DIAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, 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 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 of the drug for the individual patient. Diazepam tablets are contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. Diazepam tablets are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. They may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but are contraindicated in acute narrow-angle glaucoma. Diazepam tablets contain diazepam, a Schedule IV controlled substance. Diazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS: Abuse, Misuse, and Addiction ). The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Diazepam may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses), those who have had longer durations of use (see WARNINGS: Dependence and Withdrawal Reactions ). To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage (see DOSAGE and ADMINISTRATION: Discontinuation or Dosage Reduction of Diazepam Tablets  and WARNINGS: Dependence and Withdrawal Reactions ). Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. Tolerance to diazepam may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of diazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Product summary:

Diazepam Tablets USP, 2 mg are available as white, round, flat face, beveled edge tablets, debossed “3925” and bisected on one side and “TEVA” on the other side, containing 2 mg of diazepam, USP. NDC 0172-3925 -60   Bottles of 100 tablets NDC 0172-3925 -70   Bottles of 500 tablets Diazepam Tablets USP, 5 mg are available as yellow, round, flat face, beveled edge tablets, debossed “3926” and bisected on one side and “TEVA” on the other side, containing 5 mg of diazepam, USP. NDC 0172-3926 -60   Bottles of 100 tablets NDC 0172-3926 -70   Bottles of 500 tablets NDC 0172-3926 -80   Bottles of 1000 tablets 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. NDC 0172-3927 -60   Bottles of 100 tablets NDC 0172-3927 -70   Bottles of 500 tablets NDC 0172-3927 -80   Bottles of 1000 tablets 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. F 1/2024

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
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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 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, responses, or expressions, seizures,
sudden and severe mental or n

Summary of Product characteristics

DIAZEPAM- DIAZEPAM TABLET
TEVA PHARMACEUTICALS USA, 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 th