DIAZEPAM tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Mayne Pharma Commercial LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Diazepam Tablets USP 2 mg are white, flat-faced, bevel edge, bisected tablets imprinted MYX/941 on one side and 2 imprinted on the other side. Supplied in bottles of 100 (NDC 51862-941-01) and 500 (NDC 51862-941-05) tablets. Diazepam Tablets USP 5 mg are yellow, flat-faced, bevel edge, bisected tablets imprinted MYX/942 on one side and 5 imprinted on the other side. Supplied in bottles of 100 (NDC 51862-942-01), 500 (NDC 51862-942-05) and 1000 (NDC 51862-942-10) tablets. Diazepam Tablets USP 10 mg are light blue, flat-faced, bevel edge, bisected tablets imprinted MYX/943 on one side and 10 imprinted on the other side. Supplied in bottles of 100 (NDC 51862-943-01), 500 (NDC 51862-943-05) and 1000 (NDC 51862-943-10) tablets. 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.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Mayne Pharma Commercial 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 (CNS) depressants (including
street drugs) can cause
severe drowsiness, breathing problems (respiratory depression), coma
and death.Get emergency
help right away if any of the following happens:
•
Shallow or slowed breathing,
•
Breathing stops (which may lead to the heart stopping),
•
Excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
diazepam with opioids
affects you.
•
Risk of abuse, misuse, and addiction.There is a risk of abuse, misuse,
and addiction with
benzodiazepines, including diazepam, which can lead to overdose and
serious side effects
including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused
or misused benzodiazepines, including diazepam.These serious side
effects may also cause
delirium, paranoia, suicidal thoughts or actions, seizures, and
difficulty breathing. Call
your healthcare provider or go to the nearest hospital emergency room
right away if you
get any of these serious side effects.
•
You can develop an addiction even if you take diazepam tablets exactly
as prescribed by
your healthcare provider.
•
Take diazepam tablets exactly as your healthcare provider prescribed.
•
Do not share your diazepam tablets with other people .
•
Keep diazepam tablets in a safe place and away from children.
Physical dependence and withdrawal reactions.Diazepam tablets can
cause physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking diazepam tablets.Stopping diazepam tablets
suddenly can cause
serious and life- threatening side effects, including, unusual
movements, responses, or
expressions, seizures, sudden and severe mental or nervous system
changes, depression, se

Svojstava lijeka

DIAZEPAM- DIAZEPAM TABLET
MAYNE PHARMA COMMERCIAL LLC
----------
DIAZEPAM TABLETS USP
C-IV
RX ONLY
WARNINING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS 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 (SEE WARNINGSAND
PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING DIAZEPAM, EXPOSES USERS TO
RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR
DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE
CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING DIAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT'S RISK FOR ABUSE, MISUSE,
AND ADDICTION (SEE WARNINGS) _._
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING DIAZEPAM, MAY LEAD
TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE
AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION AND HIGHER
DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF
DIAZEPAM AFTER CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL
REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE RISK OF
WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE DIAZEPAM OR
REDUCE THE DOSAGE (SEE DOSAGE AND ADMINISTRATIONAND
WARNINGS)
DESCRIPTION
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:
16
13
2
Diazepam is available for oral administration as tablets containing 2
mg, 5 mg o