DIAZEPAM tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

DirectRX

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 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 periodically re

Toote kokkuvõte:

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. 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 In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. D 3/2017

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

DIAZEPAM- diazepam tablet
DirectRX
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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 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 tablets are safe and effective for use
longer than 4

Toote omadused

DIAZEPAM- DIAZEPAM TABLET
DIRECTRX
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DIAZEPAM C-IV
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).
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.
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:
Diazepam Structural Formula
C16H13ClN2O 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.
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