Cevimeline (Cevimeline) - Indications and Dosage

INDICATIONS AND USAGE

Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren's Syndrome.

DOSAGE AND ADMINISTRATION

The recommended dose of cevimeline hydrochloride is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.

HOW SUPPLIED

EVOXAC® is available as white, hard gelatin capsules containing 30 mg of cevimeline hydrochloride. EVOXAC® capsules have a white opaque cap and a white opaque body. The capsules are imprinted with "EVOXAC" on the cap and "30 mg" on the body with a black bar above "30 mg". It is supplied in child resistant bottles of:

100 capsules (NDC 63395-201-13)

Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)

Rx Only

Manufactured by:

YAMANOUCHI PHARMA TECHNOLOGIES, INC.

Norman, OK 73072

Distributed and Marketed by:

Daiichi Pharmaceutical Corporation

Montvale, NJ 07645

EVOXAC is a registered trademark of

Daiichi Pharmaceutical Co., Ltd.

SRT17    Revised 11/2002