Hydroxyzine Hydrochloride (Page 2 of 2)

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

DOSAGE AND 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.

HOW SUPPLIED

Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as 10/32″, Green round biconvex film-coated tablets debossed “Є” above “160” on one side and plain on the other side,

Overbagged with 10 tablets per bag, NDC 55154-7994-0

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

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

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

Manufactured by:

Epic Pharma, LLC

Laurelton, NY 11413

Manufactured in USA

Distributed By:

Cardinal Health

Dublin, OH 43017

L55015230124

Revised October 2016

MF159REV10/16

OE1518

Package/Label Display Panel

HydrOXYzine Hydrochloride Tablets, USP

25 mg

10 Tablets

Bag Label
(click image for full-size original)
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7994(NDC:0904-6617)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydroxyzine dihydrochloride (HYDROXYZINE) hydroxyzine dihydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE
MAGNESIUM STEARATE
CARNAUBA WAX
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
D&C YELLOW NO. 10
TITANIUM DIOXIDE
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
TRIACETIN
Product Characteristics
Color GREEN Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code E160
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-7994-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BAG (55154-7994-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040604 03/31/2015
Labeler — Cardinal Health 107, LLC (118546603)

Revised: 02/2024 Cardinal Health 107, LLC

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