Generic Name

Composition

Therapeutic Category

Division

Fexofenadine HCl

Fexofenadine HCl 120mg Tablets

Fexofenadine HCl 180mg Tablets

Fexofenadine HCl 30mg/5ml Suspension

Anti-histaminic/Anti-allergic

COSMO

    BRAND COMPOSITION DESCRIPTION
     NOLAR 120  Each film coated tablet contains:
     Fexofenadine Hydrochloride             120mg
    Yellow colored, oblong, film coated tablet with breakline on one side.
     NOLAR 180  Each film coated tablet contains:
     Fexofenadine Hydrochloride             180mg
    Brick red colored, oblong, biconvex, film coated tablet with breakline on one side.
     NOLAR    SUSPENSION  Each 5ml contains:
     Fexofenadine Hydrochloride BP         30mg
    White colored suspension filled in amber coloured PET bottle. Each filled bottle is labelled and packed in carton.
    PHARMACOLOGY

    Pharmacotherapeutic Group: Anti-allergic agent, H1 receptor antagonist

    Pharmacodynamic properties: NOLAR (Fexofenadine), is a competitive peripheral histamine (H1) receptor antagonist that acts on effector cells in the GI tract, blood vessels and respiratory tract. It works by blocking histamine (H1) receptors and thus prevents activation of H1 receptor-containing cells by histamine. Therefore, it help to alleviate symptoms such as runny nose and sneezing; red, watery, or itchy eyes; itchy nose, throat or roof of the mouth; itchy skin and rash. NOLAR causes less drowsiness than other antihistamines.

    Pharmacokinetic properties:
    Absorption: Absorbed rapidly from the GI tract;Time to peak plasma concentrations: 2-3 hr.
    Distribution: Enters breast milk. Protein binding: 60-70%; Does not readily pass through the blood-brain barrier.
    Metabolism: Approximately 5% of the total dose eliminated by hepatic metabolism.
    Excretion: Mainly via faeces, via urine (10% of dose); Elimination half-life: 14 hours; May be prolonged in renal impairment.

     
    INDICATIONS

    Allergic rhinitis; Chronic urticaria

     
    DOSE

    Seasonal allergic rhinitis: 120 mg once daily.
    Chronic idiopathic urticaria: 180 mg once daily.
    Child: 2-11 yr: 30 mg (5ml) twice daily.
    6 month -2 yr: 5mg (2.5ml) twice daily.

     

    PATIENT INFORMATION

     Administration:

    • NOLAR may be taken with or without food.
    • Do not take the medication within 2 hours of taking an antacid that contains aluminum hydroxide or magnesium hydroxide, as these antacids may alter the effectiveness of NOLAR.

    Food Interaction: Fruit juices such as grapefruit, orange and apple may reduce the bioavailability and exposure of NOLAR.

    Pregnancy:   Category C

    Nursing Mothers: There are no adequate and well controlled studies in women during lactation. However, when terfenadine was administered to nursing mothers, fexofenadine was found to cross into human breast milk. Therefore, NOLAR is not recommended for breast-feeding women.

    Storage:  Store in a cool and dry place; Protect from light, heat and moisture; Keep away from the reach of children.

    • 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.
    CONTRAINDICATIONS

    Hypersensitivity

     
    SPECIAL PRECAUTIONS

    Renal and hepatic impairment; Pregnancy;lactation; Heart disease; Medication that lead to fast or irregular heart disease; Children

     
    ADVERSE DRUG REACTIONS

    Viral infection (cold/flu); headache, dizziness, drowsiness, fatigue; nausea, dyspepsia, dysmenorrhoea.

     
    DRUG INTERACTIONS

    Co-administration with ketoconazole or erythromycin may increase plasma levels of fexofenadine; Administration of antacid containing aluminium or magnesiuhydroxide causes reduction in bioavailability; Pramlintide may increase the anticholinergic effect of fexofenadine; Bioavailability may be increased by verapamil; Efficacy may be reduced by rifampin; May increase adverse effects of other anticholinergics and CNS depressants; May increase arrhythmogenic effect of antipsychotic agents (phenothiazines); avoid concurrent usage; May reduce the efficacy of betahistine.

     
    PRESENTATION

    NOLAR 120: Each box contains 10 blister packs of 10 tablets per blister.

    NOLAR 180: Each box contains 10 blister packs of 10 tablets per blister.

    NOLAR Suspension: Each bottle contains 60ml of suspension.