CLARITYNE TABLET 10mg

4.1 Therapeutic indications

CLARITYNE® Products are indicated for the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning. Nasal and ocular signs and symptoms are relieved rapidly after oral administration. CLARITYNE® Products are also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.

4.3 Contraindications

CLARITYNE® Products are contraindicated in patients who are hypersensitivity to the active substance or to any of the excipients in these formulations.

4.2 Posology and method of administration

Adults and Children 12 years of age and over:

CLARITYNE® Tablet: One tablet (10 mg) once daily;

Children 6 to 12 years of age:

CLARITYNE® Tablet:

Body Weight >30 kg -- One tablet (10 mg) once daily

Safety and efficacy of CLARITYNE® has not been established in children younger than 2 years of age.

Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 5 mg once daily, or 10 mg every other day is recommended.