“Composition
One Cetirizine tablet contains:
Active ingredient
10 mg cetirizine dihydrochloride.
Excipients
Tablet core: microcrystalline cellulose, lactose, magnesium stearate monohydrate, colloidal anhydrous silicon dioxide.Tablet shell: hypromellose lactose monohydrate, macrogol 4000, dye, titanium dioxide.
Dosage and dosage
The drug should be taken in the following doses and ways:
Children from 6 to 12 years: 5 mg twice a day (half a tablet twice a day).
Adults and children over 12 years: 10 mg 1 time per day (1 tablet).
The tablets should be washed down with a glass of liquid.
Elderly patients: according to available data, in elderly patients with normal renal function, a dose reduction is not required.
Patients with moderate to severe renal impairment: There are no data to support the balance of efficacy and safety in patients with renal impairment. Since cetirizine is predominantly eliminated by the kidneys (see Contraindications), in cases where alternative treatments cannot be used, dosing intervals should be individualised based on 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) expressed in ml/min is required. CLcr (ml/min) can be obtained from the serum creatinine value (mg/dl) using the following formula: CLcr = [140 – age (years)] x weight (kg) / 72 x serum creatinine (mg/dl). ] x 0.85 for women)
Dose adjustment for adults with renal impairment:
Normal ’80 10 mg once daily
Mild 50-79 10 mg once daily
Moderate 30.49 5 mg once daily
Severe
End-stage renal disease “”Patients on dialysis””
In children with renal impairment, the dose should be adjusted individually based on renal clearance, age and body weight of the patient.
Special warnings
At therapeutic doses, no clinically significant interactions with alcohol have been identified (at a blood alcohol level of 0.5 g / l). However, caution is recommended when taking alcohol concomitantly. Caution is recommended in patients with factors predisposing to urinary retention (e.g. spinal cord injury, prostatic hyperplasia), since cetirizine may increase the risk of urinary retention. Caution is advised in patients with epilepsy and in patients at risk of seizures. Allergy skin tests are inhibited by antihistamines and a washout period of 3 days is required before testing. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take cetirizine film-coated tablets. The use of film-coated tablets is not recommended in children under 6 years of age, as this formulation does not allow for appropriate dose adjustment.”
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