Drug Catalog - Product Detail
THIOTHIXENE CP 2MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-2002-01 | MYLAN | 100 | 2MG | CAPSULE |
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Description
DESCRIPTION Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N -Dimethyl-9-[3-(4-methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide functional group is bonded to the thioxanthene nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The 1 mg capsules also contain D&C Red No. 28 and the 2 mg capsules also contain D&C Yellow No. 10. In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. Thiothixene Structural Formula
How Supplied
HOW SUPPLIED Thiothixene Capsules, USP are available containing 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP. The 1 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a powder blue opaque body filled with white to off-white powder. The capsules are 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 capsules are hard-shell gelatin capsules with a caramel opaque cap and a yellow opaque body filled with white to off-white powder. The capsules are 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 The 5 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a white opaque body filled with white to off-white powder. The capsules are 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 The 10 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a peach opaque body filled with white to off-white powder. The capsules are 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 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
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 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 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.