased suicidality risk was observed ≥1 week after initiation of anticonvulsant therapy and continued through 24 weeks.d g h j Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.d g h j

    Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression.d g h i j Anxiety, agitation, hostility, hypomania, and mania may be precursors to emerging suicidality.g

    Balance risk of suicidality with the risk of untreated illness.d g Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality.d g If suicidal thoughts or behavior emerge during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself.d i (See Advice to Patients.)

    Withdrawal Effects

    Abrupt withdrawal may result in increased seizure frequency or status epilepticus.a b c d

    Fetal/Neonatal Morbidity and Mortality

    May cause fetal harm.c d

    Reports suggest an association between use of anticonvulsants in pregnant, epileptic women and an increased incidence of birth defects in children born to these women; however, causal relationship to many anticonvulsants not established.c d f

    Neurologic manifestations (overactivity, tumors) reported in neonates whose mothers received primidone during pregnancy.f

    Do not discontinue anticonvulsants in pregnant women in whom the drugs are administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.c d

    Carefully weigh these considerations when treating or counseling epileptic women of childbearing potential.c d

    Neonatal hemorrhage (with a coagulation defect resembling vitamin K deficiency) reported in newborns whose mothers were receiving primidone during pregnancy.b c d f Administer prophylactic vitamin K to pregnant women taking primidone for one month prior to and during delivery.b c d Additionally, administer vitamin K to the neonate immediately after birth.b f

    General Precautions

    Laboratory Monitoring

    Perform baseline CBC and a sequential multiple analysis-12 (SMA-12) test every 6 months during primidone therapy.a c d

    Hematologic Effects

    Granulocytopenia, agranulocytosis, red-cell hypoplasia and aplasia rarely reported; may require discontinuance of primidone.c d

    Megaloblastic anemia may occur as a rare idiosyncrasy.c d Administer folic acid.c d

    Specific Populations

    Pregnancy

    Category D.f Safety during pregnancy not established.a c d (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

    North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients); registry information also available on the website .d

    Lactation

    Distributed into milk.a c d f Discontinue nursing or drug if excessive somnolence or drowsiness is observed in nursing infants of women receiving the drug.a c d

    Pediatric Use

    Safety and efficacy established in pediatric patients.c d

    Possible paradoxical excitement and hyperactivity or an exacerbation of existing hyperactivity in children.b

    Geriatric Use

    Possible excitement, confusion, or depression.b

    Common Adverse Effects

    Drowsiness, ataxia, vertigo, lethargy, anorexia, nausea, vomiting.a c d

    Interactions for Mysoline

    Specific Drugs

    Drug

    Interaction

    Comments

    Contraceptives (oral)

    Possible increased metabolism of both the estrogenic and progestinic components of oral contraceptivesb

    Consider alternate methods of contraceptionb

    Phenobarbital

    Possible increased sedationa b

    Use with caution,a if at all b

    Phenytoin

    Possible increase in amount of primidone converted to phenobarbital and increased sedationb

    Valproic acid

    Increased plasma phenobarbital concentrations and excessive somnolenceb

    Observe patient for possible neurologic toxicity and monitor plasma concentrations of phenobarbital; decrease dosage of primidone if neededb

    Mysoline Pharmacokinetics

    Absorption

    Bioavailability

    Approximately 60–80% absorbed from GI tract.a

    Onset

    Following oral administration, peak serum concentrations are reached in about 4 hours.a

    Plasma Concentrations

    Limited data indicate that serum primidone concentrations should be maintained at 5–12 mcg/mL to adequately control seizures and minimize risk of adverse effects.a c d

    Distribution

    Extent

    Distributed into milk in substantial quantities.a c d

    Elimination

    Metabolism

    Slowly metabolized by the liver.a Approximately 15–25% of an oral dose metabolized to phenobarbital.a

    Elimination Route

    Slowly excreted in urine as phenylethylmalonamide (PEMA), phenobarbital, and p-hydroxyphenobarbital.a

    During chronic therapy, approximately 15–25% excreted in urine unchanged and approximately 50–70% excreted as PEMA.a

