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SALAGEN TABLET 5 MG [SIN11683P]
Active ingredients: SALAGEN TABLET 5 MG
Last updated 26 October 2025
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Product Info
SALAGEN TABLET 5 MG
[SIN11683P]
Product information
Active Ingredient and Strength | PILOCARPINE HCL - 5 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | PATHEON INC - CANADA |
Registration Number | SIN11683P |
Licence Holder | PHARMAFORTE SINGAPORE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | N07AX01 |
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.
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.
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.