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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