Fresenius Kabi Expands Ready to Administer Portfolio with Glycopyrrolate Injection, USP Simplist® Prefilled Syringe

Fresenius Kabi Simplist Glycopyrrolate Injection, USP is the most recent manufacturer-prepared product available in the company's proprietary, ready-to-administer portfolio of Simplist prefilled syringes, which reduce the amount of time nurses spend preparing doses and documenting waste.¹

"Fresenius Kabi is focused on helping reduce clinician burden by expanding our ready-to-administer offerings," said John Ducker, president and CEO of Fresenius Kabi USA. "We're pleased that our Simplist prefilled syringe portfolio now includes Glycopyrrolate Injection, USP, which will minimize preparation complexity to streamline workflows and help support patient safety in the U.S."

Fresenius Kabi Glycopyrrolate Injection, USP 0.6 mg per 3 mL Simplist prefilled syringe may be administered prior to or concomitantly with Simplist Neostigmine Methylsulfate Injection, USP 3 mg per 3 mL prefilled syringe for reversal of neuromuscular blockade. See package inserts for complete dosage and administration information at www.simplist-us.com. Fresenius Kabi also offers Glycopyrrolate Injection, USP in vials.

Fresenius Kabi continues to invest in expanding its suite of ready-to-administer (RTA) offerings to assure pharmacists and nurses have a wide range of prefilled, standard strengths, single-patient delivery systems options - from bags to syringes - that streamline medication management from the pharmacy to the bedside, eliminating steps where errors can occur.

Fresenius Kabi Simplist Glycopyrrolate Injection, USP is formulated, filled and packaged in the U.S., and is the newest example of the company's commitment to investing "More in America." This effort is focused on providing more supply, more science, more support and more care to its customers and the patients they serve in the U.S. Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced U.S. pharmaceutical production and distribution facilities.

To learn more about the Simplist portfolio with pharmacy clinical education support, please visit www.simplist-us.com.

INDICATIONS AND USAGE

Glycopyrrolate Injection, for intramuscular or intravenous use, is an anticholinergic indicated:

in anesthesia (adult and pediatric patients)

• for reduction of airway or gastric secretions, and 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.

in peptic ulcer (adults)

• as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated.

IMPORTANT SAFETY INFORMATION

Do not use Glycopyrrolate Injection 0.6 mg per 3 mL single-dose prefilled syringe to administer a dose of less than 0.1 mg (0.5 mL).

Contraindications:

• Known hypersensitivity to glycopyrrolate or any of its inactive ingredients.
• Peptic ulcer patients with glaucoma; obstructive uropathy; obstructive disease of the gastrointestinal tract; 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 and Precautions:

• Precipitation of Acute Glaucoma: Glycopyrrolate Injection may cause mydriasis and increase intraocular pressure in patients with glaucoma. Advise patients with glaucoma to promptly seek medical care if they experience symptoms of acute angle closure glaucoma.
• Drowsiness or Blurred Vision: May cause drowsiness or blurred vision. Advise patients not to drive or perform hazardous work until resolved.
• Heat Prostration: Advise patients to avoid exertion and high environmental temperatures after receiving Glycopyrrolate Injection.
• Intestinal Obstruction: Diarrhea may be an early symptom of incomplete intestinal obstruction. Avoid use in patients with diarrhea and ileostomy or colostomy.
• Tachycardia: Increase in heart rate may occur. Use with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension, or hyperthyroidism.

Adverse Events: Most common adverse reactions are related to anticholinergic pharmacology and 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; bradycardia; palpitation; and decreased sweating.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions:

• Other anticholinergics or drugs with anticholinergic activity: May intensify the antimuscarinic effects and result in an increase in anticholinergic side effects.
• Potassium Chloride in a Wax Matrix: May increase severity of potassium chloride-induced gastrointestinal lesions.

Pediatric Use: 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. Large doses may cause hyperexcitability.

This Important Safety Information does not include all the information needed to use Simplist Glycopyrrolate Injection, USP safely and effectively. Please see accompanying full prescribing information for Glycopyrrolate Injection, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.

References

1. Fanikos J, Burger M, Canada T. An assessment of currently available i.v. push medication delivery systems. Am J Health Syst Pharm. 2017;74(9): e230-e235.

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