chlordiazePOXIDE HCl 25 MG Oral Capsule

WARNINGS

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.

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.

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 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.

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 resedation, 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.

DESCRIPTION

Chlordiazepoxide hydrochloride is the prototype for the benzodiazepine compounds.

It is a versatile therapeutic agent of proven value for the relief of anxiety.

Chlordiazepoxide hydrochloride is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence.

Chlordiazepoxide hydrochloride is 7-chloro-2- (methylamino)-5-phenyl-3H-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 structural formula is: C16H14ClN3O • HCl Molecular Weight: 336.22 C16H14ClN3O • HCl M.W.

336.22 Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no.

10, FD&C blue no.

1, FD&C blue no.

1 aluminum lake, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide.

The 5 mg and 25 mg also contains D&C yellow no.

10 aluminum lake, FD&C blue no.

2 aluminum lake, FD&C red no.

40 aluminum lake, propylene glycol, and synthetic black iron oxide.

In addition, the 5 mg contains D&C red no.

33 and the 10 mg also contains butyl paraben, edetate calcium disodium, dimethyl polysiloxane, ethylene glycol monoethyl ether, FD&C red no.

40, methyl paraben, propyl paraben, sodium, sodium lauryl sulfate, sodium propionate, and soya lecithin.

Chlordiazepoxide hydrochloride structural formula

HOW SUPPLIED

Repackaged by A-S Medication Solutions – Libertyville, IL See REPACKAGING INFORMATION for available configurations.

Chlordiazepoxide Hydrochoride Capsules USP, 5 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a yellow opaque body filled with white powder, imprinted in black ink barr 158, packaged in bottles of 100 and 500 capsules.

Chlordiazepoxide Hydrochloride Capsules USP, 10 mg are available as a two-piece hard gelatin capsule with a black opaque cap and a green opaque body filled with white powder, imprinted in white ink barr 033, packaged in bottles of 100 and 1000 capsules.

Chlordiazepoxide Hydrochloride Capsules USP, 25 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a white opaque body filled with white powder, imprinted in black ink barr 159, available in bottles of 100 and 500 capsules.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev.

A 8/2011

INDICATIONS AND USAGE

Chlordiazepoxide HCl capsules USP 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 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.

PEDIATRIC USE

Pediatric Use Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required (see DOSAGE AND ADMINISTRATION).

Since clinical experience with chlordiazepoxide HCl in pediatric patients under 6 years of age is limited, use in this age group is not recommended.

Hyperactive aggressive pediatric patients should be monitored for paradoxical reactions to chlordiazepoxide HCl (see PRECAUTIONS).

INFORMATION FOR PATIENTS

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 this drug.

DOSAGE AND ADMINISTRATION

Because of the wide range of clinical indications for chlordiazepoxide HCl, 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 Chlordiazepoxide HCl.