Chlordiazepoxide

What is Chlordiazepoxide?

• Chlordiazepoxide (A-poxide; Chlordiazachel; H-Tran; Librelease; Libritabs; Librium; Lygen; Mitran; Poxi), is the prototype for the benzodiazepine compounds.
• It has antianxiety, sedative, appetite-stimulating and weak analgesic actions.

Chlordiazepoxide

Chlordiazepoxide molecule spacefill

Chlordiazepoxide molecule ball

What are the uses of this medicine?

• Chlordiazepoxide is used 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.

Limitations of use:

• The effectiveness of chlordiazepoxide HCl capsules USP 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.

How does this medicine work?

• The hydrochloride salt form of chlordiazepoxide, a long-acting benzodiazepine with anxiolytic, sedative and hypnotic activity.
• Chlordiazepoxide hydrochloride exerts its effect by binding to the benzodiazepine site at the gamma-aminobutyric acid (GABA) receptor-chloride ionophore complex in the central nervous system(CNS).
• This leads to an increase in the opening of chloride channels, membrane hyperpolarization, and increases the inhibitory effect of GABA on the CNS.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with known hypersensitivity to the drug.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antihistamines
• cimetidine (Tagamet)
• Digoxin (Lanoxin)
• disulfiram (Antabuse)
• fluoxetine (Prozac, Sarafem, Selfemra)
• isoniazid (Laniazid, in Rifamate, in Rifater)
• ketoconazole (Nizoral)
• levodopa (in Ritary, in Sinemet, in Stalevo)
• medications for depression, seizures, Parkinson's disease, asthma, colds, or allergies
• metoprolol (Lopressor, Toprol XL, others)
• muscle relaxants
• oral contraceptives
• probenecid (Probalan, in Col-Probenecid)
• propranolol (Inderal, Innopran)
• rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
• sedatives
• sleeping pills
• theophylline (Elixophyllin, Theo 24, Theochron)
• tranquilizers
• valproic acid (Depakene)

Is this medicine FDA approved?

• Chlordiazepoxide was approved in the United States in 1960 and for many years was one of the most prescribed medications. Currently, it is not commonly used, having been replaced by benzodiazepines with more favorable pharmacokinetics, half-life and tolerance.

How should this medicine be used?

Recommended dosage: In Adults:

• For Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety: 5 mg or 10 mg, 3 or 4 times daily.
• For 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.

In pediatric patients:

• Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as fallows:
• 5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily).
• 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.

For 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.

For withdrawal symptoms of acute alcoholism:

• 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.

Administration:

• Chlordiazepoxide comes as a tablet and capsule to take by mouth.
• It usually is taken one to four times a day with or without food.
• Take chlordiazepoxide exactly as directed.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As:Chlordiazepoxide Hydrochoride Capsules: 5 mg, 10 mg, 25 mg

This medicine is available in fallowing brand namesː

• A-poxide; Chlordiazachel; H-Tran; Librelease; Libritabs; Librium; Lygen; Mitran; Poxi

Combination product:

• Librax (as a combination product containing Clidinium, Chlordiazepoxide)
• Limbitrol (containing Amitriptyline, Chlordiazepoxide)
• Menrium (containing Chlordiazepoxide, Esterified Estrogens)

What side effects can this medication cause?

The most common side effects of this medicine include:

• Drowsiness
• ataxia
• confusion
• skin eruptions
• edema
• minor menstrual irregularities
• nausea and constipation
• extrapyramidal symptoms
• as well as increased and decreased libido.
• lethargy
• dysarthria
• dizziness

Less common,but serious side effects may include:

• Blood dyscrasias (including agranulocytosis)
• jaundice
• hepatic dysfunction

What special precautions should I follow?

• Chlordiazepoxide HCl may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery.
• It may impair mental alertness in children.
• The concomitant use of alcohol or other central nervous system depressants may have an additive effect.
• Older adults should not usually take chlordiazepoxide because it is not as safe or effective as other medication(s) that can be used to treat the same condition.
• In general, the concomitant administration of chlordiazepoxide HCl and other psychotropic agents is not recommended.
• Paradoxical reactions, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and in hyperactive aggressive pediatric patients, and should be watched for during chlordiazepoxide HCl therapy.
• chlordiazepoxide with exacerbation of porphyria, caution should be exercised in prescribing chlordiazepoxide to patients suffering from this disease.
• 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. Abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed.
• 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.
• As with other benzodiazepines, chlordiazepoxide therapy is not associated with serum aminotransferase or alkaline phosphatase elevations, and clinically apparent liver injury from chlordiazepoxide has been reported, but is very rare.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• somnolence, confusion, coma and diminished reflexes

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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 HCl 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 HCl 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.
• 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.

Can this medicine be used 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.
• 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.

Can this medicine be used in children?

• 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.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• chlordiazepoxide hydrochloride

Inactive Ingredients:

• aluminum oxide
• anhydrous lactose
• cellulose, microcrystalline
• d&c red no. 33
• d&c yellow no. 10
• fd&c blue no. 1
• fd&c blue no. 2
• fd&c red no. 40
• ferrosoferric oxide
• gelatin
• propylene glycol
• shellac
• titanium dioxide

Who manufactures and distributes this medicine?

• Teva pharmaceuticals USA.
• Sellersville, PA

What should I know about storage and disposal of this medication?

• Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
• Store at 20° to 25°C (68° to 77°F) in a dry place.

• Dailymed label info on Chlordiazepoxide
• FDA Chlordiazepoxide

Chlordiazepoxide Resources
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Benzodiazipines

• Alprazolam
• Chlordiazepoxide
• Diazepam (Oral)
• Estazolam
• Flurazepam
• Lorazepam
• Midazolam
• Oxazepam
• Quazepam
• Temazepam
• Triazolam

Anticonvulsants Drugs

• Clobazam
• Clonazepam
• Clorazepate
• Diazepam (Intravenous)

Drug class for Chlordiazepoxide

Anticonvulsants, and Benzodiazepines]