DIAZEPAM tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

RPK Pharmaceuticals, Inc.

INN (Nama Antarabangsa):

DIAZEPAM

Komposisi:

DIAZEPAM 5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 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 useful

Ringkasan produk:

Product: 53002-3340 NDC: 53002-3340-1 10 TABLET in a BOTTLE NDC: 53002-3340-2 20 TABLET in a BOTTLE NDC: 53002-3340-3 30 TABLET in a BOTTLE

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

RPK Pharmaceuticals, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
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 tablets with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines, including diazepam
tablets, 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
tablets. These serious side effects may also include 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,

Ciri produk

DIAZEPAM- DIAZEPAM TABLET
RPK PHARMACEUTICALS, INC.
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DIAZEPAM TABLETS, USP, CIV
RX ONLY
WARNING: 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
WARNINGS AND 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 TABLETS 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
TABLETS OR REDUCE THE DOSAGE (SEE DOSAGE AND
ADMINISTRATION AND WARNINGS).
DESCRIPTION
Diazepam tablets, USP are a benzodiazepine derivative. The chemical
name of diazepam,
USP is
7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It
is an off-
white to yellow crystalline powder, insoluble in water. The structural
formula is as
follows:
C
H
ClN O M.W. 284.74
Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets
for oral
administration containing the fol