Propantheline

Name: Propantheline

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Propantheline Drug Class

Propantheline is part of the drug class:

  • Synthetic anticholinergics, quaternary ammonium compounds

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling restless or excited, redness or tingling under your skin, confusion, unusual behavior, trouble breathing, feeling like you might pass out, muscle weakness, or paralysis.

What are some things I need to know or do while I take Propantheline?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how propantheline affects you.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using propantheline while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Propantheline Description

Each tablet for oral administration contains:

Propantheline bromide USP.................................................. 15 mg

Propantheline bromide, a synthetic quaternary ammonium compound, occurs as white or nearly white crystals. It is odorless and has a bitter taste, and is very soluble in water and chloroform; practically insoluble in ether, acetone and ethyl acetate. It is designated chemically as (2-Hydroxyethyl) diisopropylmethyl-ammonium bromide xanthene-9-carboxylate.

The structural formula is:

Inactive Ingredients

Each tablet contains corn starch, hydrogenated vegetable oil, lactose monohydrate and magnesium stearate. In addition to the ingredients listed above, each tablet contains Opacode Black (monogramming ink), Opadry Clear and Opadry White. Opacode Black contains ammonium hydroxide, black iron oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Opadry Clear contains hypromellose and polyethylene glycol. Opadry White contains hypromellose, polyetheylene glycol, polysorbate 80 and titanium dioxide.

Propantheline - Clinical Pharmacology

Propantheline bromide inhibits gastrointestinal motility and diminishes gastric acid secretion. The drug also inhibits the action of acetylcholine at the postganglionic nerve endings of the parasympathetic nervous system.

Propantheline bromide is extensively metabolized in man primarily by hydrolysis to the inactive materials xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide. In a bioavailability study, peak plasma concentrations of Propantheline were achieved in about one hour, following a single oral dose.

The plasma elimination half-life of Propantheline is about 1.6 hours. Approximately 70% of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of Propantheline is about 3% after oral tablet administration.

Precautions

General

Propantheline should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, or hiatal hernia associated with reflux esophagitis, since anticholinergics may aggravate this condition.

In patients with ulcerative colitis, large doses of Propantheline may suppress intestinal motility to the point of producing paralytic ileus and, for this reason, may precipitate or aggravate toxic megacolon, a serious complication of the disease.

Information for Patients

Propantheline may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work, while taking this drug.

Drug Interactions

Anticholinergics may delay absorption of other medication given concomitantly. Excessive cholinergic blockade may occur if Propantheline is given concomitantly with belladonna alkaloids or synthetic and semisynthetic anticholinergic agents, narcotic analgesics such as meperidine, Type 1 antiarrhythmic drugs (e.g., disopyramide, procainamide, or quinidine), antihistamines, phenothiazines, tricyclic antidepressants, or other psychoactive drugs. Propantheline may also potentiate the sedative effect of phenothiazines. Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.

Concurrent use of Propantheline with slow-dissolving tablets of digoxin may cause increased serum digoxin levels. This interaction can be avoided by using only those digoxin tablets that rapidly dissolve by USP standards.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term fertility, carcinogenicity, or mutagenicity studies have been done with Propantheline.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Propantheline. It is also not known whether Propantheline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Propantheline should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Propantheline is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.

Pediatric Use

Safety and effectiveness in children have not been established.

Pharmacologic Category

  • Anticholinergic Agent

Dosing Adult

Peptic ulcer: Oral: 15 mg 3 times daily before meals or food and 30 mg at bedtime; adjust dosage according to patient response and tolerance.

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution

Adverse Reactions

Frequency not defined.

Cardiovascular: Palpitations, tachycardia

Central nervous system: Confusion, dizziness, drowsiness, headache, insomnia, nervousness

Dermatologic: Hypohidrosis

Gastrointestinal: Ageusia, bloating, constipation, nausea, vomiting, xerostomia

Genitourinary: Decreased lactation, impotence, urinary hesitancy, urinary retention

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Neuromuscular & skeletal: Weakness

Ophthalmic: Blurred vision, cycloplegia, increased intraocular pressure, mydriasis

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