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Hydroxyzine Capsules

Hydroxyzine Capsules

Pronunciation Generic Name: hydroxyzine pamoate

Dosage Form: capsule

For ProfessionalsSide EffectsDosageInteractionsMore…

HydrOXYzine Pamoate Capsules USP

Rx only

Hydroxyzine Capsules Description

Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide.  It is chemically designated as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1’-methylene bis (2hydroxy-3-naphthalene carboxylic acid) and can be structurally represented as follows:

Molecular Weight: 763.29

Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to 25 mg or 50 mg of hydroxyzine hydrochloride.  In addition, each capsule contains the following inactive ingredients:  colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, gelatin, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. The imprinting ink on the capsules contains synthetic black iron oxide.

Hydroxyzine Capsules – Clinical Pharmacology

Hydroxyzine pamoate is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines.  Hydroxyzine pamoate is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine pamoate’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

INDICATIONS

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Contraindications

Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy.  Until such data are available, hydroxyzine is contraindicated in early pregnancy.

Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

Warnings

Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

Precautions

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. Since drowsiness may occur with use of the drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine pamoate.  Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

Geriatric Use

A determination has not been made whether controlled clinical studies of  hydroxyzine pamoate included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.  In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

The extent of renal excretion of  hydroxyzine pamoate has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.  Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine pamoate and observed closely.

Adverse Reactions

Side effects reported with the administration of  hydroxyzine pamoate are usually mild and transitory in nature.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

In post-marketing experience, the following additional undesirable effects have been reported: Body as a Whole: allergic reaction, Nervous System: headache, Psychiatric: hallucination, Skin and Appendages: pruritus, rash, urticaria.

Overdosage

The most common manifestation of overdosage of  hydroxyzine pamoate is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action.)  Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects.  There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine.  However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

DOSAGE

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 mg to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.

For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 mg to 100 mg in adults, and 0.6 mg/kg in children.  When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

How is Hydroxyzine Capsules Supplied

Hydroxyzine pamoate capsules USP (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) are supplied as follows:

25 mg capsules: Dark green opaque cap/light green opaque body filled with yellow powder. Imprinted in black ink WATSON over 800 on the cap and 25 mg on the body, in bottles of 100 and 500.

50 mg capsules: Dark green opaque cap/white opaque body filled with yellow powder. Imprinted in black ink WATSON over 801 on the cap and 50 mg on the body, in bottles of 100 and 500.

Store below 30°C (86°F) [See USP].

Dispense in a tight, light resistant container as defined in USP/NF.

BIBLIOGRAPHY

Available on request.

Manufactured by:

Patheon Pharmaceuticals Inc.

Cincinnati, OH 45237  USA

Manufactured for:

Watson Pharma, Inc.

Parsippany, NJ 07054  USA

Revised:  05/2012

70025267

PRINCIPAL DISPLAY PANEL

NDC 0591-0800-01

HydrOXYzine

Pamoate

Capsules USP

25 mg*

Tartrazine Dye-Free

Watson   100 Capsules   Rx only

*Each capsule contains:

HydrOXYzine Pamoate USP equivalent to 25 mg

Hydroxyzine Hydrochloride

Usual dosage: ADULTS: 25 mg tid to 100 mg qid.

CHILDREN: Under 6 years – 50 mg daily in divided doses.

Over 6 years – 50 mg to 100 mg daily in divided doses.

Dispense in a tight, light-resistant container as defined

in USP/NF.

Store below 30ºC (86ºF). [See USP.]

Keep out of reach of children.

Manufactured By:

Patheon Pharmaceuticals Inc.

Cincinnati, OH 45237 USA

DIstributed By:

Watson Pharma, Inc.

PRINCIPAL DISPLAY PANEL

NDC 0591-0801-01

HydrOXYzine

Pamoate

Capsules USP

50 mg*

Tartrazine Dye-Free

Watson   100 Capsules   Rx only

*Each capsule contains:

HydrOXYzine Pamoate USP equivalent to 50 mg

Hydroxyzine Hydrochloride

Usual dosage: ADULTS: 25 mg tid to 100 mg qid.

CHILDREN: Under 6 years – 50 mg daily in divided doses.

Over 6 years – 50 mg to 100 mg daily in divided doses.

Dispense in a tight, light-resistant container as defined

in USP/NF.

