Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 07 February 2017

Indication(s)

INDICATIONS AND USAGE: Chlordiazepoxide HCI 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 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.

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Advisory information

contraindications
CONTRAINDICATIONS: Chlordiazepoxide HCI Capsules are contraindicated in patients with known hypersensitivity to the drug.
Special warnings and precautions

PRECAUTIONS: 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).

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.

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.

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

Information for Patients: 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.

Adverse reactions

ADVERSE REACTIONS: The necessity of discontinuing therapy because of undesirable effects has been rare.

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.

Such side effects have been infrequent and are generally controlled with reduction of dosage.

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

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.

Usage information

Dosing and administration

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.

If used as preoperative medication, 50 to 100 mg IM * one hour prior to surgery.

CHILDREN Usual Daily Dose Because of the varied response of children to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required.

Since clinical experience in children under 6 years of age is limited, the use of thedrug in this age group is not recommended.

5 mg, 2 to 4 times daily (may be increased in some children to 10 mg, 2 or 3 times daily) For the relief of withdrawal symptoms of acute alcoholism, the parenteral form * is usually used initially.

If the drug is administered orally, the suggested initial dose is 50 to 100 mg, to be followed by repeated doses as needed until agitation is controlled - up to 300 mg per day.

Dosage should then be reduced to maintenance levels.

* See package insert for Sterile Chlordiazepoxide Hydrochloride.

Management of Overdosage: Manifestations of chlordiazepoxide overdosage includes somnolence, confusion, coma and diminished reflexes.

Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following chlordiazepoxide overdosage.

General supportive measures should be employed, along with immediate gastric lavage.

Intravenous fluids should be administered and an adequate airway maintained.

Hypotension may be combated by the use of norepinephrine or metaraminol.

Dialysis is of limited value.

There have been occasional reports of excitation in patients following chlordiazepoxide overdosage; if this occurs barbiturates should not be used.

As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected.

Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access.

Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose.

Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment.

The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.

The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.

More information

Category Value
Authorisation number ANDA040746
Orphan designation No
Product NDC 55289-061
Date Last Revised 01-01-2010
Type HUMAN PRESCRIPTION DRUG
RXCUI 905369
Marketing authorisation holder PD-Rx Pharmaceuticals, Inc.