Diazepam (Valium)

Trade Name : Valium

Roche Laboratories Inc.

TABLET

Strength 2 mg/1

Storage and handling for Valium

DIAZEPAM Benzodiazepine [EPC],Benzodiazepines [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Diazepam (Valium) which is also known as Valium and Manufactured by Roche Laboratories Inc.. It is available in strength of 2 mg/1 per ml. Read more

Diazepam (Valium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see ).

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 CHClNO and the molecular weight is 284.75. The structural formula is as follows:
Valium is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate with the following dyes: 5-mg tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; 10-mg tablets contain FD&C Blue No. 1. Valium 2-mg tablets contain no dye.

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 aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.

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.

Concomitant use of benzodiazepiones, including Valium, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Valium concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Valium than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Valium, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and sedation when Valium is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see ).
Valium is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment.
Since Valium has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during Valium therapy.
As with other agents that have anticonvulsant activity, when Valium is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of Valium in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.

No data

Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia. The following have also been reported:

Diazepam is subject to Schedule IV control under the Controlled Substances Act of 1970. Abuse and dependence of benzodiazepines have been reported. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving diazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence. Once physical dependence to benzodiazepines has developed, termination of treatment will be accompanied by withdrawal symptoms. The risk is more pronounced in patients on long-term therapy.
Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance of diazepam. These withdrawal symptoms may consist of tremor, abdominal and muscle cramps, vomiting, sweating, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed.
Chronic use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena.
A transient syndrome whereby the symptoms that led to treatment with Valium recur in an enhanced form. This may occur upon discontinuation of treatment. It may be accompanied by other reactions including mood changes, anxiety, and restlessness.
Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.

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 cases, symptoms may include ataxia, diminished reflexes, hypotonia, hypotension, respiratory depression, coma (rarely), and death (very rarely). Overdose of benzodiazepines in combination with other CNS depressants (including alcohol) may be fatal and should be closely monitored.

Following overdose with oral benzodiazepines, general supportive measures should be employed including the monitoring of respiration, pulse, and blood pressure. Vomiting should be induced (within 1 hour) if the patient is conscious. Gastric lavage should be undertaken with the airway protected if the patient is unconscious. Intravenous fluids should be administered. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiac function in intensive care. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Should hypotension develop, treatment may include intravenous fluid therapy, repositioning, judicious use of vasopressors appropriate to the clinical situation, if indicated, and other appropriate countermeasures. Dialysis is of limited value.
As with the management of intentional overdosage with any drug, it should be considered that multiple agents may have been ingested.
Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. Caution should be observed in the use of flumazenil in epileptic patients treated with benzodiazepines. The complete flumazenil package insert, including , , and , should be consulted prior to use.
Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see ).

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 dosage should be increased cautiously to avoid adverse effects.

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 mgu20142 VALIUM (front)
ROCHE (twice on scored side)u00a0u00a0u00a0
5 mgu20145 VALIUM (front)
ROCHE (twice on scored side)u00a0u00a0u00a0
10 mgu201410 VALIUM (front)
ROCHE (twice on scored side)u00a0u00a0u00a0
Store at room temperature 59u00b0 to 86u00b0F (15u00b0 to 30u00b0C). Dispense in tight, light-resistant containers as defined in USP/NF.

VALIUM is a registered trademark of Hoffmann-La Roche, Inc.
Distributed by:
Roche Laboratories Inc. on behalf of Roche Products Inc.150 Clove RoadSuite 8Little Falls, NJ 07424
Revised: June 2017
u00a9 2017 Genentech, Inc. All rights reserved.

No data

Representative sample of labeling (see the section for complete listing):

NDC 0140-0004-01
Valiumn
CIV
2 mg
Each tablet contains 2 mg diazepam.
Rx only
100 tablets
Roche
10185528

NDC 0140-0005-01
Valiumn
CIV
5 mg
Each tablet contains 5 mg diazepam.
Rx only
100 tablets
Roche
10185529

NDC 0140-0006-01
Valiumn
CIV
10 mg
Each tablet contains 10 mg diazepam.
Rx only
100 tablets
Roche
10185530

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Diazepam (Valium)

Trade Name : Valium

TABLET

Storage and handling for Valium

Disclaimer

Delivery Process

Product information is meant for

Packaging and Delivery

About GNH

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Diazepam (Valium)

Trade Name : Valium

TABLET

Storage and handling for Valium

Disclaimer

Delivery Process

Product information is meant for

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?