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Bethanechol: Drug information

Bethanechol: Drug information
(For additional information see "Bethanechol: Patient drug information" and see "Bethanechol: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Urecholine [DSC]
Brand Names: Canada
  • Duvoid
Pharmacologic Category
  • Cholinergic Agonist
Dosing: Adult
Neurogenic bladder, urinary retention

Neurogenic bladder, urinary retention: Oral: Initial: 5 to 10 mg; repeat the same dose hourly until effective response or a maximum of 50 mg is reached; usual dose: 10 to 50 mg 3 to 4 times daily.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Bethanechol: Pediatric drug information")

Urinary retention, nonobstructive

Urinary retention, nonobstructive: Limited data available: Children and Adolescents: Oral: 0.3 to 0.6 mg/kg/day in 3 to 4 divided doses; maximum dose: 10 mg/dose for children. Note: Usual adult dose is 10 to 50 mg 3 to 4 times daily (Ref).

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 are derived from product labeling unless otherwise specified.

Frequency not defined:

Cardiovascular: Decreased blood pressure (with reflex tachycardia), flushing, vasomotor symptoms

Dermatologic: Diaphoresis

Gastrointestinal: Abdominal cramps, abdominal distress (including colicky pain), borborygmi, diarrhea, eructation, nausea, salivation

Genitourinary: Urinary urgency

Nervous system: Headache

Ophthalmic: Lacrimation, miosis

Respiratory: Bronchoconstriction, exacerbation of asthma

Postmarketing: Nervous system: Malaise, seizure

Contraindications

Hypersensitivity to bethanechol or any component of the formulation; hyperthyroidism, peptic ulcer disease, epilepsy, asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, or parkinsonism; mechanical obstruction of the GI or GU tract or when the strength or integrity of the GI or bladder wall is in question; when increased muscular activity of the GI tract or urinary bladder might prove harmful (eg, following urinary bladder surgery, GI resection and anastomosis, possible GI obstruction); bladder neck obstruction, spastic GI disturbances, acute inflammatory lesions of the GI tract, peritonitis, marked vagotonia.

Warnings/Precautions

Concerns related to adverse effects:

• Reflux infection: If patient has bacteriuria, there is potential for reflux infection if the sphincter fails to relax as bethanechol contracts the bladder.

Warnings: Additional Pediatric Considerations

As a cholinergic, prokinetic agent, bethanechol was historically used to treat infants and children with GERD. However, the risk of adverse effects risks outweigh efficacy benefits and use is no longer recommended (AAP [Lightdale 2013], NASPGHAN/ESPGHAN [Vandenplas 2009].

Dosage Forms: US

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

Tablet, Oral, as chloride:

Urecholine: 25 mg [DSC], 50 mg [DSC] [contains fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]

Generic: 5 mg, 10 mg, 25 mg, 50 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Bethanechol Chloride Oral)

5 mg (per each): $0.71 - $0.90

10 mg (per each): $1.31 - $2.00

25 mg (per each): $1.40 - $2.67

50 mg (per each): $2.89 - $4.27

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.

Dosage Forms: Canada

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

Tablet, Oral, as chloride:

Duvoid: 10 mg, 25 mg, 50 mg

Administration: Adult

Oral: Administer 1 hour before or 2 hours after meals (to avoid nausea and vomiting).

Administration: Pediatric

Oral: Administer 1 hour before meals or 2 hours after meals to reduce nausea and vomiting

Use: Labeled Indications

Neurogenic bladder: Treatment of neurogenic atony of the urinary bladder with retention

Urinary retention: Treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention

Medication Safety Issues
Sound-alike/look-alike issues:

Bethanechol may be confused with betaxolol

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 enhance the adverse/toxic effect of Cholinergic Agonists. Specifically, cholinergic effects may be enhanced or increased. Risk C: Monitor therapy

Beta-Blockers: May enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Risk C: Monitor therapy

Cimetropium: Cholinergic Agonists may diminish the anticholinergic effect of Cimetropium. Risk C: Monitor therapy

