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Robinul Warnings, Precautions, Pregnancy, Nursing, Abuse - Glycopyrrolate

Robinul Warnings, Precautions, Pregnancy, Nursing, Abuse - Glycopyrrolate

WARNINGS

This drug should be used with great caution, if at all, in patients with glaucoma or asthma.

In the Ambulatory Patient

Glycopyrrolate 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. In addition, in the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of glycopyrrolate injection.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with glyclopyrrolate injection would be inappropriate and possibly harmful.

PRECAUTIONS

General

Investigate any tachycardia before giving glycopyrrolate since an increase in the heart rate may occur.

Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism.

In managing ulcer patients, use glycopyrrolate injection with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis or hiatal hernia, since anticholinergic drugs may aggravate these conditions.

With overdosage, a curare-like action may occur.

Drug Interactions

The intravenous administration of any anticholinergic in the presence of cyclopropane anesthesia can result in ventricular arrhythmias; therefore, caution should be observed if glycopyrrolate injection is used during cyclopropane anethesia. If the drug is given in small incremental doses of 0.1 mg or less, the likelihood of producing ventricular arrhythmias is reduced.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. In the teratology studies, diminished rates of conception and of survival at weaning were observed in rats, in a dose-related manner. Studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits up to 1000 times the human dose and have revealed no teratogenic effects from glycopyrrolate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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 glycopyrrolate injection is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 years have not been established for the management of peptic ulcer.

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