Solvay Pharmaceuticals, Inc. Announces Commercial Availability of CREON(R) (Pancrelipase) Delayed-Releas...(nt (50%). Treatment-emergent adverse eve...),Health

Date:7/7/2009

nt (50%). Treatment-emergent adverse events occurring in at least two patients (greater than or equal to 6%) receiving CREON(R) or placebo were abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache, and weight decreased.

Warnings and precautions include fibrosing colonopathy, a rare, serious adverse reaction that has been described in association with high-dose use of pancreatic enzyme replacement therapy in the treatment of cystic fibrosis patients. Caution should be exercised when doses of CREON(R) exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). Care should be taken to ensure that CREON(R) is not chewed or retained in the mouth to avoid irritation of oral mucosa. Caution should be exercised when prescribing CREON(R) to patients with gout, renal impairment, or hyperuricemia. There is theoretical risk of viral transmission with all pancreatic enzyme products, including CREON(R). Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

CREON(R) has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks. As part of the REMS, a Medication Guide with important dosing and safety information applicable to this class of products, including CREON(R), is provided for patients and caregivers, with an emphasis on understanding the risk of fibrosing colonopathy as well as the importance of not over- or under-dosing. The FDA requires that the Medication Guide be handed out with every prescription for the drug dispensed.

For full safety and Prescribing Information about the FDA-approved formulation of CREON(R), visit www.CREON.com.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is th
'/>"/>

SOURCE Solvay Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5
Related medicine news :

1. AUDIO from Medialink and Solvay Pharmaceuticals: New Initiative Urges Women to Address Mens Health this New Year
2. AUDIO from Medialink and Solvay: Men Suffering From Symptoms of Low Testosterone Should Talk to Their Doctor
3. AUDIO from Medialink and Solvay Pharmaceuticals: Men with Type 2 Diabetes at Increased Risk for Low Testosterone Should Talk to Their Doctors
4. Biostar Pharmaceuticals, Inc. Commences the Full Implementation of New Rural Cooperative Supply Network Plan
5. Lotus Pharmaceuticals, Inc. Again Awarded GSP Certification
6. Biostar Pharmaceuticals, Inc. Begins Construction of Raw Material Processing Facility of the Herbal Plantation Base
7. Atlantic Pharmaceuticals, Inc. Announces Completion of Successful Pre-IND Meeting with FDA for Abuse Deterrent Narcotic
8. Lotus Pharmaceuticals, Inc. to Exhibit at the 2009 International Conference for Bioeconomy
9. Haemacure Reports on Strategic Collaboration with Angiotech Pharmaceuticals, Inc. and Second Quarter 2009 Financial Results
10. Keryx Biopharmaceuticals, Inc. Receives Extension for Nasdaq Listing Compliance
11. Metastorm Customer, Wyeth Pharmaceuticals, Wins CIO 100 Award for BPM Project