ility by glycopyrrolate may impact absorption of other drugs leading to increased or decreased drug exposure. dartisla odt is 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. dartisla odt is not recommended in patients taking solid oral dosage forms of potassium chloride.

prostration at high environmental temperatures : heat prostration resulting in fever and heat stroke 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, arrythmias, delirium and falls or fractures. not recommended in geriatric patients and may be contraindicated 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 dartisla odt 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 dartisla odt 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 use of dartisla odt 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 use of other anticholinergics and other medications that decrease gastrointestinal peristalsis. monitor patients for symptoms of decreased gastrointestinal motility. concomitant use of dartisla odt 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 dartisla odt does not affect them adversely. discontinue dartisla odt 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 heat stroke can occur with use of dartisla odt 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 dartisla odt. dartisla odt is not recommended in geriatric patients [see warnings and precautions ( 5.7 )] . 5.6 other conditions exacerbated by anticholinergic adverse reactions dartisla odt is 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. dartisla odt is 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 )] .

of dartisla odt [see dosage forms and strengths ( 3 ) and clinical pharmacology ( 12.3 )] . dartisla odt is not recommended for patients in whom a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg) is appropriate for initial or maintenance treatment because the dosage strength of dartisla odt may exceed the recommended initial and maintenance dosage of other oral glycopyrrolate products. 2.2 recommended dosage the recommended dosage of dartisla odt is 1.7 mg given two or three times daily administered on top of the tongue. allow the tablet to disintegrate and swallow without water [see clinical pharmacology ( 12.3 )] . the maximum recommended daily dosage of dartisla odt is 6.8 mg. administer dartisla odt at least one hour before or two hours after food [see clinical pharmacology ( 12.3 )] . use the lowest effective dosage of glycopyrrolate to control symptoms. switch patients who can be titrated to a lower dose of oral glycopyrrolate to another oral tablet dosage form of glycopyrrolate. 2.3 administration instructions use dry hands when opening the blister card and do not open the blister until ready to administer. open the package and peel back the foil on the blister to expose the tablet and gently remove from the blister. do not push the tablet through the foil. do not break or cut the tablet. immediately place the tablet on the tongue, allow it to disintegrate, and swallow without water.

orted 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 edenbridge pharmaceuticals, llc at 1-877-381-3336 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

ility by glycopyrrolate may impact absorption of other drugs leading to increased or decreased drug exposure. dartisla odt is 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. dartisla odt is not recommended in patients taking solid oral dosage forms of potassium chloride.

her 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 body weight 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, 32.5, 63 and 130 mg/kg/day for 3 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 dartisla odt and any potential adverse effects on the breastfed infant from dartisla odt. 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, dartisla odt is 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 dartisla odt.

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 body weight 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, 32.5, 63 and 130 mg/kg/day for 3 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 )] .

ion without water [see dosage and administration ( 2.2 ) ] . effect of food in healthy adults, a high-fat, high-calorie meal (939 calories, 60% fat) significantly reduced the absorption of glycopyrrolate following administration of dartisla odt 1.7 mg. the mean c max and auc were approximately 83% and 77% lower, respectively, than those observed under fasted conditions [see dosage and administration ( 2.2 )] . elimination after dartisla odt 1.7 mg administration, the mean plasma half-life was 2.8 hours. specific populations patients with renal impairment in published literature, glycopyrrolate 4 mcg/kg was administered intravenously (dartisla odt is not recommended for intravenous use) in uremic patients undergoing renal transplantation surgery. the mean auc (10.6 mcg·h/l), and 24-hour urinary excretion (7%) for glycopyrrolate were significantly different from normal healthy adult subjects undergoing general surgery (3.7 mcg·h/l, and 65%, respectively) [see use in specific populations ( 8.6 )] .

hose observed under fasted conditions [see dosage and administration ( 2.2 )] . elimination after dartisla odt 1.7 mg administration, the mean plasma half-life was 2.8 hours. specific populations patients with renal impairment in published literature, glycopyrrolate 4 mcg/kg was administered intravenously (dartisla odt is not recommended for intravenous use) in uremic patients undergoing renal transplantation surgery. the mean auc (10.6 mcg·h/l), and 24-hour urinary excretion (7%) for glycopyrrolate were significantly different from normal healthy adult subjects undergoing general surgery (3.7 mcg·h/l, and 65%, respectively) [see use in specific populations ( 8.6 )] .

airment and not to operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that dartisla odt does not affect them adversely. advise patients to discontinue dartisla odt 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 dartisla odt 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 )] . dosage and administration instructions administer dartisla odt at least one hour before or two hours after food [see dosage and administration ( 2.2 )] . use dry hands when handling the blister card and do not open the blister until ready to administer. open the package and peel back the foil on the blister to expose the tablet and gently remove from the blister. do not push the tablet through the foil. do not break or cut the tablet. immediately place the tablet on the tongue, allow it to disintegrate, and swallow without water [see dosage and administration ( 2.3 )] . manufactured by: catalent pharma solutions limited frankland road blagrove, swindon wiltshire sn5 8ru, united kingdom (gbr) manufactured for: edenbridge pharmaceuticals, llc parsippany, nj 07054 © 2021 edenbridge pharmaceuticals, llc eb-pic