ansit time decreased gastrointestinal motility by glycopyrrolate may impact absorption of other drugs leading to increased or decreased drug exposure. robinul and robinul forte 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. robinul and robinul forte are not recommended in patients taking solid oral dosage forms of potassium chloride.

se if signs or symptoms develop. ( 5.4 , 7.1 ) • heat prostration at high environmental temperatures : heat prostration resulting in fever and heatstroke can occur, especially in geriatric patients. avoid exposure to hot or very warm environmental temperatures. ( 5.5 , 5.7 ) • other conditions exacerbated by anticholinergic adverse reactions : use is not recommended in patients with autonomic neuropathy, hyperthyroidism, cardiac disease, hiatal hernia, etc. ( 5.6 , 7.1 ) • increased risk of anticholinergic adverse reactions in geriatric patients : complications include urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures. not recommended in geriatric patients and may be contraindicated in some patients with underlying medical conditions. ( 4 , 5.7 , 8.5 ) 5.1 precipitation of acute glaucoma glycopyrrolate may cause increased intraocular pressure in patients with glaucoma and reduce the effects of antiglaucoma agents. instruct patients to discontinue robinul and robinul forte and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils) [ see contraindications (4) ]. 5.2 partial or complete mechanical intestinal obstruction robinul and robinul forte may worsen intestinal mechanical obstruction, and diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. if partial or complete intestinal obstruction is suspected, discontinue the use of robinul and robinul forte and evaluate for potential intestinal obstruction [ see contraindications (4) ]. 5.3 gastrointestinal adverse reactions due to decreased gastrointestinal motility glycopyrrolate reduces gastrointestinal motility and may result in delayed gastric emptying, constipation, and intestinal pseudo-obstruction and may precipitate or aggravate paralytic ileus and toxic megacolon [ see contraindications (4) ]. the risk of gastrointestinal adverse reactions is further increased with the use of other anticholinergics and other medications that decrease gastrointestinal peristalsis. monitor patients for symptoms of decreased gastrointestinal motility. concomitant use of robinul and robinul forte and other anticholinergics or other medications that decrease gi peristalsis is not recommended [ see drug interactions (7.2) ]. 5.4 cognitive and visual adverse reactions glycopyrrolate may produce drowsiness and blurred vision and impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery, or performing other hazardous work [ see adverse reactions (6) ]. concomitant use of other drugs that have anticholinergic properties may increase these effects [ see drug interactions (7.1) ]. inform patients not to operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that robinul and robinul forte does not affect them adversely. discontinue robinul and robinul forte if signs or symptoms of cognitive or visual impairment develop. 5.5 heat prostration at high environmental temperatures in the presence of a high environmental temperature, heat prostration resulting in fever and heatstroke can occur with the use of robinul and robinul forte due to decreased sweating, particularly in geriatric patients [ see adverse reactions (6) ]. advise patients to avoid exposure to hot or very warm environmental temperatures when taking robinul and robinul forte. robinul and robinul forte are not recommended in geriatric patients [ see warnings and precautions (5.7) ] . 5.6 other conditions exacerbated by anticholinergic adverse reactions robinul and robinul forte are not recommended in patients with other conditions exacerbated by anticholinergic adverse reactions (e.g., autonomic neuropathy, hyperthyroidism, cardiac disease, and hiatal hernia associated with reflux esophagitis) and in patients taking other anticholinergic medications [ see drug interactions (7.1) ]. 5.7 increased risk of anticholinergic adverse reactions in geriatric patients geriatric patients 65 years of age and older are at increased risk of anticholinergic adverse reactions that may lead to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures. robinul and robinul forte are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [ see contraindications (4), warnings and precautions (5.2 , 5.5 ), adverse reactions (6 ) and use in specific populations (8.5) ].

ed for patients in whom a lower dosage strength of oral glycopyrrolate (e.g., robinul or another 1 mg tablet strength) is appropriate for initial or maintenance treatment because the dosage strength of robinul forte may exceed the recommended initial and maintenance dosage of oral glycopyrrolate tablets. 2.2 recommended dosage • the recommended initial dosage of robinul for adults is 1 mg three times daily (in the morning, early afternoon, and at bedtime). some patients may require 2 mg at bedtime to assure overnight control of symptoms. for maintenance, a dosage of 1 mg twice a day is frequently adequate. • the recommended dosage of robinul forte for adults is 2 mg two or three times daily at equally spaced intervals. • the maximum recommended daily dosage of glycopyrrolate is 8 mg. • use the lowest effective dosage of glycopyrrolate to control symptoms. if patients can be titrated to a lower dose, switch from robinul forte to robinul or another 1 mg oral tablet of glycopyrrolate.

reports. because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. cardiac disorders: chest, pain, hypertension, tachycardia endocrine disorders: decreased sweating eye disorders: blurred vision, cycloplegia, dilatation of the pupil, increased ocular tension gastrointestinal disorders: bloated feeling, constipation, dry mouth, dysgeusia, nausea, vomiting immune system disorders: anaphylaxis [ see contraindications (4) ] nervous system disorders: agitation, dizziness, drowsiness, headache, insomnia, mental confusion, nervousness, weakness respiratory disorders: respiratory depression, throat irritation renal and urinary disorders: urinary hesitancy, urinary retention reproductive system and breast disorders: impotence, suppression of lactation vascular disorders: flushing adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. (6) to report suspected adverse reactions, contact casper pharma llc at 1-844-5-casper (1-844-522-7737) or fda at 1-800-fda-1088 or www.fda.gov/medwatch .

ansit time decreased gastrointestinal motility by glycopyrrolate may impact absorption of other drugs leading to increased or decreased drug exposure. robinul and robinul forte 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. robinul and robinul forte are not recommended in patients taking solid oral dosage forms of potassium chloride.

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) ]. 8.2 lactation 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 robinul and robinul forte and any potential adverse effects on the breastfed infant from robinul and robinul forte. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use 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, robinul and robinul forte 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) ]. 8.6 renal impairment 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 robinul and robinul forte.

y. 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) ].

may cause cognitive or visual impairment and not operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that robinul and robinul forte do not affect them adversely. advise patients to discontinue robinul and robinul forte immediately and contact their healthcare provider if symptoms develop (e.g., drowsiness or blurred vision) [ see warnings and precautions (5.4) ]. heat prostration at high environmental temperatures inform patients that robinul and robinul forte can reduce sweating, leading to the possibility of heat exhaustion or heat stroke. advise patients to avoid exposure to hot or very warm environmental temperatures [ see warnings and precautions (5.5) ]. manufactured for: casper pharma llc east brunswick, nj 08816 manufactured by: suven pharmaceuticals limited, telangana, india m.l.no.: 24/md/ap/2009/f/cc revised: 09/2022 pib00890-05 robinul ® and robinul forte ® are registered trademarks of casper pharma llc.