Viokase (Pancrelipase)

VIOKASE®

Axcan Pharma

Pancrelipase

Oral Enzyme Therapy

Action And Clinical Pharmacology: The natural digestive enzymes in Viokase hydrolyse 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

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 And Clinical Uses: As a digestive aid 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.

Contra-Indications: Should not be used in patients hypersensitive to pork protein.

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

Pancrelipase should not be held in the mouth as the proteolytic action may cause irritation of the mucosa.

Avoid inhalation of the powder when administering pancrelipase.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of pancrelipase. The effect on human fertility is not known.

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

Lactation: 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 Reactions: The dust or finely powdered 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.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: 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.

Overdosage of pancreatic enzyme concentrate may cause diarrhea or transient intestinal upset.

No acute toxic reaction have been reported.

Dosage And Administration: Powder: Dosage for patients with cystic fibrosis: 1/4 teaspoonful (0.7 g) with meals or as directed by a physician.

Tablets: Dosage for patients with cystic fibrosis or chronic pancreatitis: 1 to 3 tablets with meals or as directed by a physician.

As a digestive aid in patients with pancreatectomy or obstruction of pancreatic ducts: 1 to 2 tablets taken at 2-hour intervals or as directed by a physician.

Availability And Storage: Powder: Tan-colored, each 0.7 g contains: lipase 16 800 USP units, protease 70 000 USP units, amylase 70 000 USP units and digests in vitro 59 g of fat, 70 g of protein and 70 g of starch. Also contains lactose. Energy: 5.4 kJ (1.3 kcal)/g. Bottles of 114 g.

Tablets: Each tan-colored, round, compressed tablet contains: lipase 8 000 USP units, protease 30 000 USP units, amylase 30 000 USP units and digests in vitro 28 g of fat, 30 g of protein and 30 g of starch. Also contains lactose. Energy:
Store at controlled room temperature (15 to 30°C). Protect from heat and moisture. Dispense tablets and powder in a tight container, preferably with a desiccant.

VIOKASE® Axcan Pharma Pancrelipase Oral Enzyme Therapy

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