cetrizine, respiratory tract agents .
ZYRTEC SYRUP Each 1 ml contains: 1 mg of Cetirizine dihydrochloride.
Cetirizine dihydrochloride is indicated in adults & children aged 2 years and above for the relief of : – nasal and ocular symptoms of seasonal and perennial allergic rhinitis. – symptoms of chronic idiopathic urticaria.
Ask your pharmacist or doctor for help if you do not understand the instructions on the box.
The recommended dose is: –
Adults: 10 mg (10 ml of oral solution or 1 tablet) once daily. A 5 mg starting dose (5 ml of oral solution or half of the tablet) may be proposed if this leads to satisfactory control of the symptoms. Children: children aged from 2 to 6 years; 2.5 mg ( 2.5 ml of oral solution) twice daily.
children aged from 6 to 12 years: 5 mg ( 5 ml of oral solution) twice daily. children over 12 years; 10 mg ( 10 ml of oral solution or one tablet) once daily. Elderly: Data does not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated .
To use this dosing table, an estimate of the patient’s creatinine clearance (Clcr) in ml/min is needed.
Dosing adjustements for adult patients with impaired renal function: In case of Normal creatinine clearance (>/= 80 ml/min.) dosage is 10 mg once daily. In case of Severe creatinine clearance (<30 ml/min.) dosage is 5 mg once every 2 days. End-stage renal disease- patients is undergoing dialysis: <10 contraindicated. In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age, and his body weight.
Hepatic impairment: No dose adjustment is needed in patients with solely hepatic impairment. Patients with hepatic impairment and renal impairment : Dose adjustment is recommended (see Renal impairment above).
OVER-DOSAGE OF ZYRTEC SYRUP
Symptoms and signs: Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Adverse events reported after an intake of at least 5 times the recommended daily dose: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention. Treatment: There is no known specific antidote to cetirizine. Should overdose occur, symptomatic or supportive treatment is recommended. Cetirizine is not effectively removed by dialysis.
Cetrizine is contraindicated in: – hypersensitivity to any of the constituents of this formulation, to hydroxyzine or to any piperazine derivatives. Patients with severe renal impairment at less than 10 ml/min creatinine clearance.
See outer pack.
PACK OF ZYRTEC SYRUP
Carton box containing one bottle of 100 ml and inner leaflet.
ZYRTEC SYRUP MANUFACTURED BY
GlaxoSmithKline-Egypt under license of UCB pharma-Switzerland.