Indicated for:

Anxiety Disorders:

• 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.

Partial Seizures:

• As adjunctive therapy in the management of partial seizures.

Acute Alcohol Withdrawal:

• The symptomatic relief of acute alcohol withdrawal.

The effectiveness of TRANXENE tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity.

TRANXENE tablets are not recommended for use in depressive neurosis or in psychotic reactions. 

TRANXENE tablets are contraindicated in patients with acute narrow angle glaucoma.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation.

Since TRANXENE has a central nervous system depressant effect, patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effects of alcohol may be increased.

Antiepileptic drugs (AEDs), including TRANXENE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. 

Caution should be observed in patients who are considered to have a psychological potential for drug dependence.

Withdrawal symptoms (similar in character to those noted with barbiturates and alcohol) have occurred following abrupt discontinuance of clorazepate. Withdrawal symptoms associated with the abrupt discontinuation of benzodiazepines have included convulsions, delirium, tremor, abdominal and muscle cramps, vomiting, sweating, nervousness, insomnia, irritability, diarrhea, and memory impairment.

There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit.

Decrease in systolic blood pressure has been observed.

An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies.

TRANXENE tablets should not be given to nursing mothers since it has been reported that nordiazepam is excreted in human breast milk.

GoToSource

• Use in patients under the age of 9. GoToSource 

• Adult dosage greater than 90 mg per day. GoToSource

• Alcohol withdrawal syndrome. GoToSource  

• Cessation of sedation in brain-injured patients. GoToSource

• Premedication for retrobulbar anesthesia in clear corneal cataract surgery. GoToSource

• Reduction of androgens in women with idiopathic hirsutism. GoToSource

• Huntington’s chorea. GoToSource 

• Chronic psychosis. GoToSource

• Neuroleptic-induced tardive dyskinesia. GoToSource

Birth defects. GoToSource 

Suicidal ideation and behavior. GoToSource

Brain damage. GoToSource

Dependency and cognitive decline. GoToSource

Withdrawal symptoms (anxiety, insomnia, autonomic hyperactivity), vertigo, mental confusion, memory impairment, paradoxical reactions (irritability, aggression, hostility and impulsivity), depression, dependence and increased rate of falls that cause hip and femur fractures in elderly patients. GoToSource

Lawsuits filed for suicidal thoughts and behavior.