DIAZEPAM tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Direct_Rx

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 Cmax of 20% in addition to a 27% decrease in AUC (range 15% to 50%) when administered with food. Distribution Diazepam and its metabolites are high

產品總結:

Diazepam Tablets USP 2 mg are white, flat-faced, bevel edge, bisected tablets imprinted MYX/941 on one side and 2 imprinted on the other side. Supplied in bottles of 100 (NDC 51862-941-01) and 500 (NDC 51862-941-05) tablets. Diazepam Tablets USP 5 mg are yellow, flat-faced, bevel edge, bisected tablets imprinted MYX/942 on one side and 5 imprinted on the other side. Supplied in bottles of 100 (NDC 51862-942-01), 500 (NDC 51862-942-05) and 1000 (NDC 51862-942-10) tablets. Diazepam Tablets USP 10 mg are light blue, flat-faced, bevel edge, bisected tablets imprinted MYX/943 on one side and 10 imprinted on the other side. Supplied in bottles of 5 (NDC 72189-400-05), 30 (NDC 72189-400-30) tablets. STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container with child-resistant closure.

授权状态:

Abbreviated New Drug Application

资料单张

DIAZEPAM- DIAZEPAM TABLET
Direct_Rx
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MEDICATION GUIDE
DIAZEPAM (dye az' e pam) TABLETS, C-IV
What is the most important information I should know about Diazepam
Tablets?
Diazepam tablets are a benzodiazepine medicine. Taking benzodiazepines
with opioid medicines, alcohol,
or other central nervous system (CNS) depressants (including street
drugs) can cause severe drowsiness,
breathing problems (respiratory depression), coma and death. Get
emergency help right away if any of the
following happens:
Shallow or slowed breathing,
Breathing stops (which may lead to the heart stopping),
Excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
diazepam with opioids affects you.
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including diazepam, which can lead to overdose and
serious side effects including coma
and death.
Serious side effects including coma and death have happened in people
who have abused or misused
benzodiazepines, including diazepam. These serious side effects may
also cause delirium, paranoia,
suicidal thoughts or actions, seizures, and difficulty breathing. Call
your healthcare provider or go to the
nearest hospital emergency room right away if you get any of these
serious side effects.
You can develop an addiction even if you take diazepam tablets exactly
as prescribed by your healthcare
provider.
Take diazepam tablets exactly as your healthcare provider prescribed.
Do not share your diazepam tablets with other people.
Keep diazepam tablets in a safe place and away from children.
Physical dependence and withdrawal reactions. Diazepam tablets can
cause physical dependence and
withdrawal reactions.
Do not suddenly stop taking diazepam tablets. Stopping diazepam
tablets suddenly can cause serious and
life- threatening side effects, including, unusual movements,
responses, or expressions, seizures, sudden
and severe mental or nervous system changes, depression, seeing or
hearing things that othe

产品特点

DIAZEPAM- DIAZEPAM TABLET
DIRECT_RX
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DIAZEPAM
Rx only
WARNINING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE,
AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death. Reserve concomitant
prescribing of
these drugs in patients for whom alternative treatment options are
inadequate.
Limit dosages and durations to the minimum required. Follow patients
for signs and
symptoms of respiratory depression and sedation (see WARNINGS and
PRECAUTIONS).
The use of benzodiazepines, including Diazepam, exposes users to risks
of abuse,
misuse, and addiction, which can lead to overdose or death. Abuse and
misuse of
benzodiazepines commonly involve concomitant use of other medications,
alcohol,
and/or illicit substances, which is associated with an increased
frequency of serious
adverse outcomes. Before prescribing Diazepam and throughout
treatment,
assess each patient's risk for abuse, misuse, and addiction (see
WARNINGS).
The continued use of benzodiazepines, including Diazepam, may lead to
clinically
significant physical dependence. The risks of dependence and
withdrawal increase
with longer treatment duration and higher daily dose. Abrupt
discontinuation or
rapid dosage reduction of Diazepam after continued use may precipitate
acute
withdrawal reactions, which can be life-threatening. To reduce the
risk of
withdrawal reactions, use a gradual taper to discontinue Diazepam or
reduce the
dosage (see DOSAGE AND ADMINISTRATION and WARNINGS)
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 C16H13ClN2O
and the molecular weight is 284.75. The structural formula is as
follows:
[Chemical Structure]
Diazepam is available for oral administration as tablets containing 2
mg, 5 mg or 10 mg
diazepam. In addition to