Chlordiazepoxide

Indications

INDICATIONS AND USAGE Chlordiazepoxide hydrochloride capsules are 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 hydrochloride capsules 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Because of the wide range of clinical indications for chlordiazepoxide, the optimum dosage varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. ADULTS USUAL DAILY DOSE Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety 5 mg or 10 mg, 3 or 4 times daily Relief of Severe Anxiety Disorders and Symptoms of Anxiety 20 mg or 25 mg, 3 or 4 times daily Geriatric Patients, or in the presence of debilitating disease 5 mg, 2 to 4 times daily Preoperative Apprehension and Anxiety: On days preceding surgery, 5 to 10 mg orally, 3 or 4 times daily.

Contraindications

CONTRAINDICATIONS Chlordiazepoxide hydrochloride capsules are contraindicated in patients with known hypersensitivity to the drug.

Warnings and precautions

WARNINGS Risks from Concomitant Use with Opioids: Concomitant use of benzodiazepines, including chlordiazepoxide, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

Storage and supply

HOW SUPPLIED Chlordiazepoxide hydrochloride capsules, USP are available in the following presentations: 5 mg hard gelatin capsules in bottles of 100 (NDC 42806-564-01), with 564 imprinted on the opaque green cap with an opaque yellow body.

Source: Chlordiazepoxide Hydrochloride (Chlordiazepoxide Hydrochloride) — US FDA prescribing information, 2023-02-07, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.