DIAZEPAM tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Apotheca, Inc.

INN (International Name):

DIAZEPAM

Sammensætning:

DIAZEPAM 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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 as follows: Manfactured by Ivax Pharmaceuticals Repackaged and Distributed for private label by Apotheca, Inc. Diazepam Tablets USP,10 mg are available as blue, round, flat-faced, beveled-edge, bisected tablet. Debossed with stylized Barr on one side and 555/164 on the other side containing 10 mg diazepam USP as follows: Manufactured by Barr Laboratories, Inc. Repackaged and Distributed for private label by Apotheca, Inc.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DIAZEPAM - DIAZEPAM TABLET
APOTHECA, INC.
----------
DIAZEPAM 5MG AND 10MG USP CS-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
IVAX PHARMACEUTICALS: 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
and C Yellow No. 10 and FD and
C Yellow No. 6);
10 mg only (FD and C Blue No. 1);magnesium stearate,microcrystalline
cellulose, pregelatinized starch,
and sodium starch glycolate.
BARR LABORATORIES: Diazepam is available in 2 mg, 5 mg and 10 mg
tablets for oral administration and
_contains the following inactive ingrediants: _
Croscarmellose cellulose,lactose monohydrate,magnesium stearate,
microcrystalline cellulose.
COLORS: FD and C blue #1 (10 mg only), D and C yellow #10 (5 mg only)
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
ABS ORPTION
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
16
13
2
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 1