Chlordiazepoxide Full Prescribing Information
Brand Name: Libritabs, Librium
Generic Name: Chlordiazepoxide
Outside U.S., Brand Names also known as: Apo-Chlordiazepoxide; Arsitran; Balance; Benpine; Benzodiapin; Cetabrium; Chlordiazachel; Chlordiazepoxidum; Chuichin; Contol; Diazebrum; Diazepina; Dipoxido; Disarim; Elenium; Epoxide; Equilibrium; Huberplex; Kalbrium; Karmoplex; Klopoxid; Lentotran; Libnum; Libritabs; Librium; Libulin; Medilium; Multum; Neo-Gnostorid; Neuropax; Normide; Nova-Pam; Novopoxide; O.C.M.; Oasil; Omnalio; Paxium; Poxi; Psicofar; Radepur; Raysedan; Reliberan; Reposal; Restocalm; Retcol; Ripolin; Risachief; Risolid; Seren; Sintesedan; Solium; Taee; Tensinyl; Tropium; Vapine; Zenecin
Librium Patient Information (in plain English)
Chlordiazepoxide (Libritabs, Librium) is a benzodiazepine used to treat anxiety and alcohol withdrawal. It may also be used to treat other conditions as determined by your doctor.
Chlordiazepoxide HCl injectable is used for the relief of acute anxiety when rapid action is required.
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Chlordiazepoxide has antianxiety, sedative, appetite-stimulating and weak analgesic actions. The precise mechanism of action is not known. The drug blocks EEG arousal from stimulation of the brain stem reticular formation. It takes several hours for peak blood levels to be reached and the half-life of the drug is between 24 and 48 hours. After the drug is discontinued plasma levels decline slowly over a period of several days.
Indications and Usage
Chlordiazepoxide (Libritabs, Librium) is 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 is contraindicated in patients with known hypersensitivity to the drug.
Chlordiazepoxide and chlordiazepoxide hydrochloride 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. PATIENTS SHOULD BE WARNED ACCORDINGLY.
Usage in Pregnancy: 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.
Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines.
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 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.
Injectable chlordiazepoxide should not be given to patients in shock or comatose states. Reduced dosage (usually 25 to 50 mg) should be used for elderly or debilitated patients, and for children twelve years or older.
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 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 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 the Patient: 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 this drug.
Chlordiazepoxide must be administered with caution to addiction-prone individuals or to those whose history suggests possible abuse.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes clozapine, disulfiram, ketoconazole, omeprazole, and valproic acid. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.
This medicine will add to the effects of other medicines and alcohol.
Drowsiness, ataxia and confusion have been reported in some patients - particularly the elderly and debilitated. They have occasionally been observed at the lower dosage ranges. In a 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.
Similarly, hypotension associated with spinal anesthesia has occurred. Pain following intramuscular injection has been reported. Changes in EEG patterns (low-voltage fast activity) have been reported in patients during and after treatment.
Drug Abuse and Dependence:
Chlordiazepoxide and chlordiazepoxide hydrochloride 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 (e.g., 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.
Signs and Symptoms
Manifestations of chlordiazepoxide overdosage include 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.
If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.
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 (Levophed) or metaraminol (Aramine). 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.
Do not exceed the recommended dosage or take this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit forming.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, away from heat and light.
- If you miss a dose of this medicine and you are using it regularly, take it as soon as possible. If you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
Optimum dosage varies with diagnosis and patient response; therefore, individual adjustment of dose is important, with minimum effective dose being used.
Adults: Usually 10 to 40 mg daily in divided doses. In severe cases, 25 mg 3 or 4 times a day may be given.
Elderly or debilitated patients: 5 mg 2 to 4 times daily.
Children: 5 mg, 2 to 4 times daily (may be increased in some children to 10 mg, 2 or 3 times daily).
Preoperative Apprehension: 5 to 10 mg, 3 to 4 times daily on days prior to surgery.
Obstetrics: 25 to 50 mg on admission.
Parenteral: Injections should be prepared immediately before administration. Chlordiazepoxide for i.m. injection is prepared by adding 2 mL of the i.m. diluent to 100 mg of drug and agitating gently until a clear solution is obtained. (The diluent should not be used if it is opalescent or hazy.) Injection should be made into the deltoid or deep into the upper outer quadrant of the gluteal muscle. A solution suitable for i.v. injection may be prepared by adding 5 mL of isotonic sodium chloride injection or sterile water for injection to 100 mg of chlordiazepoxide and agitating gently. Do not add to parenteral fluids or further dilute or mix with other drugs. The appropriate i.v. dose may be injected directly into a large lumen vein slowly over a one minute period.
Acute anxiety: 50 to 100 mg i.m. or i.v. initially; then 25 to 50 mg 3 or 4 times daily, if necessary.
Acute phobia or panic reaction: 50 to 100 mg i.m. or i.v. initially; repeat in 4 to 6 hours, if necessary.
Acute psychotic agitation: 50 to 100 mg i.m. or i.v. initially; repeat in 4 to 6 hours, if necessary.
Acute drug withdrawal: 100 mg i.m. or i.v. initially; then 50 to 100 mg in 4 to 6 hours, if necessary. Lower doses (usually 25 to 50 mg) should be used for elderly or debilitated patients and for children.
Alcoholism: 50 to 100 mg i.m. or i.v. initially; repeat in 2 to 4 hours if necessary.
Chlordiazepoxide is available as Tablets: containing 5 mg, 10 mg or 25 mg.
Chlordiazepoxide HCl is available as capsules containing 5 mg, 10 mg, or 25 mg chlordiazepoxide hydrochloride.
Chlordiazepoxide HCl injectable Duplex pack consisting of 1 ampul 100 mg dry chlordiazepoxide HCl and 1 ampul 2 mL special diluent for i.m. injection only. Duplex packages of 10.
Librium Patient Information (in plain English)
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.
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- Created: 03 January 2009
- Last Updated: 02 September 2014
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