Prescription Drug Information: Chlordiazepoxide Hydrochloride (Page 3 of 4)

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 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 re-sedation, 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.

Discontinuation or Dosage Reduction of Chlordiazepoxide

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence).

HOW SUPPLIED

Chlordiazepoxide Hydrochloride 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 “stylized barr” 158, packaged in bottles of 100 (NDC 0555-0158-02) and 500 (NDC 0555-0158-04) 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 “stylized barr” 033, packaged in bottles of 100 (NDC 0555-0033-02) and 1000 (NDC 0555-0033-05) 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 “stylized barr” 159, available in bottles of 100 (NDC 0555-0159-02) and 500 (NDC 0555-0159-04) 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.

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. J 2/2021

MEDICATION GUIDE

MEDICATION GUIDE

Chlordiazepoxide Hydrochloride (klorʺ dye azʺ e poxʹ ide hyeʺ droe klorʹ ide) Capsules, C-IV

What is the most important information I should know about Chlordiazepoxide HCl ?

  • Chlordiazepoxide HCl is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (CNS) (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens:
  • shallow or slowed breathing
  • breathing stops (which may lead to the heart stopping)
  • excessive sleepiness (sedation)

Do not drive or operate heavy machinery until you know how taking Chlordiazepoxide HCl with opioids affects you.

  • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Chlordiazepoxide HCl, which can lead to overdose and serious side effects including coma and death.
    • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Chlordiazepoxide HCl. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
    • You can develop an addiction even if you take Chlordiazepoxide HCl exactly as prescribed by your healthcare provider.
    • Take Chlordiazepoxide HCl exactly as your healthcare provider prescribed.
    • Do not share your Chlordiazepoxide HCl with other people.
    • Keep Chlordiazepoxide HCl in a safe place and away from children.
  • Physical dependence and withdrawal reactions. Chlordiazepoxide HCl can cause physical dependence and withdrawal reactions, especially if you continue to take Chlordiazepoxide HCl for several days to several weeks.
  • Do not suddenly stop taking Chlordiazepoxide HCl . Stopping Chlordiazepoxide HCl suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
  • Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
  • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • Do not take more Chlordiazepoxide HCl than prescribed or take Chlordiazepoxide HCl for longer than prescribed.

What is Chlordiazepoxide HCl ?

  • Chlordiazepoxide HCl 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 HCl is a federal controlled substance (C-IV) because it contains chlordiazepoxide that can be abused or lead to dependence. Keep Chlordiazepoxide HCl in a safe place to prevent misuse and abuse. Selling or giving away Chlordiazepoxide HCl 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 HCl is safe and effective in children under 6 years of age.
  • It is not known if Chlordiazepoxide HCl is safe and effective for use for longer than 4 months.

Do not take Chlordiazepoxide HCl if you are allergic to chlordiazepoxide or to any of the ingredients in Chlordiazepoxide HCl capsules. See the end of this Medication Guide for a complete list of ingredients in Chlordiazepoxide HCl capsules.

Before you take Chlordiazepoxide HCl, 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 HCl may harm your unborn baby. You and your healthcare provider should decide if you should take Chlordiazepoxide HCl while you are pregnant.
  • are breastfeeding or plan to breastfeed. Chlordiazepoxide HCl 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 HCl.

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

Taking Chlordiazepoxide HCl with certain other medicines can cause side effects or affect how well Chlordiazepoxide HCl or the other medicines work.

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Chlordiazepoxide HCl with your other medicines.

Do not start or stop any other medicines during treatment with Chlordiazepoxide HCl without talking to your healthcare provider first. Stopping Chlordiazepoxide HCl suddenly may cause you to have serious side effects. See, “What are the possible side effects of Chlordiazepoxide HCl?”

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take Chlordiazepoxide HCl ?

  • Take Chlordiazepoxide HCl exactly as your healthcare provider tells you to take it.
  • If you take too much Chlordiazepoxide HCl, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Chlordiazepoxide HCl ?

Chlordiazepoxide HCl may cause serious side effects, including:

  • See “What is the most important information I should know about Chlordiazepoxide HCl ?”
  • Chlordiazepoxide HCl 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 HCl affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Chlordiazepoxide HCl without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Chlordiazepoxide HCl may make your sleepiness or dizziness much worse.

The most common side effects of Chlordiazepoxide HCl 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 HCl ?

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

General information about the safe and effective use of Chlordiazepoxide HCl.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Chlordiazepoxide HCl for a condition for which it was not prescribed. Do not give Chlordiazepoxide HCl 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 HCl that is written for health professionals.

What are the ingredients in Chlordiazepoxide HCl?

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 For:

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 Rev. D 1/2021

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