Fresenius Kabi USA LLC

07/19/2018 | Press release | Archived content

Atropine Sulfate Injection, USP Now Available From Fresenius Kabi

LAKE ZURICH, Ill., July 19, 2018 - Fresenius Kabi announced today the immediate availability in the United States of Atropine Sulfate Injection, USP in an 8 mg per 20 mL presentation.

Fresenius Kabi now offers the first and only Atropine Sulfate 8 mg per 20 mL multiple-dose vial approved by the U.S. Food and Drug Administration.

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company is a leading developer, manufacturer and provider of injected and infused medicines in the United States with special expertise in producing high quality, affordable generic alternatives to more expensive brand-name drugs.

About Atropine Sulfate Injection, USP

INDICATIONS AND USAGE

Atropine is a muscarinic antagonist indicated for the temporary blockade of severe or life threatening muscarinic effects.

IMPORTANT SAFETY INFORMATION

Hypersensitivity: May cause anaphylaxis.

Worsening of Ischemic Heart Disease: In patients with ischemic heart disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid atropine-induced tachycardia, increased myocardial oxygen demand and the potential for worsening cardiac ischemia or increasing infarction size.

Acute Glaucoma: May precipitate acute glaucoma.

Pyloric Obstruction: May convert partial organic pyloric stenosis into complete obstruction.

Complete Urinary Retention: May lead to complete urinary retention in patients with prostatic hypertrophy.

Viscid Plugs: May cause thickening of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.

Benzyl Alcohol: The preservative benzyl alcohol has been associated with serious adverse events ("Gasping Syndrome") and death in neonates. Premature and low-birth weight infants may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

Most adverse reactions are directly related to Atropine's antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses.

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 Atropine Sulfate Injection, USP, safely and effectively. Please click on the following link (https://tinyurl.com/ycfa7srg) for the full prescribing information for Atropine Sulfate Injection, USP, at www.fresenius-kabi.com/us.