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|Pro-Banthine

ANTICHOLINERGICS/ANTISPASMODICS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Anaspaz ⁸
• A-Spas S/L ⁸
• Banthine ¹⁰
• Bentyl ⁵
• Cantil ⁹
• Cystospaz ⁸
• Cystospaz-M ⁸
• Donnamar ⁸
• ED-SPAZ ⁸
• Gastrosed ⁸
• Homapin ⁷
• Levbid ⁸
• Levsin ⁸
• Levsinex Timecaps ⁸
• Levsin/SL ⁸
• Pro-Banthine ¹³
• Quarzan ⁴
• Robinul ⁶
• Robinul Forte ⁶
• Symax SL ⁸
• Transderm-Scop ¹⁴

In Canada—

• Bentylol ⁵
• Buscopan ¹⁴
• Formulex ⁵
• Gastrozepin ¹²
• Levsin ⁸
• Pro-Banthine ¹³
• Propanthel ¹³
• Robinul ⁶
• Robinul Forte ⁶
• Spasmoban ⁵
• Transderm-V ¹⁴

Other commonly used names are: dicycloverine , glycopyrronium bromide , hyoscine hydrobromide , hyoscine methobromide , methanthelinium , and octatropine

Category

• Anesthesia adjunct—Scopolamine
• Antiarrhythmic—Atropine; Glycopyrrolate; Hyoscyamine; Scopolamine
• Anticholinergic—Anisotropine; Atropine; Belladonna; Clidinium; Dicyclomine; Glycopyrrolate; Homatropine; Hyoscyamine; Mepenzolate; Methantheline; Methscopolamine; Pirenzepine; Propantheline; Scopolamine
• Antidiarrheal—Glycopyrrolate
• Antidote, to cholinesterase inhibitors—Atropine; Hyoscyamine
• Antidote, to muscarine—Atropine; Hyoscyamine
• Antidote, to organophosphate pesticides—Atropine
• Antidysmenorrheal—Belladonna; Scopolamine
• Antiemetic—Scopolamine
• Antispasmodic, gastrointestinal—Dicyclomine; Scopolamine
• Antispasmodic, urinary tract—Atropine; Scopolamine
• Antivertigo agent—Belladonna; Scopolamine
• Cholinergic adjunct, curariform block—Atropine; Glycopyrrolate; Hyoscyamine

Description

The anticholinergics/antispasmodics are a group of medicines that include the natural belladonna alkaloids (atropine, belladonna, hyoscyamine, and scopolamine) and related products.

The anticholinergics/antispasmodics are used to relieve cramps or spasms of the stomach, intestines, and bladder. Some are used together with antacids or other medicine in the treatment of peptic ulcer. Others are used to prevent nausea, vomiting, and motion sickness.

Anticholinergics/antispasmodics are also used in certain surgical and emergency procedures. In surgery, some are given by injection before anesthesia to help relax you and to decrease secretions, such as saliva. During anesthesia and surgery, atropine, glycopyrrolate, hyoscyamine, and scopolamine are used to help keep the heartbeat normal. Scopolamine is also used to prevent nausea and vomiting after anesthesia and surgery. Atropine is also given by injection to help relax the stomach and intestines for certain types of examinations. Some anticholinergics are also used to treat poisoning caused by medicines such as neostigmine and physostigmine, certain types of mushrooms, and poisoning by “nerve”" gases or organic phosphorous pesticides (for example, demeton [Systox], diazinon, malathion, parathion, and ronnel [Trolene]). Also, anticholinergics can be used for painful menstruation, runny nose, and to prevent urination during sleep.

These medicines may also be used for other conditions as determined by your doctor.

The anticholinergics/antispasmodics are available only with your doctor"s prescription in the following dosage forms:

• Oral
• Anisotropine
  • Tablets (U.S.)
• Atropine
  • Tablets (U.S.)
  • Soluble tablets (U.S.)
• Belladonna
  • Tincture (U.S.)
• Clidinium
  • Capsules (U.S.)
• Dicyclomine
  • Capsules (U.S. and Canada)
  • Syrup (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Glycopyrrolate
  • Tablets (U.S. and Canada)
• Homatropine
  • Tablets (U.S.)
• Hyoscyamine
  • Extended-release capsules (U.S.)
  • Extended-release tablets (U.S.)
  • Elixir (U.S.)
  • Oral solution (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Mepenzolate
  • Tablets (U.S.)
• Methantheline
  • Tablets (U.S.)
• Methscopolamine
• Pirenzepine
  • Tablets (Canada)
• Propantheline
  • Tablets (U.S. and Canada)
• Scopolamine
  • Tablets (Canada)

