Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION:** Head & Neck Cancer Patients: The recommended initial dose of SALAGEN® Tablets is one tablet (5 mg) taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 3–6 tablets or 15–30 mg per day (Not to exceed 2 tablets per dose). Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with SALAGEN® Tablets may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance. Sjögren's Syndrome Patients: The recommended dose of SALAGEN® Tablets is one tablet (5 mg) taken four times a day. Efficacy was established by 6 weeks of use.
ORAL
Medical Information
**INDICATIONS AND USAGE:** SALAGEN® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjögren's syndrome.
**CONTRAINDICATIONS:** SALAGEN® Tablets are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.
N07AX01
pilocarpine
Manufacturer Information
PHARMAFORTE SINGAPORE PTE LTD
PATHEON INC
Active Ingredients
Documents
Package Inserts
Salagen Tablet PI.pdf
Approved: November 2, 2003