Viokase Powder, Viokase Tablets (Axcan Scandipharm)

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DESCRIPTION

VIOKASE® (pancrelipase, USP) is a pancreatic enzyme concentrate of porcine origin containing standardized lipase, protease, and amylase as well as other pancreatic enzymes. VIOKASE® is available in tablet and powder dosage form for oral administration.

The enzyme potencies of the tablets and powder are:

Inactive Ingredients:    VIOKASE® 8 and VIOKASE® 16 Tablets: Lactose, croscarmellose sodium, microcrystalline cellulose, silicon dioxide, stearic acid, talc.

VIOKASE® Powder:   Lactose, sodium chloride.

CLINICAL PHARMACOLOGY

The natural digestive enzymes in VIOKASE® hydrolyze fats into fatty acids and glycerol, split protein into amino acids, and convert carbohydrates to dextrins and short chain sugars.

Under conditions of the USP test method (in vitro) VIOKASE® has the following total digestive capacity:

VIOKASE® 8 Tablets are 468 mg immediate release tablets and are not enteric-coated.

VIOKASE® 16 Tablets are 935 mg immediate release tablets and are not enteric-coated.

The digestive capacity of a pancreatic enzyme concentrate depends on the amount that passes through the stomach unchanged and is available at the site of action in the small intestine.

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.

CONTRAINDICATIONS

Should not be used in patients hypersensitive to pork protein.

PRECAUTIONS

General:    Individuals previously sensitized to trypsin, pancreatin or pancrelipase may have allergic manifestations.

Information for Patients:    VIOKASE® should not be held in the mouth as the proteolytic action may cause irritation of the mucosa.

Avoid inhalation of the powder when administering VIOKASE®.

Carcinogenesis, Mutagenesis:    Long-term studies in animals have not been performed to evaluate the carcinogenic potential.

Pregnancy Category C:    Animal reproduction studies have not been conducted with VIOKASE®. It is also not known whether VIOKASE® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VIOKASE® should be given to a pregnant woman only if clearly needed.

Nursing Mothers:    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pancrelipase is administered to a nursing mother.

ADVERSE EFFECTS

The dust or finely powdered pancreatic enzyme concentrate is irritating to the nasal mucosa and the respiratory tract. It has been documented that inhalation of the airborne powder can precipitate an asthma attack. The literature also contains several references to asthma due to inhalation in patients sensitized to pancreatic enzyme concentrates. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricemia and hyperuricosuria. Overdosage of pancreatic enzyme concentrate may cause diarrhea or transient intestinal upset.

OVERDOSE

Acute toxicity determinations in animals have not been possible since the maximum dose that could be given orally produced no toxic reaction. In chronic feeding tests rats developed swollen salivary glands. This is believed due to the proteolytic activity and the mucosal irritation caused by tissue digestion.

No acute toxic reactions have been reported.

DOSAGE AND ADMINISTRATION

Powder: Dosage for patients with cystic fibrosis: 1/4 teaspoonful (0.7g) with meals.

Tablets: Dosage range for patients with cystic 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® 16 tablets with meals or as directed by a physician.

In patients with pancreatectomy or obstruction of pancreatic ducts: one to two VIOKASE® 8 tablets or one VIOKASE® 16 tablet taken at 2-hour intervals or as directed by a physician.

HOW SUPPLIED

VIOKASE® 8 Tablets: Tan, round, compressed tablets engraved VIOKASE® on one side and 9111 on the other side in bottles of 100 (NDC 58914-111-10) and 500 (NDC 58914-111-50).

VIOKASE® 16 Tablets: Tan, oval, biconvex tablets engraved V ¹⁶ on one side and 9116 on the other side in bottles of 100 (NDC 58914-116-10) and 500 (NDC 58914-116-50).

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.

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.

VIOKASE® is a registered trademark of Axcan Scandi-pharm Inc. VIOKASE®, Axcan Pharma™ and the Axcan Pharma™ logo are registered trademarks or trademarks used under license by Axcan Scandipharm Inc.

Rev. June 2005

Manufactured in Canada for:

Axcan Scandipharm Inc.

Birmingham, AL 35242 USA

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