Product Description.:
AN 572
tablet , white , scored , round round
Flat-faced beveled-edgeDebossed
Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. Its chemical name is 2-[(aminocarbonyl) oxy]-N,N,N-trimethyl-1-propanaminium chloride. Bethanechol chloride is a white, hygroscopic, crystalline powder having a slight amine-like odor and is freely soluble in water.
Bethanechol chloride is available as 10 mg, 25 mg, and 50 mg scored tablets intended for oral use.
Inactive Ingredients: Each tablet contains calcium pyrophosphate, magnesium stearate, microcrystalline cellulose, and corn starch. Additionally, the 50 mg strength contains: FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.
INDICATIONS AND USAGE
Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention, and neurogenic atony of the urinary bladder with retention.
CONTRAINDICATIONS
Bethanechol chloride is contraindicated in individuals with 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.
PRECAUTIONS
General
In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause a reflux infection.
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.
Cardiovascular: Fall in blood pressure with reflex tachycardia, vasomotor response.
Digestive: Colicky pain, abdominal cramps or discomfort, diarrhea, nausea and belching, salivation, and borborygmi.
Skin: Flushing, producing a feeling of warmth sensation of heat about the face sweating.
Respiratory: Asthmatic attacks and bronchial constriction.
Nervous System: Headache.
Renal: Urinary urgency.
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.
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.
