Generic Name

Composition

Therapeutic Category

Division

Cetirizine

Cetirizine HCl 10mg Tablets

Cetirizine HCl 5mg/5ml Syrup

Anti-histaminic/Anti-allergic

TIME

    BRAND COMPOSITION DESCRIPTION
    T-CET

     Each film coated tablet contains:

    Cetirizine Hydrochloride BP                   10mg

    Orange coloured, circular biconvex film coated tablet with breakline on one side and 10 embossed on the other side.

     

    T-CET SYRUP

    Each 5 ml contains:

    Cetirizine Hydrochloride BP                   5mg

    Clear colourless syrup filled in 70.00 ml overflow capacity amber coloured glass bottle.

     

    PATIENT INFORMATION

    Food Interaction: Alcohol may increase the nervous system side effects of cetirizine.

    Administration: May be taken with or without food.

    Pregnancy:Category B

    Cetirizine can pass into breast milk and harm the nursing baby. Do not breast feed while using Cetirizine.

    Storage: Store tablets between 20- 25°C

    Missed dose: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

    PHARMACOLOGY

    Pharmcotherapeutic Group: Second generation Antihistamines

     Pharmacodynamic Properties:Cetirizine is a metabolite of hydroxyzine, is an antihistamine drug. Cetirizine is a potent and highly selective antagonist of the peripheral histamine H1-receptor on effector cells in the GI tract, blood vessels and respiratory tract.

     Pharmacokinetic Properties:

    Absorption: Absorbed rapidly from the GI tract (oral); peak plasma concentrations after 1 hr. Rate, but not extent, of absorption altered by food.

    Distribution: Enters breast milk, crosses the blood-brain barrier (insignificant amounts). Protein binding: Highly bound.

    Excretion: Via the urine (as unchanged), elimination half-life: 10 hr.

     INDICATIONS

    Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis, Chronic Urticaria

     DOSAGE & ADMINISTRATION

    Adult: 10mg once daily

    Child: 6-23 month 2.5 mg once daily increased to maximum of 2.5 mg bid in children ≥12 mth; 2-5 yr 5 mg once daily or in 2 divided doses;  ≥6 yr 10 mg once daily or in 2 divided doses.

     ADVERSE DRUG REACTIONS

    Somnolence, insomnia, fatigue, dizziness, headache, pharyngitis, abdominal pain, coughing, diarrhoea, epistaxis, bronchospasm, nausea, vomiting, dry mouth.

     PRECAUTIONS

    Epileptic patients and patients at risk of convulsions, hepatic and renal impairment, elderly, pregnancy and lactation. 

    Patient Counselling: May impair ability to perform tasks requiring mental alertness or physical coordination (e.g. driving or operating heavy machinery).

     DRUG INTERACTIONS

    Additive central nervous system (CNS) depression when administered concomitantly with other CNS depressants (e.g. sedatives, tranquilizers).

     CONTRAINDICATIONS

    Hypersensitivity to cetirizine, hydroxyzine, or any component

     

     PRESENTATION

    T-CET: Each box contains 20 Blisters of 10 Tablets per strip

    T-CET SYRUP: Each bottle contains 60ml of syrup