Bethanechol Chloride

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Overview

What is Bethanechol Chloride?

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]- -trimethyl-1-propanaminium chloride. Its molecular formula is C H CIN 0 and its structural formula is:

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 Bethanechol Chloride look like?

What are the available doses of Bethanechol Chloride?

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What should I talk to my health care provider before I take Bethanechol Chloride?

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How should I use Bethanechol Chloride?

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 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 Bethanechol Chloride?

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What are the warnings of Bethanechol Chloride?

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What are the precautions of Bethanechol Chloride?

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What are the side effects of Bethanechol Chloride?

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What should I look out for while using Bethanechol Chloride?

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.

What might happen if I take too much Bethanechol Chloride?

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 oral LD of bethanechol chloride is 1510 mg/kg in the mouse.

How should I store and handle Bethanechol Chloride?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK Bethanechol Chloride Tablets, USP5 mg - White, round, scored tablets, debossed AN 57110 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/07 AV Rev. 02/15 (P) AvPAK

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Clinical Information

Chemical Structure

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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 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 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, 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 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.

Nonsteroidal anti-inflammatory drugs should not be administered prior to or concomitantly with the high doses of methotrexate, such as used in the treatment of osteosarcoma. Concomitant administration of some NSAIDs with high dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity.

Caution should be used when NSAIDs and salicylates are administered concomitantly with lower doses of methotrexate. These drugs have been reported to reduce the tubular secretion of methotrexate in an animal model and may enhance its toxicity.

Despite the potential interactions, studies of methotrexate in patients with rheumatoid arthritis have usually included concurrent use of constant dosage regimens of NSAIDs, without apparent problems. It should be appreciated, however, that the doses used in rheumatoid arthritis (7.5 to 15 mg/week) are somewhat lower than those used in psoriasis and that larger doses could lead to unexpected toxicity.

Methotrexate is partially bound to serum albumin, and toxicity may be increased because of displacement by certain drugs, such as salicylates, phenylbutazone, phenytoin, and sulfonamides. Renal tubular transport is also diminished by probenecid; use of methotrexate with this drug should be carefully monitored.

In the treatment of patients with osteosarcoma, caution must be exercised if high-dose methotrexate is administered in combination with a potentially nephrotoxic chemotherapeutic agent (e.g., cisplatin).

Methotrexate increases the plasma levels of mercaptopurine. The combination of methotrexate and mercaptopurine may therefore require dose adjustment.

Oral antibiotics such as tetracycline, chloramphenicol, and nonabsorbable broad spectrum antibiotics, may decrease intestinal absorption of methotrexate or interfere with the enterohepatic circulation by inhibiting bowel flora and suppressing metabolism of the drug by bacteria.

Penicillins may reduce the renal clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with high and low dose methotrexate. Use of methotrexate with penicillins should be carefully monitored.

The potential for increased hepatotoxicity when methotrexate is administered with other hepatotoxic agents has not been evaluated. However, hepatotoxicity has been reported in such cases. Therefore, patients receiving concomitant therapy with methotrexate and other potential hepatotoxins (e.g., azathioprine, retinoids, sulfasalazine) should be closely monitored for possible increased risk of hepatotoxicity.

Methotrexate may decrease the clearance of theophylline; theophylline levels should be monitored when used concurrently with methotrexate.

Vitamin preparations containing folic acid or its derivatives may decrease responses to systemically administered methotrexate. Preliminary animal and human studies have shown that small quantities of intravenously administered leucovorin enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered

methotrexate.

Folate deficiency states may increase methotrexate toxicity. Trimethoprim/ sulfamethoxazole has been reported rarely to increase bone marrow suppression in patients receiving methotrexate, probably by decreased tubular secretion and/or an additive antifolate effect.

General

Information for Patients:

Drug Interactions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy:

Nursing Mothers:

Pediatric Use:

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: malaise; abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; urinary urgency; headache; a fall in blood pressure with reflex tachycardia, vasomotor response; flushing producing a feeling of warmth, sensation of heat about the face, sweating bronchial constriction, asthmatic attacks : lacrimation, miosis. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email ; or FDA at 1-800-FDA-1088 or .

Causal Relationship Unknown:

Body as a Whole:

Nervous System:

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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. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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