Glycopyrrolate
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Glycopyrrolate is substantially excreted by the kidney [ see Clinical Pharmacology ]. Monitor patients with renal impairment for anticholinergic adverse reactions [ see Adverse Reactions ]. If anticholinergic adverse reactions occur, discontinue glycopyrrolate.
Drug interactions
Check glycopyrrolate against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS • Other Anticholinergic Drugs : Concomitant use is not recommended. ( 5.3 , 5.4 , 5.6 , 7.1 ) • Drugs with Altered Absorption due to Decreased GI Motility : Concomitant use is not recommended. ( 7.2 ) • GI Toxicity with Solid Oral Dosage Forms of Potassium Chloride : Concomitant use is not recommended. ( 7.3 )
7.1 Other Anticholinergic Drugs There is potential for an additive interaction between glycopyrrolate and concomitantly used anticholinergic drugs (e.g., tricyclic antidepressants, anti-epileptics, class I antiarrhythmics, anti-spasmodics, amantadine) resulting in increased anticholinergic adverse reactions. Co-administration of antipsychotics with glycopyrrolate may lead to worsening of tardive dyskinesia. Glycopyrrolate are not recommended in patients taking other anticholinergic drugs [ see Warnings and Precautions (5.3 , 5.4 , 5.6 ) ].
7.2 Drugs with Altered Absorption due to Decreased Gastrointestinal Motility and Increased Transit Time Decreased gastrointestinal motility by glycopyrrolate may impact absorption of other drugs leading to increased or decreased drug exposure. Glycopyrrolate are not recommended in patients taking other drugs that are affected by altered gastrointestinal motility [ see Warnings and Precautions (5.3) ] .
7.3 Gastrointestinal Toxicity with Solid Oral Dosage Forms of Potassium Chloride Oral glycopyrrolate may worsen gastrointestinal mucosal injury reported with solid oral dosage forms of potassium chloride due to decreased gastric motility and increased transit time, leading to prolonged contact with the gastrointestinal mucosa. Glycopyrrolate are not recommended in patients taking solid oral dosage forms of potassium chloride.
Contraindications
Glycopyrrolate are contraindicated in: • Patients at risk for anticholinergic toxicity due to an underlying medical condition, including: o Glaucoma [ see Warnings and Precautions (5.1) ] o Obstructive uropathies, including prostatic hypertrophy o Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [ see Warnings and Precautions (5.2) ] o Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [ see Warnings and Precautions (5.3) ] o Bleeding gastrointestinal ulcer o Active inflammatory or infectious colitis which can lead to toxic megacolon o History of or current toxic megacolon o Myasthenia gravis • Patients with a hypersensitivity to glycopyrrolate or any of the inactive ingredients in glycopyrrolate [ see Adverse Reactions (6) and Description (11) ]. • Patients at risk for anticholinergic toxicity due to various underlying medical conditions. ( 4 , 5.1 , 5.2 , 5.3 ) • Hypersensitivity to glycopyrrolate or the inactive ingredients. (4)
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Over decades of use, there is an absence of published data on orally administered glycopyrrolate in pregnant women, including an absence of any reports of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, at non-maternally toxic doses of oral glycopyrrolate, there were no adverse developmental effects in rats or rabbits. A pre- and post-natal development study of oral glycopyrrolate in rats showed a decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed ( see Data ).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data At non-maternally toxic doses of oral glycopyrrolate, there were no effects on embryo-fetal development or toxicity in rats or rabbits.
A pre- and post-natal development study of oral glycopyrrolate in rats showed a decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed. In a published reproductive and developmental study, male and female rats were administered glycopyrrolate in the diet at 0 mg/kg/day, 32.5 mg/kg/day, 63 mg/kg/day, and 130 mg/kg/day for 3 weeks to 5 weeks and through up to three consecutive litters. There was no indication of abnormalities in the pups of treated dams. There was a decreased rate of conception and in survival rate at weaning for all treated animals in a dose-related manner.
Diminished rates of conception may be due to diminished seminal secretion [ see Nonclinical Toxicology (13.1) ].
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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