What you need to know about drugs

Lomotil

Lomotil(diphenoxylate hcl, atropine sulfate) – Pfizer

THERAPEUTIC CLASS

Opioid/anticholinergic

INDICATIONS

Adjunctive therapy for management of diarrhea.

ADULT DOSAGE

Adults: Initial: 2 tabs or 10mL qid. Titrate: Reduce dose after symptoms are controlled. Maint: 2 tabs or 10mL qd. Max: 20mg/day diphenoxylate. D/C if symptoms not controlled after 10 days at max dose of 20mg/day (diphenoxylate).

PEDIATRIC DOSAGE

Pediatrics: 2-12 yrs: Initial: 0.3-0.4mg/kg/day of solution in four divided doses. Titrate: Reduce dose after symptoms are controlled. Maint: May be as low as 25% of initial dose. D/C if no improvement within 48 hrs.

HOW SUPPLIED

(Diphenoxylate-Atropine) Sol: 2.5mg-0.025mg/5mL [60mL]; Tab: 2.5mg-0.025mg

CONTRAINDICATIONS

Obstructive jaundice, diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria.

WARNINGS/PRECAUTIONS

Avoid in children <2 yrs. Overdosage may result in severe respiratory depression and coma, leading to brain damage or death. Avoid use with severe dehydration or electrolyte imbalance until corrective therapy is initiated. May induce toxic megacolon with acute ulcerative colitis; d/c if abdominal distention occurs or untoward symptoms develop. May cause intestinal fluid retention. Avoid with diarrhea associated with organisms that penetrate the intestinal mucosa, and with pseudomembranous enterocolitis. Extreme caution with advanced hepatorenal disease and liver dysfunction. Caution in pediatrics, especially with Down's syndrome.

ADVERSE REACTIONS

Numbness of extremities, dizziness, anaphylaxis, drowsiness, toxic megacolon, N/V, urticaria, pruritus, anorexia, pancreatitis, paralytic ileus, euphoria, malaise/lethargy.

DRUG INTERACTIONS

MAOIs may precipitate hypertensive crisis. (Diphenoxylate) May potentiate barbiturates, tranquilizers, and alcohol. Potential to prolong T1/2 of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.

PREGNANCY

Category C, caution in nursing.

MECHANISM OF ACTION

Diphenoxylate: Antidiarrheal. Atropine: Anticholinergic.

PHARMACOKINETICS

Absorption: (4 tabs): Cmax=163ng/mL; Tmax=2 hrs. Metabolism: Rapid and extensive metabolism through ester hydrolysis to diphenoxylic acid (major metabolite). Elimination: Urine (14%), feces (49%). T1/2=12-14 hrs (diphenoxylic acid).

ASSESSMENT

Assess for hypersensitivity, obstructive jaundice, diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria, severe dehydration, electrolyte imbalance, hepatic dysfunction, hepatorenal disease, ulcerative colitis, Down's syndrome, diarrhea (caused by Escherichia coli, Salmonella, Shigella), pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for severe dehydration, electrolyte imbalance, renal function, toxic megacolon in ulcerative colitis, abdominal distention, signs of atropinism, and other adverse reactions.

PATIENT COUNSELING

Instruct to take as directed and not to exceed the recommended dosage. Inform of consequences of overdosage, including severe respiratory depression and coma, possibly leading to permanent brain damage or death. Instruct to exercise caution while operating machinery/driving. Advise to avoid alcohol and other CNS depressants. Advise to keep medicines out of reach of children. Inform patient that drowsiness or dizziness may occur.

ADMINISTRATION/STORAGE

Administration: Oral route. Plastic dropper should be used when measuring liquid for administration to children. Storage: Dispense liquids in original container.


  • Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Lomotil

    Lomotil

    Pronunciation Generic Name: diphenoxylate and atropine (Oral route)

    dye-fen-OX-i-late hye-droe-KLOR-ide, AT-roe-peen SUL-fate

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • Lomocot
    • Lomotil
    • Lonox
    • Vi-Atro

    Available Dosage Forms:

    • Solution
    • Tablet

    Therapeutic Class: Antidiarrheal

    Pharmacologic Class: Atropine

    Chemical Class: Diphenoxylate

    Uses For Lomotil

    Diphenoxylate and atropine is a combination medicine used along with other measures to treat severe diarrhea in adults. Diphenoxylate helps stop diarrhea by slowing down the movements of the intestines.

