Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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.; Package/Label Display Panel – Carton – 25 mg 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 25 mg Hydroxyzine Pamoate Capsules Carton; Package/Label Display Panel – Blister – 25 mg HydrOXYzine Pamoate Capsule, USP 25 mg 25 mg Hydroxyzine Pamoate Capsule Blister; Package/Label Display Panel – Carton – 50 mg, 50 UD 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 50 mg Hydroxyzine Pamoate Capsules Carton-50UD; Package/Label Display Panel – Carton – 50 mg, 100 UD 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 50 mg Hydroxyzine Pamoate Capsules Carton-100UD; Package/Label Display Panel – Blister – 50 mg HydrOXYzine Pamoate Capsules. USP 50 mg 50 mg Hydroxyzine Pamoate Capsule Blister
- HOW SUPPLIED 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.
- Package/Label Display Panel – Carton – 25 mg 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 25 mg Hydroxyzine Pamoate Capsules Carton
- Package/Label Display Panel – Blister – 25 mg HydrOXYzine Pamoate Capsule, USP 25 mg 25 mg Hydroxyzine Pamoate Capsule Blister
- Package/Label Display Panel – Carton – 50 mg, 50 UD 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 50 mg Hydroxyzine Pamoate Capsules Carton-50UD
- Package/Label Display Panel – Carton – 50 mg, 100 UD 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 50 mg Hydroxyzine Pamoate Capsules Carton-100UD
- Package/Label Display Panel – Blister – 50 mg HydrOXYzine Pamoate Capsules. USP 50 mg 50 mg Hydroxyzine Pamoate Capsule Blister
Overview
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. Structural Formula
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 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.
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: 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.
Warnings & Precautions
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.
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 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.
Adverse Reactions
Side effects reported with the administration of hydroxyzine pamoate are usually mild and transitory in nature. Skin and Appendages Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports. 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. Cardiac System QT prolongation, Torsade de Pointes. In postmarketing 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 Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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