Mepenzolate

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Mepenzolate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Mepenzolate is an anticholinergic and antispasmodic agent that is FDA approved for the treatment of peptic ulcer. Common adverse reactions include somnolence and blurred vision.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • CANTIL is indicated for use as adjunctive therapy in the treatment of peptic ulcer. It has not been shown to be effective in contributing to the healing of peptic ulcer, decreasing the rate of recurrence, or preventing complications.

Dosing Information

  • The usual adult dose is 1 or 2 tablets (25 or 50 mg) 4 times a day preferably with meals and at bedtime. Begin with the lower dosage when possible and adjust subsequently according to the patient's response.
  • Safety and efficacy in pediatric patients have not been established.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mepenzolate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mepenzolate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Mepenzolate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mepenzolate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mepenzolate in pediatric patients.

Contraindications

Warnings

  • Diarrhea may be an early symptom of incomplete intestinal obstruction especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.
  • CANTIL may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

General

  • Use CANTIL with caution in the elderly and in all patients with:
  • This product contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin sensitivity.

Adverse Reactions

Clinical Trials Experience

  • Precise frequency data from controlled clinical studies with CANTIL are not available.
Gastrointestinal System:
Central Nervous System:
Ophthalmologic:
Dermatologic-Hypersensitivity:
Cardiovascular:
Genitourinary:
Miscellaneous:

Postmarketing Experience

There is limited information regarding Mepenzolate Postmarketing Experience in the drug label.

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

  • Reproduction studies have been performed in rats and rabbits at doses up to 30 times the human dose (based on 50 kg weight) and have shown no evidence of impaired fertility or harm to the animal fetus. There are, however, no adequate and well-controlled studies with CANTIL in pregnant women. Because animal reproduction studies are not always predictive of human response, CANTIL should be used during pregnancy only if clearly needed.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mepenzolate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mepenzolate during labor and delivery.

Nursing Mothers

  • It is not known whether CANTIL is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CANTIL is administered to a nursing woman.

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established. Studies in newborn animals (rats) show that younger animals are more sensitive to the toxic effects of CANTIL than are older animals.

Geriatic Use

  • Clinical studies of CANTIL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
  • CANTIL is contraindicated in intestinal atony of the elderly. CANTIL should be used with caution in the elderly.

Gender

There is no FDA guidance on the use of Mepenzolate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mepenzolate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mepenzolate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mepenzolate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mepenzolate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mepenzolate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Mepenzolate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Mepenzolate and IV administrations.

Overdosage

Signs and Symptoms
Oral LD50
  • The oral LD50 is greater than 750 mg/kg in mice and greater than 1000 mg/kg in rats.
Maximum Human Dose Recorded
  • The maximum human dose recorded is 375 to 500 mg in a 4-year-old child (no adverse effects reported) and 500 to 750 mg in a 30-year-old adult (resulted in death).
Dialysis
  • It is not known if the drug is dialyzable.
Treatment

Pharmacology

Template:Px
Mepenzolate
Systematic (IUPAC) name
3-(2-hydroxy-2,2-diphenylacetoxy)-1,1-dimethylpiperidinium
Identifiers
CAS number 25990-43-6
ATC code A03AB12
PubChem 4057
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox+
Mol. mass 340.44 g/mol
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

  • CANTIL diminishes gastric acid and pepsin secretion. CANTIL also suppresses spontaneous contractions of the colon. Pharmacologically, it is a post-ganglionic parasympathetic inhibitor.

Structure

  • CANTIL tablets for oral administration contain 25 mg mepenzolate bromide USP. The anticholinergic agent mepenzolate bromide USP chemically is 3-[(hydroxydiphenylacetyl)oxy]-1,1-dimethylpiperidinium bromide and has the following structure:
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Mepenzolate Pharmacodynamics in the drug label.

Pharmacokinetics

  • Radiotracer studies in which CANTIL-14C was used in animals and humans indicate the absorption following oral administration, as with other quaternary ammonium compounds, is low. Between 3 and 22% of an orally administered dose is excreted in the urine over a 5-day period, with the majority of the radioactivity appearing on Day 1. The remainder appears in the next 5 days in the feces and presumably has not been absorbed.

Nonclinical Toxicology

There is limited information regarding Mepenzolate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Mepenzolate Clinical Studies in the drug label.

How Supplied

25 mg mepenzolate bromide, compressed yellow tablets debossed MERRELL 37.

NDC 0068-0037-01: bottles of 100

Storage

  • Keep tightly closed. Store at room temperature, preferably below 86°F.
  • Protect from excessive heat. Dispense in tight containers with child-resistant closure.

Images

Drug Images

{{#ask: Page Name::Mepenzolate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 25MG TABLETS BOTTLE LABEL

NDC 0068-0037-01

Cantil® 25mg

mepenzolate bromide USP

100 Tablets

sanofi aventis

This image is provided by the National Library of Medicine.

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Patient Counseling Information

  • CANTIL may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Precautions with Alcohol

Alcohol-Mepenzolate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Cantil

Look-Alike Drug Names

There is limited information regarding Mepenzolate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.