    Since diphenoxylate is chemically related to some narcotics, it may be habit-forming if taken in doses that are larger than prescribed. To help prevent possible abuse, atropine (an anticholinergic) has been added. If higher than normal doses of the combination are taken, the atropine will cause unpleasant effects, making it unlikely that such doses will be taken again.

    Diphenoxylate and atropine combination medicine should not be used in children. Children with diarrhea should be given solutions of carbohydrates (sugars) and important salts (electrolytes) to replace the water, sugars, and important salts that are lost from the body during diarrhea. For more information on these solutions, see the Carbohydrates and Electrolytes (Systemic) monograph.

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

    Before Using Lomotil

    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

    This medicine should not be used in children. Children, especially very young children, are very sensitive to the effects of diphenoxylate and atropine. This may increase the chance of side effects during treatment. Also, the fluid loss caused by diarrhea may result in a severe condition. For this reason, it is very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

    Geriatric

    Shortness of breath or difficulty in breathing may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of diphenoxylate. Also, the fluid loss caused by diarrhea may result in a severe condition. For this reason, elderly persons should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Ambenonium
    • Potassium

    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.

    • Clorgyline
    • Digoxin
    • Furazolidone
    • Iproniazid
    • Isocarboxazid
    • Moclobemide
    • Nialamide
    • Pargyline
    • Phenelzine
    • Procarbazine
    • Rasagiline
    • Selegiline
    • Tapentadol
    • Toloxatone
    • Tranylcypromine

    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.

    • Arbutamine

    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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Alcohol abuse (or history of) or
    • Drug abuse (history of)—There is a greater chance that this medicine will become habit-forming
    • Colitis (severe)—A more serious problem of the colon may develop if you use this medicine
    • Down’s syndrome—Side effects may be more likely and severe in these patients
    • Dysentery—This condition may get worse; a different kind of treatment may be needed
    • Emphysema, asthma, bronchitis, or other chronic lung disease—There is a greater chance that this medicine may cause serious breathing problems in patients who have any of these conditions
    • Enlarged prostate or
    • Urinary tract blockage or difficult urination—Severe problems with urination may develop with the use of this medicine
    • Gallbladder disease or gallstones—Use of this medicine may cause spasms of the biliary tract and make the condition worse
    • Glaucoma—Severe pain in the eye may occur with the use of this medicine; however, the chance of this happening is small
    • Heart disease—This medicine may have some effects on the heart, which may make the condition worse
    • Hiatal hernia—The atropine in this medicine may make this condition worse; however, the chance of this happening is small
    • High blood pressure (hypertension)—The atropine in this medicine may cause an increase in blood pressure; however, the chance of this happening is small
    • Intestinal blockage—This medicine may make the condition worse
    • Kidney disease—The atropine in this medicine may build up in the body and cause side effects
    • Liver disease—The chance of central nervous system (CNS) side effects, including coma, may be greater in patients who have this condition
    • Myasthenia gravis—This medicine may make the condition worse
    • Overactive or underactive thyroid—Unwanted effects on breathing and heart rate may occur
    • Overflow incontinence—This medicine may make the condition worse

    Proper Use of diphenoxylate and atropine

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

    If this medicine upsets your stomach, your doctor may want you to take it with food.

    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. If too much is taken, it may become habit-forming.

    For patients taking the liquid form of this medicine:

    • This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount to be taken is to be measured with the specially marked dropper.

    Importance of diet and fluids while treating diarrhea :

    • In addition to using medicine for diarrhea, it is very important that you replace the fluid lost by the body and follow a proper diet. For the first 24 hours you should eat gelatin and drink plenty of caffeine-free clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, and broth. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, caffeine, and alcoholic beverages may make the condition worse.
    • If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs or symptoms of too much fluid loss occur:
      • Decreased urination
      • Dizziness and light-headedness
      • Dryness of mouth
      • Increased thirst
      • Wrinkled skin

    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 severe diarrhea:
      • For oral dosage form (oral solution):
        • Adults and teenagers—At first, the dose is 5 milligrams (mg) (2 teaspoonfuls) three or four times a day. Then, the dose is usually 5 mg (2 teaspoonfuls) once a day, as needed.
        • Children up to 12 years of age—Use is not recommended.
      • For oral dosage form (tablets):
        • Adults and teenagers—At first, the dose is 5 mg (2 tablets) three or four times a day. Then, the dose is usually 5 mg (2 tablets) once a day, as needed.
        • Children up to 12 years of age—Use is not recommended.

    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.

