Indicated for the management of anxiety disorders or for the short-term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The effectiveness of chlordiazepoxide 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.

Chlordiazepoxide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Similarly, it may impair mental alertness in children.

The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. 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 discontinuation of benzodiazepines taken continuously at therapeutic levels for several months.

In elderly and debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (10 mg or less per day initially, to be increased gradually as needed and tolerated).

Drowsiness, ataxia and confusion have been reported in some patients particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In few instances syncope has been reported. Other adverse reactions reported during therapy include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido.

Paradoxical reactions, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and in hyperactive aggressive children, and should be watched for during chlordiazepoxide therapy. The usual precautions are indicated when chlordiazepoxide HCI capsules are used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary.

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing the drug.

Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide treatment.

In view of isolated reports associating chlordiazepoxide with exacerbation of porphyria, caution should be exercised in prescribing chlordiazepoxide to patients suffering from this disease.

Blood dyscrasias (including agranulocytosis), jaundice and hepatic dysfunction have occasionally been reported during therapy. When chlordiazepoxide treatment is protracted, periodic blood counts and liver function tests are advisable.

Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide.

In general, the concomitant administration of chlordiazepoxide HCI and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be 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. 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 intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

GoToSource

• Use in patients under the age of 6. GoToSource

• Epilepsy. GoToSource

• Alcohol withdrawal. GoToSource

• Insomnia, PTSD, muscle spasms, restless legs syndrome and movement disorders. GoToSource

• Catatonia. GoToSource

Mania, weight gain, hallucination, hypotension (low blood pressure), skin eruptions, menstrual irregularity, dry mouth, hypersalivation, blood dyscrasias (blood disorder), liver and kidney dysfunction, increased risk of suicidal ideation, exacerbation of porphyria (inherited blood disorder) and respiratory depression. GoToSource

Stevens-johnson syndrome (severe skin disorder). GoToSource

Lethargy, ataxia (lack of muscle control or coordination), dysarthria (speech disorder) and liver injury. GoToSource

Abuse, addiction, paradoxical disinhibition (including irritability, aggression, hostility and impulsivity), depression and withdrawal. GoToSource

Lawsuits filed for dependence, withdrawal syndrome, overdose and death.