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|Zebrax

CHLORDIAZEPOXIDE AND CLIDINIUM (Systemic)

Some commonly used brand names are:

In the U.S.—

• Clindex
• Clinoxide
• Clipoxide
• Librax
• Lidox
• Lidoxide
• Zebrax

In Canada—

• Apo-Chlorax
• Corium
• Librax

Generic name product may be available in the U.S.

Category

• Anticholinergic-sedative

Description

Chlordiazepoxide and clidinium (klor-dye-az-e-POX-ide and kli-DI-nee-um ) is a combination of medicines used to relax the digestive system and to reduce stomach acid. It is used to treat stomach and intestinal problems such as ulcers and colitis.

Chlordiazepoxide belongs to the group of medicines known as benzodiazepines. It is a central nervous system (CNS) depressant (a medicine that slows down the nervous system).

Clidinium belongs to the group of medicines known as anticholinergics. It helps lessen the amount of acid formed in the stomach. Clidinium also helps relieve abdominal or stomach spasms or cramps.

This combination is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Capsules (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For chlordiazepoxide and clidinium, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to benzodiazepines such as alprazolam [e.g., Xanax], bromazepam [e.g., Lectopam], chlordiazepoxide [e.g., Librium], clonazepam [e.g., Klonopin], clorazepate [e.g., Tranxene], diazepam [e.g., Valium], flurazepam [e.g., Dalmane], halazepam [e.g., Paxipam], ketazolam [e.g., Loftran], lorazepam [e.g., Ativan], midazolam [e.g., Versed], nitrazepam [e.g., Mogadon], oxazepam [e.g., Serax], prazepam [e.g., Centrax], temazepam [e.g., Restoril], or triazolam [e.g., Halcion], or to clidinium or any of the belladonna alkaloids (atropine, belladonna, hyoscyamine, and scopolamine). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Clidinium (contained in this combination) has not been studied in pregnant women. However, clidinium has not been shown to cause birth defects or other problems in animal studies. Chlordiazepoxide (contained also in this combination) may cause birth defects if taken during the first 3 months of pregnancy. In addition, too much use of this medicine during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. Make sure your doctor knows if you are pregnant or if you may become pregnant before taking chlordiazepoxide and clidinium.

Breast-feeding—Chlordiazepoxide may pass into the breast milk and cause unwanted effects, such as excessive drowsiness, in nursing babies. Also, because clidinium tends to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients.

Children—There is no specific information comparing use of chlordiazepoxide and clidinium in children with use in other age groups. However, children are especially sensitive to the effects of chlordiazepoxide and clidinium. Therefore, this may increase the chance of side effects during treatment.

Older adults—Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of mouth, nose, throat, or skin; and unusual excitement or agitation may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of chlordiazepoxide and clidinium.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking chlordiazepoxide and clidinium it is especially important that your health care professional know if you are taking any of the following:

• Antacids or
• Diarrhea medicine containing kaolin or attapulgite—These medicines may reduce the blood levels of chlordiazepoxide and clidinium, which may decrease their effects; they should be taken at least 2 to 3 hours before or after the chlordiazepoxide and clidinium combination

• Central nervous system (CNS) depressants (medicines that cause drowsiness) or
• Other anticholinergics (medicines for abdominal or stomach spasms or cramps)—Use with chlordiazepoxide and clidinium may increase the side effects of either medicine

• Ketoconazole (e.g., Nizoral)—Chlordiazepoxide and clidinium may reduce the blood level of ketoconazole, which may decrease its effects; therefore, chlordiazepoxide and clidinium should be taken at least 2 hours after ketoconazole

• Potassium chloride (e.g., Kay Ciel)—Use of chlordiazepoxide and clidinium may worsen or cause sores of the stomach or intestine

Other medical problems—The presence of other medical problems may affect the use of chlordiazepoxide and clidinium. Make sure you tell your doctor if you have any other medical problems, especially:

• Difficult urination or
• Dryness of mouth (severe and continuing) or
• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Enlarged prostate or
• Glaucoma or
• Hiatal hernia or
• High blood pressure (hypertension) or
• Intestinal blockage or
• Mental depression or
• Mental illness (severe) or
• Myasthenia gravis or
• Ulcerative colitis (severe)—Use of chlordiazepoxide and clidinium may make these conditions worse

• Drug abuse or dependence—Taking chlordiazepoxide (contained in this combination) may become habit-forming, causing mental or physical dependence

• Kidney disease or
• Liver disease—Higher blood levels of chlordiazepoxide and clidinium may result, possibly increasing the chance of side effects

• Overactive thyroid—Use of chlordiazepoxide and clidinium may further increase the heart rate

Proper Use of This Medicine

Take this medicine about 1/2 to 1 hour before meals unless otherwise directed by your doctor.

Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

Dosing—The dose of chlordiazepoxide and clidinium combination will be different for different people. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of this combination medicine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (capsules)
  • To relax the digestive system and to reduce stomach acid:
    • Adults—1 or 2 capsules one to four times a day, thirty to sixty minutes before meals or food. Your doctor may change the dose if needed. However, most people usually will not take more than 8 capsules a day.
    • Children—Dose must be determined by your doctor.
    • Older adults—To start, 1 capsule two times a day. Your doctor may change the dose if needed.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If you will be taking this medicine regularly for a long time your doctor should check your progress at regular visits.

Do not take this medicine within an hour of taking medicine for diarrhea. Taking them too close together will make this medicine less effective.

This medicine may cause some people to have blurred vision or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well .

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine and also for a few days after you stop taking it .

This medicine will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine as this could possibly result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Your mouth, nose, and throat may feel very dry while you are taking this medicine. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Check with your doctor if you develop intestinal problems such as constipation . This is especially important if you are taking other medicine while you are taking chlordiazepoxide and clidinium. If these problems are not corrected, serious complications may result.

If you will be taking this medicine in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time check with your doctor if you notice any of the following side effects:

Convulsions (seizures); muscle cramps; nausea or vomiting; stomach cramps; trembling

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/10/1994

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