    Precautions While Using Lomotil

    Your doctor should check your progress at regular visits if you will be taking this medicine regularly for a long time.

    Check with your doctor if your diarrhea does not stop after two days or if you develop a fever.

    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; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

    If you think you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine may lead to unconsciousness and possibly death. Signs or symptoms of overdose include severe drowsiness; shortness of breath or troubled breathing; fast heartbeat; and unusual warmth, dryness, and flushing of the skin.

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

    This medicine may cause some people to become dizzy, 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.

    Lomotil 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:

    • Bloating
    • constipation
    • loss of appetite
    • stomach pain (severe) with nausea and vomiting

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

    • Blurred vision (continuing) or changes in near vision
    • drowsiness (severe)
    • dryness of mouth, nose, and throat (severe)
    • fast heartbeat
    • shortness of breath or troubled breathing (severe)
    • unusual excitement, nervousness, restlessness, or irritability
    • unusual warmth, dryness, and flushing of the skin

    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:

    Less common or rare

    • Blurred vision
    • confusion
    • difficult urination
    • dizziness or light-headedness
    • drowsiness
    • dryness of skin and mouth
    • fever
    • headache
    • increased body temperature
    • mental depression
    • numbness of hands or feet
    • skin rash or itching
    • swelling of the gums

    After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

    Rare

    • Increased sweating
    • muscle cramps
    • nausea or vomiting
    • shivering or trembling
    • stomach cramps

    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: Lomotil side effects (in more detail)

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Lomotil

    Lomotil

    Pronunciation Generic Name: atropine and diphenoxylate (A troe peen and DYE fen OX i late)

    Brand Name: Lomotil, Lonox, Vi-Atro

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    What is Lomotil (atropine and diphenoxylate)?

    Atropine affects the body in many different ways, such as reducing spasms in the bladder, stomach, and intestines.

    Diphenoxylate is an antidiarrheal medication.

    The combination of atropine and diphenoxylate is used to treat diarrhea.

    Atropine and diphenoxylate may also be used for other purposes not listed in this medication guide.

    What is the most important information I should know about Lomotil (atropine and diphenoxylate)?

    If you are giving this medication to a child, pay close attention to the dose. An atropine and diphenoxylate overdose is more likely to occur in a child, and can cause breathing problems or result in death or permanent brain damage.

    Use only the liquid form of this medicine in a child younger than 13 years old. Do not give atropine and diphenoxylate tablets to a child under 13.

    Drink extra water while you are taking this medication to keep from getting dehydrated.

    It may take up to 48 hours of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 10 days of treatment.

    What should I discuss with my healthcare provider before taking Lomotil (atropine and diphenoxylate)?

    Do not use this medication if you are allergic to atropine or diphenoxylate, or if you have:

    • jaundice (yellowing of your skin or eyes caused by a liver disorder);

    • diarrhea that is caused by bacteria; or
    • diarrhea caused by taking an antibiotic.

    Before taking atropine and diphenoxylate, tell your doctor if you are allergic to any drugs, or if you have:

    • blocked intestines;

    • an intestinal disorder such as ulcerative colitis or Crohn’s disease;
    • liver disease;
    • kidney disease;
    • heart disease, heart rhythm problems, or high blood pressure;
    • glaucoma;
    • Down’s syndrome;
    • a thyroid disorder;
    • problems with urination;
    • an enlarged prostate;
    • asthma or other lung problems; or
    • if you are dehydrated;

    If you have any of these conditions, you may need a dose adjustment or special tests to safely take atropine and diphenoxylate.

    FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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

    Do not give this medication to a child younger than 2 years old.

    How should I take Lomotil (atropine and diphenoxylate)?

    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.

    If you are giving this medication to a child, pay close attention to the dose. An atropine and diphenoxylate overdose is more likely to occur in a child, and can cause breathing problems or result in death or permanent brain damage.

    Use only the liquid form of this medicine in a child younger than 13 years old. Do not give atropine and diphenoxylate tablets to a child under 13.

    Take the medicine with a full glass of water. Drink extra water while you are taking atropine and diphenoxylate to keep from getting dehydrated.

    It may take up to 48 hours of using the medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 10 days of treatment.

    Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

    Store atropine and diphenoxylate at room temperature away from moisture and heat.

    Keep the medication where a child cannot reach it. An overdose of atropine and diphenoxylate can be fatal to a child.

    See also: Lomotil 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, or if a child has accidentally swallowed it. An overdose of atropine and diphenoxylate can cause breathing problems and may result in death or permanent brain damage.

