DIAZEPAM- diazepam tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

A-S Medication Solutions

INN (International Name):

DIAZEPAM

Sammensætning:

DIAZEPAM 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Diazepam tablets 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 may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets 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 tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodi

Produkt oversigt:

Product: 50090-2063 NDC: 50090-2063-4 4 TABLET in a BOTTLE

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

A-S Medication Solutions
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MEDICATION GUIDE
Diazepam Tablets, USP
(dye az' e pam)
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 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.
o
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
diazepam tablets affect you.
o
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.
o
Do not take more diazepam tablets than prescribed.
What are diazepam tablets?
•
Diazepam tablets are a prescription medicine used:
o
to treat anxiety disorders
o
for the short-term relief of the symptoms of anxiety
o
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)
o
along with other medicines for the relief of muscle spasms
o
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 tablets are safe and e

Produktets egenskaber

DIAZEPAM- DIAZEPAM TABLET
A-S MEDICATION SOLUTIONS
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WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
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 molecular formula is C
H ClN O and the molecular weight is 284.74. The
structural formula is as follows:
Diazepam is available for oral administration as tablets containing 2
mg, 5 mg or 10 mg diazepam, USP.
In addition to the active ingredient diazepam, each tablet contains
the following inactive ingredients:
colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, pregelatinized starch (corn)
and sodium lauryl sulfate. The 5 mg tablets also contain FD&C Yellow
No. 6 Aluminum Lake. The 10
mg tablets also contain FD&C Blue No. 1 Aluminum Lake and D&C Yellow
No. 10 Aluminum Lake.
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
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
when administered with a moderate fat meal. In the presence of food
mean lag times are approximately
45 minutes as compared with 15