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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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 or 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 the drug in this age group is not recommended. | 5 mg, 2 or 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 oral 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 re-sedation, 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.
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HOW SUPPLIED
Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:
5 mg: Green opaque/yellow opaque capsules, imprinted WATSON and 785 on cap and 5 mg on body, in bottles of 100 and 500.
10 mg: Black opaque/green opaque capsules, imprinted WATSON and 786 on cap and 10 mg on body, in bottles of 100 and 500.
25 mg: Green opaque/white opaque capsules, imprinted WATSON and 787 on cap and 25 mg on body, in bottles of 100 and 500.
Store at controlled room temperature 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container as defined in USP/NF.
Manufactured for:
Watson Laboratories, Inc.
Corona, CA 92880 USA
Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45215 USA
Rev. 10/03
70010564
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