Valium

INDICATIONS AND USAGE

Valium (Diazepam) 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 Reference ID: 4029651 3 secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.

WARNINGS AND PRECAUTIONS

DRUG ABUSE AND DEPENDENCE 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.

WARNINGS: 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.

ADVERSE REACTIONS

VALIUM may cause serious side effects, including: See “What is the most important information I should know about VALIUM?” Seizures. Taking VALIUM with other medicines used to treat epilepsy can cause an increase in the number or severity of grand mal seizures. Withdrawal symptoms. You may have withdrawal symptoms if you stop taking VALIUM suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping VALIUM to avoid withdrawal symptoms. Like other antiepileptic drugs, VALIUM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

OVERDOSE

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, and death. Overdose of benzodiazepines in combination with other CNS depressants (including alcohol) may be fatal and should be closely monitored.

Source:https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf