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Propantheline Drug Information Provided by Lexi-Comp

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Pronunciation

(proe PAN the leen)

Generic Available (U.S.)

Yes

Index Terms

  • Propantheline Bromide

Pharmacologic Category

  • Anticholinergic Agent

Pharmacologic Category Synonyms

  • Cholinergic Antagonist

Use: Labeled Indications

Adjunctive treatment of peptic ulcer

Use: Dental

Induce dry field (xerostomia) in oral cavity

Use: Unlabeled

Decreased salivation and drooling

Pregnancy Risk Factor

C

Lactation

Excretion in breast milk unknown/use caution

Breast-Feeding Considerations

No data reported; however, atropine may be taken while breast-feeding.

Contraindications

Severe ulcerative colitis, toxic megacolon, obstructive disease of the GI or urinary tract; glaucoma; myasthenia gravis; unstable cardiovascular adjustment in acute hemorrhage; intestinal atony of elderly or debilitated patients

Warnings/Precautions

Concerns related to adverse effects:

• CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Diarrhea: May be a sign of incomplete intestinal obstruction, treatment should be discontinued if this occurs.

• Heat prostration: May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with coronary artery disease, tachyarrhythmias, heart failure, or hypertension; evaluate tachycardia prior to administration.

• Endocrine disease: Use with caution in patients with endocrine diseases.

• Gastrointestinal infections: Use with caution in patients with GI infections.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Hiatal hernia: Use with caution in patients with hiatal hernia with reflux esophagitis.

• Hyperthyroidism: Use with caution in patients with hyperthyroidism.

• Neuropathy: Use with caution in patients with autonomic neuropathy.

• Renal impairment: Use with caution in patients with renal impairment.

Special populations:

• Elderly: Avoid long-term use in this age group due to anticholinergic adverse effects and uncertain effectiveness (Beers Criteria)

Adverse Reactions

Frequency not defined.

Cardiovascular: Palpitation, tachycardia

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

Endocrine & metabolic: Suppression of lactation

Gastrointestinal: Bloated feeling, constipation, loss of taste, nausea, vomiting, xerostomia

Genitourinary: Impotence, urinary hesitancy, urinary retention

Neuromuscular & skeletal: Weakness

Ocular: Blurred vision, cycloplegia, mydriasis, ocular tension increased

Miscellaneous: Allergic reactions, anaphylaxis, diaphoresis decreased

Metabolism/Transport Effects

None known.

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Risk C: Monitor therapy

Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy

Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy

Cannabinoids: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoids. Risk C: Monitor therapy

MAO Inhibitors: May enhance the orthostatic hypotensive effect of Orthostatic Hypotension Producing Agents. Risk C: Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Risk C: Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Risk D: Consider therapy modification

Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Risk C: Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Risk D: Consider therapy modification

Storage

Store at 20°C to 25°C (68°F to 77°F).

Mechanism of Action

Competitively blocks the action of acetylcholine at postganglionic parasympathetic receptor sites

Pharmacodynamics/Kinetics

Onset of action: 30-45 minutes

Duration: 4-6 hours

Half-life elimination, serum: Average: 1.6 hours

Dosage

Oral:

Antisecretory (unlabeled use):

Children: 1-2 mg/kg/day in 3-4 divided doses

Adults: 15 mg 3 times/day before meals or food and 30 mg at bedtime

Elderly: 7.5 mg 3 times/day before meals and at bedtime

Antispasmodic:

Children: 2-3 mg/kg/day in divided doses every 4-6 hours and at bedtime

Adults: 15 mg 3 times/day before meals or food and 30 mg at bedtime

Dental Usual Dosing

Antisecretory: Oral:

Children: 1-2 mg/kg/day in 3-4 divided doses

Adults: 15 mg 3 times/day before meals or food and 30 mg at bedtime

Elderly: 7.5 mg 3 times/day before meals and at bedtime

Administration: Oral

Administer 30 minutes before meals and at bedtime.

Dietary Considerations

Should be taken 30 minutes before meals so that the drug's peak effect occurs at the proper time. The tablet (15 mg) contains lactose 23.2 mg.

Geriatric Considerations

The primary use of propantheline in the geriatric population was for treatment of urinary incontinence due to detrusor instability. It is rarely used presently since newer agents, with fewer side effects, have been introduced. Even though it does not cross the blood-brain barrier, CNS effects have been reported. Orthostatic hypotension may also occur.

This medication is considered to be potentially inappropriate in this patient population (Beers Criteria severity: High).

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Significant xerostomia (therapeutic effect; normal salivary flow resumes upon discontinuation), dry throat, nasal dryness, and dysphagia.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause drowsiness, confusion, amnesia, nervousness, or insomnia

Mental Health: Effects on Psychiatric Treatment

Concurrent use with psychotropics may produce additive sedation or anticholinergic side effects (dry mouth)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral, as bromide: 15 mg

Pricing: U.S. (www.drugstore.com)

Tablets (Propantheline Bromide)

15 mg (30): $22.65

International Brand Names

  • Ercoril (DK)
  • Ercotina (SE)
  • Pro-Banthine (AU, BB, BE, BF, BJ, BM, BS, BZ, CI, CY, ET, FR, GB, GH, GM, GN, GY, HK, ID, IE, IN, JM, KE, LR, LU, MA, ML, MR, MU, MW, NE, NG, NL, SC, SD, SL, SN, SR, TN, TT, TW, TZ, UG, ZA, ZM, ZW)
  • Propanline (TW)

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Last full review/revision January 2012

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