Fresenius Kabi Announces Availability of Dicyclomine Hydrochloride Injection, USP 20 mg Vial

LAKE ZURICH, Ill., December 19, 2019 - Fresenius Kabi announced today the immediate availability in the United States of Dicyclomine Hydrochloride Injection, USP in 20 mg per 2 mL single-dose vial.

Dicyclomine Hydrochloride Injection, USP is an antispasmodic and anticholinergic agent indicated for the treatment of functional bowel and irritable bowel syndrome. Fresenius Kabi Dicyclomine Hydrochloride is AP rated, preservative free, and is stored at room temperature. The container closure is not made with natural rubber latex.

"Fresenius Kabi is pleased to announce the availability of this latest addition to our critical care portfolio, representing another important and affordable therapy option for clinicians and the patients they treat," said John Ducker, president and CEO of Fresenius Kabi USA.

Fresenius Kabi is a global health company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us.

About Dicyclomine Hydrochloride Injection, USP

INDICATIONS AND USAGE

Dicyclomine Hydrochloride Injection is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome.

IMPORTANT SAFETY INFORMATION

Dicyclomine Hydrochloride Injection, USP is contraindicated in the following:

• Infants less than 6 months of age
• Nursing mothers
• Unstable cardiovascular status in acute hemorrhage
• Myasthenia gravis
• Glaucoma
• Obstructive uropathy
• Obstructive disease of the gastrointestinal tract
• Severe ulcerative colitis
• Reflux esophagitis

• For Intramuscular injection only; should not be administered by any other route. Intravenous injection may result in thrombosis or thrombophlebitis and injection site reactions.

• Cardiovascular conditions: worsening of conditions.

• Peripheral and central nervous system: heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued, and supportive measures instituted.

• Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of Dicyclomine Hydrochloride.

• Myasthenia Gravis: overdose may lead to muscular weakness and paralysis. Dicyclomine Hydrochloride should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase.

• Incomplete intestinal obstruction: diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with Dicyclomine Hydrochloride would be inappropriate and possibly fatal.

• Salmonella dysenteric patients: due to risk of toxic megacolon.

• Ulcerative colitis: Dicyclomine Hydrochloride should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon.

• Prostatic hypertrophy: Dicyclomine Hydrochloride Injection should be used with caution in these patients; may lead to urinary retention.

• Hepatic and renal disease: should be used with caution.

• Geriatric: use with caution in elderly who may be more susceptible to Dicyclomine Hydrochloride adverse events.

• Antiglaucoma agents: anticholinergics antagonize antiglaucoma agents and may increase intraocular pressure.

• Anticholinergic agents: may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs.

• Antacids: interfere with the absorption of anticholinergic agents.

• Pregnancy: use only if clearly needed.

• Pediatric Use: safety and effectiveness not established.

The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness.

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 Dicyclomine Hydrochloride Injection, USP safely and effectively. Please click on the following link https://tinyurl.com/vhj4pf7 for the full prescribing information for Dicyclomine Hydrochloride Injection, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.

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