Urecholine

Name: Urecholine

What Is Bethanechol?

Bethanechol stimulates your bladder to empty.

Bethanechol is used to treat urinary retention (difficulty urinating), which may occur after surgery, after delivering a baby, and in other situations.

Bethanechol may also be used for purposes other than those listed in this medication guide.

Take bethanechol on an empty stomach 1 hour before or 2 hours after meals to prevent nausea and vomiting.

Bethanechol may cause dizziness or fainting, especially when you rise from a sitting or lying position. Rise slowly to avoid becoming dizzy, falling, or hurting yourself.

Use caution when driving, operating machinery, or performing other hazardous activities. Bethanechol may cause dizziness. If you experience dizziness, avoid these activities.

Before taking this medication, tell your doctor if you

  • have uncontrolled hyperthyroidism (an overactive thyroid);
  • have stomach ulcers;
  • have asthma;
  • have recently had bladder or intestinal surgery;
  • have a blockage in your intestinal tract;
  • have a slow heart rate or low blood pressure;
  • have a disease or blockage of the arteries in your heart (coronary artery disease);
  • have epilepsy or any other seizure disorder; or
  • have Parkinson's disease.

You may not be able to take bethanechol, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Bethanechol is in the FDA pregnancy category C. This means that it is not known whether bethanechol will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.

It is not known whether bethanechol passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Dosing & Uses

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg
  • 25mg
  • 50mg

Urinary Retention

10-50 mg PO three/four times daily

Some patients may require doses of 50-100 mg PO twice daily

Take 1 hour AC or 2 hours PC

GERD (Off-label)

25 mg PO four times daily

Take 1 hour AC or 2 hours PC

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg
  • 25mg
  • 50mg

Urinary Retention (Off-label)

0.3-0.6 mg/kg/day PO divided three/four times daily 

Take 1 hour AC or 2 hours PC

GERD (Off-label)

0.3-0.6 mg/kg/day PO divided four times daily 

Take 1 hour AC or 2 hours PC

Pregnancy & Lactation

Pregnancy Category: C

Lactation: It is not known whether this drug is excreted in milk. Because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Urecholine Overview

Urecholine is a prescription medication used to relieve difficulties in urinating caused by surgery, drugs, or other factors. Urecholine belongs to a group of drugs called cholinergic agents, which help muscles work to empty urine from the bladder.

This medication comes in tablet form and is taken 3 or 4 times a day, on an empty stomach, either 1 hour before or 2 hours after meals.

Common side effects of Urecholine include general discomfort, upset stomach, and dizziness. Do not drive or operate heavy machinery until you know how Urecholine affects you.
 

Uses of Urecholine

Urecholine is a prescription medication used to relieve difficulties in urinating caused by surgery, drugs, or other factors.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a bethanechol overdose include abdominal discomfort, increased salivation or watering mouth, flushing or hot feeling of the skin, sweating, nausea, and vomiting.

What other drugs will affect Urecholine (bethanechol)?

Before taking bethanechol, tell your doctor if you are taking any of the following medicines:

  • donepezil (Aricept);

  • tacrine (Cognex);

  • quinidine (Cardioquin, others); or

  • procainamide (Pronestyl, Procan SR).

You may not be able to take bethanechol, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with bethanechol. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.

Introduction

Cholinergic agonist.a

What are some other side effects of Urecholine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Urecholine - Clinical Pharmacology

Bethanechol chloride acts principally by producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the Gl and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol chloride is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does oral administration of the drug.

Because of the selective action of bethanechol chloride, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation.

Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.

A clinical study (Diokno, A.C.; Lapides, J.; Urol 10: 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose. Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

Adverse Reactions

Adverse reactions are rare following oral administration of bethanechol chloride, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.

The following adverse reactions have been observed:

Body as a Whole: malaise

Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation

Renal: urinary urgency

Nervous System: headache

Cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response

Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating

Respiratory: bronchial constriction, asthmatic attacks

Special Senses: lacrimation, miosis

Causal Relationship Unknown:

The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol chloride has not been established:

Body as a Whole: malaise

Nervous System: seizures

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