Chlordiazepoxide/clidinium bromide

What is Chlordiazepoxide/clidinium bromide?

• Chlordiazepoxide/clidinium bromide (Clindex; Librax), combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide.

Chlordiazepoxide

Clidinium bromide

Clinidiumbromide

What are the uses of this medicine?

Chlordiazepoxide/clidinium bromide (Clindex; Librax), is a prescription medicine that is used with other therapies for the treatment of:

• peptic ulcers
• irritable bowel syndrome (IBS)
• inflammation of the colon called acute enterocolitis

• Chlordiazepoxide HCl/Clidinium Bromide contains the medicines chlordiazepoxide HCl and clidinium bromide.
• Chlordiazepoxide HCl/Clidinium Bromide can be abused or lead to dependence. Keep Chlordiazepoxide HCl/Clidinium Bromide in a safe place to prevent misuse and abuse. Selling or giving away Chlordiazepoxide HCl/Clidinium Bromide may harm others.

How does this medicine work?

• A combination formulation containing the hydrochloride salt form of the benzodiazepine chlordiazepoxide and the bromide salt form of the quaternary ammonium antimuscarinic clidinium with anxiolytic, sedative and antispasmodic activities.
• Chlordiazepoxide binds to a specific benzodiazepine-binding site on the gamma-aminobutyric acid (GABA)-A receptor 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.
• Clidinium binds to and blocks muscarinic receptors in the gastrointestinal (GI) tract.
• This leads to a decrease in stomach secretions, GI motility and GI spasms.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have glaucoma
• have an enlarged prostate
• have a blockage of your bladder that causes problems with urination
• are allergic to chlordiazepoxide hydrochloride or clidinium bromide

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• anticoagulants such as warfarin (Coumadin, Jantoven) or an antipsychotic medication such as chlorpromazine, fluphenazine, or thioridazine
• Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

Is this medicine FDA approved?

• It was approved for medical use in the United States in 1966. It is available as a generic medication.

How should this medicine be used?

Recommended dosage:

• The dosage, therefore, should be individualized for maximum beneficial effects.
• The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

Geriatric Dosing:

• The initial dose should not exceed 2 Chlordiazepoxide HCl/Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated.

Administration:

• Take Chlordiazepoxide HCl/Clidinium Bromide exactly as your healthcare provider tells you to take it.
• Your healthcare provider may change your dose of Chlordiazepoxide HCl/Clidinium Bromide if needed. Do not change your dose of Chlordiazepoxide HCl/Clidinium Bromide or suddenly stop taking Chlordiazepoxide HCl/Clidinium Bromide without talking with your healthcare provider.
• If you take too much Chlordiazepoxide HCl/Clidinium Bromide, call your healthcare provider or go to the nearest hospital emergency room right away.

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

This medicine is available in fallowing doasage form:

• As opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide

This medicine is available in fallowing brand namesː

• Clindex; Librax

What side effects can this medication cause?

The most common side effects of this medicine may include:

• dry mouth
• nausea
• skin problems
• blurred vision
• constipation
• swelling
• irregular menstrual (periods) cycles
• increased and decreased desire for sex (libido)
• problems starting to urinate
• drowsiness, coordination problems, and confusion may happen, especially in people who are elderly or weak

Less common, but serious side effects may include:

• Stopping Chlordiazepoxide HCl/Clidinium Bromide suddenly can cause serious side effects.
• with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
• can cause abuse and dependence.

What special precautions should I follow?

• Do not stop taking Chlordiazepoxide HCl/Clidinium Bromide without first talking to your healthcare provider. Stopping Chlordiazepoxide HCl/Clidinium Bromide suddenly can cause serious side effects.
• Taking Chlordiazepoxide HCl/Clidinium Bromide with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Chlordiazepoxide HCl/Clidinium Bromide affects you.
• Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Chlordiazepoxide HCl/Clidinium Bromide without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Chlordiazepoxide HCl/Clidinium Bromide may make your sleepiness or dizziness much worse.
• Chlordiazepoxide HCl/Clidinium Bromide can cause abuse and dependence.
• Do not stop taking Chlordiazepoxide HCl/Clidinium Bromide all of a sudden. Stopping Chlordiazepoxide HCl/Clidinium Bromide suddenly can cause seizures, shaking, stomach and muscle cramps, vomiting and sweating.
• 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.
• Chlordiazepoxide HCl/Clidinium Bromide may pass through 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/Clidinium Bromide. Chlordiazepoxide HCl/Clidinium Bromide may decrease the amount of breast milk your body makes.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• somnolence, confusion, coma and diminished reflexes.
• The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation.

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 hydrochloride overdosage.
• General supportive measures should be employed, along with immediate gastric lavage.
• Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute.
• Intravenous fluids should be administered and an adequate airway maintained.
• Hypotension may be combated by the use of levarterenol or metaraminol.
• Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects.
• Dialysis is of limited value. Should excitation occur, 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.

Can this medicine be used in pregnancy?

• Chlordiazepoxide HCl/Clidinium Bromide may harm your unborn baby.
• Avoid taking Chlordiazepoxide HCl/Clidinium Bromide during the first trimester of pregnancy.
• Tell your healthcare provider right away if you become pregnant during treatment with Chlordiazepoxide HCl/Clidinium Bromide.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: chlordiazepoxide hydrochloride and clidinium bromide
• Inactive ingredients: corn starch, lactose and talc. Gelatin capsule shells may contain methylparaben, propylparaben, and potassium sorbate, with the following dye systems: D&C Yellow No. 10 and FD&C Green No. 3.

Who manufactures and distributes this medicine?

Distributed by:

• Cameron Pharmaceuticals
• Louisville, KY USA

Manufactured by:

• Valeant Pharmaceuticals International, Inc.
• Steinbach, MB Canada

• Librax is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

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

• Store Chlordiazepoxide HCl/Clidinium Bromide at room temperature 77°F (25°C).
• Keep Chlordiazepoxide HCl/Clidinium Bromide and all medicines out of the reach of children.

• Dailymed label info on Chlordiazepoxide/clidinium bromide
• FDA Chlordiazepoxide/clidinium bromide

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