    Half-life

    Primidone: One manufacturer stated 21 hours; other clinicians suggested 10–12 hours.a

    PEMA: 24–48 hours.a

    Special Populations

    Removed by hemodialysis.a

    Stability

    Storage

    Oral

    Tablets

    Tight, light-resistant containers at 20–25°C.c d

    Actions

    • Shares the actions of barbiturate-derivative anticonvulsants and has sedative properties similar to phenobarbital.a

    • Exact mechanism of antiepileptic action is unknown; primidone and its metabolites (phenobarbital and PEMA) have anticonvulsant activity.c d
    • Effective in subhypnotic doses.a

    Advice to Patients

    • Risk of suicidality (anticonvulsants may increase risk of suicidal thoughts or actions in about 1 in 500 people).d g h i j Importance of patients, family, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one’s life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).d g h j

    • Importance of informing patients that several weeks of therapy may be required before therapeutic efficacy can be assessed.c d
    • Importance of informing patients not to stop primidone therapy abruptly; may precipitate seizures or status epilepticus.a b c d
    • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products, as well as any concomitant illnesses.c
    • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed; advise pregnant women of possible risk to fetus.a d f Importance of clinicians informing women about the existence of and encouraging enrollment in pregnancy registries (see Pregnancy under Cautions).d
    • Importance of informing patients of other important precautionary information.c d (See Cautions.)

    Preparations

    Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

    * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

    Primidone
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Oral

    Tablets

    50 mg*

    Mysoline (scored)

    Valeant

    Primidone Tablets

    250 mg*

    Mysoline (scored)

    Valeant

    Primidone Tablets

    Comparative Pricing

    This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

    Mysoline 250MG Tablets (VALEANT): 30/$218.98 or 90/$633.99

    Mysoline 50MG Tablets (VALEANT): 90/$179.99 or 270/$519.96

    Primidone 250MG Tablets (AMNEAL PHARMACEUTICALS): 90/$69.99 or 270/$191.98

    Primidone 50MG Tablets (LANNETT): 90/$39.99 or 270/$109.97

    Disclaimer

    This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

    The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

    AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

    References

    a. AHFS drug information 2007. McEvoy GK, ed. Primidone. Bethesda, MD: American Society of Health-System Pharmacists; 2008.

    b. AHFS drug information 2007. McEvoy GK, ed. Anticonvulsants General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2254-8.

    c. Mutual Pharmaceuticals. Primidone tablets prescribing information. Philadelphia, PA; 2006 Nov.

    d. Valeant Pharmaceuticals North America. Mysoline (primidone) tablets prescribing information. Aliso Viejo, CA; 2009 May.

    e. Food and Drug Administration. Drugs or vaccines used in registries for specific diseases. From the FDA web site. Rockville, MD; Undated. Accessed 2008 Mar 20.

    f. Primidone. In: Briggs GG, Freeman RK, Yaffe SJ. Drug in pregnancy and lactation: a reference guide to fetal and neonatal risk. 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2008;1525-8.

    g. US Food and Drug Administration. Information for healthcare professionals: suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA web site.

    h. US Food and Drug Administration. FDA News: FDA alerts health care providers to risk of suicidal thoughts and behavior with antiepileptic medications. Rockville, MD; 2008 Jan 31. From the FDA website.

    i. US Food and Drug Administration. Suicidal behavior and ideation and antiepileptic drugs: update 5/5/2009. Rockville, MD; 2009 May 5. From the FDA website. Accessed 2009 Oct 21.

    j. US Food and Drug Administration. FDA Alert: Suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.

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    Mysoline

    Mysoline

    Generic Name: primidone (PRIM i done)

    Brand Name: Mysoline

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    What is Mysoline (primidone)?

    Primidone is an anti-epileptic drug, also called an anticonvulsant.

    Primidone is used to control seizures.

    Primidone may also be used for other purposes not listed in this medication guide.

    What is the most important information I should know about Mysoline (primidone)?

    You should not use this medication if you are allergic to primidone or phenobarbital (Luminal, Solfoton), or if you have porphyria.

