Propantheline Bromide

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Overview

What is Propantheline Bromide?

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:

What does Propantheline Bromide look like?

What are the available doses of Propantheline Bromide?

Sorry No records found.

What should I talk to my health care provider before I take Propantheline Bromide?

Sorry No records found

How should I use Propantheline Bromide?

Propantheline bromide is effective as adjunctive therapy in the treatment of peptic ulcer.

The usual initial adult dose of propantheline bromide tablets is 15 mg taken 30 minutes before each meal and 30 mg at bedtime (a total of 75 mg daily). Subsequent dosage adjustment should be made according to the patient’s individual response and tolerance.

What interacts with Propantheline Bromide?

Propantheline is contraindicated in patients with:

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What are the warnings of Propantheline Bromide?

Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see ).

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of propantheline.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

With overdose, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). Propantheline may cause increased heart rate and therefore, should be used with caution in patients with heart disease.

What are the precautions of Propantheline Bromide?

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

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.

What are the side effects of Propantheline Bromide?

Varying degrees of drying of salivary secretions may occur as well as decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia, and increased ocular tension. Other reported adverse reactions include urinary hesitancy and retention, tachycardia, palpitations, loss of the sense of taste, headache, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, bloated feeling, impotence, suppression of lactation, and allergic reactions or drug idiosyncracies including anaphylaxis, urticaria and other dermal manifestations.

What should I look out for while using Propantheline Bromide?

Propantheline is contraindicated in patients with:

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of propantheline.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

With overdose, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). Propantheline may cause increased heart rate and therefore, should be used with caution in patients with heart disease.

What might happen if I take too much Propantheline Bromide?

The symptoms of overdosage with propantheline progress from an intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma.

Measures to be taken are (1) immediate induction of emesis or lavage of the stomach and (2) injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg, and (3) monitoring of vital signs and managing as necessary.

Fever may be treated symptomatically (cooling blanket or alcohol sponging). Excitement of a degree which demands attention may be managed with thiopental sodium 2% solution given slowly intravenously or diazepam, 5 to 10 mg intravenously or 10 mg intramuscularly. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, mechanical respiration should be instituted and maintained until effective respiratory action returns.

The oral LD of propantheline bromide is 780 mg/kg in the mouse and 370 mg/kg in the rat.

How should I store and handle Propantheline Bromide?

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016Propantheline Bromide Tablets USP15 mg tablets are supplied as white, film-coated tablets imprinted in black ink with product identification “54 303.”NDC 0054-4721-25: Bottles of 100 TabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant container as defined in the USP/NF.Distr. by: Pharmaceuticals Corp.Eatontown, NJ 077244071101//07 Revised March 2016

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Clinical Information

Chemical Structure

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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.

Non-Clinical Toxicology

Propantheline is contraindicated in patients with:

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of propantheline.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

With overdose, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). Propantheline may cause increased heart rate and therefore, should be used with caution in patients with heart disease.

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.

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.

Varying degrees of drying of salivary secretions may occur as well as decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia, and increased ocular tension. Other reported adverse reactions include urinary hesitancy and retention, tachycardia, palpitations, loss of the sense of taste, headache, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, bloated feeling, impotence, suppression of lactation, and allergic reactions or drug idiosyncracies including anaphylaxis, urticaria and other dermal manifestations.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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