    Early overdose symptoms may include dry skin, dry mouth or nose, blurred vision, restless feeling, feeling too warm or cold, tingly feeling, and a fast heart rate.

    Progressing symptoms of an atropine and diphenoxylate overdose include weakness, pinpoint pupils in the eyes, weak or shallow breathing, fainting, or coma. Report any early overdose symptoms to your doctor as soon as possible.

    What should I avoid while taking Lomotil (atropine and diphenoxylate)?

    This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

    Avoid drinking alcohol while you are taking this medication. Alcohol can increase some of the side effects of atropine and diphenoxylate.

    Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by atropine and diphenoxylate. Tell your doctor if you regularly use any of these other medicines.

    Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor’s instructions about the type and amount of liquids you should drink.

    Lomotil (atropine and diphenoxylate) 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.

    Stop using this medication and call your doctor at once if you have any of these serious side effects:

    • stomach pain or bloating;

    • ongoing or worsening diarrhea;
    • diarrhea that is watery or bloody;
    • numbness in your hands or feet;
    • depressed mood;
    • confusion, unusual thoughts or behavior;
    • fast heart rate; or
    • urinating less than usual or not at all.

    Less serious side effects may include:

    • drowsiness, dizziness, headache;

    • tired or restless feeling;
    • nausea, vomiting, upset stomach, loss of appetite; or
    • skin rash, or itching.

    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: Lomotil side effects (in more detail)

    What other drugs will affect Lomotil (atropine and diphenoxylate)?

    Before taking atropine and diphenoxylate, tell your doctor if you are using any of the following drugs:

    • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

    • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

    This list is not complete and there may be other drugs that can interact with atropine and diphenoxylate. 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 Lomotil resources

    • Side Effects
    • Recommended Dosage
    • Pregnancy Warnings
    • Drug Images
    • Drug Interactions
    • Support Group
    • 18 Reviews - Add your own review/rating
    • Generic Availability
    • Lomotil MedFacts Consumer Leaflet (Wolters Kluwer)
    • Lomotil Advanced Consumer (Micromedex) – Includes Dosage Information
    • Lomotil Prescribing Information (FDA)

    Compare Lomotil with other medications

    • Diarrhea

    Where can I get more information?

    • Your pharmacist can provide more information about atropine and diphenoxylate.

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Lomotil

    Lomotil

    Pronunciation Generic Name: diphenoxylate hydrochloride and atropine sulfate

    Dosage Form: Tablets and Liquid

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Lomotil® Cv

    (diphenoxylate hydrochloride

    and atropine sulfate tablets, USP)

    Tablets

    (diphenoxylate hydrochloride

    and atropine sulfate oral solution, USP)

    Liquid

    Lomotil Description

    Each Lomotil tablet and each 5 ml of Lomotil liquid for oral use contains:

    diphenoxylate hydrochloride   2.5 mg

    atropine sulfate …………….. 0.025 mg

    Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula:

    Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula:

    A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.

    Inactive ingredients of Lomotil tablets include acacia, corn starch, magnesium stearate, sorbitol, sucrose, and talc. Inactive ingredients of Lomotil liquid include cherry flavor, citric acid, ethyl alcohol 15%, FD&C Yellow No. 6, glycerin, sodium phosphate, sorbitol, and water.

    Lomotil – Clinical Pharmacology

    Diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. After a 5-mg oral dose of carbon-14 labeled diphenoxylate hydrochloride in ethanolic solution was given to three healthy volunteers, an average of 14% of the drug plus its metabolites was excreted in the urine and 49% in the feces over a four-day period. Urinary excretion of the unmetabolized drug constituted less than 1% of the dose, and diphenoxylic acid plus its glucuronide conjugate constituted about 6% of the dose. In a 16-subject crossover bioavailability study, a linear relationship in the dose range of 2.5 to 10 mg was found between the dose of diphenoxylate hydrochloride (given as Lomotil liquid) and the peak plasma concentration, the area under the plasma concentration-time curve, and the amount of diphenoxylic acid excreted in the urine. In the same study the bioavailability of the tablet compared with an equal dose of the liquid was approximately 90%. The average peak plasma concentration of diphenoxylic acid following ingestion of four 2.5-mg tablets was 163 ng/ml at about 2 hours, and the elimination half-life of diphenoxylic acid was approximately 12 to 14 hours.

