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 Sjögrens syndrome.

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.

Sjögrens 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.

SALAGEN Tablets, 5 mg, are white, film coated, round tablets, coded MGI 705. Each tablet contains 5 mg pilocarpine hydrochloride.

They are supplied as follows:

NDC 58063-705-10 bottles of 100

Storage: Store at Controlled Room Temperature 15°-30°C (59°-86°F).

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