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|Butibel

BELLADONNA ALKALOIDS AND BARBITURATES (Systemic)

Some commonly used brand names are:

In the U.S.—

• Antrocol ²
• Barbidonna ¹
• Barbidonna No. 2 ¹
• Barophen ¹
• Bellalphen ¹
• Butibel ³
• Donnamor ¹
• Donnapine ¹
• Donnatal ¹
• Donnatal Extentabs ¹
• Donnatal No. 2 ¹
• Donphen ¹
• Hyosophen ¹
• Kinesed ¹
• Malatal ¹
• Relaxadon ¹
• Spaslin ¹
• Spasmolin ¹
• Spasmophen ¹
• Spasquid ¹
• Susano ¹

In Canada—

• Donnatal ¹
• Donnatal Extentabs ¹

Category

• Anticholinergic-sedative—Atropine and Phenobarbital; Atropine, Hyoscyamine, Scopolamine, and Phenobarbital; Belladonna and Butabarbital

Description

Belladonna alkaloids and barbiturates are combination medicines taken to relieve cramping and spasms of the stomach and intestines. They are used also to decrease the amount of acid formed in the stomach.

These medicines are available only with your doctor"s prescription in the following dosage forms:

• Oral
• Atropine, Hyoscyamine, Scopolamine, and Phenobarbital
  • Capsules (U.S.)
  • Elixir (U.S. and Canada)
  • Tablets (U.S. and Canada)
  • Chewable tablets (U.S.)
  • Extended-release tablets (U.S. and Canada)
• Atropine and Phenobarbital
  • Capsules (U.S.)
  • Elixir (U.S.)
  • Tablets (U.S.)
• Belladonna and Butabarbital
  • Elixir (U.S.)
  • Tablets (U.S.)

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 belladonna alkaloids and barbiturates, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to belladonna alkaloids (atropine, belladonna, hyoscyamine, and scopolamine) or to barbiturates (butabarbital, phenobarbital). Also, tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Belladonna alkaloids have not been shown to cause problems in humans. However, barbiturates (contained in this medicine) have been shown to increase the chance of birth defects in humans. Also, when taken during pregnancy, barbiturates may cause bleeding problems in the newborn baby. Be sure that you have discussed this with your doctor before taking this medicine.

Breast-feeding—Belladonna alkaloids or barbiturates have not been shown to cause problems in nursing babies. However, traces of the belladonna alkaloids and barbiturates pass into the breast milk. Also, because the belladonna alkaloids tend to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients.

Children—Severe side effects may be more likely to occur in infants and children, especially those with spastic paralysis or brain damage. Unusual excitement, nervousness, restlessness, or irritability and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of belladonna alkaloids. Also, when belladonna alkaloids are given to children during hot weather, a rapid increase in body temperature may occur. In addition, the barbiturate in this medicine could cause some children to become hyperactive.

Older adults—Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of mouth, nose, throat, or skin; and unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of belladonna alkaloids and barbiturates. Also, eye pain may occur, which may be a sign of glaucoma.

Other medicines—Although certain medicines should not be used together at all, in other cases two 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 belladonna alkaloids and barbiturates, it is especially important that your health care professional know if you are taking any of the following:

• Adrenocorticoids (cortisone-like medicine) or
• Corticotropin (ACTH)—Belladonna alkaloids and barbiturates may decrease the response to these medicines

• Antacids or
• Diarrhea medicine containing kaolin or attapulgite—These medications may decrease the response to belladonna alkaloids

• Anticholinergics (medicine for abdominal or stomach spasms or cramps)—Belladonna alkaloids and barbiturates may increase the response to anticholinergics

• Anticoagulants (blood thinners)—Belladonna alkaloids and barbiturates may decrease the effect of this medicine

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—The CNS effects of either medicine could be increased

• Ketoconazole (e.g., Nizoral)—Using ketoconazole with this combination medicine may lessen the effects of ketoconazole and barbiturates

