DIAZEPAM tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

NCS HealthCare of KY, LLC dba Vangard Labs

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

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. NDC 0615-7799 -39 5 mg packaged in blistercards of 30 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. 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

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

NCS HealthCare of KY, LLC dba Vangard Labs
----------
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 know

Termékjellemzők

DIAZEPAM- DIAZEPAM TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
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).
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
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
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
16
13
2
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
concentr