Rivastigmine: Cholinergic Agonists may enhance the adverse/toxic effect of Rivastigmine. Specifically, cholinergic effects may be enhanced or increased. Rivastigmine may enhance the adverse/toxic effect of Cholinergic Agonists. Management: Use of rivastigmine with a cholinergic agonist is not recommended unless clinically necessary. If the combination is necessary, monitor for increased cholinergic effects. Risk D: Consider therapy modification

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Breastfeeding Considerations

It is not known if bethanechol is present in breast milk. Due to the potential for serious adverse reactions in the nursing infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.

Mechanism of Action

Due to stimulation of the parasympathetic nervous system, bethanechol increases bladder muscle tone causing contractions which initiate urination. Bethanechol also stimulates gastric motility, increases gastric tone and may restore peristalsis.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 30 minutes; Peak effect: ~60 to 90 minutes

Duration: ~1 hour (with therapeutic doses); up to 6 hours with large doses (300 to 400 mg)

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

  • (AR) Argentina: Miotonachol;
  • (AT) Austria: Myocholine;
  • (AU) Australia: Urecholine | Uro-carb;
  • (BE) Belgium: Muscaran | Myocholine glenwood;
  • (BR) Brazil: Liberan;
  • (CH) Switzerland: Myocholine;
  • (CO) Colombia: Betanecol;
  • (DE) Germany: Myocholine | Myocholine glenwood;
  • (EE) Estonia: Myocholine glenwood;
  • (ES) Spain: Myo hermes;
  • (FI) Finland: Urecholine;
  • (FR) France: Myocholine | Urecholine;
  • (GB) United Kingdom: Myotonine;
  • (IE) Ireland: Myotonine;
  • (IL) Israel: Myocholine | Urecholine;
  • (IN) India: Bchol | Betawic | Bethanax | Betheran | Macpee | Mictuease | Urivoid | Urotone;
  • (IT) Italy: Urecholine;
  • (JO) Jordan: Myocholine glenwood;
  • (JP) Japan: Besakororu;
  • (KR) Korea, Republic of: Ausnechol | Besacolin | Hinechol | Hinecol | Mytonin | Twotinechol | Uninechol | Urecholine;
  • (NO) Norway: Myocholine;
  • (PH) Philippines: Uriflow;
  • (PR) Puerto Rico: Bethanechol cl | Urecholine;
  • (SG) Singapore: Bethanechol | Urecholine;
  • (TH) Thailand: Ucholine | Urecholine;
  • (TW) Taiwan: Benecol | Bethancol | Bethanechol | Dampurine | Duvoid | Mesacol | Urecholine | Urecol | Wecoli;
  • (ZA) South Africa: Urecholine
  1. ASHP. Standardize 4 Safety Initiative Compounded Oral Liquid Version 1.01. July 2017. https://www.ashp.org/-/media/assets/pharmacy-practice/s4s/docs/s4s-ashp-oral-compound-liquids.ashx?la=en&hash=4C2E4F370B665C028981B61F6210335AD5D0D1D6.
  2. Bethanechol Chloride tablets, USP [prescribing information]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; September 2021.
  3. 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.
  4. Gearhart JP, Rink RC, Mouriquand DPE., eds. Pediatric Urology. 2nd ed. Philadelphia, PA: Library of Congress Cataloging-in-Publication Data; 2010.
  5. Goldman A, Hain R, Liben S, eds. Palliative Care for Children. 2nd ed. New York, NY: Oxford University Press; 2012.
  6. Lightdale JR, Gremse DA; Section on Gastroenterology, Hepatology, and Nutrition. Gastroesophageal reflux: management guidance for the pediatrician. Pediatrics. 2013;131(5):e1684-1695. [PubMed 23629618]
  7. Urecholine (bethanechol) [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA; September 2015.
  8. Vandenplas Y, Rudolph CD, Di Lorenzo C, et al. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr. 2009;49(4):498-547. [PubMed 19745761]
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