Bethanechol Chloride 25 mg/1
Bethanechol Chloride · TABLET · Amneal Pharmaceuticals of New York LLC
Bethanechol Chloride is a tablet containing bethanechol chloride at 25 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.
Key Facts
- Brand Name
- Bethanechol Chloride
- Generic Name
- Bethanechol Chloride
- NDC Code (Product)
53746-573- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040855
- Marketing Start
- 04/15/2022
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Wedgewood Village Pharmacy, LLC
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
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 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 ).
Contraindications
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 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.
Frequently Asked Questions
What is Bethanechol Chloride used for?
Bethanechol Chloride contains Bethanechol Chloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Bethanechol Chloride a controlled substance?
Bethanechol Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Bethanechol Chloride?
The generic name for Bethanechol Chloride is Bethanechol Chloride. There are no other listed brand versions of Bethanechol Chloride.
What is the NDC code for Bethanechol Chloride 25 mg/1?
The NDC (National Drug Code) for Bethanechol Chloride 25 mg/1 is 53746-573, listed by Amneal Pharmaceuticals of New York LLC.
Other Bethanechol Chloride Dosages
- Bethanechol Chloride10 mg/160687-689
- Bethanechol Chloride50 mg/162135-758
- Bethanechol Chloride10 mg/123155-935
- Bethanechol Chloride5 mg/123155-934
- Bethanechol Chloride25 mg/160687-700
- Bethanechol Chloride25 mg/123155-936
- Bethanechol Chloride5 mg/162135-755
- Bethanechol Chloride10 mg/165162-572
- Bethanechol Chloride25 mg/165162-573
- Bethanechol Chloride10 mg/10832-0511
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)