Methscopolamine bromide

Methscopolamine bromide
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];

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Methscopolamine bromide FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Methscopolamine bromide 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 Methscopolamine bromide in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

Glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

Methscopolamine Bromide 2.5 mg Tablets/ Methscopolamine Bromide 5 mg Tablets are contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.

Warnings

In the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with drug use.

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.

Methscopolamine bromide 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.

With overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.

Precautions

1. General precautions: Use Methscopolamine Bromide 2.5 mg Tablets/Methscopolamine Bromide 5 mg Tablets with caution in the elderly and in all patients with: autonomic neuropathy; hepatic or renal disease; or ulcerative colitis-large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason precipitate or aggravate "toxic megacolon," a serious complication of the disease.

The drug also should be used with caution in patients having hyperthyroidism, coronary heart disease, congestive heart failure, tachyrhythmia, tachycardia, hypertension, or prostatic hypertrophy.

2. Information for patient: See statement under WARNINGS.

3. Laboratory tests: Progress of the peptic ulcer under treatment should be followed by upper gastrointestinal contrast radiology or endoscopy to insure healing. Stool tests for occult blood and blood hemoglobin or hematocrit values should be followed to rule out bleeding from the ulcer.

Adverse Reactions

Clinical Trials Experience

The following-adverse reactions have been observed, but there is not enough data to support an estimate of frequency.

Cardiovascular: Tachycardia, palpitation.

Allergic: Severe allergic reaction or drug idiosyncrasies including anaphylaxis.

CNS: Headaches, nervousness, mental confusion, drowsiness, dizziness.

Special Senses: Blurred vision, dilation of the pupil, cycloplegia, increased ocular tension, loss of taste.

Renal: Urinary hesitancy and retention.

Gastrointestinal: Nausea, vomiting, constipation, bloated feeling.

Dermatologic: Decreased sweating, urticaria and other dermal manifestations.

Miscellaneous: Xerostomia, weakness, insomnia, impotence, suppression of lactation.

Postmarketing Experience

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

Drug Interactions

Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine bromide.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Animal reproduction studies have not been conducted with methscopolamine bromide. It also is not known whether methscopolamine bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methscopolamine bromide should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Methscopolamine bromide in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when methscopolamine bromide is administered to a nursing woman.

Pediatric Use

Safety and efficacy in children have not been established.

Geriatic Use

There is no FDA guidance on the use of Methscopolamine bromide in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Methscopolamine bromide Administration in the drug label.

Monitoring

There is limited information regarding Methscopolamine bromide Monitoring in the drug label.

IV Compatibility

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

Overdosage

The symptoms of overdosage with Methscopolamine Bromide 2.5 mg Tablets/Methscopolamine Bromide 5 mg Tablets progress from intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma.

Measures to be taken are (1) induction of emesis and (2) injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (alcohol sponging, ice packs). Excitement of a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 ml of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

The oral LD50 in rats is 1,352 to 2,617 mg/kg.

No data is available on the dialyzability of methscopolamine bromide.

Pharmacology

Methscopolamine bromide
Systematic (IUPAC) name
(1R,2S,4R,5S,7R)-{[(2R)-3-hydroxy-2-phenylpropanoyl]oxy}-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane
Identifiers
CAS number	155-41-9
ATC code	A03BB03 S01FA03 (WHO)
PubChem	441342
DrugBank	DB00462
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	318.388 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	3–4 hrs
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

Mechanism of Action

There is limited information regarding Methscopolamine bromide Mechanism of Action in the drug label.

Structure

There is limited information regarding Methscopolamine bromide Structure in the drug label.

Pharmacodynamics

There is limited information regarding Methscopolamine bromide Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Methscopolamine bromide Pharmacokinetics in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Methscopolamine bromide How Supplied in the drug label.

Storage

There is limited information regarding Methscopolamine bromide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Methscopolamine bromide Patient Counseling Information in the drug label.

Precautions with Alcohol

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

Brand Names

There is limited information regarding Methscopolamine bromide Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Methscopolamine bromide 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.