REACTINE Tablet, Capsule, Syrup Ref.[27789] Active ingredients: Cetirizine

Recommended Dosage and Dosage Adjustment

The recommended initial dose of REACTINE (cetirizine hydrochloride) is 5 to 10 mg, depending on symptom severity, given as a single daily dose, with or without food. If sufficient response is not obtained with the nonprescription strengths of 5 or 10 mg, the dose may be increased and prescribed as necessary to the maximum recommended daily dose of 20 mg. The time of administration, with or without food, may be varied to suit individual patient needs.

In patients with moderate hepatic and/or renal impairment or adults 65 years and over, a starting dose of 5 mg/day is recommended.

REACTINE should not be administered to children under 2 years of age, unless advised by a physician.

Clinical studies to date support treatment for up to 6 months thus medical recommendation is advised for long-term use.

Specific dosing directions for various dosage forms of REACTINE are provided below:

Tablets (taken with or without food)

• Children 6-12 years of age: One 10 mg (extra strength) tablet (film-coated or orally disintegrating tablet), once daily. For twice daily dosing, one 5 mg (regular strength) film-coated tablet in the morning and one 5 mg filmcoated tablet in the evening.
• Adults and children 12 years of age and over: One or two 5 mg (regular strength) tablets (film-coated) or one 10 mg (extra strength) tablet (film-coated or orally disintegrating tablet), once daily.
• Adults 65 years of age and over: One 5 mg (regular strength) tablet (film-coated) once daily. Consult a doctor if unsure about dosage.

Note: 20 mg film-coated tablets are only available under prescription; please consult your physician

Capsules (liquid gels)

• Adults and children 12 years of age and over: One 10 mg capsule, once daily.

Syrup (taken with or without food)

• Children 2-6 years of age: 5 mL of syrup given once daily. For twice daily dosing, 2.5 mL of syrup in the morning and 2.5 mL of syrup in the evening.
• Children 6-12 years of age: 10 mL of syrup once daily. For twice daily dosing, 5 mL in the morning and 5 mL in the evening.
• Adults and Children 12 years of age and over: 5 or 10 mL of syrup once daily.
• Adults 65 years of age and over: 5 mL of syrup once daily. Consult a doctor if unsure about dosage.

Overdose has been reported with REACTINE (cetirizine hydrochloride). Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with symptoms that could suggest an anticholinergic effect. Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, hypertension, tremor, and urinary retention. Hyperactivity and severe lethargy have been seen in children. 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 REACTINE (cetirizine hydrochloride). REACTINE (cetirizine hydrochloride) is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested. The minimal lethal oral dose in rodents is at least 590 times the maximum clinically studied dose.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Recommended storage: Store between 15°-30°C.

REACTINE Allergy Liquid Gels (cetirizine hydrochloride capsules, 10 mg): Store at temperatures between 15°-30°C. Avoid high humidity and excessive heat (above 40°C). Protect from light.