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All about: Propantheline Bromide

Big Image Pronouncation: (pro-PAN-thuh-leen BROE-mide)
Class: Quaternary anticholinergic

Trade Names:
Pro-Banthine
- Tablets 7.5 mg
- Tablets 15 mg

Propanthel (Canada)

Mechanism of Action

Pharmacology

Exerts anticholinergic effects, resulting in GI smooth muscle relaxation and diminished volume and acidity of GI secretions.

Pharmacokinetics

Absorption

Poor GI absorption, only 10% to 25% of oral dose is absorbed. T max is approximately 1 hr.

Distribution

Not fully determined.

Metabolism

Extensively metabolized by hydrolysis to inactive metabolites.

Elimination

Renal (70%, mostly as metabolites and 3% as propantheline). Half-life is 1.6 hr.

Duration

6 hr.

Indications and Usage

Adjunctive therapy in treatment of peptic ulcer.

Unlabeled Uses

Treatment of secretory and spastic disorders of GI tract, biliary tract, urinary tract, and bladder.

Contraindications

Hypersensitivity to anticholinergic drugs; narrow-angle glaucoma; adhesions between iris and lens; obstructive uropathy; obstructive disease of GI tract; paralytic ileus; intestinal atony of elderly or debilitated patient; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; hepatic or renal disease; tachycardia; myocardial ischemia; unstable cardiovascular status in acute hemorrhage; myasthenia gravis.

Dosage and Administration

Peptic Ulcer
Adults

PO 15 mg 30 min before meals and 30 mg at bedtime.

Patients with Mild Manifestations, Elderly Patients or Those of Small Stature

PO 7.5 mg tid.

Secretory Disorders
Adults

PO 1.5 mg/kg/day in 3 to 4 divided doses.

Spastic Disorders
Adults

PO 2 to 3 mg/kg/day in divided doses q 4 to 6 hr and at bedtime.

General Advice

  • Do not crush or allow patient to chew tablets.
  • Administer antacids 1 hr before or after propantheline.

Storage/Stability

Store at room temperature in tight container.

Drug Interactions

Antacids

Decrease absorption of propantheline if given together.

Drugs with anticholinergic effects (eg, antihistamines, antiparkinson drugs, tricyclic antidepressants)

Additive peripheral anticholinergic side effects.

Haloperidol

May cause decreased serum haloperidol levels, worsened schizophrenic symptoms and tardive dyskinesia.

Phenothiazines

May decrease antipsychotic effectiveness of phenothiazines; may produce additive anticholinergic effects.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Palpitations; tachycardia.

CNS

Headache; flushing; nervousness; drowsiness; weakness; dizziness; confusion; insomnia; fever; mental confusion or excitement; restlessness; tremor.

Dermatologic

Severe allergic reactions including anaphylaxis, urticaria and dermal manifestations.

EENT

Blurred vision; mydriasis; photophobia; cycloplegia; increased intraocular pressure; dilated pupils; nasal congestion; altered taste perception.

GI

Dry mouth; nausea; vomiting; dysphagia; heartburn; constipation; bloated feeling; paralytic ileus.

Genitourinary

Urinary hesitancy and retention; impotence.

Miscellaneous

Suppression of lactation; decreased sweating.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

For elderly or debilitated patients, drug may cause excitement, agitation, drowsiness, and other untoward manifestations, even in small doses.

Special Risk Patients

Use drug with caution in patients with glaucoma, autonomic neuropathy, hepatic or renal disease, ulcerative colitis, hyperthyroidism, coronary artery disease, CHF, cardiac tachyarrhythmias, tachycardia, hypertension, prostatic hypertrophy and hiatal hernia associated with reflux esophagitis.

Diarrhea

May be symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. Treatment of diarrhea with drug is inappropriate and possibly harmful.

Gastric ulcer

May delay gastric emptying rate and complicate therapy.

Heat prostration

Can occur in presence of high environmental temperature.

Overdosage

Symptoms

Dry mouth, thirst, vomiting, nausea, abdominal distention, paralytic ileus, difficulty swallowing, muscular weakness, paralysis, CNS stimulation (restlessness, anxiety), delirium (disorientation, hallucinations), drowsiness, stupor, fever, dizziness, headache, seizures, ataxia, coma, circulatory failure, rapid pulse and respiration, vasodilation, tachycardia with weak pulse, hypertension, hypotension, respiratory depression, palpitations, urinary urgency with difficulty in micturition, blurred vision, photophobia, dilated pupils, leukocytosis, flushed hot dry skin, rash.

Patient Information

  • Advise patient to take drug 30 min before meals and at bedtime unless directed otherwise by health care provider.
  • Instruct patient not to chew or crush tablets.
  • Warn patient that drug increases risk of heat prostration and caution patient to avoid becoming overheated by exercise or high environmental temperatures.
  • Instruct patient to report the following symptoms to health care provider: drowsiness, dizziness, urinary hesitancy and retention, blurred vision, diarrhea or constipation, skin rash, flushing, or eye pain.
  • Tell patient to take sips of water frequently, suck on ice chips or sugarless hard candy or chew sugarless gum if dry mouth occurs.
  • Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.

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