"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"...
(pancrelipase) tablets, for oral use
VIOKACE is a pancreatic enzyme preparation for oral administration consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, amylases, and proteases.
Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble in alcohol.
The active ingredient evaluated in clinical trials is lipase. VIOKACE is dosed by lipase units.
Inactive ingredients in VIOKACE include: colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc.
10,440 USP units of lipase; 39,150 USP units of protease; 39,150 USP units of amylase tablets are tan, round biconvex and have VIO9111 engraved on one side and 9111 on the other side.
20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase tablets are tan, oval, biconvex with V16 engraved on one side and 9116 on the other side.
What are the possible side effects of pancrelipase?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.
Less serious side effects may include:
- nausea or vomiting;
- mild stomach pain or upset;
- diarrhea or constipation;
- bloating or gas;
- greasy stools;
- rectal irritation;
- headache, dizziness;
- cough; or
Last reviewed on RxList: 3/12/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Viokace 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.