Label: HYDROXYZINE PAMOATE capsule

Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula:

Hydroxyzine pamoate capsules, USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate.

The capsule shell ingredients for the 25 mg capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule shell contains D&C Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide.

The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze.

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.

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.

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 is contraindicated in patients with a prolonged QT interval.

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

Hydroxyzine is contraindicated in patients with known hypersensitivity to hydroxyzine products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.

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.

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

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.

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.

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 to 100 mg four times a day; children under 6 years, 50 mg daily in divided doses; and 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: in adults, 25 mg three times a day or four times a day; children under 6 years, 50 mg daily in divided doses; and 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 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.

Hydroxyzine pamoate capsules, USP (hydroxyzine pamoate, USP equivalent to hydroxyzine hydrochloride), 25 mg are available as light yellow opaque cap and pink opaque body filled with yellow powder, imprinted in black ink stylized “barr” over “323” on one piece and “25” on the other piece, packaged in:
Unit dose packages of 100 (10 x 10) NDC 60687-696-01

Hydroxyzine pamoate capsules, USP (hydroxyzine pamoate, USP equivalent to hydroxyzine hydrochloride), 50 mg are available as light yellow opaque cap and maroon opaque body filled with yellow powder, imprinted in black ink stylized “barr” over “302” on one piece and “50” on the other piece, packaged in:
Unit dose packages of 50 (5 x 10) NDC 60687-707-65
Unit dose packages of 100 (10 x 10) NDC 60687-707-01.

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Keep this and all medications out of the reach of children.

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Teva Pharmaceuticals as follows:
(25 mg / 100 UD) NDC 60687-696-01 packaged from NDC 0555-0323
(50 mg / 50 UD) NDC 60687-707-65 packaged from NDC 0555-0302
(50 mg / 100 UD) NDC 60687-707-01 packaged from NDC 0555-0302

Distributed by:
American Health Packaging
Columbus, OH 43217

8469601/1023

NDC 60687- 696-01

HydrOXYzine Pamoate
Capsules, USP

25 mg

100 Capsules (10 x 10)                Rx Only

Each Capsule Contains:
Hydroxyzine pamoate, USP equivalent to 25 mg of
hydroxyzine hydrochloride.

Usual Dosage: See full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 0555-0323, Teva Pharmaceuticals.

Distributed by: American Health Packaging, Columbus,
Ohio 43217

769601
0469601/1023

HydrOXYzine
Pamoate
Capsule, USP

25 mg

NDC 60687- 707-65

HydrOXYzine Pamoate
Capsules, USP

50 mg

50 Capsules (5 x 10)                 Rx Only

Each Capsule Contains:
Hydroxyzine pamoate, USP equivalent to 50 mg of hydroxyzine
hydrochloride.

Usual Dosage: See full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0555-0302, Teva Pharmaceuticals.

Distributed by: American Health Packaging, Columbus, Ohio 43217

770765
0470765/1023

NDC 60687- 707-01

HydrOXYzine Pamoate
Capsules, USP

50 mg

100 Capsules (10 x 10)                Rx Only

Each Capsule Contains:
Hydroxyzine pamoate, USP equivalent to 50 mg of
hydroxyzine hydrochloride.

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 0555-0302, Teva Pharmaceuticals.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

770701
0470701/0923

HydrOXYzine
Pamoate
Capsules. USP   50 mg