    Before taking this medication, tell your doctor if you are allergic to any drugs, or if you are pregnant or breast-feeding.

    You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

    Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

    If you are taking primidone to prevent seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking primidone. Follow your doctor’s instructions.

    To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

    Do not change your dose of primidone without your doctor’s advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

    Carry an ID card or wear a medical alert bracelet stating that you are taking primidone, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

    What should I discuss with my healthcare provider before taking Mysoline (primidone)?

    You should not use this medication if you are allergic to primidone or phenobarbital (Luminal, Solfoton), or if you have porphyria.

    You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

    Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

    Before taking this medication, tell your doctor if you are allergic to any drugs, or if you are pregnant or breast-feeding.

    Primidone may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Do not start taking primidone during pregnancy without your doctor’s advice.

    If you become pregnant while taking primidone, do not stop taking it without telling your doctor. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by taking primidone.

    If you have taken primidone during pregnancy, be sure to tell the doctor who delivers your baby about your primidone use. Both you and the baby may need to receive medications to prevent excessive bleeding during delivery and just after birth.

    Primidone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    How should I take Mysoline (primidone)?

    Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

    Primidone is usually taken 2 to 4 times daily. If you are switching to primidone from another seizure medication, you may need to start taking primidone only at bedtime. Follow your doctor’s instructions.

    If you are taking primidone to treat seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking primidone. Follow your doctor’s instructions.

    To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

    Do not change your dose of primidone without your doctor’s advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

    Carry an ID card or wear a medical alert bracelet stating that you are taking primidone, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

    Store primidone at room temperature away from moisture, light, and heat.

    See also: Mysoline dosage (in more detail)

    What happens if I miss a dose?

    Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention if you think you have used too much of this medicine.

    Symptoms of a primidone overdose are not known.

    What should I avoid while taking Mysoline (primidone)?

    Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using primidone.

    Mysoline (primidone) side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

    Call your doctor at once if you have any of these serious side effects:

    • slurred speech;

    • loss of balance or coordination;
    • easy bruising or bleeding; or
    • unusual weakness.

    Less serious side effects may include:

    • dizziness, drowsiness, spinning sensation;

    • nausea, vomiting, loss of appetite;
    • feeling irritable;
    • blurred vision;
    • mild skin rash; or
    • impotence, loss of interest in sex.

    This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Mysoline side effects (in more detail)

    What other drugs will affect Mysoline (primidone)?

    There may be other drugs that can interact with primidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

    Next Page → Side Effects

    More Mysoline resources

    • Side Effects
    • Recommended Dosage
    • Pregnancy Warnings
    • Drug Images
    • Drug Interactions
    • Support Group
    • 6 Reviews - Add your own review/rating
    • Generic Availability
    • Mysoline Prescribing Information (FDA)
    • Mysoline MedFacts Consumer Leaflet (Wolters Kluwer)
    • Mysoline Monograph (AHFS DI)
    • Mysoline Advanced Consumer (Micromedex) – Includes Dosage Information
    • Primidone Prescribing Information (FDA)
    • Primidone Professional Patient Advice (Wolters Kluwer)

    Compare Mysoline with other medications

    • Seizures

    Where can I get more information?

    • Your pharmacist can provide more information about primidone.

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    Mysoline

    Mysoline

    Generic Name: primidone

    Dosage Form: tablet

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Mysoline®

    (primidone, USP)

    Anticonvulsant

    Rx only

    Mysoline Description

    Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula:

    Mysoline* (primidone) is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog.

    Mysoline 50 mg and 250 mg tablets contain the following inactive ingredients: Microcrystalline Cellulose, NF; Lactose, USP; Methylcellulose, USP; Sodium Starch Glycolate, NF; Talc, USP; Sodium Lauryl Sulfate, NF; Magnesium Stearate, NF; Water, USP, Purified.

    Mysoline 250 mg tablets also contain Ferric Oxide Yellow, NF.

    _______________________________________________________________________________

    * Registered trademark of Valeant Pharmaceuticals North America.

