Valium

Description

Valium (diazepam) is a benzodiazepine derivative developed through original Roche research. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless cyrstalline compound, insoluble in water and has a molecular weight of 284.74. Valium 5-mg tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10 dyes. Valium 10-mg tablets contain FD&C Blue No. 1 dye. Valium 2-mg tablets contain no dye.

Warnings

Valium is not of value in the treatment of psychotic patients and should ot be employed in lieu of appropriate treatment. As is true of most preparations containing CNS-acting drugs, patients receiving Valium should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle. As with other agents which 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 withdrawl of Valium in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures. 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. Usage in Pregnancy: An increased risk on congenital malformations associated with the use of minor tranquilizers (diazepam, meprobamate and chlordiazepoxide) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intent to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

Management of Overdosage

Manifestations of valium overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following overdosage. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of Levophed (levarterenol) or Aramine (metaraminol). Dialysis is of limited value. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested. Flumazenin, a specific benzodiazepine-receptor antagonish, 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 intraveneous 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. 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. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS, should be consulted prior to use. Withdrawl symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines.

Imprint on tablets

2 mg--2 VALIUM (front); ROCHE (scored side) 5 mg--5 VALIUM (front); ROCHE (scored side) 10 mg--10 VALIUM (front); ROCHE (scored side) Roche Products Roche Products Inc. Manati, Puerto Rico 00674