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:

	VIOKASE® 8 Tablet	VIOKASE® 16 Tablet	VIOKASE® Powder Each 0.7 g (1/4 Teaspoonful)
Lipase, USP units	8,000	16,000	16,800
Protease, USP units	30,000	60,000	70,000
Amylase, USP units	30,000	60,000	70,000

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

Last updated on RxList: 12/9/2008

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.

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® 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.

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 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 updated on RxList: 12/9/2008

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.

No information provided.

Last updated on RxList: 12/9/2008

No information provided.

General

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

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.

Last updated on RxList: 12/9/2008

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.

Should not be used in patients hypersensitive to pork protein.

Last updated on RxList: 12/9/2008

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 Tablet	VIOKASE® 16 Tablet	VIOKASE® Powder Each 0.7 g (1/4 Teaspoonful)
Dietary fat, grams	28	56	59
Dietary protein, grams	30	60	70
Dietary starch, grams	30	60	70

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.

Last updated on RxList: 12/9/2008

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®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Last updated on RxList: 12/9/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

DIGESTIVE ENZYMES - ORAL

USES: This medication contains digestive enzymes, which are natural substances needed by the body to help break down and digest food. It is used when the pancreas cannot make or does not release enough digestive enzymes into the gut to digest the food. Depending on the amount of enzymes in your product, it may be used for indigestion, as a supplement, or as replacement therapy (e.g., in chronic pancreatitis, cystic fibrosis, cancer of the pancreas, after surgery on the pancreas or gut).

HOW TO USE: Take this medication by mouth with meals and snacks as directed by your doctor.

Dosage is based on your medical condition, diet, and response to therapy.

If you are using the tablet form of the medication, make sure not to keep it in the mouth because doing so can cause irritation to the gums and cheeks. Swallow the medication with water. For the chewable tablets, chew thoroughly before swallowing.

If you are using the capsule form of the medication and swallowing is difficult, the capsule may be opened and the powder mixed with food or liquid.

Be careful not to inhale any of the powder because doing so can irritate the inside of the nose or cause an asthma attack.

Use this medication regularly to get the most benefit from it.

If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication.

Do not change brands or dosage forms of this product without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Diarrhea, abdominal pain/cramps, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe abdominal discomfort, frequent/painful urination, joint pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this digestive enzyme, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: acarbose, miglitol.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this digestive enzyme.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: iron supplements.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this product with others.

MISSED DOSE: If you miss a dose, take the next dose with your next meal or snack as directed. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.