DailyMed Label: Robinul

DailyMed Label: Robinul

2022

DailyMed Prescription

Robinul

Glycopyrrolate

Casper Pharma LLC

NDC: 70199-007

NDC: 70199-008

NDC: 70199-007

NDC: 70199-007

NDC: 70199-008

NDC: 70199-007

NDC: 70199-008

NDC: 70199-007

NDC: 70199-008

NDC: 70199-007

NDC: 70199-007

NDC: 70199-008

NDC: 70199-008

ROBINUL and ROBINUL FORTE tablets contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C 19 H 28 BrNO 3 , the molecular weight is 398.3 g/mol, and the structural formula is: Each ROBINUL tablet contains glycopyrrolate, USP 1 mg, as the active ingredient. Each ROBINUL FORTE tablet contains glycopyrrolate, USP 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate. robinul-1

ROBINUL and ROBINUL FORTE are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use ROBINUL and ROBINUL FORTE are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. ROBINUL and ROBINUL FORTE are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. (1) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)

Important Dosing Information (2.1) • ROBINUL FORTE is not recommended for patients initiating treatment or receiving maintenance treatment with ROBINUL or another 1 mg dosage strength of oral glycopyrrolate tablets. Recommended Dosage (2.2) • The recommended initial dosage of ROBINUL 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 2mg two or three times daily at equally spaced intervals. • The maximum recommended daily dosage 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. • ROBINUL FORTE is not recommended 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. • 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.

Tablets: • 1 mg, white, round, flat-faced, beveled-edge tablet, debossed “CS” and “007” on one side and functionally scored on the other side. • 2 mg, white, round, flat-faced, beveled-edge tablet, debossed “CS” score “008” on one side and plain on the other side. • Tablets: 1 mg (functionally scored) and 2 mg (3)

ROBINUL and ROBINUL FORTE 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 ROBINUL and ROBINUL FORTE [ 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)

•  Precipitation of Acute Glaucoma : May increase intraocular pressure; if symptoms occur, discontinue use and promptly seek medical care. ( 4 , 5.1 ) •  Partial or Complete Mechanical Intestinal Obstruction : Diarrhea may be an early symptom, especially in patients with ileostomy or colostomy. If the obstruction is suspected, discontinue use and evaluate the patient for obstruction. ( 4 , 5.2 ) •  GI Adverse Reactions Due to Decreased GI Motility : Delayed gastric emptying, constipation, and intestinal pseudo-obstruction may occur and precipitate or aggravate paralytic ileus and toxic megacolon; not recommended for use with anticholinergics or other medications that decrease GI peristalsis. ( 4 , 5.3 , 7.1 ) •  Cognitive and Visual Adverse Reactions : May impair mental and/or physical function. Inform patients not to operate motor vehicles or perform other hazardous tasks until reasonably certain they are not adversely affected; discontinue use 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 ) 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) ]. 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) ]. 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) ]. 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. 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) ] . 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) ]. 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) ].

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

•  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 ) There is potential for an additive interaction between glycopyrrolate and concomitantly used anticholinergic drugs (e.g., tricyclic antidepressants, anti-epileptics, class I antiarrhythmics, anti­spasmodics, amantadine) resulting in increased anticholinergic adverse reactions. Co-administration of antipsychotics with glycopyrrolate may lead to worsening of tardive dyskinesia. ROBINUL and ROBINUL FORTE are not recommended in patients taking other anticholinergic drugs [ see Warnings and Precautions (5.3 , 5.4 , 5.6 ) ]. 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) ] . 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.

•  Renal Impairment : Monitor patients with renal impairment; if anticholinergic adverse reactions occur, discontinue use. ( 8.6 ) 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) ]. 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. 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, 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) ]. 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.

ROBINUL (glycopyrrolate) tablets, 1 mg are white, round, flat-faced, beveled-edge tablet, debossed “CS” and “007” on one side and functionally scored on the other side. Available as • Bottles of 30  NDC 70199-007-30 • Bottles of 90  NDC 70199-007-90 ROBINUL FORTE (glycopyrrolate) tablets, 2 mg are white, round, flat-faced, beveled-edge tablet, debossed “CS” score “008” on one side and plain on the other side. Available as • Bottles of 30  NDC 70199-008-30 • Bottles of 90  NDC 70199-008-90 Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in a tight container.

Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions. No formal pharmacodynamic studies have been conducted with ROBINUL and ROBINUL FORTE. Patients with Renal Impairment In the published literature, glycopyrrolate 4 mcg/kg was administered intravenously (ROBINUL and ROBINUL FORTE are 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) ] .

Reproduction studies in rats resulted in diminished rates of conception in a dose-related manner. Studies in dogs suggest that diminished rates of conception may be due to diminished seminal secretion, which is evident at high doses of glycopyrrolate.

Robinul ® (glycopyrrolate, USP) tablets 1 mg Bottles of 90      NDC 70199-007-90 Robinul ® Forte (glycopyrrolate, USP) tablets 2mg                                                                                                                       Bottles of 90      NDC 70199-008-90 robinul-2 robinul-3