HYDROXYZINE HYDROCHLORIDE tablet

HYDROXYZINE HYDROCHLORIDE by

Drug Labeling and Warnings

HYDROXYZINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by Direct Rx, DirectRx. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOW SUPPLIED

Hydroxyzine Hydrochloride Tablets, USP are available as follows:

10 mg tablets: round, film coated white tablets. Debossed H on one side and 500 on the reverse side. They are available as follows:

Bottles of 100: NDC: 23155-500-01

Bottles of 500: NDC: 23155-500-05

Bottles of 1000: NDC: 23155-500-10

25 mg tablets: round, film coated white tablets. Debossed H over 501 on one side and plain on the reverse side. They are available as follows:

Bottles of 100: NDC: 23155-501-01

Bottles of 500: NDC: 23155-501-05

Bottles of 1000: NDC: 23155-501-10

50 mg tablets: round, film coated white tablets. Debossed H over 502 on one side and plain on the reverse side. They are available as follows:

Bottles of 100: NDC: 23155-502-01

Bottles of 500: NDC: 23155-502-05

Bottles of 1000: NDC: 23155-502-10

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

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51U000000193US07

Rev. 10/2019

DOSAGE & ADMINISTRATION

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 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: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.

OVERDOSAGE

The most common manifestation of hydroxyzine overdosage 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 levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts its pressor action.

Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose.

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.

INDICATIONS & USAGE

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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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.

CLINICAL PHARMACOLOGY

Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines. Hydroxyzine 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's clinical effects are usually noted within 15 to 30 minutes after oral administration.

DESCRIPTION

Hydroxyzine hydrochloride, USP has the chemical name of (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride.

stucture
Molecular Formula: C21H27ClN2O2 · 2HCl Molecular Weight: 447.83

Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water.

Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROXYZINE HYDROCHLORIDE 
hydroxyzine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72189-333(NDC:23155-500)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROXYZINE DIHYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)	HYDROXYZINE DIHYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSPOVIDONE (UNII: 2S7830E561)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	H;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-333-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204279	03/03/2022

Labeler - Direct Rx (079254320)

Registrant - Direct Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRx		079254320	repack(72189-333)