VALIUM- diazepam tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

PD-Rx Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

DIAZEPAM

रचना:

DIAZEPAM 5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Valium is 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, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Valium 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 Valium may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Valium 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 of the drug for the in

उत्पाद समीक्षा:

For oral administration, Valium is supplied as round, flat-faced scored tablets with V-shaped perforation and beveled edges. Valium is available as follows: 5 mg, yellow - bottles of 6 (NDC 55289-117-06) and 12 (NDC 55289-117-12), bottles of 20 (NDC 55289-117-20). Engraved on tablets: 5 mg—5 VALIUM ® (front) ROCHE (twice on scored side)    Store at room temperature 59° to 86°F (15° to 30°C). Dispense in tight, light-resistant containers as defined in USP/NF.

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
VALIUM (VAL-EE-UM)
(DIAZEPAM) TABLETS, C-IV
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: June 2017
What is the most important information I should know about VALIUM?
•
VALIUM is 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.
•
VALIUM 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 VALIUM affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
VALIUM without first talking to your healthcare provider. When taken
with alcohol or
drugs that cause sleepiness or dizziness, VALIUM may make your
sleepiness or dizziness
much worse.
•
Do not take more VALIUM than prescribed.
What is VALIUM?
•
VALIUM is 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
•
VALIUM is a federal controlled substance (C-IV) because it can be
abused or lead to
dependence. Keep VALIUM in a safe place to prevent misuse and abuse.
Selling or giving away
VALIUM 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 VALIUM is safe and effective in children under 6
months of age.
•
It is not known if VALIUM is safe and effective for use lon

उत्पाद विशेषताएं

VALIUM- DIAZEPAM TABLET
PD-RX PHARMACEUTICALS, INC.
----------
VALIUM CIV
BRAND OF
DIAZEPAM
TABLETS
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.
DESCRIPTION
Valium (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:
Valium 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, corn starch, pregelatinized starch and calcium
stearate with the following dyes: 5-mg
tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; 10-mg tablets
contain FD&C Blue No. 1.
Valium 2-mg tablets contain no dye.
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
®
16
13
2
Absorption
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. Ther