• Parenteral
• Atropine
  • Injection (U.S. and Canada)
• Dicyclomine
  • Injection (U.S. )
• Glycopyrrolate
  • Injection (U.S. and Canada)
• Hyoscyamine
  • Injection (U.S. )
• Scopolamine
  • Injection (U.S. and Canada)

• Rectal
• Scopolamine
  • Suppositories (Canada)

• Transdermal
• Scopolamine
  • Transdermal disk (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 anticholinergics/antispasmodics the following should be considered:

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

Pregnancy—If you are pregnant or if you may become pregnant, make sure your doctor knows if your medicine contains any of the following:

• Atropine —Atropine has not been shown to cause birth defects or other problems in animals. However, when injected into humans during pregnancy, atropine has been reported to increase the heartbeat of the fetus.
• Belladonna —Studies on effects in pregnancy have not been done in either humans or animals.
• Clidinium —Clidinium has not been studied in pregnant women. However, clidinium has not been shown to cause birth defects or other problems in animal studies.
• Dicyclomine —Dicyclomine has been associated with a few cases of human birth defects but dicyclomine has not been confirmed as the cause.
• Glycopyrrolate —Glycopyrrolate has not been studied in pregnant women. However, glycopyrrolate did not cause birth defects in animal studies, but did decrease the chance of becoming pregnant and the newborn"s chance of surviving after weaning.
• Hyoscyamine —Studies on effects in pregnancy have not been done in either humans or animals. However, when injected into humans during pregnancy, hyoscyamine has been reported to increase the heartbeat of the fetus.
• Mepenzolate —Mepenzolate has not been studied in pregnant women. However, studies in animals have not shown that mepenzolate causes birth defects or other problems.
• Propantheline —Studies on effects in pregnancy have not been done in either humans or animals.
• Scopolamine —Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—Although these medicines may pass into the breast milk, they have not been reported to cause problems in nursing babies. However, the flow of breast milk may be reduced in some patients. The use of dicyclomine in nursing mothers has been reported to cause breathing problems in infants.

Children—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 anticholinergics. Also, when anticholinergics are given to children during hot weather, a rapid increase in body temperature may occur. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be more likely to cause severe side effects. Shortness of breath or difficulty in breathing has occurred in children taking dicyclomine.

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 anticholinergics. 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 anticholinergics/antispasmodics, 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 or
• Ketoconazole (e.g., Nizoral)—Using these medicines with an anticholinergic may lessen the effects of the anticholinergic

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—Taking scopolamine with CNS depressants may increase the effects of either medicine

• Other anticholinergics (medicine for abdominal or stomach spasms or cramps) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Taking anticholinergics with tricyclic antidepressants or other anticholinergics may cause an increase in the effects of the anticholinergic

• Potassium chloride (e.g., Kay Ciel)—Using this medicine with an anticholinergic may make gastrointestinal problems caused by potassium worse

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

• Bleeding problems (severe)—These medicines may increase heart rate, which would make bleeding problems worse

• Brain damage (in children)—May increase the CNS effects of this medicine

• Colitis (severe) or
• Dryness of mouth (severe and continuing) or
• Enlarged prostate or
• Fever or
• Glaucoma or
• Heart disease or
• Hernia (hiatal) or
• High blood pressure (hypertension) or
• Intestinal blockage or other intestinal problems or
• Lung disease (chronic) or
• Myasthenia gravis or
• Toxemia of pregnancy or
• Urinary tract blockage or difficult urination—These medicines may make these conditions worse

• Down"s syndrome—These medicines may cause an increase in pupil dilation and heart rate

• Kidney disease or
• Liver disease—Higher blood levels may occur and cause an increase in side effects

• Overactive thyroid—These medicines may further increase heart rate

• Spastic paralysis (in children)—This condition may increase the effects of the anticholinergic

Proper Use of This Medicine

Take this medicine only as directed . 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. To do so may increase the chance of side effects.

Dosing—The dose of the anticholinergic/antispasmodic 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 your medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of solution or syrup that 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 depends on the medical problem for which you are taking this medicine .

• For anisotropine
• For oral dosage forms (tablets):
  • To treat duodenal or stomach ulcers:
    • Older adults, adults, and teenagers—50 milligrams (mg) three times a day. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.

