Bethanechol chloride: Difference between revisions

Bethanechol chloride
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Latest revision as of 15:24, 8 August 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Overview

Bethanechol chloride is an urinary antispasmodic that is FDA approved for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. Common adverse reactions include flushing, abdominal cramps, diarrhea and urinary incontinence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

Dosage:

Initial: 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given.
Usual dose range: 10 to 50 mg three or four times a day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bethanechol chloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bethanechol chloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Not FDA approved in pediatric patients

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bethanechol chloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bethanechol chloride in pediatric patients.

Contraindications

Hypersensitivity to bethanechol chloride, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism.

Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

Warnings

There is limited information regarding Bethanechol chloride Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

There is limited information regarding Bethanechol chloride Postmarketing Experience in the drug label.

Drug Interactions

Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS): B2 There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bethanechol chloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bethanechol chloride during labor and delivery.

Nursing Mothers

It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and 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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

There is no FDA guidance on the use of Bethanechol chloride in geriatric settings.

Gender

There is no FDA guidance on the use of Bethanechol chloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bethanechol chloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bethanechol chloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bethanechol chloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

Long-term studies in animals have not been performed to evaluate the effects upon fertility of bethanechol chloride.

Immunocompromised Patients

There is no FDA guidance one the use of Bethanechol chloride in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Monitoring

There is limited information regarding Bethanechol chloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Bethanechol chloride and IV administrations.

Overdosage

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin (“hot feeling”), sweating, nausea and vomiting.

Atropine sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

Pharmacology


Bethanechol chloride
Systematic (IUPAC) name
2-(Carbamoyloxy)-N,N,N-trimethylpropan-1-aminium
Identifiers
CAS number	674-38-4
ATC code	N07AB02
PubChem	2370
DrugBank	DB01019
Chemical data
Formula	Template:OrganicBox atom Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox
Mol. mass	161.221 g/mol
SMILES	eMolecules & PubChem
Synonyms	2-[(aminocarbonyl)oxy]- N,N,N-trimethyl- 1-propanaminium
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	?
Excretion	?
Therapeutic considerations
Pregnancy cat.	C(US)
Legal status
Routes	Oral, subcutaneous

Mechanism of Action

Bethanechol chloride acts principally by producing the effects of stimulation of the para- sympathetic 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. Bethan- echol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Structure

It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its structural formula is:

Pharmacodynamics

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.

Pharmacokinetics

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 effec- tiveness. 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride.

Clinical Studies

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.

How Supplied

Bethanechol chloride 5 mg tablet

Available in bottles of 100

Bethanechol chloride 10 mg tablet

Available in bottles of 100

Bethanechol chloride 25 mg tablet

Available in bottles of 100

Bethanechol chloride 50 mg tablet

Available in bottles of 100

Storage

Store at 20° to 25°C (68° to 77°F)

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Bethanechol chloride should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.

Precautions with Alcohol

Alcohol-Bethanechol chloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Urecholine ^[1]

Look-Alike Drug Names

There is limited information regarding Bethanechol chloride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

↑ "FDA LABEL: URECHOLINE- bethanechol chloride tablet".

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[1] "FDA LABEL: URECHOLINE- bethanechol chloride tablet".

[1]

@@ Line 130: / Line 130: @@
 :* Available in bottles of 100
 |storage=Store at 20° to 25°C (68° to 77°F)
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 |alcohol=Alcohol-Bethanechol chloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
@@ Line 154: / Line 147: @@
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Bethanechol chloride: Difference between revisions

Latest revision as of 15:24, 8 August 2015

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Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Causal Relationship Unknown

Postmarketing Experience

Drug Interactions

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatic Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Administration and Monitoring

Administration

Monitoring

IV Compatibility

Overdosage

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Clinical Studies

How Supplied

Storage

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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