Glycopyrrolate Injection, USP
  • "AP" rated to Robinul®*
  • Vial closure is not made with natural rubber latex
  • Preserved with 0.9% Benzyl Alcohol




NDC Number
Strength
Size
Shelf Pack
Availability
Product Information
Arrow Up 0517-4605-25 0.2 mg/mL 5 mL Multiple Dose Vial 25 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036284 1449123 5170964 1424001 079921
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
4605-25 25 32 50


Arrow Up 0517-4620-25 0.2 mg/mL 20 mL Multiple Dose Vial 25 In stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036283 1464890 5170261 1102938 076265
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
4620-25 25 12 48


Arrow Up 0517-4601-25 0.2 mg/mL 1 mL Single Dose Vial 25 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036280 1431931 5170204 1197185 076307
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
4601-25 25 90 40


Arrow Up 0517-4602-25 0.2 mg/mL 2 mL Single Dose Vial 25 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036281 2464907 5170329 1419944 076208
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
4602-25 25 20 198


*Rubinul is a registered trademark of West-Ward Pharmaceutical Corp


NDC Number
Arrow Up 0517-4605-25
Strength
0.2 mg/mL
Size
5 mL Multiple Dose Vial
Shelf Pack
25
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036284 1449123 5170964 1424001 079921
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
4605-25 25 32 50


NDC Number
Arrow Up 0517-4620-25
Strength
0.2 mg/mL
Size
20 mL Multiple Dose Vial
Shelf Pack
25
Availability
In stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036283 1464890 5170261 1102938 076265
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
4620-25 25 12 48


NDC Number
Arrow Up 0517-4601-25
Strength
0.2 mg/mL
Size
1 mL Single Dose Vial
Shelf Pack
25
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036280 1431931 5170204 1197185 076307
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
4601-25 25 90 40


NDC Number
Arrow Up 0517-4602-25
Strength
0.2 mg/mL
Size
2 mL Single Dose Vial
Shelf Pack
25
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036281 2464907 5170329 1419944 076208
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
4602-25 25 20 198


*Rubinul is a registered trademark of West-Ward Pharmaceutical Corp


INDICATIONS AND USAGE In Anesthesia: Glycopyrrolate Injection, USP 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, USP 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.
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, Glycopyrrolate Injection, USP may be contraindicated in 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. WARNINGS This drug should be used with great caution, if at all, in patients with glaucoma. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources. Glycopyrrolate Injection, USP may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate (due to decreased sweating), particularly in children and the elderly. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with Glycopyrrolate Injection, USP would be inappropriate and possibly harmful. PRECAUTIONS General
Investigate any tachycardia before giving Glycopyrrolate Injection, USP since an increase in the heart rate may occur. Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism. Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. Dosage adjustments may be necessary.
Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, prostatic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions. Drug Interactions:
The concurrent use of Glycopyrrolate Injection, USP with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects.
Pregnancy
Teratogenic Effects-Pregnancy Category B: Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Glycopyrrolate Injection, USP is administered to a nursing woman. As with other anticholinergics, glycopyrrolate may cause suppression of lactation.
Pediatric Use
Due to its benzyl alcohol content, Glycopyrrolate Injection, USP, should not be used in neonates, i.e., patients less than 1 month of age. Safety and effectiveness in pediatric patients below the age of 16 years have not been established. Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer.
ADVERSE REACTIONS Anticholinergics, including Glycopyrrolate Injection USP, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons. In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Postmarketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.










INDICATIONS AND USAGE In Anesthesia: Glycopyrrolate Injection, USP 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, USP 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.
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, Glycopyrrolate Injection, USP may be contraindicated in 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. WARNINGS This drug should be used with great caution, if at all, in patients with glaucoma. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources. Glycopyrrolate Injection, USP may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate (due to decreased sweating), particularly in children and the elderly. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with Glycopyrrolate Injection, USP would be inappropriate and possibly harmful. PRECAUTIONS General
Investigate any tachycardia before giving Glycopyrrolate Injection, USP since an increase in the heart rate may occur. Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism. Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. Dosage adjustments may be necessary.
Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, prostatic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions. Drug Interactions:
The concurrent use of Glycopyrrolate Injection, USP with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects.
Pregnancy
Teratogenic Effects-Pregnancy Category B: Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Glycopyrrolate Injection, USP is administered to a nursing woman. As with other anticholinergics, glycopyrrolate may cause suppression of lactation.
Pediatric Use
Due to its benzyl alcohol content, Glycopyrrolate Injection, USP, should not be used in neonates, i.e., patients less than 1 month of age. Safety and effectiveness in pediatric patients below the age of 16 years have not been established. Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer.
ADVERSE REACTIONS Anticholinergics, including Glycopyrrolate Injection USP, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons. In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Postmarketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.


© 2017, American Regent, Inc., A Luitpold Pharmaceuticals, Inc. Company
PP-AS-US-0014     4/2017