VALIUM Tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Roche Laboratories Inc.

Λέξεις κλειδιά

0140-0004 0140-0005 0140-0006

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BOXED WARNING SECTION

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, ...

1. 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, ...

2. Clinical Pharmacology

Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma ...

3. Indications and Usage

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 ...

4. Contraindications

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 ...

5. Warnings

Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including Valium, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, ...

6. Precautions

Hepatic Insufficiency Decreases in clearance and protein binding, and increases in volume of distribution and half-life have been reported in patients with cirrhosis. In such patients, a 2- to 5-fold increase ...

6.1. General

If Valium is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed particularly with known compounds ...

6.2. Information for Patients

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory ...

6.4. Drug Interactions

Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

In studies in which mice and rats were administered diazepam in the diet at a dose of 75 mg/kg/day (approximately 6 and 12 times, respectively, the maximum recommended human dose [MRHD=1 mg/kg/day] on ...

6.7. Pregnancy

Category D (see WARNINGS: Pregnancy).

6.10. Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established.

6.11. Geriatric Use

In elderly patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (2 mg to 2.5 mg once or twice daily, initially to ...

7. Adverse Reactions

Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia. The following have also been reported: Central Nervous System: confusion, depression, dysarthria, headache, ...

8. Drug Abuse and Dependence

Controlled Substance Valium contains diazepam, a Schedule IV controlled substance. Abuse Valium is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, ...

9. Overdosage

Overdose of benzodiazepines is usually manifested by central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, confusion, and lethargy. In more serious ...

10. Dosage and Administration

Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases ...

11. How Supplied

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); ...

12. Storage and Handling

Store at room temperature 59º to 86ºF (15º to 30ºC). Dispense in tight, light-resistant containers as defined in USP/NF.