Store below 30ºC (86ºF). [See USP.]

Keep out of reach of children.

Manufactured By:

Patheon Pharmaceuticals Inc.

Cincinnati, OH 45237 USA

DIstributed By:  Watson Pharma, Inc.

HYDROXYZINE PAMOATE 

hydroxyzine pamoate capsule

Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0591-0800
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE PAMOATE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
GELATIN  
MAGNESIUM STEARATE  
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
FERROSOFERRIC OXIDE  
STARCH, CORN  
Product Characteristics
Color GREEN (dark green opaque/light green opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code WATSON;800;25;mg
Contains         
Packaging
# Item Code Package Description
1 NDC:0591-0800-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC
2 NDC:0591-0800-05 500 CAPSULE (500 CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040156 07/15/1996
HYDROXYZINE PAMOATE 

hydroxyzine pamoate capsule

Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0591-0801
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE PAMOATE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
GELATIN  
MAGNESIUM STEARATE  
STARCH, CORN  
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
FERROSOFERRIC OXIDE  
Product Characteristics
Color GREEN (opaque dark green) , WHITE (opaque white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code WATSON;801;50;mg
Contains         
Packaging
# Item Code Package Description
1 NDC:0591-0801-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC
2 NDC:0591-0801-05 500 CAPSULE (500 CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040156 06/15/1996
Labeler - Watson Laboratories, Inc. (106931488)
Establishment
Name Address ID/FEI Operations
Patheon Pharmaceuticals Inc. 005286822 ANALYSIS(0591-0800, 0591-0801), LABEL(0591-0800, 0591-0801), MANUFACTURE(0591-0800, 0591-0801), PACK(0591-0800, 0591-0801)

Revised: 10/2012   Watson Laboratories, Inc.

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Hydroxyzine capsules

Hydroxyzine capsules

Pronunciation Generic Name: hydroxyzine (hye-DROX-i-zeen)

Brand Name: Examples include Atarax and Vistaril

OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

Hydroxyzine capsules is used for:

Treating anxiety, for sedation before and after general anesthesia, and to treat itching due to certain allergic conditions, including hives and contact dermatitis (eg, poison ivy). It also may be used for other conditions as determined by your doctor.

Hydroxyzine capsules is an antihistamine. It works by affecting the brain to reduce anxiety. It also has other activities, including opening breathing tubes, relieving pain or allergy symptoms, and preventing or treating nausea and vomiting caused by motion sickness.

Do NOT use hydroxyzine capsules if:

  • you are allergic to any ingredient in hydroxyzine capsules
  • you are taking sodium oxybate (GHB)
  • you are in your first 3 months of pregnancy

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

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Before using hydroxyzine capsules:

Some medical conditions may interact with hydroxyzine capsules. 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 asthma, glaucoma, difficulty urinating, urinary or intestinal blockage, a prostate disease, or a blood disease
  • if you drink alcoholic beverages

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

  • Sodium oxybate (GHB) because side effects such as an increase in sleep duration and slowed breathing may occur

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

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

  • Take hydroxyzine capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If you miss a dose of hydroxyzine capsules and you are using it regularly, take it as soon as possible. If it is almost time for you 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 hydroxyzine capsules.

Important safety information:

  • Hydroxyzine capsules may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use hydroxyzine capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Avoid drinking alcohol or using medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using hydroxyzine capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • The effectiveness of hydroxyzine capsules as anxiety treatment for longer than 4 months is not known.
  • Use hydroxyzine capsules with caution in the ELDERLY; they may be more sensitive to its effects.
  • Hydroxyzine capsules should not be used in NEWBORNS; safety and effectiveness in newborns have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use hydroxyzine capsules if you are in your first 3 months of pregnancy. If you think you may be pregnant, contact your doctor right away. It is not known if hydroxyzine capsules is found in breast milk. Do not breast-feed while taking hydroxyzine capsules.

Possible side effects of hydroxyzine capsules:

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:

Drowsiness; dry mouth.

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); involuntary movements.

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 unusual drowsiness and dizziness.

Proper storage of hydroxyzine capsules: Store hydroxyzine capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light in a tightly closed container. Do not store in the bathroom. Keep hydroxyzine capsules out of the reach of children and away from pets.

General information:

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

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

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