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  • Chlorpheniramine maleate tablet 4 mg ; dosage, side effects – And Medicine

    (Chlorpheniramine Maleate BP)
    Tablet, Syrup & Injection
    DESCRIPTION

    Chlorpheniramine Maleate which belongs to the alkylamine group of Hrantihistamines. It is a potent antihistamine. Chlorpheniramine also has a weak antimuscarinic, moderate antiserotonin and local anaesthetic actions.
    Oral absorption > 80%
    Presystemic metabolism < 20%
    tmax about 2.5 – 6.0 hrs.
    Plasma half-life range 2 – 43 hrs.
    Volume of distribution 1 – 10 l.kg-1
    Plasma protein binding 69 – 72%
    tmax = Time to reach peak plasma concentration
    COMPOSITION
    Chlorpheniramine maleate Tablet : Each tablet contains
    Chlorpheniramine Maleate BP 4 mg.
    Chlorpheniramine maleate ® Syrup : Each 5 ml contains
    Chlorpheniramine Maleate BP 2 mg.
    Chlorpheniramine maleate ® Injection : Each ml contains
    Chlorpheniramine Maleate BP 10 mg.
    INDICATIONS
    It is used for the symptomatic relief of allergic conditions including: a Allergic rhinitis and conjunctivitis a Urticaria a Angioedema a Pruritic skin disorders a Emergency treatment of anaphylactic reactions (as an adjunct)
    DOSAGE AND ADMINISTRATION Oral dose
    Adults
    A dose of 4 mg every 4 to 6 hours upto a maximum of 24 mg daily.
    Children
    1 – 2 years : 1 mg twice daily.
    2 – 5 years : 1 mg every 4 to 6 hours (maximum 6 mg daily). 6-12 years : 2 mg every 4 to 6 hours (maximum 12 mg daily).
    Parenteral dose
    It may be given by intramuscular, subcutaneous, or by slow intravenous injection
    over a period of 1 minute.
    The usual dose is 10 – 20 mg, repeated if required and the total dose given by
    these routes in 24 hours should not normally exceed 40 mg.
    For children, doses of 87.5 meg per kg body-weight subcutaneously four times
    daily have been suggested.
    CONTRAINDICATIONS
    a Known allergy to Chlorpheniramine
    a Not recommended to be used during pregnancy
    DRUG INTERACTIONS
    Centrally effective Hi-antihistamines might add to sedative effects of psychotropic drugs for example. This has not been proved with therapeutic doses of chlorpheniramine.
    The combination of hypnotics and Ht-antihistamines are considered more dangerous than either agent alone but, again, no specific data with chlorpheniramine is available. MAO inhibitors may interact with antihistamines, chlorpheniramine included, in dangerous ways, particularly with the fixed combinations of antihistamines and indirectly-acting sympathomimetics.
    Food may reduce the absorption of chlorpheniramine. Pharmacodynamic interactions (sedation, excitation) with alcohol can be dangerous with large doses.
    SIDE EFFECTS/ADVERSE REACTIONS
    Drowsiness, dizziness, blurred vision, dry mouth and gastrointestinal upsets may occur. Large doses produce central nervous system depression and occasionally tremors or convulsions. Reports of haematological disorders are rare. Injections may be irritant and cause transient hypotension or stimulation of the CNS.
    PRECAUTIONS
    It should be used with caution in patients with closed-angle glaucoma, urinary retention, prostatic hypertrophy, or pyloroduodenal obstruction, epilepsy, and severe cardiovascular disorders.
    Many antihistamines may cause drowsiness; patients so affected should not drive or operate machinery. Patients should avoid alcoholic drink.
    Antihistamines should not be given to premature infants or neonates; this group of patients has an increased susceptibility to antimuscarinic effects. Elderly patients are also more susceptible to many adverse effects of antihistamines. including antimuscarinic effects, sedation, and hypotension.
    USE IN PREGNANCY AND LACTATION
    The safety of chlorpheniramine in pregnancy has not been established.
    The drug is excreted in small amounts in breast milk, and mothers taking the drug should not breast-feed.
    USE IN CHILDREN
    It may be used in children in appropriate doses and not recommended in neonates.
    PACKAGING Chlorpheniramine maleate ® Tablet Chlorpheniramine maleate ® Syrup
    Chlorpheniramine maleate ® Injection
    Box containing 10×10 & 50×10 tablets of blister/strip pack. Bottle containing 60 ml syrup & Bottle containing 100 ml_ syrup. Ampoule of 1 mL into boxes of 10 & Ampoule of 2 mL into boxes of 10.
    PHARMACEUTICAL PRECAUTIONS
    Keep in a cool dry place, away from light.
    WARNING
    Keep out of the reach of children.

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