DIAZEPAM tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Direct_Rx

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Diazepam Tablets USP 2 mg are scored, round, white tablets imprinted DAN 5621 and 2 supplied in bottles of 100, 500 and 1000. Diazepam Tablets USP 5 mg are scored, round, yellow tablets imprinted DAN 5619 and 5 supplied in bottles of 100, 500 and 1000. Diazepam Tablets USP 10 mg are scored, round, blue tablets imprinted DAN 5620 and 10 supplied in bottles of 100, 500 and 1000. STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container with child-resistant closure.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

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 benzo
diazepines 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 tha

Charakteristika produktu

DIAZEPAM- DIAZEPAM TABLET
DIRECT_RX
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DIAZEPAM
WARNINING: RISKS FROM CONCOMITANT USE WITH OPIODS
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.
Revised: May 2018
Rx only
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 C16H13ClN2O and the
molecular weight is 284.75. The
structural formula is as follows:
[Chemical Structure]
Diazepam 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, magnesium stearate and microcrystalline cellulose.
Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10.
Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.
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 – 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