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Propantheline (United States and Canada: Not available): Drug information

Propantheline (United States and Canada: Not available): Drug information
(For additional information see "Propantheline (United States and Canada: Not available): Patient drug information" and see "Propantheline (United States and Canada: Not available): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Anticholinergic Agent
Dosing: Adult

Note: Propantheline has been discontinued in the United States for >1 year.

Peptic ulcer

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.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Avoid use (Ref).

Dosing: Pediatric

(For additional information see "Propantheline (United States and Canada: Not available): Pediatric drug information")

Note: Propantheline has been discontinued in the United States for >1 year.

GI or bladder spasm, irritable bowel syndrome

GI or bladder spasm, irritable bowel syndrome: Limited data available: Children and Adolescents: Oral: 1.5 to 3 mg/kg/day in divided doses every 4 to 6 hours (Ref); maximum daily dose: 75 mg/day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

Contraindications

Glaucoma; obstructive disease of the gastrointestinal tract (eg, pyloroduodenal stenosis, achalasia, paralytic ileus); obstructive uropathy (eg, bladder-neck obstruction due to prostatic hypertrophy); intestinal atony of elderly or debilitated patients; severe ulcerative colitis or toxic megacolon complicating ulcerative colitis; unstable cardiovascular adjustment in acute hemorrhage; myasthenia gravis.

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; discontinue treatment 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.

• 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.

• Ulcerative colitis: Use with caution in patients with ulcerative colitis; large doses may suppress intestinal motility.

Special populations:

• Older adult: Use with caution.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer’s labeling.

Warnings: Additional Pediatric Considerations

Infants, patients with Down syndrome, and children with spastic paralysis or brain damage may be hypersensitive to antimuscarinic effects.

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Product Availability

Propantheline has been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as bromide:

Generic: 15 mg [DSC]

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Propantheline Bromide Oral)

15 mg (per each): $3.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: Administer 30 minutes before meals and at bedtime.

Administration: Pediatric

Oral: Administer 30 minutes before meals and at bedtime

Use: Labeled Indications

Peptic ulcer: Adjunctive therapy in the treatment of peptic ulcer

Medication Safety Issues
Older Adult: High-risk medication:

Beers Criteria: GI antispasmodics with strong anticholinergic properties (propantheline) are identified in the Beers Criteria as a potentially inappropriate medications to be avoided in patients ≥65 years (independent of diagnosis or condition) due to their highly anticholinergic properties and uncertain effectiveness as an antispasmodic (Beers Criteria [AGS 2023]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

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

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification

Digoxin: Propantheline may increase the serum concentration of Digoxin. Risk C: Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Breastfeeding Considerations

It is not known if propantheline is excreted in breast milk. Suppression of lactation may occur with anticholinergics. The manufacturer recommends that caution be exercised when administering propantheline to nursing women.

Dietary Considerations

Some products may contain lactose.

Mechanism of Action

Competitively blocks the action of acetylcholine at postganglionic parasympathetic receptor sites and inhibits gastrointestinal motility

Pharmacokinetics (Adult Data Unless Noted)

Duration: 6 hours

Metabolism: Hepatic via hydrolysis to inactive metabolites

Half-life elimination, serum: ~1.6 hours

Time to peak, plasma: ~1 hour

Excretion: Urine (3%; ~70% as metabolites)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BD) Bangladesh: Prokind | Propa;
  • (CH) Switzerland: Pro banthine;
  • (FI) Finland: Ercoril;
  • (HK) Hong Kong: Probanthine | Propantheline;
  • (ID) Indonesia: Probanthine;
  • (IL) Israel: Probanthine;
  • (IN) India: Probanthine;
  • (JP) Japan: Pro banthine;
  • (NO) Norway: Ercoril;
  • (PR) Puerto Rico: Propantheline br;
  • (SA) Saudi Arabia: Probanthine;
  • (SE) Sweden: Pro banthine;
  • (TH) Thailand: Pro banthine;
  • (TW) Taiwan: Probanthine | Propantheline;
  • (VE) Venezuela, Bolivarian Republic of: Pro banthine
  1. 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2081. doi:10.1111/jgs.18372 [PubMed 37139824]
  2. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  3. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm [PubMed 6423951]
  4. Gal P, Reed M. Medications. In: Kliegman RM, Behrman RE, Jenson HB, et al, eds. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, PA: Saunders Elsevier; 2007: 2955-2999.
  5. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  6. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  7. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  8. Propantheline bromide [prescribing information]. Eatontown, NJ: West-Ward Pharmaceuticals Corp; March 2016.
  9. Rudolph AM, Hoffman JIE, Rudolph CD, eds. Rudolph's Pediatrics. 20th ed. Stamford, CT: Appleton & Lange; 1996.
  10. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  11. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  12. Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219. [PubMed 17555487]
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