URECHOLINE Tablet (2015)
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Teva Women's Health, Inc.
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1. Description
Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-<em>N</em> ...
2. Clinical Pharmacology
Bethanechol chloride acts principally by producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction ...
3. 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 ...
4. Contraindications
Hypersensitivity to bethanechol chloride, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy ...
6.1. General
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 ...
6.2. Information for Patients
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 ...
6.4. 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 ...
6.6. 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.
6.7. Pregnancy
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 ...
6.9. 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 in nursing ...
6.10. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
7. 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. ...
9. 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 ...
10. 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 ...
11. How Supplied
Urecholine <sup></sup> (Bethanechol Chloride Tablets USP) is available as follows: 5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the scored side and plain on the other ...
12. Storage and Handling
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ...