Salagen (Pilocarpine Hydrochloride) - Indications and Dosage

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 Sjogren's Syndrome.

DOSAGE AND ADMINISTRATION

Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.

Head & Neck Cancer Patients:    The recommended initial dose of SALAGEN® Tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 15-30 mg per day. (Not to exceed 10 mg 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.

Sjogren's Syndrome Patients:    The recommended dose of SALAGEN® Tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.

HOW SUPPLIED

SALAGEN® Tablets, 5 mg, are white, film coated, debossed round tablets, coded SAL 5. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows:

NDC 58063-705-10 bottles of 100

Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

SALAGEN® Tablets, 7.5 mg, are blue, film coated, debossed round tablets, coded SAL 7.5. Each tablet contains 7.5 mg pilocarpine hydrochloride. They are supplied as follows:

NDC 58063-775-10 bottles of 100

Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Manufactured by:IN-10619/Y

Patheon YM Inc.,

Toronto, Ontario, M3B 1Y5

For:

MGI PHARMA, INC., Bloomington, MN 55437

© 2003 MGI PHARMA, INC.                     September 2003

SALAGEN® is a registered trademark of

MGI PHARMA, INC.

                                                               43-5025-008        2/04