DIAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

DIAZEPAM

Composition:

DIAZEPAM 5 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 5 mg are scored, round, yellow tablets imprinted DAN 5619 and 5 supplied in Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-5880-61. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Major Pharmaceuticals
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This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: May 2018
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 tablet

Summary of Product characteristics

DIAZEPAM- DIAZEPAM TABLET
MAJOR PHARMACEUTICALS
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DIAZEPAM TABLETS USP
C-IV
Revised: May 2018
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).
•
•
•
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
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.
16
13
2
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 – 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