CHLORPROMAZINE- chlorpromazine hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

CHLORPROMAZINE HYDROCHLORIDE

Composition:

CHLORPROMAZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depr

Product summary:

Chlorpromazine hydrochloride tablets, USP are available as: 25 mg: Round, film-coated, butterscotch colored tablets, debossed GG 476 on one side and 25 on the reverse side, and supplied as: NDC 0615-1546-39 blisterpacks of 30. 50 mg: Round, film-coated, butterscotch colored tablets, debossed GG 407 on one side and 50 on the reverse side, and supplied as: NDC 0615-1547-39 blisterpacks of 30. For use only in severe neuropsychiatric conditions: 100 mg: Round, film-coated, butterscotch colored tablets, debossed GG 437 on one side and 100 on the reverse side, and supplied as: NDC 0615-1548-39 blisterpacks of 30. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORPROMAZINE- CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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CHLORPROMAZINE HYDROCHLORIDE TABLETS, USP
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.
CHLORPROMAZINE
HYDROCHLORIDE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
(SEE WARNINGS).
DESCRIPTION
Chlorpromazine hydrochloride, a dimethylamine derivative of
phenothiazine, has a chemical formula of
2-chloro-10-[3-(dimethylamino)propyl] phenothiazine monohydrochloride.
It is available in tablets for
oral administration. It has the following structural formula:
Chlorpromazine hydrochloride occurs as white or slightly creamy white,
odorless, crystalline powder
which darkens on prolonged exposure to light.
Each tablet, for oral administration, contains 10, 25, 50, 100, or 200
mg chlorpromazine hydrochloride.
Inactive ingredients: D & C Red #30 Aluminum Lake, D & C Yellow #10
Aluminum Lake, FD & C Bl