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [Eldepryl]; tranylcypromine [e.g., Parnate])—Taking belladonna alkaloids and barbiturates while you are taking or within 2 weeks of taking monoamine oxidase inhibitors may increase the effects of the barbiturates

• Potassium chloride (e.g., Slow K or K-Dur)—May cause an increase in lesions (sores) of the stomach or intestine

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

• Asthma, emphysema, or other chronic lung disease or
• Dryness of mouth (severe and continuing) or
• Enlarged prostate or
• Glaucoma or
• Heart disease or
• Hyperactivity (in children) or
• Intestinal blockage or other intestinal problems or
• Urinary tract blockage or difficult urination—Belladonna alkaloids and barbiturates may make these conditions worse

• Brain damage (in children) or
• Spastic paralysis (in children)—These conditions may increase the effects of the medicine

• Down"s syndrome (mongolism)—This condition may increase the side effects of the medicine

• Kidney disease or
• Liver disease—Higher levels of the belladonna alkaloid and barbiturate may result, possibly leading to increased side effects

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 . Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing—The dose of belladonna alkaloids and barbiturates combination will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these combination medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or the amount of solution you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking these combination products .

• For atropine, hyoscyamine, scopolamine, and phenobarbital combination
• For stomach or intestine problems:
  • For oral dosage form (capsules or tablets):
    • Older adults, adults, and teenagers—1 or 2 capsules two to four times a day. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults and teenagers—The usual dose is 1 to 2 teaspoonfuls (5 to 10 milliliters [mL]) three or four times a day. Your doctor may change the dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 to 7.5 mL every four to six hours. Your doctor may change the dose if needed.
  • For oral dosage form (chewable tablets):
    • Older adults, adults, and teenagers—Chew 1 or 2 tablets three or four times a day. Your doctor may change the dose if needed.
    • Children up to 2 years of age—Use is not recommended.
    • Children 2 to 12 years of age—1/2 to 1 tablet three or four times a day. Your doctor may change the dose if needed.
  • For oral dosage form (extended-release tablets):
    • Older adults, adults, and teenagers—1 tablet every eight to twelve hours. Your doctor may change the dose if needed.
    • Children—Use is not recommended.

• For atropine and phenobarbital
• For stomach or intestine problems:
  • For oral dosage form (capsules or tablets):
    • Older adults, adults, and teenagers—1 or 2 capsules or tablets two to four times a day. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Older adults, adults, and teenagers—1 to 2 teaspoonfuls (5 to 10 milliliters [mL]) three or four times a day. Your doctor may change the dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 to 3 mL every four to six hours. Your doctor may change the dose if needed.

• For belladonna and butabarbital
• For stomach or intestine problems:
  • For oral dosage form (solution):
    • Older adults, adults and teenagers—1 to 2 teaspoonfuls (5 to 10 milliliters [mL]) three or four times a day. Your doctor may change the dose if needed.
    • Children up to 6 years of age—1.25 to 2.5 mL three or four times a day. Your doctor may change the dose if needed.
    • Children 6 to 12 years of age—2.5 to 5 mL three or four times a day. Your doctor may change the dose if needed.
  • For oral dosage form (tablets):
    • Older adults, adults, and teenagers—1 or 2 tablets three or four times a day. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.

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 this medicine out of the reach of children. Overdose of belladonna alkaloids and barbiturates is especially dangerous in young children.
• Store away from heat and direct light.
• Do not store the capsule or tablet 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.
• Keep the liquid form of this medicine from freezing.
• 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

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 antihistamines or medicine for hay fever, other allergies, or colds; 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 taking this medicine .

Do not take this medicine within 1 hour of taking antacids or medicine for diarrhea. Taking them too close together will make the belladonna alkaloids less effective.

Belladonna alkaloids 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 overheating could possibly result in heat stroke. This is especially important in children taking belladonna alkaloids.

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

This medicine may cause some people to have blurred vision or to become drowsy, dizzy, 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 not alert or able to see well .

This medicine may cause dryness of the mouth, nose, and throat. 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.

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:

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

Revised: 08/09/2000

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