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 0185-0674-01 bottles of 100
NDC 0185-0674-05 bottles of 500
NDC 0185-0674-10 bottles of 1000
50 mg
(equivalent to 50 mg hydroxyzine hydrochloride) are dark green/white capsules imprinted “ E 615” and supplied as:
NDC 0185-0615-01 bottles of 100
NDC 0185-0615-05 bottles of 500
NDC 0185-0615-10 bottles of 1000
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
NDC 0185-0674-01
HydrOXYzine Pamoate Capsules, USP
25 mg*
Rx only
100 Capsules
Sandoz
Package/Label Display Panel
NDC 0185-0615-01
HydrOXYzine Pamoate Capsules, USP
50 mg*
Rx only
100 Capsules
Sandoz
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0185-0613-01
HydrOXYzine Pamoate Capsules, USP
25 mg*
“Contains FD&C Yellow No. 6 as a color additive”
Rx only
100 Capsules
Sandoz
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
HYDROXYZINE PAMOATE hydroxyzine pamoate capsule | ||||||||||||||||||||||||||||||||||||||
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Labeler — RedPharm Drug, Inc. (828374897) |
Establishment | |||
Name | Address | ID/FEI | Operations |
EPM Packaging | 079124340 | repack (67296-0222) |
Revised: 01/2022 RedPharm Drug, Inc.
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