"The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
Fecal incontinence is the inability to control bowel movements and is a common problem, espec"...
DOSAGE AND ADMINISTRATION
Powder: Dosage for patients with cystic fibrosis: 1/4 teaspoonful (0.7 g) with meals. Tablets: Dosage range for patients with c®ystic fibrosis or chronic pancreatitis is from 8,000 to 32,000 Lipase USP Units taken with meals, i.e., one to four VIOKASE 8 tablets or one to two VIOKASE® (pancrelipase tablets, powder) 16 tablets with meals or as directed by a physician.
In patients with pancreatectomy or obstruction of pancreatic ducts: one to two VIOKASE® (pancrelipase tablets, powder) 8 tablets or one VIOKASE® (pancrelipase tablets, powder) 16 tablet taken at 2-hour intervals or as directed by a physician.
VIOKASE® (pancrelipase tablets, powder) 8 Tablets: Tan, round, compressed tablets engraved VIOKASE (pancrelipase tablets, powder) on one side and 9111 on the other side in bottles of 100 (NDC 58914-111-10) and 500 (NDC 58914-111-50).
VIOKASE® (pancrelipase tablets, powder) 16 Tablets: Tan, oval, biconvex tablets engraved V16 on one side and 9116 on the other side in bottles of 100 (NDC 58914-116-10).
Powder: Tan powder in bottles of 8 oz (227 g) (NDC 58914-115-08).
Store in tightly closed container in a dry place at a temperature not exceeding 25°C (77°F).
Dispense tablets and powder in tight container, preferably with a desiccant.
For product information please call 1-800-742-6706.
1. Regan PT, Malagelada J-R, DiMagno EP, Gianzman SL, Go VLW. Comparative effects of antacids, cimetidine and enteric coating on the therapeutic response to oral enzymes in severe pancreatic insufficiency. N Engl J Med 1977;297:854-8.
2. Graham DY. Enzyme replacement therapy of exocrine pancreatic insufficiency in man. N Eng J Med 1977;296:1314-7.
REV. June 2008. Manufactured in Canada for: AXCAN PHARMA US, INC., 22 Inverness Center Parkway Birmingham, AL 35242 USA. www.axcan.com. FDA rev date: n/a
Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Viokase 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.
Get the latest treatment options.