Anticholinergics and antispasmodics (oral route, parenteral route, rectal route, transdermal route)


    Brand Name

    US Brand Name

    Akineton

    Artane

    Bentyl

    Cantil

    Cogentin

    Colidrops Pediatric

    Cystospaz

    Dartisla ODT

    Detrol

    Ditropan

    Ed-Spaz

    Enablex

    HyoMax

    HyoMax-DT

    HyoMax-FT

    HyoMax-SR

    Hyosyne

    IB-Stat

    Levsinex

    Neosol

    Norflex

    Nulev

    Oscimin

    Oscimin-SR

    Oxytrol

    Pamine

    Pro-Banthine

    Pro-Hyo

    Robinul

    Sanctura

    Scopodex

    Spacol T/S

    Spasdel

    Symax

    Symax Duotab

    Symmetrel

    Toviaz

    Transderm Scop

    Urispas

    Vesicare

    Canadian Brand Name

    Buscopan

    Levsin

    Pms-Trihexyphenidyl

    Transderm-V


    Description

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

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

    Anticholinergics and 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 procedures.

    Anticholinergics are used to treat poisoning caused by medicines such as neostigmine and physostigmine, certain types of mushrooms, and “nerve” gases or organic phosphorous pesticides (eg, demeton [Systox®], diazinon, malathion, parathion, and ronnel [Trolene®]). Anticholinergics can be used for painful menstruation, runny nose, and to prevent urination during sleep.

    The anticholinergics and antispasmodics are available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet, Extended Release
    • Tablet
    • Solution
    • Syrup
    • Capsule
    • Capsule, Extended Release
    • Elixir
    • Tablet, Disintegrating
    • Suspension
    • Patch, Extended Release
    • Gel/Jelly
    • Tablet, Chewable
    • Liquid

    Before Using

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Unusual excitement, nervousness, restlessness, or irritability, and unusual warmth, dryness, and flushing of the skin are more likely to occur in children. Children 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 with breathing has occurred in children taking dicyclomine.

    Geriatric

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

    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 women during pregnancy, atropine increased the heartbeat of the fetus.
    • Belladonna—Belladonna has not been studied in pregnant women 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 animals.
    • 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—Hyoscyamine has not been studied in pregnant women or animals. However, when injected into women during pregnancy, hyoscyamine increased 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—Propantheline has not been studied in pregnant women or animals.
    • Scopolamine—Scopolamine has not been studied in pregnant women or animals.

    Breastfeeding

    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 is contraindicated and should not be used in nursing mothers because it has been reported to cause breathing problems in infants.

    Drug Interactions

    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 any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

    • Ambenonium
    • Bepridil
    • Bromopride
    • Cisapride
    • Dronedarone
    • Fluconazole
    • Itraconazole
    • Ketoconazole
    • Levoketoconazole
    • Mavorixafor
    • Mesoridazine
    • Nelfinavir
    • Pimozide
    • Piperaquine
    • Posaconazole
    • Potassium
    • Potassium Chloride
    • Potassium Citrate
    • Saquinavir
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Ziprasidone

    Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abiraterone Acetate
    • Abiraterone Acetate, Micronized
    • Aclidinium
    • Adagrasib
    • Alfentanil
    • Alfuzosin
    • Alprazolam
    • Amantadine
    • Amifampridine
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Amobarbital
    • Amoxapine
    • Anagrelide
    • Anileridine
    • Apomorphine
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Asciminib
    • Asenapine
    • Astemizole
    • Atazanavir
    • Atropine
    • Avacopan
    • Azithromycin
    • Baclofen
    • Bedaquiline
    • Belladonna
    • Benzhydrocodone
    • Benztropine
    • Biperiden
    • Boceprevir
    • Bromazepam
    • Brompheniramine
    • Buprenorphine
    • Bupropion
    • Buserelin
    • Buspirone

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

    • Bleeding problems (severe) or
    • Heart failure or
    • Hyperthyroidism (an overactive thyroid) or
    • Tachycardia (increased heart rate)—These medicines may increase the heart rate and make these conditions worse.
    • Brain damage (in children)—This condition may increase the unwanted nervous system effects of these medicines.
    • Colitis (severe) or
    • Dryness of the 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 severe constipation or
    • Lung disease (chronic) or
    • Myasthenia gravis 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 size and heart rate for patients with this condition.
    • Liver disease—This condition may cause higher blood levels of the medicines which could increase the side effects.
    • Spastic paralysis (in children)—This condition may increase the effects of the medicines.

