CHLORPROMAZINE HYDROCHLORIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

AvPAK

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 depressants (alcohol, barbiturates, narcotics, etc).

leaflet_short:

Chlorpromazine Hydrochloride Tablets USP, 10 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B” with black ink on one side and plain on the other side. They are available as follows: NDC 50268-162-15 (10 tablets per card, 5 cards per carton). Chlorpromazine Hydrochloride Tablets USP, 25 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B2” with black ink on one side and plain on the other side. They are available as follows: NDC 50268-163-15 (10 tablets per card, 5 cards per carton). Chlorpromazine Hydrochloride Tablets USP, 50 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B3” with black ink on one side and plain on the other side. They are available as follows: NDC 50268-164-15 (10 tablets per card, 5 cards per carton). THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine Hydrochloride Tablets USP, 100 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B4” with black ink on one side and plain on the other side. They are available as follows: NDC 50268-165-15 (10 tablets per card, 5 cards per carton). Chlorpromazine Hydrochloride Tablets USP, 200 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B5” with black ink on one side and plain on the other side. They are available as follows: NDC 50268-166-12 (5 tablets per card, 4 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children. Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 12-2019-01 AV 01/20 (P)

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET,
FILM COATED
AVPAK
----------
CHLORPROMAZINE HYDROCHLORIDE TABLETS, USP
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.
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, USP is a white to almost white
crystalline powder. It is
very soluble in water, freely soluble in ethanol (96%).
Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100
mg, or 200 mg
of chlorpromazine hydrochloride, USP.
Inactive ingredients: hypromellose, lactose monohydrate, magnesium
stearate,
polyethylene gl