Bethanechol chloride (bethanechol) , a cholinergic agent, is a synthetic esler which is structurally and pharmacologically related to acetylcholine. It is designated chemically as Z-[(aminocarbony) oxy]-N, N, (V-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is: It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C~ Yellow # 10 Lake and FD&C Yellow # 6 Lake.

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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. Read the Bethanechol Chloride (bethanechol) Side Effects Center for a complete guide to possible side effectsLearn More »

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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).

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Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fail in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fail in the blood pressure. Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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bethanechol chloride is indicated for the treatment of acute postoperative and postpartum non obstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

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Hypersensitivity to bethanechol chloride (bethanechol) tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor Instability, coronary artery disease, epilepsy and parkinsonism. bethanechol chloride (bethanechol) 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.Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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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.

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Bethanechol Chloride (bethanechol) Tablets, USP 5 mg - White, 7/16" diameter, round flat faced bevel edge tablets: one side scored and debossed BCL bisect 5, one side debossed 832, in bottles of 100 and 1000, and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each). 10 mg - White, 7/16" diameter, round flat faced bevel edge tablets; one side scored and debossed BCL bisect 10, one side debossed 832, in bottles of 100. 250 and 1000, and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each). 25 mg - Yellow, 7/16" diameter, round flat faced bevel edge tablets; one side scored and debossed BCL bisect 25, one side debossed 832, in bottles of 100, 250, 500 and 1000, and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each). 50 mg - Yellow, 7/16" diameter, round fiat faced bevel edge tablets; one side scored and debossed BCL bisect 50, one side debossed 832, in bottles of 100, 500 and 1000. and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each). Store at 20-25°C (68-7?°F) and excursions permitted to 15-30"C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP Keep out of reach of children. Rev. 05-05. Manufactured by: UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447. FDA Rev date: 6/1/2005 Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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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 reflux infection. 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. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride (bethanechol) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bethanechol chloride (bethanechol) should be given to a pregnant woman only if clearly needed. 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 (bethanechol) 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.Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com