FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
In the presence of a high environmental temperature, heal prostration (fever and heat stroke due to decreased sweating) can occur with the use of Glycopyrrolate.
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.
Glycopyrrolate may produce drowsiness or 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 the 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 know 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For use as adjunctive therapy in the treatment of peptic ulcer.
History
There is currently no drug history available for this drug.
Other Information
Glycopyrrolate tablets USP contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide.
Each glycopyrrolate tablet USP, intended for oral administration, contains glycopyrrolate equivalent to 1 mg or 2 mg. In addition, it also contains the following inactive ingredients: lactose monohydrate, dibasic calcium phosphate anhydrous, povidone, sodium starch glycolate and magnesium stearate.
The structural formula of glycopyrrolate is represented below:
Molecular Formula: C19H28BrNO3
Molecular Weight: 398.33
Each tablet contains 1 mg or 2 mg of Glycopyrrolate, USP.
Inactive Ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate
Sources
Iope Perfect Skin 1 Manufacturers
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Amorepacific
Iope Perfect Skin 1 | Quinn Pharmaceuticals, Llc
The dosage of Glycopyrrolate Tablets, USP 1 mg and 2 mg 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, USP
1 mg. The recommended initial dosage of Glycopyrrolate Tablets, USP 1 mg 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, USP
2 mg. The recommended dosage of Glycopyrrolate Tablets, USP 2 mg 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.
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