    In dogs, diphenoxylate hydrochloride has a direct effect on circular smooth muscle of the bowel that conceivably results in segmentation and prolongation of gastrointestinal transit time. The clinical antidiarrheal action of diphenoxylate hydrochloride may thus be a consequence of enhanced segmentation that allows increased contact of the intraluminal contents with the intestinal mucosa.

    Indications and Usage for Lomotil

    Lomotil is effective as adjunctive therapy in the management of diarrhea.

    Contraindications

    Lomotil is contraindicated in patients with

    1. Known hypersensitivity to diphenoxylate or atropine.
    2. Obstructive jaundice.
    3. Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria.

    Warnings

    Lomotil IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO, ESPECIALLY IN CHILDREN. Lomotil IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE OVERDOSAGE). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.

    THE USE OF Lomotil SHOULD BE ACCOMPANIED BY APPROPRIATE FLUID AND ELECTROLYTE THERAPY, WHEN INDICATED. IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS PRESENT, Lomotil SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED. DRUG-INDUCED INHIBITION OF PERISTALSIS MAY RESULT IN FLUID RETENTION IN THE INTESTINE, WHICH MAY FURTHER AGGRAVATE DEHYDRATION AND ELECTROLYTE IMBALANCE.

    Lomotil SHOULD BE USED WITH SPECIAL CAUTION IN YOUNG CHILDREN BECAUSE THIS AGE GROUP MAY BE PREDISPOSED TO DELAYED DIPHENOXYLATE TOXICITY AND BECAUSE OF THE GREATER VARIABILITY OF RESPONSE IN THIS AGE GROUP.

    Antiperistaltic agents may prolong and/or worsen diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella, Shigella), and pseudomembranous enterocolitis associated with broad-spectrum antibiotics. Antiperistaltic agents should not be used in these conditions.

    In some patients with acute ulcerative colitis, agents that inhibit intestinal motility or prolong intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and Lomotil therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop.

    Since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of Lomotil with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis.

    Lomotil should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function since hepatic coma may be precipitated.

    Diphenoxylate hydrochloride may potentiate the action of barbiturates, tranquilizers, and alcohol. Therefore, the patient should be closely observed when any of these are used concomitantly.

    Precautions

    General

    Since a subtherapeutic dose of atropine has been added to the diphenoxylate hydrochloride, consideration should be given to the precautions relating to the use of atropine. In children, Lomotil should be used with caution since signs of atropinism may occur even with recommended doses, particularly in patients with Down’s syndrome.

    Information For Patients

    INFORM THE PATIENT (PARENT OR GUARDIAN) NOT TO EXCEED THE RECOMMENDED DOSAGE AND TO KEEP Lomotil OUT OF THE REACH OF CHILDREN AND IN A CHILD-RESISTANT CONTAINER. INFORM THE PATIENT OF THE CONSEQUENCES OF OVERDOSAGE, INCLUDING SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH. Lomotil may produce drowsiness or dizziness. The patient should be cautioned regarding activities requiring mental alertness, such as driving or operating dangerous machinery. Potentiation of the action of alcohol, barbiturates, and tranquilizers with concomitant use of Lomotil should be explained to the patient. The physician should also provide the patient with other information in this labeling, as appropriate.

    Drug Interactions

    Known drug interactions include barbiturates, tranquilizers, and alcohol. Lomotil may interact with MAO inhibitors (see Warnings).

    In studies with male rats, diphenoxylate hydrochloride was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day. Therefore, diphenoxylate has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.

    Carcinogenesis, Mutagenesis, Impairment Of Fertility

    No long-term study in animals has been performed to evaluate carcinogenic potential. Diphenoxylate hydrochloride was administered to male and female rats in their diets to provide dose levels of 4 and 20 mg/kg/day throughout a three-litter reproduction study. At 50 times the human dose (20 mg/kg/day), female weight gain was reduced and there was a marked effect on fertility as only 4 of 27 females became pregnant in three test breedings. The relevance of this finding to usage of Lomotil in humans is unknown.

    Pregnancy

    Pregnancy Category C. Diphenoxylate hydrochloride has been shown to have an effect on fertility in rats when given in doses 50 times the human dose (see above discussion). Other findings in this study include a decrease in maternal weight gain of 30% at 20 mg/kg/day and of 10% at 4 mg/kg/day. At 10 times the human dose (4 mg/kg/day), average litter size was slightly reduced.

    Teratology studies were conducted in rats, rabbits, and mice with diphenoxylate hydrochloride at oral doses of 0.4 to 20 mg/kg/day. Due to experimental design and small numbers of litters, embryotoxic, fetotoxic, or teratogenic effects cannot be adequately assessed. However, examination of the available fetuses did not reveal any indication of teratogenicity.

