TRANXENE* T-TAB® TABLETS CIV
(clorazepate dipotassium tablets, USP)

• Tranxene is a benzodiazepine.
• Tranxene is available for oral administration as Tranxene T-Tab® tablets (3.75 mg, 7.5 mg, or 15 mg).

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Indication

TRANXENE is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.

TRANXENE tablets are indicated as an adjunctive therapy in the management of partial seizures and for the symptomatic relief of acute alcohol withdrawal.

Important Safety Information

TRANXENE is contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.

TRANXENE tablets are not recommended for use in depressive neuroses or in psychotic reactions, and in patients less than 9 years of age.

Patients taking TRANXENE tablets should be cautioned against engaging in hazardous occupations requiring mental alertness and should be advised against the simultaneous use of other CNS depressant drugs.

Withdrawal symptoms have occurred following abrupt discontinuation of TRANXENE.  Caution should be observed in patients who are considered to have a potential for drug dependence.

Antiepileptic drugs (AEDs), including TRANXENE, increase the risk of suicidal thoughts or behavior. Patients should be monitored for the emergence or worsening of depression, or suicidal thoughts or behavior.

During the first trimester of pregnancy and while lactating, use of TRANXENE should almost always be avoided.

Patients taking TRANXENE for a prolonged period should have blood counts and liver function tests periodically.  Elderly or debilitated patients should be started on lower doses and monitored closely.

The most commonly reported adverse event was drowsiness.  There have been reports of abnormal liver and kidney function, and decreases in hematocrit and systolic blood pressure.

For more information, please see Full Prescribing Information.