ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Bethanechol: Pediatric drug information

Bethanechol: Pediatric drug information
(For additional information see "Bethanechol: Drug information" and see "Bethanechol: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Urecholine [DSC]
Brand Names: Canada
  • Duvoid
Therapeutic Category
  • Cholinergic Agent
Dosing: Pediatric
Urinary retention, nonobstructive

Urinary retention, nonobstructive: Limited data available: Children and Adolescents: Oral: 0.3 to 0.6 mg/kg/day in 3 to 4 divided doses; maximum dose: 10 mg/dose for children. Note: Usual adult dose is 10 to 50 mg 3 to 4 times daily (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Adult

(For additional information see "Bethanechol: Drug information")

Neurogenic bladder, urinary retention

Neurogenic bladder, urinary retention: Oral: Initial: 5 to 10 mg; repeat the same dose hourly until effective response or a maximum of 50 mg is reached; usual dose: 10 to 50 mg 3 to 4 times daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined:

Cardiovascular: Decreased blood pressure (with reflex tachycardia), flushing, vasomotor symptoms

Dermatologic: Diaphoresis

Gastrointestinal: Abdominal cramps, abdominal distress (including colicky pain), borborygmi, diarrhea, eructation, nausea, salivation

Genitourinary: Urinary urgency

Nervous system: Headache

Ophthalmic: Lacrimation, miosis

Respiratory: Bronchoconstriction, exacerbation of asthma

Postmarketing: Nervous system: Malaise, seizure

Contraindications

Hypersensitivity to bethanechol or any component of the formulation; hyperthyroidism, peptic ulcer disease, epilepsy, asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, or parkinsonism; mechanical obstruction of the GI or GU tract or when the strength or integrity of the GI or bladder wall is in question; when increased muscular activity of the GI tract or urinary bladder might prove harmful (eg, following urinary bladder surgery, GI resection and anastomosis, possible GI obstruction); bladder neck obstruction, spastic GI disturbances, acute inflammatory lesions of the GI tract, peritonitis, marked vagotonia.

Warnings/Precautions

Concerns related to adverse effects:

• Reflux infection: If patient has bacteriuria, there is potential for reflux infection if the sphincter fails to relax as bethanechol contracts the bladder.

Warnings: Additional Pediatric Considerations

As a cholinergic, prokinetic agent, bethanechol was historically used to treat infants and children with GERD. However, the risk of adverse effects risks outweigh efficacy benefits and use is no longer recommended (AAP [Lightdale 2013], NASPGHAN/ESPGHAN [Vandenplas 2009].

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as chloride:

Urecholine: 25 mg [DSC], 50 mg [DSC] [contains fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]

Generic: 5 mg, 10 mg, 25 mg, 50 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Bethanechol Chloride Oral)

5 mg (per each): $0.71 - $0.90

10 mg (per each): $1.31 - $2.00

25 mg (per each): $1.40 - $2.67

50 mg (per each): $2.89 - $4.27

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as chloride:

Duvoid: 10 mg, 25 mg, 50 mg

Extemporaneous Preparations

5 mg/mL Oral Suspension (ASHP Standard Concentration) (ASHP 2017)

A 5 mg/mL suspension may be made with tablets and either a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Plus and Ora-Sweet SF or 1:4 concentrated cherry syrup and simple syrup, NF mixture. Crush twelve 50 mg tablets in a mortar and reduce to a fine powder. Add small portions of chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 120 mL. Label “shake well” and “refrigerate.” Stable for 60 days refrigerated (preferred) or at room temperature (Allen 1998; Nahata 2014).

Allen LV Jr, Erickson MA. Stability of bethanechol chloride, pyrazinamide, quinidine sulfate, rifampin, and tetracycline hydrochloride in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1998;55(17):1804-1809.9775343
Nahata MC and Pai VB. Pediatric Drug Formulations. 6th ed. Cincinnati, OH: Harvey Whitney Books Co; 2014.

1 mg/mL Oral Suspension

A 1 mg/mL solution may be made with tablets. Crush twelve 10 mg tablets in a mortar and reduce to a fine powder. Add small portions of sterile water and mix to a uniform paste; mix while adding sterile water in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with sterile water, and add quantity of sterile water sufficient to make 120 mL. Label “shake well” and “refrigerate”. Stable for 30 days (Schlatter 1997).

Schlatter JL, Saulnier JL. Bethanechol chloride oral solutions: stability and use in infants. Ann Pharmacother. 1997;31(3):294-296.9066934
Administration: Pediatric

Oral: Administer 1 hour before meals or 2 hours after meals to reduce nausea and vomiting

Administration: Adult

Oral: Administer 1 hour before or 2 hours after meals (to avoid nausea and vomiting).

