Viokace(pancrelipase)tablets
Viokace (pancrelipase) 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. The pancreatic enzymes in Viokace act like digestive enzymes physiologically secreted by the pancreas.
Viokace is speicifcally approved in combination with a proton pump inhibitor for adults with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.
Viokace is supplied as a tablet for oral administration. Since Viokace is not enteric-coated, it should be taken in combination with a proton pump inhibitor. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of Viokace should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
Viokace
Manufacturer:
Aptalis Pharmaceutical Technologies

Pharmacological Class:
Pancreatic enzymes (porcine).

Active Ingredient(s):
Lipase 10440 units, protease 39150 units, amylase 39150 units; tabs.

Also:
VIOKACE 20880
Lipase 20880 units, protease 78300 units, amylase 78300 units; tabs.
Indication(s):
Treatment of exocrine pancreatic insufficiency in adults due to chronic pancreatitis or pancreatectomy, in combination with a proton pump inhibitor.

Pharmacology:
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. The pancreatic enzymes in Viokace catalyze the hydrolysis of fats to monoglycerides, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Clinical Trials:
The short-term safety and efficacy of Viokace were eva luated in a randomized, double-blind, placebo-controlled, parallel group study comparing Viokace Tablets (20880 USP units of lipase per tablet) to placebo in 50 patients, ages 24 to 70, with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. Eighteen patients had a history of pancreatectomy (11 were treated with Viokace). All patients were maintained on a controlled high fat diet of 100 grams of fat per day. After a wash-out period (6 to 7 days), patients were randomized to a fixed dose of Viokace (22 tablets per day; 6 tablets per meal and 2 tablets with 2 of 3 snacks) or placebo, in combination with a proton pump inhibitor. Forty-nine patients completed the double-blind treatment period (6 to 7 days); 29 patients received Viokace, and 20 patients received placebo.

The coefficient of fat absorption (CFA) was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.

The wash-out period mean CFA was 48% in the Viokace treatment group and was 57% in the placebo group. At the end of the double-blind treatment period, the mean CFA was 86% with Viokace treatment compared to 58% with placebo. The mean difference in CFA at the end of the double-blind treatment period was 28 percentage points in favor of Viokace treatment with 95% Confidence Interval of (21, 37) and P ≤0.0001.

Legal Classification:
Rx

Adults:
See literature. Start at the lowest recommended dose and increase gradually. Individualize based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Swallow whole; do not crush or chew tabs. Do not allow drug to remain in mouth. Initially 500 lipase units/kg per meal. Max: 2500 lipase units/kg per meal (or ≤10000 lipase units/kg per day), or <4000 lipase units/g fat ingested per day.

Children:
Not established.

Warnings/Precautions:
Not interchangeable with any other pancrelipase products. Fibrosing colonopathy (with high doses); risk of stricture formation (monitor). Pork allergy. Potential viral transmission. Gout. Renal impairment. Hyperuricemia. Contents irritating to mucosa. Lactose intolerance. Pregnancy (Cat.C). Nursing mothers.

Adverse Reaction(s):
Biliary tract stones, anal pruritus; fibrosing colonopathy, hyperuricemia, allergic reactions.

How Supplied:
Tabs—100

Last Updated:
7/18/2012