VALIUM- diazepam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Roche Laboratories Inc.

INN (International Name):

diazepam

Composition:

diazepam 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Valium is 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, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Valium 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 Valium may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Valium 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. Valium is 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. Valium is also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. It may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow-angle glaucoma. Valium contains diazepam, a Schedule IV controlled substance. Valium 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). Valium 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 Valium or reduce the dosage (see DOSAGE and ADMINISTRATION: Discontinuation or Dosage Reduction of Valium 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. Tolerance to Valium 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 Valium may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Product summary:

For oral administration, Valium is supplied as round, flat-faced scored tablets with V-shaped perforation and beveled edges. Valium is available as follows: 2 mg, white - bottles of 100 (NDC 0140-0004-01); 5 mg, yellow - bottles of 100 (NDC 0140-0005-01) and 500 (NDC 0140-0005-14); 10 mg, blue - bottles of 100 (NDC 0140-0006-01) and 500 (NDC 0140-0006-14). Engraved on tablets: 2 mg—2 VALIUM® (front) ROCHE (twice on scored side) 5 mg—5 VALIUM® (front) ROCHE (twice on scored side) 10 mg—10 VALIUM® (front) ROCHE (twice on scored side) Store at room temperature 59º to 86ºF (15º to 30ºC). Dispense in tight, light-resistant containers as defined in USP/NF.

Authorization status:

New Drug Application

Patient Information leaflet

Roche Laboratories Inc.
----------
MEDICATION GUIDE
VALIUM (VAL-EE-UM)
(DIAZEPAM)
TABLETS, C-IV
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: February/2021
What is the most important information I should know about VALIUM?
•
VALIUM is 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
VALIUM with opioids
affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including VALIUM, 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 VALIUM. 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 VALIUM exactly as
prescribed by your
healthcare provider.
•
Take VALIUM exactly as your healthcare provider prescribed.
•
Do not share your VALIUM with other people.
•
Keep VALIUM in a safe place and away from children.
•
Physical dependence and withdrawal reactions. VALIUM can cause
physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking VALIUM. Stopping VALIUM suddenly can cause
serious
and life- threatening side effects, including, unusual movements,
responses, or
expressions, seizures, sudden and severe mental or nervous system
cha

Summary of Product characteristics

VALIUM- DIAZEPAM TABLET
ROCHE LABORATORIES INC.
----------
VALIUM CIV
BRAND OF DIAZEPAM
TABLETS
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 VALIUM, 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 VALIUM AND THROUGHOUT TREATMENT, ASSESS EACH
PATIENT'S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS)_._
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING VALIUM, 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
VALIUM 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 VALIUM OR
REDUCE THE DOSAGE (SEE DOSAGE AND ADMINISTRATION AND
WARNINGS)_._
DESCRIPTION
Valium (diazepam) is a benzodiazepine derivative. The chemical name of
diazepam is 7-
chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is
a colorless to
light yellow crystalline compound, insoluble in water. The empirical
formula is
C
H
ClN O and the molecular weight is 284.75. The structural formula is as
follows:
®
16
13
2
Valium is available for oral administration as tablets containing 2
mg, 5 mg or