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F).

Use

Treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and retention due to neurogenic atony of the urinary bladder with retention (All indications: FDA approved in adults)

Medication Safety Issues
Sound-alike/look-alike issues:

Bethanechol may be confused with betaxolol

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May enhance the adverse/toxic effect of Cholinergic Agonists. Specifically, cholinergic effects may be enhanced or increased. Risk C: Monitor therapy

Beta-Blockers: May enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Risk C: Monitor therapy

Cimetropium: Cholinergic Agonists may diminish the anticholinergic effect of Cimetropium. Risk C: Monitor therapy

Rivastigmine: Cholinergic Agonists may enhance the adverse/toxic effect of Rivastigmine. Specifically, cholinergic effects may be enhanced or increased. Rivastigmine may enhance the adverse/toxic effect of Cholinergic Agonists. Management: Use of rivastigmine with a cholinergic agonist is not recommended unless clinically necessary. If the combination is necessary, monitor for increased cholinergic effects. Risk D: Consider therapy modification

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Monitoring Parameters

Monitor for signs of bronchoconstriction or urinary tract infection

Mechanism of Action

Due to stimulation of the parasympathetic nervous system, bethanechol increases bladder muscle tone causing contractions which initiate urination. Bethanechol also stimulates gastric motility, increases gastric tone and may restore peristalsis.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 30 minutes; Peak effect: ~60 to 90 minutes

Duration: ~1 hour (with therapeutic doses); up to 6 hours with large doses (300 to 400 mg)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Miotonachol;
  • (AT) Austria: Myocholine;
  • (AU) Australia: Urecholine | Uro-carb;
  • (BE) Belgium: Muscaran | Myocholine glenwood;
  • (BR) Brazil: Liberan;
  • (CH) Switzerland: Myocholine;
  • (CO) Colombia: Betanecol;
  • (DE) Germany: Myocholine | Myocholine glenwood;
  • (EE) Estonia: Myocholine glenwood;
  • (ES) Spain: Myo hermes;
  • (FI) Finland: Urecholine;
  • (FR) France: Myocholine | Urecholine;
  • (GB) United Kingdom: Myotonine;
  • (IE) Ireland: Myotonine;
  • (IL) Israel: Myocholine | Urecholine;
  • (IN) India: Bchol | Betawic | Bethanax | Betheran | Macpee | Mictuease | Urivoid | Urotone;
  • (IT) Italy: Urecholine;
  • (JO) Jordan: Myocholine glenwood;
  • (JP) Japan: Besakororu;
  • (KR) Korea, Republic of: Ausnechol | Besacolin | Hinechol | Hinecol | Mytonin | Twotinechol | Uninechol | Urecholine;
  • (NO) Norway: Myocholine;
  • (PH) Philippines: Uriflow;
  • (PR) Puerto Rico: Bethanechol cl | Urecholine;
  • (SG) Singapore: Bethanechol | Urecholine;
  • (TH) Thailand: Ucholine | Urecholine;
  • (TW) Taiwan: Benecol | Bethancol | Bethanechol | Dampurine | Duvoid | Mesacol | Urecholine | Urecol | Wecoli;
  • (ZA) South Africa: Urecholine
  1. ASHP. Standardize 4 Safety Initiative Compounded Oral Liquid Version 1.01. July 2017. https://www.ashp.org/-/media/assets/pharmacy-practice/s4s/docs/s4s-ashp-oral-compound-liquids.ashx?la=en&hash=4C2E4F370B665C028981B61F6210335AD5D0D1D6.
  2. Bethanechol Chloride tablets, USP [prescribing information]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; September 2021.
  3. Gal P, Reed M. Medications. In: Kliegman RM, Behrman RE, Jenson HB, et al, eds. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, PA: Saunders Elsevier; 2007: 2955-2999.
  4. Gearhart JP, Rink RC, Mouriquand DPE., eds. Pediatric Urology. 2nd ed. Philadelphia, PA: Library of Congress Cataloging-in-Publication Data; 2010.
  5. Goldman A, Hain R, Liben S, eds. Palliative Care for Children. 2nd ed. New York, NY: Oxford University Press; 2012.
  6. Lightdale JR, Gremse DA; Section on Gastroenterology, Hepatology, and Nutrition. Gastroesophageal reflux: management guidance for the pediatrician. Pediatrics. 2013;131(5):e1684-1695. [PubMed 23629618]
  7. Urecholine (bethanechol) [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA; September 2015.
  8. Vandenplas Y, Rudolph CD, Di Lorenzo C, et al. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr. 2009;49(4):498-547. [PubMed 19745761]
Topic 13061 Version 257.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