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Cetirizin

Cetirizine
Film-coated tablets 10 mg
Oral solution 1mg/1ml 120ml                                                          

ATC  R06A E07
Prescription-only medicine
Medicine reimburse by Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION

Oral-solution

Adults and adolescents over 12 years: 10mg once daily as 10ml oral solution (2 teaspoons);

Children from 6 to 12 years: 5mg twice daily as 5ml oral solution (1 full teaspoon) twice daily;

Children from 2 to 6 years: 2.5mg twice daily as 2.5ml oral solution (1 half teaspoon) twice daily;


Film-coated tablets of 10 mg are indicated in adults and children over 12 years of age:

Adults and children over 12 years: 1 tablet (10 mg) once daily.
Older patients: Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
Patients with moderate to severe renal impairment: There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via renal route, in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function.

Dosing adjustments for adult patients with impaired renal function

Group Creatinine Clearance  Dosage
Normal ≥ 80 10 mg once daily
Mild 50-79 10 mg once daily
Moderate* 30-49 5 mg once daily
Severe* <30 5 mg once every 2 days
End-stage renal disease – patients undergoing dialysis* <10 Contraindicated

*Cetirizin film-coated tablet should not be used in adults with moderate or severe renal impairment, as it does not allow the necessary dose adjustments.

Patients with hepatic impairment: No dose adjustment is needed in patients with solely hepatic impairment.

Patients with hepatic and renal impairment: Adjustment of the dose is recommended (see Patients with moderate to severe renal impairment above).


Method of administration: The tablet needs to be swallowed with a glass of water.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

Description

COMPOSITION

Each film-coated tablet contains 10 mg cetirizine dihydrochloride, excipients.

THERAPEUTIC INDICATIONS

Cetirizin is indicated for the relief of symptoms of seasonal and perennial allergic rhinitis (nasal and ocular symptoms) and chronic idiopathic urticaria.

CONTRAINDICATIONS

Hypersensitivity to the active substance, to any of the excipients of the medicine, to hydroxyzine or to any piperazine derivatives.
Patients with severe renal impairment with a creatinine clearance below 10 ml/min.


PACKAGING

Box with 20 film-coated tablets of 10 mg in a blister package.