"The U.S. Food and Drug Administration today expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one.
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DOSAGE AND ADMINISTRATION
One capsule every 12 hours. In difficult cases administration may be increased to one capsule every 8 hours or two capsules every 12 hours.
Papaverine Hydrochloride Sustained Release Capsules are supplied as: 150 mg brown and clear capsules, imprinted E 5156 and are available in bottles of 100, 500 and 1000.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured for: Sandoz Inc. Princeton, NJ 08540. Manufactured by: Epic Pharma, LLC. Laurelton, NY 11413. Rev. 11/08.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/31/2009
Additional Papaverine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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