Abbreviated Prescribing Information for Use in the ...
Abbreviated Prescribing Information for Use in the International
Area. Based on the International Prescribing Information (NCDS 5) and prepared to
meet the requirements of the GSK International Pharmaceutical Promotional and
Marketing Policy.
Zyrtec Oral Drops
COMPOSITION: Each 1 ml contains: Cetrizine (as Cetrizine Dihydrochloride) 10 mg.
Excipients: Acetic acid, glycerol, methyl parahydroxy benzoate, sodium acetate
(trihydrate), saccharin sodium, propylene glycol, propyl parahydroxybenzoate, purified
water. Indications: In adults and children from the age of 6 years (for the treatment of):
Allergic rhinitis, seasonal (hay fever, pollinosis; and perennial). Allergic conjunctivitis,
Chronic idiopathic urticaria. In children from 2 ¨C 6 years for the treatment of: Seasonal
allergic rhinitis. Dosage and Administration: Seasonal allergic rhinitis: Adults and
youth over the age of 12 years: The recommended dosage is 10 mg once daily (20 drops).
Children from 6 to 12 years: 10 mg once daily (20 drops) for a maximum of 4 weeks.
Alternatively, the dosage can be divided into two administrations (10 drops in the
morning and evening respectively). Children from 2-6 years: The recommended daily
dosage is 5 mg and should be divided into two administrations (5 drops respectively in
the morning and evening). Allergic conjunctivitis: Adults and youth over the age of 12
rears: The recommended dosage is 10 mg once daily (20 drops). Children from 6 to 12
years: 10 mg once daily (20 drops) for a maximum of 4 weeks. Alternatively, the dosage
can be divided into two administrations (10 drops in the morning and evening
respectively). Perennial allergic rhinitis, chronic idiopathic urticaria: Adults and
adolescents over 12 years: The recommended dosage is 10 mg once daily (1 film tablet
or 20 drops). Children from 6 to 12 years: The recommended dosage is 10 mg once daily
20 drops). Alternatively, the dosage can be divided into two administrations (one 10
drops in the morning and evening respectively). Dosage for special patient populations:
Elderly patients: Due to possibly reduced renal function, a dosage adaptation may be
indicated in elderly patients (see below Patients with restricted renal function). Patients
with restricted renal function: The dosage intervals must be individually adjusted in
accordance with renal function. The dosage adaptation should be performed in
accordance with the following table. When using this table for a dosage adaptation, the
patient¡¯s creatinine clearance (Clcr) must be estimated in ml/min.
The Clcr in ml/min can be determined from the serum creatinine levels (mg/dl) according
to the following formula:
Clcr = ([140 ¨C age (years)] x weight (kg)/72 x serum creatinine (mg/dl) (x 0.85 in women)
Dosage adaptation in patients with restricted renal function
Group
Normal
Slight
Moderate
Severe
Terminal renal insufficiency
Patients requiring dialysis
Creatinine
clearance
(mg/ml)
>80
50-79
30-49
10-30
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