DIAZEPAM- diazepam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

DIAZEPAM

Composition:

DIAZEPAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 usefulness

Product summary:

Diazepam Tablets USP 10 mg are scored, round, blue tablets imprinted DAN 5620 and 10 supplied . NDC 68071-4030-5 Bottles of 15 NDC 68071-4030-3 Bottles of 30 NDC 68071-4030-6 Bottles of 60 NDC 68071-4030-9 Bottles of 90 Dispense in tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIAZEPAM- DIAZEPAM TABLET
NUCARE PHARMACEUTICALS,INC.
----------
DIAZEPAM TABLETS USP
C-IV
RX ONLY
DESCRIPTION
Diazepam is a benzodiazepine derivative. The chemical name of diazepam
is 7-chloro-1,3-dihydro-1-
methyl-5-phenyl-2H-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:
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.
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 (range 15% to 50%) when administered with food.
16
13
2
max
Distribution
Diazepam and its metabolites are highly bound to plasma proteins
(diazepam 98%). Diazepam and its
metabolites cross the blood-brain and placental barriers and are also
found in breast milk in
concentrati