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 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 SUPPLIED

HydrOXYzine Pamoate Capsules, USP, for oral administration, are available as

25 mg

equivalent to 25 mg hydroxyzine hydrochloride) are light green/dark green capsules imprinted E 613 and supplied as:

NDC 68071-2255-2 BOTTLES OF 20

NDC 68071-2255-9 BOTTLES OF 90

Storage

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

Protect from moisture.

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

KEEP TIGHTLY CLOSED.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

25 mg

Manufactured by

Sandoz Inc.

Princeton, NJ 08540

50 mg

Manufactured for

Sandoz Inc.

Princeton, NJ 08540

Manufactured by

Epic Pharma, LLC

Laurelton, NY 11413

46192627

Rev. December 2016

MF0674REV12/16

OS7127

Rev. October 2016

MF0615REV10/16

Package/Label Display Panel

PDP
(click image for full-size original)

HYDROXYZINE PAMOATE
hydroxyzine pamoate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2255(NDC:0185-0674)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE PAMOATE (HYDROXYZINE) HYDROXYZINE DIHYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C GREEN NO. 3
FD&C YELLOW NO. 6
FD&C RED NO. 40
FERROSOFERRIC OXIDE
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color green (light green/dark green) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code E613
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2255-2 20 CAPSULE in 1 BOTTLE None
2 NDC:68071-2255-9 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087479 12/14/1981
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-2255)

Revised: 05/2022 NuCare Pharmaceuticals,Inc.

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