    There are no adequate and well-controlled studies in pregnant women. Lomotil should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus.

    Nursing Mothers

    Caution should be exercised when Lomotil is administered to a nursing woman, since the physicochemical characteristics of the major metabolite, diphenoxylic acid, are such that it may be excreted in breast milk and since it is known that atropine is excreted in breast milk.

    Pediatric Use

    Lomotil may be used as an adjunct to the treatment of diarrhea but should be accompanied by appropriate fluid and electrolyte therapy, if needed. Lomotil IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. Lomotil should be used with special caution in young children because of the greater variability of response in this age group. SeeWarnings and Dosage and Administration. In case of accidental ingestion by children, see Overdosage for recommended treatment.

    Adverse Reactions

    At therapeutic doses, the following have been reported; they are listed in decreasing order of severity, but not of frequency:

    Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache.

    Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus.

    Gastrointestinal system: toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort.

    The following atropine sulfate effects are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes. These effects may occur, especially in children.

    THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH.

    Drug Abuse and Dependence

    Controlled Substance

    Lomotil is classified as a Schedule V controlled substance by federal regulation. Diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine.

    Drug abuse and dependence

    In doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction.

    Diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. At high doses it exhibits codeine-like subjective effects. The dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. The insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. A dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. Since addiction to diphenoxylate hydrochloride is possible at high doses, the recommended dosage should not be exceeded.

    Overdosage

    RECOMMENDED DOSAGE SCHEDULES SHOULD BE STRICTLY FOLLOWED. THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN, SINCE AN OVERDOSAGE MAY RESULT IN SEVERE, EVEN FATAL, RESPIRATORY DEPRESSION.

    Diagnosis: Initial signs of overdosage may include dryness of the skin and mucous membranes, mydriasis, restlessness, flushing, hyperthermia, and tachycardia followed by lethargy or coma, hypotonic reflexes, nystagmus, pinpoint pupils, and respiratory depression. Respiratory depression may be evidenced as late as 30 hours after ingestion and may recur despite an initial response to narcotic antagonists. TREAT ALL POSSIBLE Lomotil OVERDOSAGES AS SERIOUS AND MAINTAIN MEDICAL OBSERVATION FOR AT LEAST 48 HOURS, PREFERABLY UNDER CONTINUOUS HOSPITAL CARE.

    Treatment: In the event of overdose, induction of vomiting, gastric lavage, establishment of a patent airway, and possibly mechanically assisted respiration are advised. In vitro and animal studies indicate that activated charcoal may significantly decrease the bioavailability of diphenoxylate. In noncomatose patients, a slurry of 100 g of activated charcoal can be administered immediately after the induction of vomiting or gastric lavage.

    A pure narcotic antagonist (eg, naloxone) should be used in the treatment of respiratory depression caused by Lomotil. When a narcotic antagonist is administered intravenously, the onset of action is generally apparent within two minutes. It may also be administered subcutaneously or intramuscularly, providing a slightly less rapid onset of action but a more prolonged effect.

    To counteract respiratory depression caused by Lomotil overdosage, the following dosage schedule for the narcotic antagonist naloxone hydrochloride should be followed:

    Adult dosage: An initial dose of 0.4 mg to 2 mg of naloxone hydrochloride may be administered intravenously. If the desired degree of counteraction and improvement in respiratory functions is not obtained, it may be repeated at 2- to 3-minute intervals. If no response is observed after 10 mg of naloxone hydrochloride has been administered, the diagnosis of narcotic-induced or partial narcotic-induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.

    Children: The usual initial dose in children is 0.01 mg/kg body weight given I.V. If this dose does not result in the desired degree of clinical improvement, a subsequent dose of 0.1 mg/kg body weight may be administered. If an I.V. route of administration is not available, naloxone hydrochloride may be administered I.M. or S.C. in divided doses. If necessary, naloxone hydrochloride can be diluted with sterile water for injection.

    Following initial improvement of respiratory function, repeated doses of naloxone hydrochloride may be required to counteract recurrent respiratory depression. Supplemental intramuscular doses of naloxone hydrochloride may be utilized to produce a longer-lasting effect.

