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 Pamine® 2.5 mg/Pamine® Forte 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.
4. 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.
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.
7. 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.
Anticholinergic drugs may suppress lactation.
8. Pediatric use
Safety and efficacy in children have not been established.
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