Thiothixene (Thiothixene) - Indications and Dosage

INDICATIONS AND USAGE

Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.

DOSAGE AND ADMINISTRATION

Dosage of thiothixene capsules should be individually adjusted depending on the chronicity and severity of the symptoms of schizophrenia. In general, small doses should be used initially and gradually increased to the optimal effective level, based on patient response.

Some patients have been successfully maintained on once a day thiothixene capsule therapy.

The use of thiothixene capsules in children under 12 years of age is not recommended because safe conditions for its use have not been established.

In milder conditions, an initial dose of 2 mg three times daily is recommended. If indicated, a subsequent increase to 15 mg/day total daily dose is often effective.

In more severe conditions, an initial dose of 5 mg twice daily is recommended.

The usual optimal dose is 20 mg to 30 mg daily. If indicated, an increase to 60 mg/day total daily dose is often effective. Exceeding a total daily dose of 60 mg rarely increases the beneficial response.

HOW SUPPLIED

Thiothixene Capsules, USP are available containing 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP.

The 1 mg capsule is a hard-shell gelatin capsule with a caramel opaque cap and a powder blue opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 1001 in black ink on both the cap and body. They are available as follows:

NDC 0378-1001-01
bottles of 100 capsules

The 2 mg capsule is a hard-shell gelatin capsule with a caramel opaque cap and a yellow opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 2002 in black ink on both the cap and body. They are available as follows:

NDC 0378-2002-01
bottles of 100 capsules

NDC 0378-2002-10
bottles of 1000 capsules

The 5 mg capsule is a hard-shell gelatin capsule with a caramel opaque cap and a white opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 3005 in black ink on both the cap and body. They are available as follows:

NDC 0378-3005-01
bottles of 100 capsules

NDC 0378-3005-10
bottles of 1000 capsules

The 10 mg capsule is a hard-shell gelatin capsule with a caramel opaque cap and a peach opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 5010 in black ink on both the cap and body. They are available as follows:

NDC 0378-5010-01
bottles of 100 capsules

NDC 0378-5010-10
bottles of 1000 capsules

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED JANUARY 2009
THTX:R18