    Since the duration of action of diphenoxylate hydrochloride is longer than that of naloxone hydrochloride, improvement of respiration following administration may be followed by recurrent respiratory depression. Consequently, continuous observation is necessary until the effect of diphenoxylate hydrochloride on respiration has passed. This effect may persist for many hours. The period of observation should extend over at least 48 hours, preferably under continuous hospital care. Although signs of overdosage and respiratory depression may not be evident soon after ingestion of diphenoxylate hydrochloride, respiratory depression may occur from 12 to 30 hours later.

    Lomotil Dosage and Administration

    DO NOT EXCEED RECOMMENDED DOSAGE.

    Adults: The recommended initial dosage is two Lomotil tablets four times daily or 10 ml (two regular teaspoonfuls) of Lomotil liquid four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets or 10 ml of liquid) daily.

    Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.

    Children: Lomotil is not recommended in children under 2 years of age and should be used with special caution in young children (see Warnings and Precautions). The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use Lomotil liquid. Do not use Lomotil tablets for this age group.

    Only the plastic dropper should be used when measuring Lomotil liquid for administration to children.

    Dosage schedule for children: The recommended initial total daily dosage of Lomotil liquid for children is 0.3 to 0.4 mg/kg, administered in four divided doses. The following table provides an approximate initial daily dosage recommendation for children.

    Age

    (years)

    Approximate weight Dosage in ml

    (four times daily)

    (kg) (lb)
    2 11–14 24–31 1.5–3.0
    3 12–16 26–35 2.0–3.0
    4 14–20 31–44 2.0–4.0
    5 16–23 35–51 2.5–4.5
    6–8 17–32 38–71 2.5–5.0
    9–12 23–55 51–121 3.5–5.0

    These pediatric schedules are the best approximation of an average dose recommendation which may be adjusted downward according to the overall nutritional status and degree of dehydration encountered in the sick child. Reduction of dosage may be made as soon as initial control of symptoms has been achieved. Maintenance dosage may be as low as one-fourth of the initial daily dosage. If no response occurs within 48 hours, Lomotil is unlikely to be effective.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    How is Lomotil Supplied

    Tablets—round, white, with SEARLE debossed on one side and 61 on the other side and containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate, supplied as:

    NDC Number        Size

    0025-0061-31        bottle of 100

    0025-0061-51        bottle of 500

    0025-0061-52        bottle of 1,000

    0025-0061-55        bottle of 2,500

    0025-0061-34        carton of 100 unit dose

    Liquid—containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate per 5 ml; bottles of 2 fl oz (NDC Number 0025-0066-02). Dispense only in original container.

    A plastic dropper calibrated in increments of 1/2 ml (1/4 mg) with a capacity of 2 ml (1 mg) accompanies each 2-oz bottle of Lomotil liquid. Only this plastic dropper should be used when measuring Lomotil liquid for administration to children.

    Rx only

    LAB-0065-2.0

    LOMOTIL 

    diphenoxylate hydrochloride and atropine sulfate tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0025-0061
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    diphenoxylate hydrochloride (diphenoxylate) diphenoxylate 2.5 mg
    atropine sulfate (atropine) atropine 0.025 mg
    Inactive Ingredients
    Ingredient Name Strength
    acacia  
    corn starch  
    magnesium stearate  
    sorbitol  
    sucrose  
    talc  
    Product Characteristics
    Color WHITE (white) Score no score
    Shape ROUND (round) Size 6mm
    Flavor Imprint Code SEARLE;61
    Contains         
    Coating false Symbol false
    Packaging
    # Item Code Package Description
    1 NDC:0025-0061-31 100 TABLET (100 TABLET) in 1 BOTTLE
    2 NDC:0025-0061-51 500 TABLET (500 TABLET) in 1 BOTTLE
    3 NDC:0025-0061-52 1000 TABLET (1000 TABLET) in 1 BOTTLE
    4 NDC:0025-0061-55 2500 TABLET (2500 TABLET) in 1 BOTTLE
    5 NDC:0025-0061-34 100 TABLET (100 TABLET) in 1 CARTON
    LOMOTIL 

    diphenoxylate hydrochloride and atropine sulfate liquid

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0025-0066
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    diphenoxylate hydrochloride (diphenoxylate) diphenoxylate 2.5 mg  in 5 mL
    atropine sulfate (atropine) atropine 0.025 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    cherry flavor  
    citric acid  
    ethyl alcohol 15%  
    FD&C Yellow No. 6  
    glycerin  
    sodium phosphate  
    sorbitol  
    water  
    Packaging
    # Item Code Package Description
    1 NDC:0025-0066-02 60 mL (60 MILLILITER) in 1 BOTTLE
    Labeler - G.D. Searle LLC

    Revised: 04/2006   G.D. Searle LLC

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Lomotil

    Lomotil

    Pronunciation Generic Name: atropine/diphenoxylate (AT-row-peen/dye-fen-OX-i-late)

    Brand Name: Examples include Lomotil and Lonox

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    Lomotil is used for:

    Treating diarrhea. It may also be used for other conditions as determined by your doctor.

