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Bethanechol Drug Information Provided by Lexi-Comp

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Pronunciation

(be THAN e kole)

Generic Available (U.S.)

Yes

Index Terms

  • Bethanechol Chloride

Brand Names: U.S.

  • Urecholine®

Brand Names: Canada

  • Duvoid®
  • PMS-Bethanechol

Pharmacologic Category

  • Cholinergic Agonist

Use: Labeled Indications

Treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention; treatment of neurogenic atony of the urinary bladder with retention

Use: Unlabeled/Investigational

Gastroesophageal reflux

Pregnancy Risk Factor

C

Pregnancy Considerations

Reproduction studies have not been conducted.

Lactation

Excretion in breast milk unknown/not recommended

Contraindications

Hypersensitivity to bethanechol or any component of the formulation; mechanical obstruction of the GI or GU tract or when the strength or integrity of the GI or bladder wall is in question; hyperthyroidism, peptic ulcer disease, epilepsy, asthma, bradycardia, vasomotor instability, coronary artery disease, hypotension, or parkinsonism

Warnings/Precautions

Concerns related to adverse effects:

• Reflux infection: Potential for reflux infection if the sphincter fails to relax as bethanechol contracts the bladder.

Adverse Reactions

Frequency not defined.

Cardiovascular: Hypotension, tachycardia, flushed skin

Central nervous system: Headache, malaise, seizure

Gastrointestinal: Abdominal cramps, belching, borborygmi, colicky pain, diarrhea, nausea, vomiting, salivation

Genitourinary: Urinary urgency

Ocular: Lacrimation, miosis

Respiratory: Asthmatic attacks, bronchial constriction

Miscellaneous: Diaphoresis

Metabolism/Transport Effects

None known.

Drug Interactions

Acetylcholinesterase Inhibitors: May enhance the adverse/toxic effect of Cholinergic Agonists. 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. Management: Administer these agents in combination with caution, and monitor for conduction disturbances. Avoid methacholine with any beta blocker due to the potential for additive bronchoconstriction. Risk C: Monitor therapy

Storage

Store at room temperature of 15°C to 30°C (59°F to 86°F).

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.

Pharmacodynamics/Kinetics

Onset of action: 30-90 minutes

Duration: Up to 6 hours

Absorption: Variable

Dosage

Oral:

Children:

Urinary retention (unlabeled use): 0.3-0.6 mg/kg/day in 3-4 divided doses

Gastroesophageal reflux (unlabeled use): 0.3-0.6 mg/kg/day in 3-4 divided doses

Adults:

Urinary retention, neurogenic bladder: Initial: 10-50 mg 3-4 times/day (some patients may require dosages of 50-100 mg 4 times/day). To determine effective dose, may initiate at a dose of 5-10 mg, with additional doses of 5-10 mg hourly until an effective cumulative dose is reached. Cholinergic effects at higher oral dosages may be cumulative.

Gastroesophageal reflux (unlabeled): 25 mg 4 times/day

Elderly: Use the lowest effective dose

Administration: Oral

Should be administered 1 hour before meals or 2 hours after meals.

Monitoring Parameters

Observe closely for side effects.

Test Interactions

Increased lipase, amylase (S), bilirubin, aminotransferase [ALT/AST] (S)

Dietary Considerations

Should be taken 1 hour before meals or 2 hours after meals.

Patient Education

Take on an empty stomach to avoid nausea or vomiting. Maintain adequate hydration, unless instructed to restrict fluid intake. May cause dizziness, hypotension, vomiting, or loss of appetite. Report persistent abdominal discomfort; significantly increased salivation, sweating, tearing, or urination; flushed skin; chest pain or palpitations; acute headache; unresolved diarrhea; excessive fatigue, insomnia, dizziness, or depression; increased muscle, joint, or body pain; vision changes or blurred vision; or respiratory difficulty or wheezing.

Geriatric Considerations

Urinary incontinence in elderly patients should be investigated. Bethanechol may be used for overflow incontinence (ie, dribbling) caused by an atonic or hypotonic bladder, but clinical efficacy is variable.

