Laboratories: elevated transaminases and alkaline phosphatase.
Category D (see WARNINGS : Pregnancy ).
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 be increased gradually as needed and tolerated).
5 mg - 5 VALIUM (front) ROCHE (twice on scored side).
These withdrawal symptoms may consist of tremor, abdominal and muscle cramps, vomiting, sweating, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. 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. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance of diazepam. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. 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.
An increased risk of congenital malformations and other developmental abnormalities associated with the use of benzodiazepine drugs during pregnancy has been suggested. There may also be non- teratogenic risks associated with the use of benzodiazepines during pregnancy. In addition, children born to mothers receiving benzodiazepines on a regular basis late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy.
2 mg - 2 VALIUM (front) ROCHE (twice on scored side).
Should this occur, use of the drug should be discontinued. Psychiatric and paradoxical reactions are known to occur when using benzodiazepines (see ADVERSE REACTIONS ). These reactions are more likely to occur in children and the elderly.
Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after Valium therapy and are of no known significance.
10 mg - 10 VALIUM (front) ROCHE (twice on scored side).
In such patients, a 2- to 5- fold increase in mean half-life has been reported. Benzodiazepines are commonly implicated in hepatic encephalopathy. Decreases in clearance and protein binding, and increases in volume of distribution and half-life have been reported in patients with cirrhosis. Delayed elimination has also been reported for the active metabolite desmethyldiazepam. Increases in half-life have also been reported in hepatic fibrosis and in both acute and chronic hepatitis (see CLINICAL PHARMACOLOGY : Pharmacokinetics in Special Populations : Hepatic Insufficiency ).
Gastrointestinal System: constipation, nausea, gastrointestinal disturbances.
With newborn infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants). Special care must be taken when Valium is used during labor and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate respiratory depression in the neonates.
As with the management of intentional overdosage with any drug, it should be considered that multiple agents may have been ingested.
Call your doctor at once if you have:
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 that may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants (see DRUG INTERACTIONS ).
Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA. Revised: August 2015.
Injury, Poisoning and Procedural Complications: There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcohol), and in the elderly.
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.
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.
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.
Urogenital System: incontinence, changes in libido, urinary retention.
Special Senses: blurred vision, diplopia, dizziness Cardiovascular System: hypotension.
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 with alcohol is not recommended due to enhancement of the sedative effect.
The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression or anxiety associated with depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary.
There have also been reports that the metabolic elimination of phenytoin is decreased by diazepam.
Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia. The following have also been reported:.
The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug. In general, the use of diazepam in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus.
Valium is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment.
If Valium is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of Valium, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, narcotics, barbiturates, MAO inhibitors and other antidepressants.
Oral Valium may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
In debilitated 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 be increased gradually as needed and tolerated).
Central Nervous System: confusion, depression, dysarthria, headache, slurred speech, tremor, vertigo.
Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse (see Drug Abuse And Dependence ).
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. The risk is more pronounced in patients on long-term therapy. Once physical dependence to benzodiazepines has developed, termination of treatment will be accompanied by withdrawal symptoms. Diazepam is subject to Schedule IV control under the Controlled Substances Act of 1970. Abuse and dependence of benzodiazepines have been reported.
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.
Inappropriate behavior and other adverse behavioral effects have been reported when using benzodiazepines. Should these occur, use of the drug should be discontinued. They are more likely to occur in children and in the elderly. Psychiatric and Paradoxical Reactions: stimulation, restlessness, acute hyperexcited states, anxiety, agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, increased muscle spasticity, insomnia, sleep disturbances, and nightmares.
Metabolites of this drug are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Extensive accumulation of diazepam and its major metabolite, desmethyldiazepam, has been noted following chronic administration of diazepam in healthy elderly male subjects. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Safety and effectiveness in pediatric patients below the age of 6 months have not been established.
Some loss of response to the effects of benzodiazepines may develop after repeated use of Valium for a prolonged time.
Valium is indicated for the management of anxiety disorders or for the shortterm 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.
