DIAZEPAM tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Direct_Rx

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

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. 2 mg packaged in bottles of 100 tablets 2 mg packaged in bottles of 500 tablets 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. 5 mg packaged in bottles of 100 tablets 5 mg packaged in bottles of 500 tablets 5 mg packaged in bottles of 1000 tablets 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. 10 mg packaged in bottles of 100 tablets 10 mg packaged in bottles of 500 tablets 10 mg packaged in bottles of 1000 tablets 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

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

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 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

Ապրանքի հատկությունները

DIAZEPAM- DIAZEPAM TABLET
DIRECT_RX
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DIAZEPAM
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 1