Cetirizine Sandoz 10mg

Therapeutic indications

Cetirizina Sandoz is used in the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and in the symptomatic treatment of chronic idiopathic urticaria.

Dosage and method of use

Cetirizina Sandoz is administered in the following doses:

Children aged 6 to 12 years: 5 mg twice a day (half tablet twice a day).
Adults and children over 12 years of age: 10 mg once daily (1 tablet). The tablets should be taken with a glass of liquid.
Elderly patients: based on available data, no dose reduction is required in elderly subjects with normal renal function.
Patients with moderate to severe renal insufficiency: the intervals between doses should be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this posology, it is necessary to have an estimate of the patient's creatinine clearance (CLcr) in ml / min. CLcr (ml / min) can be obtained starting from the value of serum creatinine (mg / dl) using the following formula: clcr equals [140 - age (years)] x weight (kg) divided by 72 x serum creatinine (mg / dl) (x 0.85 for women).
Dosage adjustment for adults with impaired renal function. Clcr> = 80 ml / min: 10 mg once a day; mild clcr 50 -79 ml / min: 10 mg once daily; moderate clcr 30 -49 ml / min: 5 mg once daily; severe <30 ml / min: 5 mg once every two days; end-stage kidney disease -
Patients on dialysis: contraindicated. In pediatric patients with renal insufficiency, the dose will have to be individually adjusted, taking into account the renal clearance and the patient's body weight.
Patients with hepatic insufficiency: Patients with hepatic insufficiency only do not require any dosage adjustments.
Patients with hepatic and renal insufficiency: dose adjustment is recommended.

Contraindications

Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any derivative of piperazine; patients with severe renal insufficiency with creatinine clearance less than 10 ml / min.

Special warnings

At therapeutic doses, there was no evidence of clinically significant interactions with alcohol (for blood alcohol levels of 0.5 g / l). However, caution is advised in case of concomitant alcohol intake. Caution is advised in epileptic patients and in patients at risk for seizures. The use of the film-coated tablet formulation is not recommended in children younger than 6 years, as this formulation does not allow for appropriate dose adjustment.

Skin tests for allergy diagnosis are inhibited by antihistamines and a washout period of 3 days is required before undergoing tests. The medicinal product must not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Pregnancy and breastfeeding

Very few clinical data on exposed pregnancies are available for cetirizine. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Caution should be used when prescribing the medicine to pregnant women. Cetirizine is excreted in breast milk in concentrations representing 0.25-0.90 of those measured in plasma, based on the sampling time after administration. Therefore, care should be taken when prescribing cetirizine to women who are breastfeeding.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Caution

do not use the medicine after the expiry date indicated on the package.

Composition

Cetirizin Sandoz contains:
Active ingredient: 10 mg of cetirizine dichlorohydrate
Excipients: Lactose monohydrate, Microcrystalline cellulose, Silica, colloidal anhydrous, Magnesium stearate