Get emergency medical help if you have any of these signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Overdose of benzodiazepines is usually manifested by central nervous system depression ranging from drowsiness to coma. In more serious cases, symptoms may include ataxia, diminished reflexes, hypotonia, hypotension, respiratory depression, coma (rarely), and death (very rarely). In mild cases, symptoms include drowsiness, confusion, and lethargy. Overdose of benzodiazepines in combination with other CNS depressants (including alcohol) may be fatal and should be closely monitored.
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 ; 5 mg, yellow - bottles of 100 ( NDC and 500 ( NDC ; 10 mg, blue - bottles of 100 ( NDC and 500 ( NDC. Engraved on tablets:.
Diazepam passes into breast milk. Breastfeeding is therefore not recommended in patients receiving Valium.
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Antegrade amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behavior.
Valium is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. 6 and D&C Yellow No. Valium 2-mg tablets contain no dye. 1. 10; 10-mg tablets contain FD&C Blue No. 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.
2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms—2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated. Not for use in pediatric patients under 6 months.
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. Special attention should be paid to respiratory and cardiac function in intensive care. Intravenous fluids should be administered. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Following overdose with oral benzodiazepines, general supportive measures should be employed including the monitoring of respiration, pulse, and blood pressure. Gastric lavage should be undertaken with the airway protected if the patient is unconscious. Vomiting should be induced (within 1 hour) if the patient is conscious.
Cleft palate and encephalopathy are the most common and consistently reported malformations produced in these species by administration of high, maternally toxic doses of diazepam during organogenesis. Rodent studies have indicated that prenatal exposure to diazepam doses similar to those used clinically can produce long-term changes in cellular immune responses, brain neurochemistry, and behavior. Diazepam has been shown to be teratogenic in mice and hamsters when given orally at daily doses of 100 mg/kg or greater (approximay eight times the maximum recommended human dose or greater on a mg/m² basis).
This may occur upon discontinuation of treatment. It may be accompanied by other reactions including mood changes, anxiety, and restlessness. Rebound Anxiety: A transient syndrome whereby the symptoms that led to treatment with Valium recur in an enhanced form. 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.
Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS, should be consulted prior to use. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. 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. Caution should be observed in the use of flumazenil in epileptic patients treated with benzodiazepines. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment.
Since Valium has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNSdepressant drugs during Valium therapy.
The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin- 2-one. The empirical formula is C 16 H 13 ClN 2 O and the molecular weight is 284.75. The structural formula is as follows:. It is a colorless to light yellow crystalline compound, insoluble in water. Valium (diazepam) is a benzodiazepine derivative.
In studies in which mice and rats were administered diazepam in the diet at a dose of 75 mg/kg/day (approximay 6 and 12 times, respectively, the maximum recommended human dose on a mg/m² basis) for 80 and 104 weeks, respectively, an increased incidence of liver tumors was observed in males of both species. The data currently available are inadequate to determine the mutagenic potential of diazepam. Reproduction studies in rats showed decreases in the number of pregnancies and in the number of surviving offspring following administration of an oral dose of 100 mg/kg/day (approximay 16 times the MRHD on a mg/m² basis) prior to and during mating and throughout gestation and lactation. No adverse effects on fertility or offspring viability were noted at a dose of 80 mg/kg/day (approximay 13 times the MRHD on a mg/m² basis).
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Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see Drug Abuse And Dependence ).
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.
Diazepam peak concentrations are 30% lower when antacids are administered concurrently. The lower peak concentrations appear due to a slower rate of absorption, with the time required to achieve peak concentrations on average 20 - 25 minutes greater in the presence of antacids. However, this difference was not statistically significant. However, there is no effect on the extent of absorption.
Skin and Appendages: skin reactions.
Other: changes in salivation, including dry mouth, hypersalivation.
Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy.
There is a potentially relevant interaction between diazepam and compounds which inhibit certain hepatic enzymes (particularly cytochrome P450 3A and 2C19). Data indicate that these compounds influence the pharmacokinetics of diazepam and may lead to increased and prolonged sedation. At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole.
A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.Valium