• For atropine
• For oral dosage form (tablets):
  • To treat duodenal or stomach ulcers, intestine problems, or urinary problems:
    • Older adults, adults, and teenagers—300 to 1200 micrograms (mcg) every four to six hours.
    • Children—Dose is based on body weight. The usual dose is 10 mcg per kilogram (kg) (4.5 mcg per pound) of body weight every four to six hours. However, the dose will not be more than 400 mcg every four to six hours.
• For injectable dosage form:
  • To treat duodenal or stomach ulcers or intestine problems:
    • Older adults, adults, and teenagers—400 to 600 mcg injected into a muscle, vein, or under the skin every four to six hours.
    • Children—The dose is based on body weight. The usual dose is 10 mcg per kilogram (kg) (4.5 mcg per pound) of body weight injected under the skin every four to six hours. However, the dose will not be more than 400 mcg every four to six hours.
  • To treat heart problems:
    • Older adults, adults, and teenagers—400 to 1000 mcg injected into a vein every one to two hours as needed. The total dose will not be more than 2 mg.
    • Children—The dose is based on body weight. The usual dose is 10 to 30 mcg per kilogram (kg) (4.5 to 13.6 mcg per pound) of body weight injected under the skin.

• For belladonna
• For oral dosage form (oral solution):
  • To treat duodenal or stomach ulcers or intestine problems:
    • Older adults, adults, and teenagers—180 to 300 micrograms (mcg) three or four times a day. The dose should be taken 30 to 60 minutes before meals and at bedtime. Your doctor may change the dose if needed.
    • Children—The dose is based on body weight. The usual dose is 9 mcg per kilogram (kg) (4 mcg per pound) of body weight three or four times a day.

• For clidinium
• For oral dosage form (capsules):
  • To treat duodenal or stomach ulcers:
    • Older adults, adults, and teenagers—2.5 to 5 milligrams (mg) three or four times a day. The dose should be taken before meals and at bedtime. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.

• For dicyclomine
• For oral dosage forms (capsules, extended-release tablets, syrup, tablets):
  • To treat intestine problems:
    • Older adults, adults, and teenagers—10 to 20 milligrams (mg) three or four times a day. Some people may take 30 mg two times a day. Your doctor may change the dose if needed. Your dose will not be more than 160 mg a day.
    • Children 2 years of age and older—5 to 10 mg three or four times a day. Your doctor may change the dose if needed.
    • Children 6 months to 2 years of age—5 to 10 mg of the syrup three or four times a day. Your doctor may change the dose if needed.
    • Children up to 6 months of age—Use is not recommended.
• For injectable dosage form:
  • To treat intestine problems:
    • Older adults, adults, and teenagers—20 mg injected into a muscle every four to six hours. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.

• For glycopyrrolate
• For oral dosage form (tablets):
  • To treat duodenal or stomach ulcers:
    • Older adults, adults, and teenagers—To start, 1 to 2 milligrams (mg) two or three times a day. Some people may also take 2 mg at bedtime. Your doctor may change the dose if needed. However, your dose will not be more than 8 mg a day.
    • Children—Dose must be determined by your doctor.
• For injectable dosage form:
  • To treat duodenal or stomach ulcers:
    • Older adults, adults, and teenagers—100 to 200 micrograms (mcg) injected into a muscle or vein. The dose may be repeated every four hours up to four times a day.
    • Children—Dose must be determined by your doctor.

• For homatropine
• For oral dosage form:
  • To treat duodenal or stomach ulcers:
    • Older adults, adults, and teenagers—5 to 10 milligrams (mg) three or four times a day. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.

• For hyoscyamine
• For oral dosage forms (capsules, elixir, oral solution, tablets):
  • To treat duodenal or stomach ulcers, intestine problems, or urinary problems:
    • Older adults, adults, and teenagers—125 to 500 micrograms (mcg) four to six times a day. Some people may take 375 mcg two times a day. The tablets should be taken 30 to 60 minutes before meals. Your doctor may change the dose if needed.
    • Children—Dose is based on body weight. The usual dose is 12.5 to 187 mcg every four hours if needed.
• For injectable dosage form:
  • To treat duodenal or stomach ulcers or intestine problems:
    • Older adults, adults, and teenagers—250 to 500 mcg injected into a muscle, vein, or under the skin every four to six hours.
    • Children—Dose must be determined by your doctor.

• For mepenzolate
• For oral dosage form (tablets):
  • To treat duodenal or stomach ulcers or intestine problems:
    • Older adults, adults, and teenagers—25 to 50 milligrams (mg) four times a day, with meals and at bedtime. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.

• For methantheline
• For oral dosage form (tablets):
  • To treat intestine or stomach ulcers, intestine problems, or urinary problems:
    • Older adults, adults, and teenagers—50 to 100 milligrams (mg) every six hours. Your doctor may change the dose if needed.
    • Children 1 year of age and older—12.5 to 50 mg four times a day. Your doctor may change the dose if needed.
    • Children 1 month to 1 year of age—12.5 mg four times a day. Your doctor may change the dose if needed.
    • Children up to 1 month of age—12.5 mg two times a day. Your doctor may change the dose if needed.

