5. Carcinogenesis, mutagenesis, impairment of fertility
No long-term studies in animals have been performed to evaluate carcinogenic potential.
Pregnancy Category 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.
The symptoms of overdosage with Pamine® 2.5 mg/Pamine® Forte 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.
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.
Pamine® 2.5 mg/Pamine® Forte 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.
DRUG ABUSE AND DEPENDENCE
- Gilman A, Gilman AB, Goodman LA, eds.
The Pharmacological Basis of Therapeutics.
6th ed. New York: MacMillan Publishing Company.1980.
- American Hospital Formulary Service. American Society of Hospital Pharmacists. Bethesda, Maryland.
- Domino EF, Corasen G. Central and Peripheral Effects of Muscarinic Cholinergic Blocking Agents in Man. Anesthesiology 1967;28:568-574.
- Mogensen L, Orinius E. Arrhythmic Complications after Parasympathetic Treatment of Bradyarrhythmias in a Coronary Care Unit. Acta Med Scand 1971;190:495-498.
- Neeld JB Jr., et al. Cardiac Rate and Rhythm Changes with Atropine and Methscopolamine. Clin Pharmacol Ther 1975;17(3):290-295.
A DIVISION OF BRADLEY PHARMACEUTICALS, INC.
Fairfield, NJ 07004-2402 USA
Mikart, Inc., Atlanta, GA 30318 USA
©2005 Bradley Pharmaceuticals, Inc.
-- advertisement --