DIAZEPAM tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

diazepam (UNII: Q3JTX2Q7TU) (diazepam - UNII:Q3JTX2Q7TU)

Доступна з:

RedPharm Drug Inc.

ІПН (Міжнародна Ім'я):

diazepam

Склад:

diazepam 5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Diazepam Tablets USP 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 does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the

Огляд продуктів:

Diazepam Tablets USP 2 mg are scored, round, white tablets imprinted DAN 5621 and 2 supplied in bottles of 100, 500 and 1000. Diazepam Tablets USP 5 mg are scored, round, yellow tablets imprinted DAN 5619 and 5 supplied in bottles of 100, 500 and 1000. Diazepam Tablets USP 10 mg are scored, round, blue tablets imprinted DAN 5620 and 10 supplied in bottles of 100, 500 and 1000. Dispense in tight, light-resistant container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DIAZEPAM - DIAZEPAM TABLET
REDPHARM DRUG INC.
----------
DRUG LABEL SECTIONS C16H13CLN2O
M.W. 284.74 DIAZEPAM TABLETS USP 2 MG, 5 MG AND 10
MG, FOR ORAL ADMINISTRATION, CONTAIN THE FOLLOWING INACTIVE
INGREDIENTS: ANHYDROUS LACTOSE,
MAGNESIUM STEARATE AND MICROCRYSTALLINE CELLULOSE. DIAZEPAM TABLETS
USP 5 MG ALSO CONTAIN
D&C YELLOW NO. 10. DIAZEPAM TABLETS USP 10 MG ALSO CONTAIN FD&C BLUE
NO. 1.
DES CRIPTION:
Diazepam is a benzodiazepine derivative. Chemically, diazepam is
7-Chloro-1,3-dihydro-1-methyl-5-
phenyl-2_H_-1,4-benzodiazepin-2-one. It is a colorless crystalline
compound, and is insoluble in water.
The structural formula is represented below: C
H ClN O M.W. 284.74
Diazepam Tablets USP 2 mg, 5 mg and 10 mg, for oral administration,
contain the following inactive
ingredients: anhydrous lactose, magnesium stearate and
microcrystalline cellulose.
Diazepam Tablets USP 5mg also contain D and C Yellow No. 10.
Diazepam Tablets USP 10 mg also contain FD and C Blue No. 1.
PHARMACOLOGY
In animals, diazepam appears to act on parts of the limbic system, the
thalamus and hypothalamus, and
induces calming effects. Diazepam, unlike chlorpromazine and
reserpine, has no demonstrable
peripheral autonomic blocking action, nor does it produce
extrapyramidal side effects; however,
animals treated with diazepam do have a transient ataxia at higher
doses. Diazepam was found to have
transient cardiovascular depressor effects in dogs. Long-term
experiments in rats revealed no
disturbances of endocrine function.
Oral LD of diazepam is 720 mg/kg in mice and 1240 mg/kg in rats.
Intraperitoneal administration of
400 mg/kg to a monkey resulted in death on the sixth day.
REPRODUCTION STUDIES
A series of rat reproduction studies was performed with diazepam in
oral doses of 1, 10, 80 and 100
mg/kg. At 100 mg/kg there was a decrease in the number of pregnancies
and surviving offspring in these
rats. Neonatal survival of rats at doses lower than 100 mg/kg was
within normal limits. Several neonates
in these rat reproduction studies showed sk