DIAZEPAM tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Quality Care Products, LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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. 55700-058-30 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

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Quality Care Products, LLC
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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.
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.
•
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 a

Karakteristik produk

DIAZEPAM- DIAZEPAM TABLET
QUALITY CARE PRODUCTS, LLC
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DIAZEPAM TABLETS USP CIVRX ONLY
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 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:
C
H
ClN O 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.
CLINICAL PHARMACOLOGY
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
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
concentratio