DIAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tablets 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 periodi

Product summary:

Diazepam Tablets, USP are available containing 5 mg or 10 mg of diazepam, USP. The 5 mg tablets are orange, round, scored tablets debossed with MYLAN over 345 on one side and the other side being scored. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5554-0 The 10 mg tablets are green, round, scored tablets debossed with MYLAN over 477 on one side and the other side being scored. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5074-0 Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST:  Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Cardinal Health 107, LLC
----------
MEDICATION GUIDE
Diazepam Tablets, USP
(dye az' e pam)
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
affect you.
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
they contain diazepam that 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 than 4 months.
Do not take diazepam tablets if you:
•
are allergic to diazepam or any of the ingredients in diazepam
tablets. See the end of this Medication
Guide for a complete list of ingredie

Summary of Product characteristics

DIAZEPAM- DIAZEPAM TABLET
CARDINAL HEALTH 107, LLC
----------
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Diazepam is a benzodiazepine derivative. The chemical name of diazepam
is 7-Chloro-
1,3-dihydro-1-methyl-5-phenyl-2 _H_-1,4-benzodiazepin-2-one. It is a
colorless to light
yellow crystalline compound, insoluble in water. The molecular formula
is C
H
ClN
O
and the molecular weight is 284.74. The structural formula is as
follows:
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 TABLETS, 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 TABLETS,
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 TABLETS 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) _._
16
13
2
Diazepam is available for oral administration as tab