MEPROBAMATE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

MEPROBAMATE (UNII: 9I7LNY769Q) (MEPROBAMATE - UNII:9I7LNY769Q)

Предлага се от:

Alembic Pharmaceuticals Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.  Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.

Каталог на резюме:

Meprobamate Tablets USP 200 mg are white to off white, round, biconvex, uncoated tablets debossed with "L125" on one side and break line on other side. NDC 62332-019-30         Bottle of 30 NDC 62332-019-31         Bottle of 100 NDC 62332-019-91         Bottle of 1000 Meprobamate Tablets USP 400 mg are white to off white, round, biconvex, uncoated tablets debossed with "L105" on one side and break line on other side. NDC 62332-020-30        Bottle of 30 NDC 62332-020-31        Bottle of 100 NDC 62332-020-91        Bottle of 1000 Dispense in well-closed container with child-resistant closure. Store at controlled room temperature, excursions permitted to 15°C-30°C (59°F-86°F). Preserve in well closed container. Call your doctor for medical advice about side effects. You may report side effects to Alembic Pharmaceuticals Limited at 1-866 210 9797 or FDA at 1-800-FDA-1088. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 09/2021

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

MEPROBAMATE - MEPROBAMATE TABLET
ALEMBIC PHARMACEUTICALS INC.
----------
MEPROBAMATE TABLETS USP
RX ONLY
DESCRIPTION
Meprobamate is a white powder with a characteristic odor and a bitter
taste. It is slightly
soluble in water, freely soluble in acetone and alcohol, and sparingly
soluble in ether. The
structural formula of meprobamate is:
C H
N O M.W. 218.25
Meprobamate Tablets USP 200 mg and 400 mg for oral administration
contain the
following inactive ingredients: colloidal silicon dioxide, magnesium
stearate,
microcrystalline cellulose, sodium starch glycolate and pregelatinised
starch.
CLINICAL PHARMACOLOGY
Meprobamate is a carbamate derivative which has been shown in animal
studies to have
effects at multiple sites in the central nervous system including the
thalamus and limbic
system.
INDICATIONS AND USAGE
9
18
2
4
Meprobamate tablets are indicated for the management of anxiety
disorders or for the
short-term relief of the symptoms of anxiety. Anxiety or tension
associated with the
stress of everyday life usually do not require treatment with an
anxiolytic.
The effectiveness of meprobamate tablets in long-term use, that is,
more than 4
months, has not been assessed by systematic clinical studies. The
physician should
periodically reassess the usefulness of the drug for the individual
patient.
CONTRAINDICATIONS
Acute intermittent porphyria as well as allergic or idiosyncratic
reactions to
meprobamate or related compounds such as carisoprodol, mebutamate,
tybamate, or
carbromal.
WARNINGS
DRUG DEPENDENCE
Physical dependence, psychological dependence, and abuse have
occurred. When
chronic intoxication from prolonged use occurs, it usually involves
ingestion of greater
than recommended doses and is manifested by ataxia, slurred speech,
and vertigo.
Therefore, careful supervision of dose and amounts prescribed is
advised, as well as
avoidance of prolonged administration, especially for alcoholics and
other patients with a
known propensity for taking excessive quantities of drugs.
Sudden withdrawal of the drug afte