Chlordiazepoxide HCl

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Overview

What is Chlordiazepoxide HCl?

Chlordiazepoxide hydrochloride is the prototype for the benzodiazepine compounds.

Chlordiazepoxide hydrochloride is 7-chloro-2-(methylamino)-5-phenyl-3 -1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows:

Each capsule, for oral administration, contains 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride. In addition, each capsule contains the following inactive ingredients: D&C red #28 (10 mg only), D&C yellow #10, FD&C blue #1, FD&C red #40 (10 mg only), FD&C yellow #6 (10 mg only), gelatin, hydrogenated vegetable oil, lactose anhydrous, methylparaben, microcrystalline cellulose, propylparaben, silicon dioxide, sodium lauryl sulfate and titanium dioxide.

What does Chlordiazepoxide HCl look like?

What are the available doses of Chlordiazepoxide HCl?

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What should I talk to my health care provider before I take Chlordiazepoxide HCl?

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How should I use Chlordiazepoxide HCl?

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.

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.

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.

For the relief of withdrawal symptoms of acute alcoholism

*See package insert for Sterile Chlordiazepoxide Hydrochloride.

Management of Overdosage:

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 complete flumazenil package insert including and should be consulted prior to use.

What interacts with Chlordiazepoxide HCl?

Chlordiazepoxide HCI Capsules are contraindicated in patients with known hypersensitivity to the drug.

What are the warnings of Chlordiazepoxide HCl?

Alcohol or other sedative drugs may enhance the drowsiness caused by oxybutynin chloride.

Chlordiazepoxide 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. (See section.)

What are the precautions of Chlordiazepoxide HCl?

In elderly or 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 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.

What are the side effects of Chlordiazepoxide HCl?

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.

What should I look out for while using Chlordiazepoxide HCl?

Chlordiazepoxide HCI Capsules are contraindicated in patients with known hypersensitivity to the drug.

Chlordiazepoxide 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. (See section.)

What might happen if I take too much Chlordiazepoxide HCl?

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How should I store and handle Chlordiazepoxide HCl?

Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564Chlordiazepoxide Hydrochloride Capsules USP are supplied as follows:5 mg: Green opaque/yellow opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.10 mg: Black opaque/green opaque capsules, imprinted and on cap and on body, in bottles of 100 and 500.25 mg: Green opaque/white opaque capsules, imprinted and on cap and 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 USAManufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USARev. 10/0370010564

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Chlordiazepoxide HCI 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. Chlordiazepoxide is excreted in the urine, with 1 to 2% unchanged and 3 to 6% as a conjugate.

Animal Pharmacology:

Hostile monkeys were made tame by oral drug doses which did not cause sedation. Chlordiazepoxide revealed a "taming" action with the elimination of fear and aggression. The taming effect of chlordiazepoxide was further demonstrated in rats made vicious by lesions in the septal area of the brain. The drug dosage which effectively blocked the vicious reaction was well below the dose which caused sedation in these animals.

The LD of parenterally administered chlordiazepoxide HCl was determined in mice (72 hours) and rats (5 days), and calculated according to the method of Miller and Tainter, with the following results: mice, I.V., 123 ±12 mg/kg; mice, I.M., 366 ±7 mg/kg; rats, I.V., 120 ± 7 mg/kg; rats, l.M., > 160 mg/kg.

Effects On Reproduction:

Non-Clinical Toxicology

Chlordiazepoxide HCI Capsules are contraindicated in patients with known hypersensitivity to the drug.

Chlordiazepoxide 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. (See section.)

There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given.

Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.

False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of

In elderly or 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 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.

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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