    ACTIONS

    Mysoline raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidone’s antiepileptic action is not known.

    Primidone per se has anticonvulsant activity as do its two metabolites, phenobarbital and phenylethylmalonamide (PEMA). In addition to its anticonvulsant activity, PEMA potentiates the anticonvulsant activity of phenobarbital in experimental animals.

    Indications and Usage for Mysoline

    Mysoline, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.

    Contraindications

    Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS).

    Warnings

    The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed.

    Suicidal Behavior and Ideation

    Antiepileptic drugs (AEDS), including Mysoline, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

    Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

    The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

    The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.

    Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

    Table 1 Risk by indication for antiepileptic drugs in the pooled analysis
    Indication Placebo

    Patients with

    Events Per

    1000 Patients

    Drug Patients

    with Events

    Per 1000

    Patients

    Relative Risk:

    Incidence

    of Events in

    Drug Patients/

    Incidence

    in Placebo

    Patients

    Risk

    Difference:

    Additional

    Drug Patients

    with Events

    Per 1000

    Patients

    Epilepsy 1.0 3.4 3.5 2.4
    Psychiatric 5.7 8.5 1.5 2.9
    Other 1.0 1.8 1.9 0.9
    Total 2.4 4.3 1.8 1.9

    The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

    Anyone considering prescribing Mysoline or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

    Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

    Usage in Pregnancy

    To provide information regarding the effects of in utero exposure to Mysoline, physicians are advised to recommend that pregnant patients taking Mysoline enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

    The effects of Mysoline in human pregnancy and nursing infants are unknown.

    Recent reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to diphenylhydantoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.

    The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship.

    There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors leading to birth defects, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorders are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.

    The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential. Neonatal hemorrhage, with a coagulation defect resembling vitamin K deficiency, has been described in newborns whose mothers were taking primidone and other anticonvulsants. Pregnant women under anticonvulsant therapy should receive prophylactic vitamin K1 therapy for one month prior to, and during, delivery.

    Precautions

    The total daily dosage should not exceed 2 g. Since Mysoline therapy generally extends over prolonged periods, a complete blood count and a sequential multiple analysis-12 (SMA-12) test should be made every six months.

    In Nursing Mothers

    There is evidence in mothers treated with primidone, the drug appears in the milk in substantial quantities. Since tests for the presence of primidone in biological fluids are too complex to be carried out in the average clinical laboratory, it is suggested that the presence of undue somnolence and drowsiness in nursing newborns of Mysoline-treated mothers be taken as an indication that nursing should be discontinued.

    Information for Patients

    Suicidal Thinking and Behavior – Patients, their caregivers, and families should be counseled that AEDs, including Mysoline, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

    Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see Usage in Pregnancy section).

    Please refer to the Mysoline Medication Guide provided with the product for more information.

    Adverse Reactions

    The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness, and morbilliform skin eruptions. Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, have been reported rarely. These and, occasionally, other persistant or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to Mysoline and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication.

    Mysoline Dosage and Administration

    Adult Dosage

    Patients 8 years of age and older who have received no previous treatment may be started on Mysoline according to the following regimen using either 50 mg or scored 250 mg Mysoline tablets:

    Days 1 to 3: 100 to 125 mg at bedtime.

    Days 4 to 6: 100 to 125 mg b.i.d.

    Days 7 to 9: 100 to 125 mg t.i.d.

    Day 10 to maintenance: 250 mg t.i.d.

    For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg Mysoline tablets in divided doses (250 mg t.i.d. or q.i.d.). If required, an increase to five or six 250 mg tablets daily may be made but daily doses should not exceed 500 mg q.i.d.

    INITIAL: ADULTS AND CHILDREN OVER 8
    KEY: •=50 mg tablet; ●=250 mg tablet
    DAY 1 2 3 4 5 6
    AM •• •• ••
    NOON
    PM •• •• •• •• •• ••
    DAY 7 8 9 10 11 12
    AM •• •• •• Adjust to

    Maintenance

    NOON •• •• ••    
    PM •• •• ••    

    Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 μg/mL.

