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Urecholine
Overview
What is Urecholine?
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]-, , -trimethyl-1-propanaminium chloride. Its structural formula is:
CHCIN0 M.W. 196.68
It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water.
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: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 25 mg and 50 mg tablets also contain D&C Yellow #10 aluminum lake and FD&C Yellow #6 aluminum lake.
What does Urecholine look like?
What are the available doses of Urecholine?
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What should I talk to my health care provider before I take Urecholine?
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How should I use Urecholine?
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 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).
What interacts with Urecholine?
Hypersensitivity to bethanechol chloride, 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.
What are the warnings of Urecholine?
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What are the precautions of Urecholine?
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 infection.
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 lying or sitting position.
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.
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
Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride 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 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.
What are the side effects of Urecholine?
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
What should I look out for while using Urecholine?
Hypersensitivity to bethanechol chloride, 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.
What might happen if I take too much Urecholine?
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 of bethanechol chloride is 1510 mg/kg in the mouse.
How should I store and handle Urecholine?
Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015Urecholine (Bethanechol Chloride Tablets USP) is available as follows:5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the 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 ALL MEDICATIONS OUT OF THE REACH OF CHILDRENTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. A 9/2015
Clinical Information
Chemical Structure
No Image foundClinical 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 sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.
Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.
Effects on the Gl and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol chloride is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does oral administration of the drug.
Because of the selective action of bethanechol chloride, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation.
Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.
A clinical study (Diokno, A.C.; Lapides, J.; : 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose. Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.
Non-Clinical Toxicology
Hypersensitivity to bethanechol chloride, 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.
Caution should be exercised when propranolol hydrochloride extended-release capsules are administered with drugs that have an affect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see in ).
Alcohol when used concomitantly with propranolol, may increase plasma levels of propranolol.
Cardiovascular Drugs
Antiarrhythmics
Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following co-administration with propranolol.
Caution should be exercised when administering propranolol hydrochloride extended-release capsules with drugs that slow A-V nodal conduction, e.g., lidocaine and calcium channel blockers.
Digitalis Glycosides
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Calcium Channel Blockers
Caution should be exercised when patients receiving a beta-blocker are administered a calcium-channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction.
There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.
Co-administration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure.
ACE Inhibitors
When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction.
The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol hydrochloride extended-release capsules should be administered cautiously to patients withdrawing from clonidine.
Alpha Blockers
Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers.
Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.
Reserpine
Patients receiving catecholamine-depleting drugs, such as reserpine should be closely observed for excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.
Inotropic Agents
Patients on long-term therapy with propranolol may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore not indicated in the treatment of propranolol overdose (see ).
Isoproterenol and Dobutamine
Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. Also, propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.
Non-Cardiovascular Drugs
Nonsteroidal Anti-Inflammatory Drugs
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been reported to blunt the antihypertensive effect of beta-adrenoreceptor blocking agents.
Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate.
Antidepressants
The hypotensive effects of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers by interfering with the beta- blocking activity of propranolol.
Anesthetic Agents
Methoxyflurane and trichloroethylene may depress myocardial contractility when administered with propranolol.
Warfarin
Propranolol when administered with warfarin increases the concentration of warfarin. Prothrombin time, therefore, should be monitored.
Neuroleptic Drugs
Hypotension and cardiac arrest have been reported with the concomitant use of propranolol and haloperidol.
Thyroxine
Thyroxine may result in a lower than expected T concentration when used concomitantly with propranolol.
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 infection.
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
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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