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zydus lifesciences limited - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) -

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cantrell drug company - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate 0.2 mg in 1 ml

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rising pharmaceuticals, inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - for use as adjunctive therapy in the treatment of peptic ulcer. 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 are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

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stason pharmaceuticals, inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - indications: for use as adjunctive therapy in the treatment of peptic ulcer. 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 are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

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solco healthcare us, llc - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - in anesthesia glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. in peptic ulcer for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer

United States - English - NLM (National Library of Medicine)

solco healthcare us, llc - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - in anesthesia glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. in peptic ulcer for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer

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shionogi inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate 1 mg - for use as adjunctive therapy in the treatment of peptic ulcer. 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. robinul (glycopyrrolate) tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.   limitations of use glycopyrrolate is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. glycopyrrolate tablets are contraindicated in: -  patients at risk for anticholinergic toxicity due to an underlying medical condition, including: glaucoma [ see warnings and precautions (5.1) ] obstructive uropathies, including prostatic hypertrophy mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [ see warnings and precautions (5.2) ] gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [ see warnings and precautions (5.3)] bleeding gastrointestinal ulcer active inflammatory or infectious colitis which can lead to toxic megacolon history of or current toxic megacolon myasthenia gravis  - glaucoma [ see warnings and precautions (5.1) ] - obstructive uropathies, including prostatic hypertrophy - mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [ see warnings and precautions (5.2) ] - gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [ see warnings and precautions (5.3)] - bleeding gastrointestinal ulcer - active inflammatory or infectious colitis which can lead to toxic megacolon - history of or current toxic megacolon - myasthenia gravis  - patients with a hypersensitivity to glycopyrrolate or any of the inactive ingredients in glycopyrrolate tablets [ see adverse reactions (6) and description (11) ]. 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 nonclinicaltoxicology (13.1) ]. risk summary there are no data on the presence of glycopyrrolate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. as with other anticholinergic drugs, glycopyrrolate may cause suppression of lactation. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for glycopyrrolate tablets and any potential adverse effects on the breastfed infant from glycopyrrolate tablets. safety and effectiveness in pediatric patients have not been established. geriatric patients 65 years of age and older may be more sensitive to the anticholinergic adverse reactions of glycopyrrolate leading to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures; therefore, glycopyrrolate tablets are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [ see contraindications (4) and warnings and precautions (5) ]. glycopyrrolate is substantially excreted by the kidney [ see clinical pharmacology (12.3) ]. monitor patients with renal impairment for anticholinergic adverse reactions [ see adverse reactions (6) ]. if anticholinergic adverse reactions occur, discontinue glycopyrrolate tablets.

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fresenius kabi usa, llc - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate injection, usp (0.2 mg/ml) is an anticholinergic indicated for use in: anesthesia (all ages) - for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, - intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and - for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents. peptic ulcer (adults) - as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. glycopyrrolate injection is contraindicated in: - patients with known hypersensitivity to glycopyrrolate injection or any of its inactive ingredients. - peptic ulcer patients with the following concurrent conditions: 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. risk summary limited data are available with glycopyrrolate use during pregnancy have not identified a drug-associated risk of birth defects and miscarriage, however, most of the reported exposures occurred after the first trimester. most of the available data are based on studies with exposures that occurred at the time of cesarean-section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant apgar scores (see data ). in animal reproduction studies in pregnant rats and rabbits administered glycopyrrolate orally (rats) and intramuscularly (rabbits) during the period of organogenesis, no teratogenic effects were seen at 320-times and 5 times the maximum recommended human dose (mrhd) of 2 mg (on a mg/m2 basis), respectively (see data ). the estimated background risk for 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 the clinically recognized pregnancies is 2-4% and 15−20%, respectively. data human data published, randomized, controlled trials over several decades, which compared the use of glycopyrrolate to another antimuscarinic agent in pregnant women during cesarean section, have not identified adverse maternal or infant outcomes. in normal doses (0.004 mg/kg), glycopyrrolate does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. concentrations of glycopyrrolate in umbilical venous and arterial blood and in the amniotic fluid are low after intramuscular administration to parturients. therefore, glycopyrrolate does not appear to penetrate through the placental barrier in significant amounts. there are no studies on the safety of glycopyrrolate exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to glycopyrrolate during pregnancy. in addition, there are no data on the risk of miscarriage following fetal exposure to glycopyrrolate. animal data reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 5 times the maximum recommended daily human dose on a mg/m2 basis). these studies produced no teratogenic effects to the fetus. a preclinical study on reproductive performance of rats given glycopyrrolate resulted in a decreased rate of conception and survival at weaning. risk summary there are no data on the presence of glycopyrrolate in either human milk or animal milk, the effects on the breastfed infant, or the effects on milk production. as with other anticholinergics, glycopyrrolate may cause suppression of lactation [see adverse reactions (6)] . the developmental and health benefits of breast feeding should be considered along with the mother's clinical need for glycopyrrolate injection and any potential adverse effects on the breastfed child from glycopyrrolate injection or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer. dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients. infants, patients with down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects. a paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including glycopyrrolate injection. infants and young children are especially susceptible to the toxic effects of anticholinergics. clinical studies of glycopyrrolate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy. renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. dosage adjustments may be necessary [see clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

ranbaxy pharmaceuticals inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - for use as adjunctive therapy in the treatment of peptic ulcer. 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.