Allergy Relief Tablets - Cetirizine

02231603

2 years from date of manufacture

Cetirizine HCI 10mg

Carnuba wax, cornstarch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, and titanium dioxide.

ANTIHISTAMINE DRUGS

White, ovoid, biconvex, film-coated tablet scored and engraved 10 MG on one side, APO on the other side.

Diameter: 0.2140 x 0.3500 arc rectangle
Thickness: 0.137" - 0.147"

Store at room temperature (15 to 30°C). Protect from moisture.

For fast and long-lasting relief (24 hours) of itchy, watery eyes, sneezing and runny nose.

Adults and children 12 years and over: Take 1/2 to 1 tablet daily. Adults 65 years and over: half of an Extra Strength (10mg) tablet every 24 hours. Consult a physician if unsure about the dosage. Prolonged use only as directed by a physician.

This product should not be taken by anyone who is pregnant or nursing a baby, or by anyone with liver or kidney disease, unless advised by a physician. Exercise due caution when driving or operating a vehicle or potentially dangerous machinery. Keep this and all medications out of the reach of children.

No clinically significant drug interactions have been found with theophylline, pseudoephedrine, cimetidine, erythromycin and ketoconazole. Epidemiologic data suggests that there also would not be interaction with other macrolide antibiotics or imidazole antifungals. In clinical trials, cetirizine has been safely administered with beta-agonists, non-steroidal anti-inflammatory drugs, oral contraceptives, narcotic analgesics, corticosteroids, H2-antagonists, cephalosporins, penicillins, thyroid hormones and thiazide diuretics. Interaction studies with cetirizine and alcohol or diazepam indicate that cetirizine hydrochloride does not increase alcohol-induced or diazepam-induced impairment of motor and mental performance.

Contraindicated in those patients with a known hypersensitivity to cetirizine hydrochloride or to its parent compound, hydroxyzine.

In clinical development programs (domestic and international), cetirizine has been evaluated in more than 6000 treated patients at daily doses ranging from 5 to 20 mg. Most adverse reactions reported during cetirizine therapy were mild to moderate. The more common adverse reactions were headache and somnolence. The incidence of headache associated with cetirizine hydrochloride was not different from placebo. The incidence of somnolence associated with cetirizine hydrochloride was dose related and predominantly mild to moderate. Dry mouth and fatigue were also reported. Weight gain was reported as an adverse event in 0.4% of cetirizine patients in placebo controlled trials. In an open study of six months duration, the mean weight gain was 2.8% after 20 weeks, with no further increase at 26 weeks. Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy, without evidence of jaundice, hepatitis or other clinical findings.

Somnolence has been reported in cases of overdose up to 150 mg. If an acute overdose occurs, evacuation of the stomach should be considered during the first few hours after this overdose. Treatment should be symptomatic and supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine. Cetirizine is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.