    In Patients Already Receiving Other Anticonvulsants

    Mysoline should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn. When therapy with Mysoline alone is the objective, the transition from concomitant therapy should not be completed in less than two weeks.

    Pediatric Dosage

    For children under 8 years of age, the following regimen may be used:

    Days 1 to 3: 50 mg at bedtime.

    Days 4 to 6: 50 mg b.i.d.

    Days 7 to 9: 100 mg b.i.d.

    Day 10 to maintenance: 125 mg t.i.d. to 250 mg t.i.d.

    For children under 8 years of age, the usual maintenance dosage is 125 to 250 mg three times daily or, 10 to 25 mg/kg/day in divided doses.

    How is Mysoline Supplied

    Mysoline Tablets

    Each square-shaped, scored, yellow tablet, identified by “Mysoline 250″ and an embossed M, contains 250 mg of primidone, in bottles of 100 (NDC 66490-691-10)

    Each square-shaped, scored, white tablet, identified by “Mysoline 50″ and an embossed M, contains 50 mg of primidone, in bottles of 100 (NDC 66490-690-10)

    The appearance of these tablets is a trademark of Valeant Pharmaceuticals North America.

    Store at 20°C-25°C (68°F-77°F).

    [See USP controlled room temperature].

    Dispense in a tight, light-resistant container with a child-resistant closure.

    Manufactured by:

    Piramal Healthcare Ltd.

    Plot No. 67-70, Sector – 2, Pithampur, 454775,

    Dist. Dhar, Madhya Pradesh, INDIA

    Distributed by:

    Valeant Pharmaceuticals North America

    One Enterprise

    Aliso Viejo, CA 92656 U.S.A.

    Part No. EM 10142/b

    Rev. 07/10

    MEDICATION GUIDE

    Mysoline ( My-so- lean)

    (primidone)

    Tablets

    Read this Medication Guide before you start taking Mysoline and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

    What is the most important information I should know about Mysoline?

    Do not stop taking Mysoline without first talking to your healthcare provider.

    Stopping Mysoline suddenly can cause serious problems.

    Mysoline can cause serious side effects, including:

    Like other antiepileptic drugs, Mysoline may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

    Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

    • thoughts about suicide or dying
    • attempts to commit suicide
    • new or worse depression
    • new or worse anxiety
    • feeling agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
    • new or worse irritability
    • acting aggressive, being angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking (mania)
    • other unusual changes in behavior or mood

    How can I watch for early symptoms of suicidal thoughts and actions?

    • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled.

    Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

    Do not stop Mysoline without first talking to a healthcare provider.

    • Stopping Mysoline suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

    Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

    What is Mysoline?

    Mysoline is a prescription medicine used alone or with other medicines to treat people with:

    • generalized tonic-clonic (grand mal) seizures
    • complex partial (psychomotor) seizures
    • partial (focal) epileptic seizures.

    Who should not take Mysoline?

    Do not take Mysoline if you:

    • have a genetic disorder called porphyria
    • are allergic to phenobarbital

    What should I tell my healthcare provider before taking Mysoline?

    Before you take Mysoline, tell your healthcare provider if you:

    • have or have had depression, mood problems or suicidal thoughts or behavior
    • have any other medical conditions
    • are pregnant or planning to become pregnant. Mysoline may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Mysoline. You and your healthcare provider will decide if you should take Mysoline while you are pregnant.
      • If you become pregnant while taking Mysoline, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
    • are breastfeeding or plan to breastfeed. Mysoline can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Mysoline.

    Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Mysoline with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

    Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

    How should I take Mysoline?

    Take Mysoline exactly as prescribed. Your healthcare provider will tell you how much Mysoline to take and when to take it.

    • Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
    • Do not stop taking Mysoline without first talking to your healthcare provider. Stopping Mysoline suddenly can cause serious problems.
    • If you take too much Mysoline, call your healthcare provider or local Poison Control Center right away.

    What should I avoid while taking Mysoline?

    • Mysoline can make you sleepy or dizzy. Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking Mysoline without first discussing this with your healthcare provider. Taking Mysoline with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Mysoline affects you. Mysoline can slow your thinking and motor skills.

