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Viokase

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Viokase

INDICATIONS

VIOKASE® (pancrelipase, USP) is indicated in the treatment of exocrine pancreatic insufficiency as associated with but not limited to cystic fibrosis, chronic pancreatitis, pancreatectomy, or obstruction of the pancreas ducts.

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.

HOW SUPPLIED

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.

References:

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.

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