Pamine (Methscopolamine Bromide) - Drug Interactions, Contraindications, Overdosage

DRUG INTERACTIONS

5. Carcinogenesis, mutagenesis, impairment of fertility

No long-term studies in animals have been performed to evaluate carcinogenic potential.

6. Pregnancy

Teratogenic effects

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.

OVERDOSAGE

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.

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.

Pamine^® 2.5 mg/Pamine^® Forte 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.