Dental Health: Effects on Dental Treatment

This is a cholinergic agent similar to pilocarpine; expect to see salivation and sweating in patients.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

Contraindicated in Parkinson's disease

Nursing: Physical Assessment/Monitoring

Assess bladder and sphincter adequacy prior to administering medication.

Dosage Forms

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

Tablet, oral, as chloride: 5 mg, 10 mg, 25 mg, 50 mg

Urecholine®: 5 mg, 10 mg, 25 mg, 50 mg [scored]

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

Tablets (Bethanechol Chloride)

5 mg (90): $59.99

10 mg (90): $89.99

25 mg (90): $128.99

50 mg (90): $179.99

Tablets (Urecholine)

10 mg (90): $119.99

50 mg (90): $381.84

Extemporaneously Prepared

A 1 mg/mL solution may be made with tablets. Crush twelve 10 mg tablets in a mortar and reduce to a fine powder. Add small portions of sterile water and mix to a uniform paste; mix while adding sterile water in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with sterile water, and add quantity of sterile water sufficient to make 120 mL. Label “shake well” and “refrigerate”. Stable for 30 days (Schlatter, 1997).

A 5 mg/mL suspension may be made with tablets and either a 1:1 mixture of Ora-Plus® and Ora-Sweet® or Ora-Plus® and Ora-Sweet® SF or 1:4 concentrated cherry syrup and simple syrup, NF mixture. Crush twelve 50 mg tablets in a mortar and reduce to a fine powder. Add small portions of chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 120 mL. Label “shake well” and “refrigerate”. Stable for 60 days refrigerated (preferred) or at room temperature (Allen, 1998; Nahata, 2004).

Allen LV Jr and Erickson MA, "Stability of Bethanechol Chloride, Pyrazinamide, Quinidine Sulfate, Rifampin, and Tetracycline Hydrochloride in Extemporaneously Compounded Oral Liquids," Am J Health Syst Pharm, 1998, 55(17):1804-9.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations, 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Schlatter JL and Saulnier JL, "Bethanechol Chloride Oral Solutions: Stability and Use in Infants," Ann Pharmacother, 1997, 31(3):294-6.

References

Andersson KE, “Current Concepts in the Treatment of Disorders of Micturition,” Drugs, 1988, 35(4):477-94.

Borzyskowski M and Mundy AR, “The Management of the Neuropathic Bladder in Childhood,” Pediatr Nephrol, 1988, 2(1):56-66

Farrell RL, Roling GT, and Castell DO, “Cholinergic Therapy of Chronic Heartburn. A Controlled Trial,” Ann Intern Med, 1974, 80(5):573-6.

Holloway RH, McCallum RW. “A Practical Approach to Gastroesophageal Reflux,” Drug Ther, 1983, 13(3):151-60.

Guerra MF and Ives TJ, “Bethanechol and Hypothermia,” Ann Intern Med, 1983, 99(2):279-80.

Romanowski GL, Shimp LA, Balson AB, et al, “Urinary Incontinence in the Elderly: Etiology and Treatment,” Drug Intell Clin Pharm, 1988, 22(7-8):525-33.

Sher PP, “Drug Interferences With Clinical Laboratory Tests,” Drugs, 1982, 24(1):24-63.

Sondheimer JM, Mintz, HL, and Michaels M. “Bethanechol Treatment of Gastroesophageal Reflux in Infants: Effect on Continuous Esophageal pH Records.,” J Pediatr, 1984, 104(1):128-31.

International Brand Names

  • Dampurine (TW)
  • Hinecol (KP)
  • Liberon (BR)
  • Miotonoachol (AR)
  • Muscaran (BE, LU)
  • Myo Hermes (ES)
  • Myocholine Glenwood (CH)
  • Myocholine-Glenwood (AT, DE, IT)
  • Myotonin (KP)
  • Myotonine Chloride (GB, UY)
  • Ucholine (TH)
  • Uninechol (KP)
  • Urecholine (FI)
  • Uriflow (PH)
  • Urocarb (AU)
  • Urotone (IN)
  • Wecoli (TW)

Lexi-Comp.com

Last full review/revision December 2011

Content last modified December 2011

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