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Hydroxyzine Capsules

Pronunciation

Generic Name: hydroxyzine pamoate
Dosage Form: capsule

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.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 90 NDC 42291-322-90, bottles of 500 NDC 42291-322-50.

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 90 NDC 42291-323-90, bottles of 500 NDC 42291-323-50.

Store below 30°C (86°F) [See USP].

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

Manufactured for:

AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 05/12
AV Rev. 01/16 (P)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE
NDC
42291-322-50
HydrOXYzine Pamoate Capsule USP
25 mg*
Tartrazine Dye-Free
500 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 the reach of children.

Manufactured for:
AvKARE, Inc
Pulaski, TN 38487

Mfg. Rev. 70023145       AV Rev. 01/14 (P)

N3 4229132250   5

AvKARE
NDC
42291-323-90
HydrOXYzine Pamoate Capsule USP
50 mg*
Tartrazine Dye-Free
90 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 the reach of children.

Manufactured for:
AvKARE, Inc
Pulaski, TN 38487

Mfg. Rev. 70023146         AV Rev. 02/14 (P)

N3   4229132390   2

HYDROXYZINE PAMOATE  
hydroxyzine pamoate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42291-322(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:42291-322-90 90 CAPSULE in 1 BOTTLE
2 NDC:42291-322-50 500 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040156 03/07/2013
HYDROXYZINE PAMOATE  
hydroxyzine pamoate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42291-323(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:42291-323-90 90 CAPSULE in 1 BOTTLE
2 NDC:42291-323-50 500 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040156 03/07/2013
Labeler - AvKARE, Inc. (796560394)
Revised: 01/2016
 
AvKARE, Inc.
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