THIOTHIXENE capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

THIOTHIXENE (UNII: 7318FJ13YJ) (THIOTHIXENE - UNII:7318FJ13YJ)

Mevcut itibaren:

Amneal Pharmaceuticals NY LLC

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. Thiothixene capsules are contraindicated in patients with circulatory collapse, comatose states, central nervous system depression due to any cause, and blood dyscrasias. Thiothixene capsules are contraindicated in individuals who have shown hypersensitivity to the drug. It is not known whether there is a cross sensitivity between the thioxanthenes and the phenothiazine derivatives, but this possibility should be considered.

Ürün özeti:

Thiothixene Capsules USP, 1 mg are supplied as size ‘4’ hard gelatin capsules with a caramel opaque colored cap and a blue opaque colored body, imprinted 'AA10A' on body, with black ink containing white to off-white granular powder. They are available as follows: Bottles of 100 with child-resistant closure:                     NDC 60219-1673-1 Bottles of 1000:                                                               NDC 60219-1673-7 Thiothixene Capsules USP, 2 mg are supplied as size ‘4’ hard gelatin capsules with a caramel opaque colored cap and a yellow opaque colored body, imprinted 'AA11A' on body, with black ink containing white to off-white granular powder. They are available as follows: Bottles of 100 with child-resistant closure:                     NDC 60219-1674-1 Bottles of 1000:                                                               NDC 60219-1674-7 Thiothixene Capsules USP, 5 mg are supplied as size ‘4’ hard gelatin capsules with a caramel opaque colored cap and a white opaque colored body, imprinted 'AA12A' on body, with black ink containing white to off-white granular powder. They are available as follows: Bottles of 100 with child-resistant closure:                     NDC 60219-1675-1 Bottles of 1000:                                                               NDC 60219-1675-7 Thiothixene Capsules USP, 10 mg are supplied as size ‘4’ hard gelatin capsules with a caramel opaque colored cap and a peach opaque colored body, imprinted 'AA13A' on body, with black ink containing white to off-white granular powder. They are available as follows: Bottles of 100 with child-resistant closure:                     NDC 60219-1676-1 Bottles of 1000:                                                               NDC 60219-1676-7 Storage 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

THIOTHIXENE- THIOTHIXENE CAPSULE
AMNEAL PHARMACEUTICALS NY LLC
----------
THIOTHIXENE CAPSULES, USP
(1 MG, 2 MG, 5 MG AND 10 MG)
RX ONLY
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. ANALYSES OF
SEVENTEEN PLACEBO-CONTROLLED TRIALS (MODAL DURATION OF 10 WEEKS),
LARGELY IN PATIENTS TAKING ATYPICAL ANTIPSYCHOTIC DRUGS, REVEALED A
RISK OF
DEATH IN DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF
DEATH IN PLACEBO-TREATED PATIENTS. OVER THE COURSE OF A TYPICAL
10-WEEK
CONTROLLED TRIAL, THE RATE OF DEATH IN DRUG-TREATED PATIENTS WAS ABOUT
4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN THE PLACEBO GROUP. ALTHOUGH
THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED TO BE
EITHER CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR
INFECTIOUS
(E.G., PNEUMONIA) IN NATURE. OBSERVATIONAL STUDIES SUGGEST THAT,
SIMILAR
TO ATYPICAL ANTIPSYCHOTIC DRUGS, TREATMENT WITH CONVENTIONAL
ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE EXTENT TO WHICH THE
FINDINGS OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE
ATTRIBUTED TO THE ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME
CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR. THIOTHIXENE IS NOT
APPROVED
FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (SEE
WARNINGS).
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.
It has a molecular
formula C
H
N O S and the molecular weight is 443.63 g/mol.
The chemical structure is:
23
29
3
2 2
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 Thiothixene Capsules, USP contains 1 mg, 2 mg, 5 mg or 10 mg of
thiothixene,
USP and the foll