Methscopolamine Bromide Information
Methscopolamine bromide (Methscopolamine bromide) Description
Methscopolamine bromide (Methscopolamine bromide) 2.5 mg Tablets/Methscopolamine bromide (Methscopolamine bromide) 5 mg Tablets contain Methscopolamine bromide (Methscopolamine bromide) , an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide (Methscopolamine bromide) melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform.
The chemical name for Methscopolamine bromide (Methscopolamine bromide) is 3-Oxa-9-azoniatricyclo [3.3.1.0] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7()-(1, 2, 4, 5, 7)]- and the molecular weight is 398.30.
The structural formula is represented below:
Methscopolamine bromide (Methscopolamine bromide) 2.5 mg Tablets for oral administration contain 2.5 mg of Methscopolamine bromide (Methscopolamine bromide) . Methscopolamine bromide (Methscopolamine bromide) 5 mg Tablets for oral administration contain 5 mg of Methscopolamine bromide (Methscopolamine bromide) .
Inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.
Contains no lactose.
Methscopolamine bromide (Methscopolamine bromide) Clinical Pharmacology
Methscopolamine bromide (Methscopolamine bromide) is an anticholinergic agent which possesses most of the pharmacologic actions of that drug class. These include reduction in volume and total acid content of gastric secretion, inhibition of gastrointestinal motility, inhibition of salivary excretion, dilation of the pupil and inhibition of accommodation with resulting blurring of vision. Large doses may result in tachycardia.
Methscopolamine bromide (Methscopolamine bromide) Pharmacokinetics
Methscopolamine bromide (Methscopolamine bromide) is a quaternary ammonium derivative of scopolamine. As a class, these agents are poorly and unreliably absorbed. Total absorption of quaternary ammonium derivatives of the alkaloids is 10-25%. Rate of absorption is not available. Quaternary ammonium salts have limited absorption from intact skin, and conjunctival penetration is poor. Little is known of the fate and excretion of most of these agents. Following oral administration, drug effects appear in about one hour and persist for 4 to 6 hours. Methscopolamine bromide (Methscopolamine bromide) has limited ability to cross the blood-brain barrier. The drug is excreted primarily in the urine and bile, or as unabsorbed drug in feces. There is no data on the presence of methscopolamine in breast milk; traces of atropine have been found after administration of atropine.
Methscopolamine bromide (Methscopolamine bromide) Indications And Usage
Adjunctive therapy for the treatment of peptic ulcer.
Methscopolamine bromide (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.
Methscopolamine bromide (Methscopolamine bromide) 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 (Methscopolamine bromide) 2.5 mg Tablets/Methscopolamine bromide (Methscopolamine bromide) 5 mg Tablets are contraindicated in patients who are hypersensitive to Methscopolamine bromide (Methscopolamine bromide) or related drugs.
Methscopolamine bromide (Methscopolamine bromide) Warnings
In the presence of high environmental temperature, heat prostration (fever and heatstroke 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 (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.
Methscopolamine bromide (Methscopolamine bromide) Precautions
Use Methscopolamine bromide (Methscopolamine bromide) 2.5 mg Tablets/Methscopolamine bromide (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.
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 (Methscopolamine bromide) is administered to a nursing woman.
Anticholinergic drugs may suppress lactation.
Methscopolamine bromide (Methscopolamine bromide) Adverse Reactions
The following adverse reactions have been observed, but there is not enough data to support an estimate of frequency.
Methscopolamine bromide (Methscopolamine bromide) Drug Abuse And Dependence
Methscopolamine bromide (Methscopolamine bromide) Overdosage
The symptoms of overdosage with Methscopolamine bromide (Methscopolamine bromide) 2.5 mg Tablets/Methscopolamine bromide (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 maybe 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 LD in rats is 1,352 to 2,617 mg/kg.
No data is available on the dialyzability of Methscopolamine bromide (Methscopolamine bromide) .
Methscopolamine bromide (Methscopolamine bromide) Dosage And Administration
The average dosage of Methscopolamine bromide (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 (Methscopolamine bromide) is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.
Methscopolamine bromide (Methscopolamine bromide) How Supplied
Methscopolamine bromide (Methscopolamine bromide) 2.5 mg Tablets are available as white, round tablets, debossed with “F” on one side and “482” on the other side, in the following package size:
Bottles of 100 (NDC 0168-0482-99)
Methscopolamine bromide (Methscopolamine bromide) 5 mg Tablets are available as white, oval tablets, debossed with “F” on one side and “483” on the other side, in the following package size:
Dose Pack (5 blisters of 12 tablets)
Box of 60 (NDC 0168-0483-60)
Store at 15°-30°C (59°-86°F).
Methscopolamine bromide (Methscopolamine bromide) References
Manufactured for:
A division of Nycomed US Inc.
Melville, New York 11747
Manufactured by:
Atlanta, GA 30318 USA
Code 935C00
Rev. 12/09
IL295A
R1/09
Methscopolamine bromide (Methscopolamine bromide) Principal Display Panel
NDC 0168-0482-99
fougera
Methscopolamine bromide (Methscopolamine bromide)
2.5 mg Tablets
100 Tablets
Rx only