    What are the possible side effects of Mysoline?

    See “What is the most important information I should know about Mysoline?”.

    Mysoline may cause other serious side effects including:

    • Sleepiness that can be severe, especially when you first start taking Mysoline.
    • Mysoline may rarely cause blood problems. Symptoms may include:
      • fever, swollen glands, or sore throat that come and go or do not go away
      • Frequent infections or an infection that does not go away
      • tiredness
      • shortness of breath
    • Mysoline may rarely cause allergic reactions. Symptoms may include:
      • skin rash
      • hives
      • sores in your mouth
      • blistering or peeling skin

    The most common side effects of Mysoline include:

    • problems with walking and moving
    • feelings of dizziness, spinning, or swaying (vertigo)

    These are not all the possible side effects of Mysoline. For more information, ask your healthcare provider or pharmacist.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store Mysoline?

    Store Mysoline at room temperature between 68ºF to 77ºF (20ºC to 25ºC) in a tight, light-resistant container

    Keep Mysoline and all medicines out of the reach of children.

    General Information about Mysoline

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mysoline for a condition for which it was not prescribed. Do not give Mysoline to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about Mysoline. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Mysoline that is written for health professionals.

    For more information, go to www.VALEANT.com or call 1-877-361-2719

    What are the ingredients in Mysoline?

    Active Ingredient: primidone

    Inactive ingredients: microcrystalline cellulose, lactose monohydrate, methylcellulose, sodium starch glycolate, sodium lauryl sulfate, magnesium stearate, talc, purified water and ferric oxide yellow (250 mg tablet only)

    VALEANT®

    Pharmaceuticals North America

    Aliso Viejo, CA 92656

    Issued July 2010

    This Medication Guide has been approved by the U.S. Food and Drug Administration

    Part No. EM 10142/b

    Rev. 07/10

    PRINCIPAL DISPLAY PANEL – 250 mg Tablet Bottle Label

    NDC 66490-691-10

    Rx Only

    Mysoline®

    (primidone, USP)

    ORIGINAL

    TABLET

    DESIGN &

    FORMULATION

    250 mg

    SEALED FOR

    YOUR PROTECTION

    100 Tablets

    VALEANT®

    PRINCIPAL DISPLAY PANEL – 50 mg Tablet Bottle Label

    NDC 66490-690-10

    Rx Only

    Mysoline®

    (primidone, USP)

    50 mg

    SEALED FOR

    YOUR PROTECTION

    100 Tablets

    VALEANT®

    Mysoline 

    primidone tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66490-690
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Primidone (Primidone) Primidone 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    cellulose, microcrystalline  
    lactose Monohydrate  
    Methylcellulose (15 CPS)  
    sodium starch glycolate type a potato  
    talc  
    sodium lauryl sulfate  
    Magnesium stearate  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape SQUARE Size 6mm
    Flavor Imprint Code Mysoline;50;M
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:66490-690-10 100 TABLET (TABLET) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA009170 06/24/2009
    Mysoline 

    primidone tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66490-691
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Primidone (Primidone) Primidone 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    cellulose, microcrystalline  
    lactose Monohydrate  
    Methylcellulose (15 CPS)  
    sodium starch glycolate type a potato  
    talc  
    sodium lauryl sulfate  
    Magnesium stearate  
    ferric oxide yellow  
    Product Characteristics
    Color YELLOW Score 2 pieces
    Shape SQUARE (square-shaped) Size 10mm
    Flavor Imprint Code Mysoline;250;M
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:66490-691-10 100 TABLET (TABLET) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA009170 06/24/2009
    Labeler - Valeant Pharmaceuticals North America (831922468)
    Establishment
    Name Address ID/FEI Operations
    Piramal Healthcare Limited 862202793 MANUFACTURE

    Revised: 08/2010   Valeant Pharmaceuticals North America

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    Mysoline

    Mysoline

    Generic Name: primidone (PRIM-i-done)

    Brand Name: Mysoline

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Mysoline is used for:

    Treating and preventing seizures. It may be taken alone or with other medicines. It may also be used for other conditions as determined by your doctor.

