Propantheline bromide

Propantheline bromide
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Propantheline bromide is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

Dosing Information

• 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Propantheline bromide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Propantheline bromide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Propantheline bromide in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Propantheline bromide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Propantheline bromide in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• 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.

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.

Adverse Reactions

Clinical Trials Experience

• 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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Propantheline bromide in the drug label.

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• 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.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Propantheline bromide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Propantheline bromide during labor and delivery.

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.

Geriatic Use

There is no FDA guidance on the use of Propantheline bromide with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Propantheline bromide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Propantheline bromide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Propantheline bromide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Propantheline bromide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Propantheline bromide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Propantheline bromide in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Propantheline bromide in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Propantheline bromide in the drug label.

Overdosage

• 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 LD50 of propantheline bromide is 780 mg/kg in the mouse and 370 mg/kg in the rat.

Pharmacology

There is limited information regarding Propantheline bromide Pharmacology in the drug label.

Mechanism of Action

• 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.

Structure

• Each tablet for oral administration contains:

• Propantheline bromide.................................................. 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:

This image is provided by the National Library of Medicine.

Inactive Ingredients

• The tablets contain hydroxypropyl methylcellulose, lactose, magnesium stearate, starch, sterotex, and other ingredients.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Propantheline bromide in the drug label.

Pharmacokinetics

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. There is limited information regarding Pharmacokinetics of Propantheline bromide in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Clinical Studies

There is limited information regarding Clinical Studies of Propantheline bromide in the drug label.

How Supplied

• Propantheline Bromide Tablets USP
• 15 mg white film-coated tablets
• (Identified 54 303).
• NDC 0054-4721-25: Bottles of 100 tablets.

• Dispense in tight, light-resistant container as defined in the USP/NF.
• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Storage

There is limited information regarding Propantheline bromide Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Propantheline bromide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Propantheline bromide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

• 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.

Precautions with Alcohol

• Alcohol-Propantheline bromide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Label Page=Propantheline bromide
 |Label Name=Propantheline bromide04.png

}}

{{#subobject:

 |Label Page=Propantheline bromide
 |Label Name=Propantheline bromide05.png

}}