Cetirizine Hydrochloride (Page 3 of 3)

Post-Marketing Experience

In the post-marketing period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide, thrombocytopenia, acute generalized exanthematous postulosis (AGEP) and rebound pruritus-pruritus within a few days after discontinuation of cetirizine, usually after long-term use (e.g., months to years) of cetirizine.

DRUG ABUSE AND DEPENDENCE

There is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.

OVERDOSAGE

Overdosage has been reported with cetirizine hydrochloride. In one adult patient who took 150 mg of cetirizine hydrochloride, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18 month old pediatric patient who took an overdose of cetirizine hydrochloride (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness. Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine hydrochloride. Cetirizine hydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested. The acute minimal lethal oral doses were 237 mg/kg in mice (approximately 95 times the maximum recommended daily oral dose in adults on a mg/m2 basis, or approximately 40 times the maximum recommended daily oral dose in infants on a mg/m2 basis) and 562 mg/kg in rats (approximately 460 times the maximum recommended daily oral dose in adults on a mg/m2 basis, or approximately 190 times the maximum recommended daily oral dose in infants on a mg/m2 basis). In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver.

DOSAGE AND ADMINISTRATION

Cetirizine hydrochloride oral solution USP, 1 mg/mL can be taken without regard to food consumption.

Children 2 to 5 Years for Chronic Urticaria

The recommended initial dose of cetirizine hydrochloride oral solution in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) oral solution once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful oral solution once a day, or one ½ teaspoonful oral solution given every 12 hours.

Children 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Uriticaria

The recommended dose of cetirizine hydrochloride oral solution in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.

HOW SUPPLIED

Cetirizine hydrochloride oral solution USP, 5 mg/5 mL (1 mg/mL) is colorless to slightly yellow with a banana-grape flavor. Each teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride.

Cetirizine hydrochloride oral solution is supplied as follows:

120 mL plastic bottles NDC 51672-4070-8

STORAGE

Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; or Store refrigerated, 2° to 8°C (36° to 46°F).

Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: July, 2018
71381-0718-7
543

PRINCIPAL DISPLAY PANEL — 120 mL Bottle Carton

NDC 51672-4070-8

120 mL

Cetirizine
Hydrochloride
Oral Solution
USP,

1 mg/mL*

FOR ORAL USE ONLY

Rx only

TARO

PRINCIPAL DISPLAY PANEL -- 120 mL Bottle Carton
(click image for full-size original)
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4070
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
acetic acid
glycerin
methylparaben
propylene glycol
propylparaben
water
sodium acetate anhydrous
sucrose
Product Characteristics
Color YELLOW (colorless to slightly yellow) Score
Shape Size
Flavor GRAPE, BANANA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4070-8 1 BOTTLE in 1 CARTON contains a BOTTLE
1 120 mL in 1 BOTTLE This package is contained within the CARTON (51672-4070-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076601 05/01/2014
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE (51672-4070)

Revised: 08/2018 Taro Pharmaceuticals U.S.A., Inc.

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