pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Cholinergic Muscarinic Agonists.

Cholinergic Muscarinic

Indications

Sourced from openFDA
  • Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Contraindications

Sourced from openFDA
  • Hypersensitivity to bethanechol chloride tablets, 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.contraindicated

Dosage & administration

Sourced from openFDA

Dosage must be individualized, depending on the type and severity of the condition to be treated. Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur. The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 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. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour. If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE ).

Adverse reactions

Sourced from openFDA

Adverse reactions are rare following oral administration of bethanechol, 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 has not been established: Body as a whole: malaise; Nervous System: seizures. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Sourced from openFDA

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 LD 50 of bethanechol chloride is 1510 mg/kg in the mouse.

Approval history

Sourced from openFDA
  • Jun 1, 2005ANDAANDA040633Upsher Smith Labs
  • Jun 1, 2005ANDAANDA040634Upsher Smith Labs
  • Jun 1, 2005ANDAANDA040635Upsher Smith Labs
  • Jun 1, 2005ANDAANDA040636Upsher Smith Labs
  • Oct 26, 2007ANDAANDA040728Chartwell Rx
  • Nov 21, 2007ANDAANDA040855Amneal Pharm
  • May 4, 2010ANDAANDA091256Heritage Pharma

Literature

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Recent PubMed references pinned to Bethanechol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Bethanechol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Bethanechol work?
Mechanism-of-action class: Cholinergic Muscarinic Agonists.
What is Bethanechol used for?
According to FDA labeling, Bethanechol carries indications including: Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Bethanechol?
Bethanechol is classified as Choline esters, Cholinergic Muscarinic Agonist, Cholinergic Muscarinic Agonists, Increased Bladder Contractility, Increased GI Smooth Muscle Tone, Stimulation Gastric Mucous Secretion, Stimulation Pancreatic Enzymatic Secretion, Stimulation Pancreatic Fluid/Electrolyte Secretion.
What are the contraindications for Bethanechol?
Bethanechol labeling lists contraindications including: Hypersensitivity to bethanechol chloride tablets, 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.. Always consult the full prescribing information and a clinician.
Note. Data for bethanechol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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