    Mysoline is an anticonvulsant. It works by decreasing nerve impulses in the nervous system, which helps to reduce seizures.

    Do NOT use Mysoline if:

    • you are allergic to any ingredient in Mysoline or to phenobarbital
    • you have the blood disease porphyria
    • you are taking sodium oxybate (GHB)

    Contact your doctor or health care provider right away if any of these apply to you.

    Before using Mysoline:

    Some medical conditions may interact with Mysoline. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have a history of drug abuse or dependence, mental or mood problems (eg, depression), or suicidal thoughts or behaviors
    • if you have liver problems, lung problems, or breathing problems
    • if you will be receiving anesthesia (eg, methoxyflurane)

    Some MEDICINES MAY INTERACT with Mysoline. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Sodium oxybate (GHB), stiripentol, or valproic acid because the risk of severe side effects such as severe drowsiness and incoordination may be increased
    • Anticoagulants (eg, warfarin), aromatase inhibitors (eg, exemestane), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, prednisone), doxycycline, epothilones (eg, ixabepilone), estrogen, griseofulvin, HIV protease inhibitors (eg, darunavir, lopinavir), hydantoins (eg, phenytoin), mammalian target of rapamycin (MTOR) inhibitors (eg, everolimus), maraviroc, metronidazole, nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, etravirine), oral contraceptives (eg, birth control pills), quinidine, tacrolimus, teniposide, theophylline, tolvaptan, or tyrosine kinase inhibitors (eg, lapatinib) because their effectiveness may be decreased by Mysoline

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Mysoline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Mysoline:

    Use Mysoline as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Take Mysoline by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
    • Take Mysoline on a regular schedule to get the most benefit from it.
    • Taking Mysoline at the same time each day will help you remember to take it.
    • Do not suddenly stop taking Mysoline. You may have an increased risk of side effects (eg, seizures). If you need to stop Mysoline or add a new medicine, your doctor will gradually lower your dose.
    • Continue to take Mysoline even if you feel well. Do not miss any doses.
    • If you miss a dose of Mysoline, take it as soon as possible. If it is within 1 hour of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

    Ask your health care provider any questions you may have about how to use Mysoline.

    Important safety information:

    • Mysoline may cause drowsiness, dizziness, lightheadedness, and vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Mysoline with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Mysoline may contain tartrazine dye (FD & C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
    • It may take several weeks for Mysoline to work well. Do not stop taking Mysoline without talking with your doctor.
    • Patients who take Mysoline may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Mysoline closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
    • Hormonal birth control (eg, birth control pills) may not work as well while you are using Mysoline. To prevent pregnancy, use an extra form of birth control (eg, condoms).
    • Tell your doctor or dentist that you take Mysoline before you receive any medical or dental care, emergency care, or surgery.
    • Lab tests, including complete blood cell counts, may be performed while you use Mysoline. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
    • PREGNANCY and BREAST-FEEDING: Mysoline may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mysoline while you are pregnant. Mysoline is found in breast milk. Do not breast-feed while taking Mysoline.

    If you suddenly stop taking Mysoline, you may experience WITHDRAWAL symptoms, including anxiety, dizziness, hallucinations, lightheadedness, muscle twitching, nausea, seizures, sleeplessness, trembling hands and fingers, vomiting, or weakness.

    Possible side effects of Mysoline:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Dizziness; drowsiness; lightheadedness; loss of appetite; loss of coordination; nausea; vomiting.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sexual ability; double vision or unusual eye movements; fever; measles-like rash; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes, suicidal thoughts or attempts); new or worsening seizures; unusual tiredness or weakness.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; trouble breathing; uncontrolled eye movement.

    Proper storage of Mysoline: Store Mysoline at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, light, and moisture. Keep Mysoline out of the reach of children and away from pets.

    General information:

    • If you have any questions about Mysoline, please talk with your doctor, pharmacist, or other health care provider.
    • Mysoline is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Mysoline or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Mysoline. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Mysoline. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Mysoline.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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