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Viokase

Last reviewed on RxList: 12/9/2008
Drug Description

VIOKASE®
(pancrelipase, USP) Tablets, Powder

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® (pancrelipase tablets, powder) 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® (pancrelipase tablets, powder) 8 and VIOKASE® (pancrelipase tablets, powder) 16 Tablets: Lactose, croscarmellose sodium, microcrystalline cellulose, silicon dioxide, stearic acid, talc. VIOKASE® (pancrelipase tablets, powder) Powder: Lactose, sodium chloride.

For Consumers

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
  • weight...
Indications & Dosage

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.

DOSAGE AND ADMINISTRATION

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® (pancrelipase tablets, powder) 16 tablets with meals or as directed by a physician.

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

HOW SUPPLIED

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

VIOKASE® (pancrelipase tablets, powder) 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

Side Effects & Drug Interactions

SIDE 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.

DRUG INTERACTIONS

No information provided.

FDA Logo

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.

Warnings & Precautions

WARNINGS

No information provided.

PRECAUTIONS

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® (pancrelipase tablets, powder) . It is also not known whether VIOKASE® (pancrelipase tablets, powder) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VIOKASE® (pancrelipase tablets, powder) 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.

Overdosage & Contraindications

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.

CONTRAINDICATIONS

Should not be used in patients hypersensitive to pork protein.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

The natural digestive enzymes in VIOKASE® (pancrelipase tablets, powder) 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® (pancrelipase tablets, powder) 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® (pancrelipase tablets, powder) 8 Tablets are 468 mg immediate release tablets and are not enteric-coated. VIOKASE® (pancrelipase tablets, powder) 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.

Medication Guide

PATIENT INFORMATION

VIOKASE® (pancrelipase tablets, powder) 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® (pancrelipase tablets, powder) .

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

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