Bethanechol Chloride

INDICATIONS AND USAGE Bethanechol Chloride Tablets, USP are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

DOSAGE AND ADMINISTRATION 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 mg to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 mg 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 ).

CONTRAINDICATIONS 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.

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 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 To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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.

DESCRIPTION Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl) oxy]- N,N,N -trimethyl-1-propanaminium chloride. Its molecular formula is C 7 H 17 CIN 2 O 2 and its structural formula is: Bethanechol chloride, USP 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. Bethanechol chloride Tablets, USP also contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate, Type A. The 25 mg and 50 mg tablets also contain D&C Yellow No.10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Structural Formula

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 LD 50 of bethanechol chloride is 1,510 mg/kg in the mouse.

HOW SUPPLIED Bethanechol Chloride Tablets, USP, 5 mg are supplied as white, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘571’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100: NDC 65162-571-10 Bottle of 500: NDC 65162-571-50 Bottle of 1000: NDC 65162-571-11 Bethanechol Chloride Tablets, USP, 10 mg are supplied as white, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘572’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100: NDC 65162-572-10 Bottle of 500: NDC 65162-572-50 Bottle of 1000: NDC 65162-572-11 Bethanechol Chloride Tablets, USP, 25 mg are supplied as yellow, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘573’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100: NDC 65162-573-10 Bottle of 500: NDC 65162-573-50 Bottle of 1000: NDC 65162-573-11 Bethanechol Chloride Tablets, USP, 50 mg are supplied as yellow, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘574’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100: NDC 65162-574-10 Bottle of 500: NDC 65162-574-50 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. This container is not intended for household use. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2018-03