DIAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Diazepam (UNII: Q3JTX2Q7TU) (Diazepam - UNII:Q3JTX2Q7TU)

Available from:

Rebel Distributors Corp.

INN (International Name):

Diazepam

Composition:

Diazepam 2 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, 2 mg are available as white, round, flat faced, beveled edge tablets, debossed “Z” and “3925” with a bisect on one side and “2” on the other side containing 2 mg diazepam USP, packaged in bottles of 30 and 90 tablets. Diazepam Tablets USP, 5 mg are available as yellow, round, flat faced, beveled edge tablets, debossed “Z” and “3926” with a bisect on one side and “5” on the other side containing 5 mg diazepam USP packaged in bottles of 2, 10, 12, 15, 20, 30, 45, 60 and 90 tablets. Diazepam Tablets USP, 10 mg are available as light blue, round, flat faced, beveled edge tablets, debossed “Z” and “3927” on one side and “10” on the other side, containing 10 mg diazepam USP, packaged in bottles of 5, 15, 30, 48, 60 and 90 tablets. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Iss. 2/2009 Manufactured In Ireland By: IVAX PHARMACEUTICALS IRELAND Waterford, Ireland Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged by: REBEL DISTRIBUTORS CORP. Thousand Oaks, CA 91320 DIAZEPAM TABLETS USP

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIAZEPAM- DIAZEPAM TABLET
REBEL DISTRIBUTORS CORP.
----------
DIAZEPAM TABLETS USP CIV
RX ONLY
DESCRIPTION
Diazepam is a benzodiazepine derivative. Chemically, 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, and is
insoluble in water. Its structural formula is:
C
H ClN O M.W. 284.75
Diazepam is available as 2 mg, 5 mg, and 10 mg tablets for oral
administration and contains the
following inactive ingredients: anhydrous lactose, colloidal silicon
dioxide; colorants: 5 mg only (D&C
Yellow No. 10 and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1);
magnesium stearate,
microcrystalline cellulose, pregelatinized starch, and sodium starch
glycolate.
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 to 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.
Distribution
16
13
2
max
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
concentrations approximately one tenth of those in maternal plasma
(days 3 to 9 post-partum). In