Moset®
Cetirizine

COMPOSITION
MOSET® tablet: Each film coated tablet contains Cetirizine Dihydrochloride BP 10mg.

PHARMACOLOGICAL INFORMATION
Pharmacological Action
MOSET® (Cetirizine) is a metabolite of hydroxyzine. It is a second-generation, reversible, competitive inhibitor of histamine at the histamine-1 (H1) receptor. Cetirizine prevents, but does not reverse, pharmacological responses mediated by histamine, at the H1-receptor.

Mechanism of Action
MOSET® (Cetirizine) is a potent histamine H1 receptor antagonist. In usual dosages cetirizine penetrate the blood brain barrier only to a slight extent, and that is why cetirizine & other newer antihistamines do not cause central sedation & psychomotor impairment.
MOSET® (Cetirizine) inhibits the histamine mediated 'early' phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the 'late' phase of the allergic pathway. Cetirizine also provides a protective effect from bronchospasm induced by inhaled histamine in asthmatics.

CLINICAL INFORMATION
Therapeutic Indications

• Seasonal Allergic Rhinitis: MOSET®(Cetirizine) is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing, and redness of the eyes.
• Perennial Allergic Rhinitis: MOSET® (Cetirizine) is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, occular pruritus, and tearing.
• Chronic Urticaria: MOSET® (Cetirizine) is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 2 years of age and older. It significantly reduces the occurrance, severity, and duration of hives and significantly reduces pruritus.

Dosages and administration
MOSET® (Cetirizine) can be taken without regard to food consumption. Moset is available as 5mg and 10mg tablets and 5mg and 10mg chewable tablets which can be taken with or without water.
Adults and Children 12 Years and Older: The recommended initial dose of Moset is 5mg or 10mg per day in adults and children 12 years and older, depending on symptom severity. Most patients in clinical trials started at 10 mg. MOSET® (Cetirizine) is given as a single daily dose. The time of administration may be varied to suit individual patient needs.
Children 6 to 11 Years: The recommended initial dose of MOSET® (Cetirizine) in children aged 6 to 11 years is 5mg or 10mg once daily depending on symptom severity. The time of administration may be varied to suit individual patient needs.
Children 2 to 5 Years: The recommended initial dose of MOSET® (Cetirizine) in children aged 2 to 5 years is 2.5mg once daily. The dosage in this age group can be increased to a maximum dose of 5mg per day.

Use in Children
MOSET® (Cetirizine) is effective and well tolerated in children. No special precautions are required in children over 6 years of age.

Contraindications
MOSET® (Cetirizine) is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to it or its parent compound-Hydroxyzine.

Use in patients with Impaired Hepatic Function
In moderate to severe hepatic impairment, half the recommended daily dose should be used.

Use in patient with Impaired Renal Function
In patients with renal impairment, where the creatinine clearance is less than 40ml/min, the recommended daily dose of cetirizine should be 5mg.

Elderly Patients
No dose adjustment is necessary in healthy elderly patients with normal renal function.

Drug Interaction
There are no reports of hazardous interactions with other drugs to date. Concomitant administration with alcohol or diazepam does not impair psychomotor performance any more than the impairment of performance produced by alcohol alone.

Use In Pregnancy & Lactation
Pregnancy: MOSET® (Cetirizine) is not teratogenic in animals. Since the animal studies are not always predictive of human response, it should be used only if the potential benefit justifies the potential risk to the fetus.
Lactation: The extent of MOSET® (Cetirizine) excretion in human breast milk is unknown but some animal studies have shown excretion in breast milk. Nursing mothers are advised not to take this medication.

Undesirable Effects
No potentially life threatening effects have been encountered.

PHARMACEUTICAL INFORMATION
Storage & Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
MOSET® tablet: Each commercial box contains 5x10's tablet in blister pack.