DIAZEPAM tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Medsource Pharmaceuticals

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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 30 tablets. 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.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

Medsource Pharmaceuticals
----------
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 benzo
diazepines with opioid medicines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death.
•
Diazepam tablets can make you sleepy or dizzy, and can slow your
thinking and motor skills.
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know
how diazepam tablets affect you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
diazepam tablets without first talking to your healthcare provider.
When taken with
alcohol or drugs that cause sleepiness or dizziness, diazepam tablets
may make your
sleepiness or dizziness much worse.
•
Do not take more diazepam tablets than prescribed.
What are diazepam tablets?
•
Diazepam tablets are a prescription medicine used:
•
to treat anxiety disorders
•
for the short-term relief of the symptoms of anxiety
•
to relieve the symptoms of alcohol withdrawal including agitation,
shakiness (tremor),
sudden and severe mental or nervous system changes (delirium tremens)
and seeing or
hearing things that others do not see or hear (hallucinations)
•
along with other medicines for the relief of muscle spasms
•
along with other medicines to treat seizure disorders
•
Diazepam tablets are a federal controlled substance (C-IV) because it
can be abused or lead to
dependence. Keep diazepam tablets in a safe place to prevent misuse
and abuse. Selling or giving
away diazepam tablets may harm others, and is against the law. Tell
your healthcare provider if
you have abused or been dependent on alcohol, prescription medicines
or street drugs.
•
It is not known if diazepam tablets are safe and effective in children
under 6 months of age.
•
It is not known if diazepam tab

Características técnicas

DIAZEPAM- DIAZEPAM TABLET
MEDSOURCE PHARMACEUTICALS
----------
DIAZEPAM TABLETS 10 MG USP
C-IV
RX ONLY
WARNINING: RISKS FROM CONCOMITANT USE WITH OPIODS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death (see DRUG INTERACTIONS).
Reserve concomitant prescribing of these drugs for use 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.
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
16
13
2
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