pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Cholinergic Antagonists.

Cholinergic

Indications

Sourced from openFDA
  • Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.

Contraindications

Sourced from openFDA
  • 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 Tablets, 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.contraindicated

Dosage & administration

Sourced from openFDA

The average dosage of Methscopolamine Bromide Tablets is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects. If the patient is experiencing symptoms such as severe abdominal pain or cramping which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one- half hour before meals and at bedtime. If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions. Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects. The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms. On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs. If methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

6. Pregnancy Teratogenic effects Animal reproduction studies have not been conducted with methscopolamine bromide. It is also 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.

Overdosage

Sourced from openFDA

The symptoms of overdosage with Methscopolamine Bromide Tablets, 2.5 mg and 5 mg 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 to 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 LD 50 in rats is 1,352 to 2,617 mg/kg. No data is available on the dialyzability of methscopolamine bromide.

Approval history

Sourced from openFDA
  • Dec 6, 2011ANDAANDA040642Breckenridge Pharm
  • Sep 24, 2012ANDAANDA200602Unichem
  • Feb 1, 2024ANDAANDA216786Ne Rx Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
141 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Diarrhoea1511%
  2. 2Nausea1511%
  3. 3Vomiting1511%
  4. 4Drug Ineffective149.9%
  5. 5Fatigue149.9%
  6. 6Pain139.2%
  7. 7Headache107.1%
  8. 8Fall96.4%
  9. 9Off Label Use85.7%
  10. 10Abdominal Pain75.0%
  11. 11Anxiety75.0%
  12. 12Seizure75.0%
  13. 13Tachycardia75.0%
  14. 14Weight Decreased75.0%
  15. 15Decreased Appetite64.3%

Literature

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Recent PubMed references pinned to Methscopolamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Frequently asked questions

How does Methscopolamine work?
Mechanism-of-action class: Cholinergic Antagonists.
What is Methscopolamine used for?
According to FDA labeling, Methscopolamine carries indications including: Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Methscopolamine?
Methscopolamine is classified as Anticholinergics, Belladonna alkaloids, semisynthetic, quaternary ammonium compounds, Anticholinergic, Cholinergic Antagonists, Decreased GI Motility, Inhibition Gastric Acid Secretion, Pupillary Dilation, Salivation Inhibition.
What are the brand names for Methscopolamine?
Methscopolamine is marketed under brand names including Pamine.
What are the contraindications for Methscopolamine?
Methscopolamine labeling lists contraindications including: 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 Tablets, 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.. Always consult the full prescribing information and a clinician.
Note. Data for methscopolamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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