Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Glycopyrrolate Tablets, USP 1 mg are uncoated, round, flat face white tablets with beveled edge and debossed with “0475” on one side and bisected on the other. Glycopyrrolate Tablets, USP 1 mg in bottles of 100 (NDC 69076-475-01). Glycopyrrolate Tablets, USP 2 mg are uncoated, round, flat face white tablets with beveled edges and debossed with “0476” on one side and bisected on the other. Glycopyrrolate Tablets, USP 2 mg in bottles of 100 (NDC 69076-476-01). Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight container. Rx only Manufactured by: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 Distributed by: Quinn Pharmaceuticals 954-755-0502 www.quinnrx.com Made in USA Rev: 03/2021 (4) R50242; Quinn Pharmaceuticals NDC 69076-475-01 Rx only Glycopyrrolate Tablets, USP 1 mg WHITE DYE-FREE 100 Tablets Glycopyrrolate tablet - 1 mg Label; Quinn Pharmaceuticals NDC 69076-476-01 Rx only Glycopyrrolate Tablets, USP 2 mg WHITE DYE-FREE 100 Tablets Glycopyrrolate Tablet - 2 mg Label
- HOW SUPPLIED Glycopyrrolate Tablets, USP 1 mg are uncoated, round, flat face white tablets with beveled edge and debossed with “0475” on one side and bisected on the other. Glycopyrrolate Tablets, USP 1 mg in bottles of 100 (NDC 69076-475-01). Glycopyrrolate Tablets, USP 2 mg are uncoated, round, flat face white tablets with beveled edges and debossed with “0476” on one side and bisected on the other. Glycopyrrolate Tablets, USP 2 mg in bottles of 100 (NDC 69076-476-01). Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight container. Rx only Manufactured by: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 Distributed by: Quinn Pharmaceuticals 954-755-0502 www.quinnrx.com Made in USA Rev: 03/2021 (4) R50242
- Quinn Pharmaceuticals NDC 69076-475-01 Rx only Glycopyrrolate Tablets, USP 1 mg WHITE DYE-FREE 100 Tablets Glycopyrrolate tablet - 1 mg Label
- Quinn Pharmaceuticals NDC 69076-476-01 Rx only Glycopyrrolate Tablets, USP 2 mg WHITE DYE-FREE 100 Tablets Glycopyrrolate Tablet - 2 mg Label
Overview
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. 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: C 19 H 28 BrNO 3 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 Chemical Structure
Indications & Usage
For use as adjunctive therapy in the treatment of peptic ulcer.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS In the presence of a high environmental temperature, heat 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. Pregnancy 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. Nursing Mothers 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. Pediatric Use Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.
Contraindications
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); 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. Glycopyrrolate Tablets, USP are contraindicated in those patients with a hypersensitivity to glycopyrrolate.
Adverse Reactions
Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions. Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations.
Drug Interactions
There are no known drug interactions.
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