Glycopyrrolate 1 MG Oral Tablet
WARNINGS
In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of glycopyrrolate.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomyor colostomy .
In this instance treatment with this drug would be inappropriate and possibly harmful.
Glycopyrrolate may produce drowsiness and blurred vision.
In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug.
Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.
The safety of this drug during pregnancy has not been established.
The use of any drug during pregnancy requires that potential benefits of the drug be weighed against possible hazards to mother and child.
Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner.
Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.
Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience.
Such experience has revealed no reports of teratogenic or other fetus-damaging potential.
No controlled studies to establish the safety of the drug in pregnancy have been performed.
It is not known whether this drug is excreted in human milk.
As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.
DRUG INTERACTIONS
There are no known drug interactions.
OVERDOSAGE
The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.
To guard against further absorption of the drug-use gastric lavage, cathartics and/or enemas.
To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.
To combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.
To combat respiratory depression-administer oxygen; utilize a respiratory stimulant such as Dopram®* i.v.; artificial respiration.
DESCRIPTION
Glycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate.
Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide.
Its empirical formula is C 19 H 28 BrNO 3 , its molecular weight is 398.33, and its structural formula is: Each 1 mg tablet contains: Glycopyrrolate, USP 1mg Each 2 mg tablet contains: Glycopyrrolate, USP 2mg Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate MM1
HOW SUPPLIED
Glycopyrrolate tablets 1 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “400” below the bisect on one side of the tablet, and plain on the other side.
Available in bottles of 100 (NDC 49884-065-01).
Glycopyrrolate tablets 2 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “401” below the bisect on one side of the tablet, and plain on the other side.
Available in bottles of 100 (NDC 49884-066-01).
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Rx only * Dopram ® is a registered trademark of Baxter Healthcare Corporation.
Manufactured by: Par Pharmaceutical Companies, Inc.
Spring Valley, NY 10977 Rev: 07/2010 OS065-01-1-02
INDICATIONS AND USAGE
INDICATIONS & USAGE For use as adjunctive therapy in the treatment of peptic ulcer.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION The dosage of glycopyrrolate should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions.
The presently recommended maximum daily dosage of glycopyrrolate is 8 mg.
Glycopyrrolate Tablets 1 mg.
The recommended initial dosage of glycopyrrolate for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime).
Some patients may require two tablets at bedtime to assure overnight control of symptoms.
For maintenance, a dosage of one tablet twice a day is frequently adequate.
Glycopyrrolate Tablets 2 mg.
The recommended dosage of glycopyrrolate for adults is one tablet two or three times daily at equally spaced intervals.
Glycopyrrolate tablets are not recommended for use in pediatric patients under the age of 12 years.