Chlordiazepoxide Hydrochloride (Page 2 of 3)

DRUG ABUSE AND DEPENDENCE:

Chlordiazepoxide HCI 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 (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.

DOSAGE AND ADMINISTRATION:

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.

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

20 mg or 25 mg, 3 or 4 times daily

Geriatric patients, or in the presence of

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* one hour prior to surgery.

CHILDREN Usual Daily Dose

Because of the varied response of children to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required. Since clinical experience in children under 6 years of age is limited, the use of the

5 mg, 2 to 4 times daily (may be increased in some children to 10 mg, 2 or 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 Sterile Chlordiazepoxide Hydrochloride.

Management of 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 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 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.

HOW SUPPLIED:

Chlordiazepoxide HCI Capsules is available as:

25 mg: Green/white capsule. Identified with stylized b arr /159. Available in blisters of:

30

NDC 67046-910-30

Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.

Store at controlled room temperature 15°-30°C (59°-86°F) in a dry place.

MANUFACTURED BY

BARR LABORATORIES, INC.

POMONA, NY 10970

BR-158, 033, 159

Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original–04/2010–NJW

MEDICATION GUIDE

MEDICATION GUIDE

Chlordiazepoxide (KLOR-dye-AZ-e-POX-ide) Hydrochloride Capsules, C-IV

What is the most important information I should know about chlordiazepoxide?

Chlordiazepoxide is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
Chlordiazepoxide can make you sleepy or dizzy, and can slow your thinking and motor skills.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how chlordiazepoxide affects you.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide may make your sleepiness or dizziness much worse.

Do not take more chlordiazepoxide than prescribed.

What is chlordiazepoxide?

Chlordiazepoxide is a prescription medicine used:

to treat anxiety disorders
for the short-term relief of the symptoms of anxiety
to treat withdrawal symptoms of acute alcoholism
preoperatively to treat apprehension and anxiety

Chlordiazepoxide is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep chlordiazepoxide in a safe place to prevent misuse and abuse. Selling or giving away chlordiazepoxide may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
It is not known if chlordiazepoxide is safe and effective in children under 6 years of age.
It is not known if chlordiazepoxide is safe and effective for use for longer than 4 months.

Do not take chlordiazepoxide if you are allergic to chlordiazepoxide or to any of the ingredients in chlordiazepoxide hydrochloride capsules.

See the end of this Medication Guide for a complete list of ingredients in chlordiazepoxide hydrochloride capsules.

Before you take chlordiazepoxide, tell your healthcare provider about all of your medical conditions, including if you:

have or have had depression, mood problems, or suicidal thoughts or behavior
have a history of drug or alcohol abuse or addiction
have liver or kidney problems
are pregnant or plan to become pregnant. Chlordiazepoxide may harm your unborn baby. You and your healthcare provider should decide if you should take chlordiazepoxide while you are pregnant
are breastfeeding or plan to breastfeed. Chlordiazepoxide may pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take chlordiazepoxide.

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

Taking chlordiazepoxide with certain other medicines can cause side effects or affect how well chlordiazepoxide or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take chlordiazepoxide?

Take chlordiazepoxide exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much chlordiazepoxide to take and when to take it.
If you take too much chlordiazepoxide, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking chlordiazepoxide?

Chlordiazepoxide can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how chlordiazepoxide affects you.
You should not drink alcohol while taking chlordiazepoxide. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of chlordiazepoxide?

Chlordiazepoxide may cause serious side effects, including:

See “What is the most important information I should know about chlordiazepoxide?”
Abuse and dependence. Taking chlordiazepoxide can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
Withdrawal symptoms. You may have withdrawal symptoms if you stop taking chlordiazepoxide suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping chlordiazepoxide to avoid withdrawal symptoms.

The most common side effects of chlordiazepoxide include:

drowsiness

loss of control of body movements (ataxia)

confusion

These are not all the possible side effects of chlordiazepoxide. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store chlordiazepoxide?

Store chlordiazepoxide at room temperature between 68°F to 77°F (20°C to 25°C).
Keep chlordiazepoxide hydrochloride capsules in a tightly closed container and out of the light. Keep chlordiazepoxide and all medicines out of the reach of children.

General information about the safe and effective use of chlordiazepoxide.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use chlordiazepoxide for a condition for which it was not prescribed. Do not give chlordiazepoxide to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about chlordiazepoxide that is written for health professionals.

What are the ingredients in chlordiazepoxide hydrochloride capsules?

Active ingredient: chlordiazepoxide hydrochloride

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 contain 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.

Manufactured by:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

For more information, go to www.tevagenerics.com or call 1-888-838-2872.

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 8/2016

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