Fresenius Kabi Introduces Glycopyrrolate Injection, USP Simplist® Prefilled Syringes in 0.2 mg per 1 mL and 0.4 mg per 2 mL Presentations
First FDA Approved Glycopyrrolate Prefilled Syringe Available in U.S.
April 29, 2019
LAKE ZURICH, Ill., April 29, 2019 - Fresenius Kabi announced today the immediate availability in the United States of Glycopyrrolate Injection, USP in 0.2 mg per 1 mL and 0.4 mg per 2 mL single dose in Simplist® ready-to-administer prefilled syringes.
Glycopyrrolate Injection, USP in the Simplist prefilled syringe is the first ready-to-administer prefilled syringe available in the United States for this medication. Until now, Glycopyrrolate syringe presentations have only been available in the U.S. as compounded products.
The Simplist prefilled syringes complement Fresenius Kabi Glycopyrrolate in vials, which are offered in 0.2 mg per mL, 0.4 mg per 2 mL, 1 mg per 5 mL and 4 mg per 20 mL presentations.
“Fresenius Kabi is pleased to again expand our Simplist prefilled syringe portfolio,” said John Ducker, president and CEO of Fresenius Kabi USA. “This is the 12th Simplist prefilled syringe we’ve launched since 2016. For clinicians, particularly in the operating room, the need for clarity and convenience is real and we’re meeting that need with a pre-labeled, prefilled Glycopyrrolate syringe.”
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
About Simplist® Glycopyrrolate Injection, USP
Indications and Usage
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.
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.
Important Safety Information
Glycopyrrolate Injection, USP is contraindicated in the following:
- Patients with known hypersensitivity to glycopyrrolate or any of its inactive ingredients.
- In the management of peptic ulcer patients, because of the longer duration of therapy, Glycopyrrolate Injection may be contraindicated in patients with the following concurrent conditions: 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.
Glaucoma: Use with great caution, if at all.
Drowsiness and Blurred Vision: Use caution while performing activities requiring mental alertness.
Heat prostration: May cause decrease sweating.
Incomplete intestinal obstruction: Diarrhea may be an early symptom. In patients with an ileostomy or colostomy, treatment with glycopyrrolate injection would be inappropriate and possibly harmful.
Tachycardia: May increase heart rate, investigate any tachycardia before giving glycopyrrolate.
Patients with coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism: Use with caution.
Renal impairment: Renal elimination of glycopyrrolate may be severely impaired in patients with renal failure.
Use Glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostatic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions.
The use of anticholinergic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying due to antral statis
Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer.
Adverse effects related to anticholinergics may include: Xerostomia, 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 include: Anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.
Adverse events reported from post-marketing experience with glycopyrrolate include: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures, respiratory arrest, injection site reactions including pruritus, edema, erythema, and pain. Heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase have been reported.
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.
This Important Safety Information does not include all the information needed to use Glycopyrrolate Injection, USP safely and effectively. Please click on this link (https://tinyurl.com/y2gwl96r) for the full prescribing information for Glycopyrrolate Injection, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.
For additional information about all Simplist ready-to-administer prefilled syringes please visit www.simplist-us.com.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany.