DIAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

DIAZEPAM

Composition:

DIAZEPAM 2 mg

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 2 mg, 5 mg or 10 mg of diazepam, USP. The 2 mg tablets are white to off-white, round, scored tablets debossed with MYLAN over 271 on one side and scored on the other side. They are available as follows: NDC 0378-0271-01 bottles of 100 tablets NDC 0378-0271-05 bottles of 500 tablets The 5 mg tablets are orange, round, scored tablets debossed with MYLAN over 345 on one side and scored on the other side. They are available as follows: NDC 0378-0345-01 bottles of 100 tablets NDC 0378-0345-05 bottles of 500 tablets The 10 mg tablets are green, round, scored tablets debossed with MYLAN over 477 on one side and scored on the other side. They are available as follows: NDC 0378-0477-01 bottles of 100 tablets NDC 0378-0477-05 bottles of 500 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST:  Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mylan Pharmaceuticals Inc.
----------
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:
o
Shallow or slowed breathing,
o
Breathing stops (which may lead to the heart stopping),
o
Excessive sleepiness (sedation).
Do not drive or operate heavy machinery until you know how taking
diazepam tablets with opioids
affect 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.
o
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.
o
You can develop an addiction even if you take diazepam tablets exactly
as prescribed by your
healthcare provider.
o
Take diazepam tablets exactly as your healthcare provider prescribed.
o
Do not share your diazepam tablets with other people.
o
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.
o
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, d

Summary of Product characteristics

DIAZEPAM- DIAZEPAM TABLET
MYLAN PHARMACEUTICALS INC.
----------
DIAZEPAM TABLETS, USP
2 MG, 5 MG AND 10 MG
RX ONLY
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 284.7. 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
Dia