    Proper Use

    To use any of these medicines by mouth:

    • Take the medicine 30 minutes to 1 hour before meals unless otherwise directed by your doctor.
    • Do not take the medicine within 2 or 3 hours of taking an antacid or a medicine for diarrhea. Taking the medicine too close together with antacids or antidiarrhea medicines may prevent the medicine from working properly.

    To use the injectable form of dicyclomine:

    • The injectable form should only be given intramuscularly (into a muscle). Do not give it intravenously (into a vein).
    • The injectable form should only be used for 1 or 2 days. Your doctor may give you an oral medicine that works the same way.

    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 patch 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 the patch.
    • Apply the patch to the hairless area of skin behind the ear. Do not place it over any cuts or irritations.

    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 medicines in this class 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 medicines. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine 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 depend on the medical problem for which you are using the medicine.

    For anisotropine

    • For oral dosage forms (tablets):
      • To treat duodenal or stomach ulcers:
        • Older adults, adults, and teenagers—50 milligrams (mg) three times per day. Your doctor may adjust 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 4 to 6 hours.
        • Children—Dose is based on body weight. The usual dose is 10 mcg per kilogram (kg) of body weight every 4 to 6 hours. However, the dose will not be more than 400 mcg every 4 to 6 hours.
    • For injectable dosage form:
      • To treat duodenal or stomach ulcers or intestine problems:
        • Older adults, adults, and teenagers—400 to 600 micrograms (mcg) injected into a muscle, vein, or under the skin every 4 to 6 hours.
        • Children—The dose is based on body weight. The usual dose is 10 mcg per kilogram (kg) of body weight injected under the skin every 4 to 6 hours. However, the dose will not be more than 400 mcg every 4 to 6 hours.
      • To treat heart problems:
        • Older adults, adults, and teenagers—400 to 1000 micrograms (mcg) injected into a vein every 1 to 2 hours as needed. The total dose will not be more than 2 milligrams (mg).
        • Children—The dose is based on body weight. The usual dose is 10 to 30 mcg per kilogram (kg) of body weight injected into a vein.

    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, syrup, tablets):
      • To treat intestine problems:
        • Older adults, adults, and teenagers—20 milligrams (mg) four times per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 160 mg per day.
        • Children and infants—Use is not recommended.
        • Infants younger than 6 months of age—Avoid use; use is contraindicated.
    • For injectable dosage form (intramuscular only):
      • To treat intestine problems:
        • Older adults, adults, and teenagers—10 to 20 milligrams (mg) injected into a muscle four times per day.
        • Children and infants—Use is not recommended.
        • Infants younger than 6 months of age—Avoid use; use is contraindicated.

    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 patch behind the ear at least 4 hours before the antinausea effect is needed.
        • Children—Use is not recommended.
      • To treat nausea and vomiting after surgery
        • Older adults, adults, and teenagers—Apply one 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.

    Storage

    Keep out of the reach of children.

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

    Do not keep outdated medicine or medicine no longer needed.

    Keep the liquid form of this medicine tightly closed and keep it from freezing. Do not refrigerate the syrup form of this medicine.


    Precautions

    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 central nervous system (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 and antispasmodics 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.

    Side Effects

    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 immediately if any of the following side effects occur:

    Rare

    • Confusion (especially in the elderly)
    • dizziness, lightheadedness that continues, or fainting
    • eye pain
    • skin rash or hives

    Incidence not known

    • Cough
    • difficulty with swallowing
    • fast irregular, pounding, or racing heartbeat or pulse
    • fever
    • hives or welts
    • hoarseness
    • irritation
    • itching skin
    • joint pain, stiffness, or swelling
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • redness of the skin
    • shortness of breath
    • skin rash
    • tightness in the chest
    • trouble with breathing
    • wheezing

    Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Constipation
    • decreased sweating
    • dryness of the mouth, nose, throat, or skin

    Less common or rare

    • Bloated feeling
    • blurred vision
    • difficult urination
    • difficulty with swallowing
    • drowsiness
    • false sense of well-being
    • headache
    • increased sensitivity of eyes to light
    • loss of memory
    • nausea or vomiting
    • redness or other signs of irritation at the place of injection
    • trouble with sleeping
    • unusual tiredness or weakness

    Incidence not known

    • Decreased interest in sexual intercourse
    • inability to have or keep an erection
    • loss in sexual ability, desire, drive, or performance
    • loss of taste

    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
    • pupil of one eye is larger (patch only)
    • sensitivity of eyes to light (patch only)
    • trouble in sleeping

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

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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