DIAZEPAM tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (국제 이름):

DIAZEPAM

구성:

DIAZEPAM 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 Tablets USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets USP are 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 Tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should

제품 요약:

Diazepam Tablets USP, 2 mg are available as white, round, flat face, beveled edge tablets, debossed “3925” and bisected on one side and “TEVA” on the other side, containing 2 mg of diazepam, USP. Diazepam Tablets USP, 5 mg are available as yellow, round, flat face, beveled edge tablets, debossed “3926” and bisected on one side and “TEVA” on the other side, containing 5 mg of diazepam, USP. Diazepam Tablets USP, 10 mg are available as light blue, round, flat face, beveled edge tablets, debossed “3927” and bisected on one side and “TEVA” on the other side, containing 10 mg of diazepam, USP. NDC 0615-7800-39 10 mg packaged in blistercards of 30 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. C 1/2015

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DIAZEPAM- DIAZEPAM TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
DIAZEPAM TABLETS USP
CIV
DESCRIPTION
Diazepam Tablets USP are a benzodiazepine derivative. Chemically,
diazepam, USP 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 Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets
for oral administration and contain
the following inactive ingredients: anhydrous lactose, colloidal
silicon dioxide; colorants: 5 mg only
(D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only
(FD&C Blue No. 1
aluminum lake); magnesium stearate, microcrystalline cellulose,
pregelatinized corn 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 appr