Hydroxyzine Pamoate (Page 2 of 2)

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.

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.

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, 50–100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50–100 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, 50–100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50–100 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 SUPPLIED

Hydroxyzine Pamoate Capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) are available as:

25 mg capsules: Hard gelatin capsules, green opaque cap, green opaque body, cap and body imprinted EP136 in black ink. They are supplied as follows:

Carton of 100 capsules (10 capsules per blister pack x 10), NDC 0904-7065-61

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

Dispense in tight, light resistant containers (USP).

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

Image

51U000000US04

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Revised: 11/2019

Package/Label Display Panel

Hydroxyzine Pamoate

25 mg*

100 Capsules

carton label
(click image for full-size original)
HYDROXYZINE PAMOATE
hydroxyzine pamoate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7065(NDC:14539-674)
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
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C RED NO. 40
FD&C BLUE NO. 1
Product Characteristics
Color GREEN (BLACK) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code EP136
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7065-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0904-7065-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201507 06/03/2013
Labeler — Major Pharmaceuticals (191427277)

Revised: 09/2020 Major Pharmaceuticals

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