DIAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIAZEPAM (UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

DIAZEPAM

Composition:

DIAZEPAM 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diazepam 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 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 usefulness of

Product summary:

For oral administration, Diazepam Tablets, USP are supplied as: 2 mg- white, flat-faced beveled edge scored tablets, debossed "2682" on one side and "V" on the reverse side, supplied in bottles of 60 and 100. 5 mg- yellow, flat-faced beveled edge scored tablets, debossed "2683" on one side and "V" on the reverse side, supplied in bottles of 2, 3, 5, 7, 10, 14, 30, 60 and 90. 10 mg- blue, flat-faced beveled edge scored tablets, debossed "2684" on one side and "V" on the reverse side, supplied in bottles of 5,7,8, 10, 20, 30 and 60.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIAZEPAM- DIAZEPAM TABLET
AIDAREX PHARMACEUTICALS LLC
----------
DIAZEPAM TABLETS, USP
CIV
RX ONLY
DESCRIPTION
Diazepam is a benzodiazepine derivative. The chemical name of diazepam
is 7-chloro-1,3-dihydro-1-
methyl-5-phenyl-2_H_-1,4-benzodiazepin-2-one. It is a colorless to
light yellow crystalline compound,
insoluble in water. The empirical formula is C
H ClN O and the molecular weight is 284.75. The
structural formula is as follows:
Diazepam is available for oral administration as tablets containing 2
mg, 5 mg or 10 mg diazepam. In
addition to the active ingredient diazepam, each tablet contains the
following inactive ingredients:
calcium stearate, colloidal silicon dioxide, croscarmellose sodium,
lactose monohydrate and
microcrystalline cellulose with the following dyes: 5-mg tablets
contain D&C Yellow #10 aluminum
lake; 10-mg tablets contain FD&C Blue #1 aluminum lake. Diazepam 2-mg
tablets contain no dye.
CLINICAL PHARMACOLOGY
Diazepam is a benzodiazepine that exerts anxiolytic, sedative,
muscle-relaxant, anticonvulsant and
amnestic effects. Most of these effects are thought to result from a
facilitation of the action of gamma
aminobutyric acid (GABA), an inhibitory neurotransmitter in the
central nervous system.
PHARMACOKINETICS
Absorption
After oral administration >90% of diazepam is absorbed and the average
time to achieve peak plasma
concentrations is 1 - 1.5 hours with a range of 0.25 to 2.5 hours.
Absorption is delayed and decreased
when administered with a moderate fat meal. In the presence of food
mean lag times are approximately
45 minutes as compared with 15 minutes when fasting. There is also an
increase in the average time to
achieve peak concentrations to about 2.5 hours in the presence of food
as compared with 1.25 hours
when fasting. This results in an average decrease in C
of 20% in addition to a 27% decrease in AUC
16
13
2
max
(range 15% to 50%) when administered with food.
Distribution
Diazepam and its metabolites are highly bound to plasma proteins
(diazepam 98%). Diazepam and its
metabol