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FDA Approves Third Drug In BD Simplist™ Prefilled Injectable Line Of Products

IMPORTANT SAFETY INFORMATION Diphenhydramine hydrochloride is contraindicated in neonates, premature infants, and as antihistamine therapy in nursing mothers and as a local anesthetic and when a patient is hypersensitive to other antihistamines of similar chemical structure.

Considerable caution should be used in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.

Local necrosis has been associated with the use of subcutaneous or intradermal use of the drug. It has an atropine-like action and, therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension and in patients with lower respiratory disease including asthma.

It has additive effects with alcohol and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

The most frequent adverse reactions are: Nervous System: sedation, sleepiness, dizziness, disturbed coordination; GI System: epigastric distress; and Respiratory System: thickening of bronchial secretions

Please see full prescribing information for additional important safety information.

About BD BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.

References

  1. Ondansetron PI.
  2. U.S. Food and Drug Administration. Current Drug Shortages Index. Available at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314742.htm and viewed on July 18, 2013.

Contact: Alyssa Zeff Public Relations (201) 847-4358 Alyssa_Zeff@bd.com

 

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