Drug Detail:Librium (Chlordiazepoxide [ klor-dye-az-e-pox-ide ])
Drug Class: Benzodiazepines
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 Librium 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 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, eg, excitement, stimulation and acute rage, have been reported in psychiatric patients and in hyperactive aggressive pediatric patients, and should be watched for during Librium therapy. The usual precautions are indicated when Librium is 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 Librium. In view of isolated reports associating chlordiazepoxide with exacerbation of porphyria, caution should be exercised in prescribing chlordiazepoxide to patients suffering from this disease.
Drug Abuse and Dependence
Chlordiazepoxide hydrochloride capsules are classified by the Drug Enforcement Administration as a Schedule IV controlled substance.
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 (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.
Librium Dosage and Administration
Because of the wide range of clinical indications for Librium, 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* 1 hour prior to surgery.
PEDIATRIC PATIENTS | USUAL DAILY DOSE |
Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required. Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended. | 5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 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 Injectable Librium (chlordiazepoxide HCl).
LIBRIUM
chlordiazepoxide hydrochloride capsule, gelatin coated |
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LIBRIUM
chlordiazepoxide hydrochloride capsule, gelatin coated |
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LIBRIUM
chlordiazepoxide hydrochloride capsule, gelatin coated |
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Labeler - Valeant Pharmaceuticals North America LLC (042230623) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Legacy Pharmaceuticals | 026611520 | MANUFACTURE(0187-3750, 0187-3751, 0187-3758) |