DIAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

DIAZEPAM

Composition:

DIAZEPAM 5 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 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

Product summary:

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. Bottle of 2 - 68788-9207-0 Bottle of 6 - 68788-9207-5 Bottle of 10 - 68788-9207-4 Bottle of 15 - 68788-9207-1 Bottle of 20 - 68788-9207-2 Bottle of 30 - 68788-9207-3 Bottle of 60 - 68788-9207-6 Bottle of 90 - 68788-9207-9 Bottle of 100 - 68788-9207-8 lets 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. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. E 7/2021 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals, Inc.
----------
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.
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
contains 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 diazepa

Summary of Product characteristics

DIAZEPAM- DIAZEPAM TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
DIAZEPAM TABLETS, USP, CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
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:
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).
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