Source: FDA, National Drug Code (US) Revision Year: 2015
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.
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
In urinary retention, if the sphincter fails to relax as bethanechol chloride contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.
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.
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.
Teratogenic Effects: Pregnancy Category 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.
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.
Safety and effectiveness in pediatric patients have not been established.
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