    Lomotil is an antidiarrheal and anticholinergic combination. It works by decreasing the motion of muscles in the intestines and prolonging the time it takes to move the contents through the body.

    Do NOT use Lomotil if:

    • you are allergic to any ingredient in Lomotil
    • you have diarrhea caused by certain conditions (eg, pseudomembranous colitis, enterotoxin-producing bacteria, food poisoning)
    • you have jaundice (yellowing of the eyes or skin)
    • you have a blockage of the stomach or bowel, angle-closure glaucoma, myasthenia gravis, urinary blockage, excess acid in the stomach or throat, esophagus problems (eg, difficulty swallowing, inflammation), bowel muscle weakness, or heart problems with severe bleeding
    • you are taking sodium oxybate (GHB)

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

    Before using Lomotil:

    Some medical conditions may interact with Lomotil. 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 jaundice (yellowing of the eyes or skin) or megacolon
    • if you have abnormal blood levels of electrolytes (eg, potassium, sodium), ulcerative colitis, liver or kidney problems, Down syndrome, numbness due to nerve damage, prostate problems (enlarged prostate), a blockage of the bladder, trouble urinating, heart problems (eg, congestive heart failure, irregular heartbeat), hiatal hernia, asthma, open-angle glaucoma, or risk factors for glaucoma
    • if you are dehydrated

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

    • Antihistamines (eg, diphenhydramine), medicine for Parkinson disease (eg, benztropine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Lomotil’s side effects
    • Barbiturates (eg, phenobarbital) or sodium oxybate (GHB) because the risk of their side effects may be increased by Lomotil
    • Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) because the risk of serious side effects, including severe high blood pressure, may be increased

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Lomotil 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 Lomotil:

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

    • Take Lomotil by mouth with or without food.
    • If you miss a dose of Lomotil and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

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

    Important safety information:

    • Lomotil may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lomotil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Lomotil; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
    • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. This could increase the risk of serious side effects.
    • If your symptoms do not get better within 10 days (2 days for children) or if they get worse, check with your doctor.
    • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
    • Report any symptoms of fluid or electrolyte loss to your doctor: dry mouth; thirst; weakness; lethargy; drowsiness; restlessness; muscle pain or cramps; muscle weakness; low blood pressure; infrequent urination; rapid heartbeat; stomach disorders such as nausea and vomiting.
    • Lomotil may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
    • Tell your doctor or dentist that you take Lomotil before you receive any medical or dental care, emergency care, or surgery.
    • Use Lomotil with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.
    • Lomotil should not be used in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.
    • Caution is advised when using Lomotil in CHILDREN 13 years of age and older; they may be more sensitive to its effects.
    • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lomotil while you are pregnant. Lomotil is found in breast milk. If you are or will be breast-feeding while you use Lomotil, check with your doctor. Discuss any possible risks to your baby.

    When used for longer than a few weeks or at high doses, some people develop a need to continue taking Lomotil. This is known as DEPENDENCE or addiction. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

    Possible side effects of Lomotil:

    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:

    Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth, nose, or skin; headache; loss of appetite; loss of taste; nausea; nervousness.

    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); abdominal bloating or swelling; agitation; changes in heartbeat; confusion; continued or severe diarrhea; delirium; difficulty focusing your eyes; difficulty urinating; exaggerated sense of well-being; excitement; fast/irregular heartbeat; fever; hallucinations; numbness of the hands or feet; severely enlarged pupils; severe or prolonged restlessness; speech disturbance; unusual weakness; vomiting.

    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 coma; difficulty breathing; dilated or constricted pupils; disorientation; fever; flushing; hallucinations; hyperactivity; muscle weakness; restlessness; seizures; severe dizziness; unusual eye movements; urinary retention; vomiting.

    Proper storage of Lomotil: Store Lomotil at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lomotil out of the reach of children and away from pets.

    General information:

    • If you have any questions about Lomotil, please talk with your doctor, pharmacist, or other health care provider.
    • Lomotil 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 Lomotil 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 Lomotil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Lomotil. 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 Lomotil.

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

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>