• For methscopolamine
• For oral dosage form (tablets):
  • To treat duodenal or stomach ulcers or intestine problems:
    • Older adults, adults, and teenagers—2.5 to 5 milligrams (mg) four times a day, one-half hour before meals and at bedtime. Your doctor may change the dose if needed.
    • Children—Dose is based on body weight. The usual dose is 200 micrograms (mcg) per kilogram (kg) (90.9 mcg per pound) of body weight four times a day. The dose should be taken before meals and at bedtime.

• For pirenzepine
• For oral dosage form (tablets):
  • To treat duodenal or stomach ulcers or intestine problems:
    • Older adults, adults, and teenagers—50 milligrams (mg) two times a day, in the morning and at bedtime. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.

• For propantheline
• For oral dosage form (tablets):
  • To treat duodenal or stomach ulcers:
    • Older adults, adults, and teenagers—7.5 to 15 milligrams (mg) three times a day, one-half hour before meals, and 30 mg at bedtime. Your doctor may change the dose if needed.
    • Children—Dose is based on body weight. The usual dose is 375 micrograms (mcg) per kilogram (kg) (170 mcg per pound) of body weight four times a day. Your doctor may change the dose if needed.

• For scopolamine
• For oral dosage form (tablets):
  • To treat urinary problems or intestine problems or painful menstruation:
    • Older adults, adults, and teenagers—10 to 20 milligrams (mg) three or four times a day. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.
• For injectable dosage form:
  • To treat urinary problems or intestine problems:
    • Older adults, adults, and teenagers—10 to 20 mg three or four times a day. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.
• For rectal dosage form (suppository):
  • To treat urinary problems or intestine problems or painful menstruation:
    • Older adults, adults, and teenagers—Insert one 10 mg suppository rectally three or four times a day. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.
• For transdermal dosage form (patch):
  • To treat motion sickness:
    • Older adults, adults, and teenagers—Apply one 1.0 milligram (mg) patch behind ear at least four hours before antinausea effect is needed.
    • Children—Use is not recommended.
  • To treat nausea and vomiting after surgery
    • Older adults, adults and teenagers—Apply one 1.0 mg patch behind the ear the evening before surgery to prevent nausea and vomiting after surgery
    • Children—Use is not recommended.

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.

For patients taking any of these medicines by mouth :

• Take this medicine 30 minutes to 1 hour before meals unless otherwise directed by your doctor.

To use the rectal suppository form of scopolamine :

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
• To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

To use the transdermal disk form of scopolamine :

• This medicine usually comes with patient directions. Read them carefully before using this medicine.
• Wash and dry your hands thoroughly before and after handling.
• Apply the disk to the hairless area of skin behind the ear. Do not place over any cuts or irritations.

Storage—To store this medicine:

• Keep out of the reach of children. Overdose 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 tightly closed and keep it from freezing. Do not refrigerate the syrup form of this medicine.
• 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 think you or someone else may have taken an overdose, get emergency help at once . Taking an overdose of any of the belladonna alkaloids or taking scopolamine with alcohol or other CNS depressants may lead to unconsciousness and possibly death. Some signs of overdose are clumsiness or unsteadiness; dizziness; severe drowsiness; fever; hallucinations (seeing, hearing, or feeling things that are not there); confusion; shortness of breath or troubled breathing; slurred speech; unusual excitement, nervousness, restlessness, or irritability; fast heartbeat; and unusual warmth, dryness, and flushing of skin.

These medicines may 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 , since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

Check with your doctor before you stop using this medicine . Your doctor may want you to reduce gradually the amount you are using before stopping completely. Stopping this medicine may cause withdrawal side effects such as vomiting, sweating, and dizziness.

Anticholinergics may cause some people to have blurred vision. Make sure your vision is clear before you drive or do anything else that could be dangerous if you are not able to see well . These medicines may also cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses may help lessen the discomfort from bright light.

These medicines, especially in high doses, may cause some people to become dizzy or drowsy. 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 .

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help lessen this problem.

These medicines 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 medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For patients taking scopolamine :

• 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 using this medicine .

For patients taking any of these medicines by mouth :

• Do not take this medicine within 2 or 3 hours of taking antacids or medicine for diarrhea. Taking antacids or antidiarrhea medicines and this medicine too close together may prevent this medicine from working properly.

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:

Incidence not known

For patients using scopolamine :

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

Anxiety; irritability; nightmares; trouble in sleeping

For patients using the transdermal disk of scopolamine :

• While using the disk or even after removing it, your eyes may become more sensitive to light than usual. You may also notice the pupil in one eye is larger than the other. Check with your doctor if this side effect continues or is bothersome

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, anticholinergics/antispasmodics are used in certain patients with the following medical conditions:

• Diarrhea
• Excessive watering of mouth
• Asthma treatment (atropine)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 01/31/2005

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