INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo VIOKASE® TABLETS
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

VIOKASE® TABLETS

COMPOSITION:
Each tablet contains:
Lipase         6 500 N.F.
Protease         32 000 N.F.
Amylase         48 000 N.F.
Each tablet digests (in vitro):
Fat         23 g
Protein         32 g
Starch         48 g

PHARMACOLOGICAL CLASSIFICATION:
A 31 Enzymatic Preparations.

PHARMACOLOGICAL ACTION:
Each tablet contains sufficient pancreatic enzymes to digest, in vitro, 32 grams of dietary protein, 48 grams of dietary starch, and 23 grams of dietary fat. Viokase is used as a digestive aid and in the treatment of pancreatic insufficiency. Viokase contains less than 1% of fat and is not enteric coated.

INDICATIONS:
Pancreatic insufficiency associated with Cystic Fibrosis, pancreatitis, post-gastrectomy, post-cholecystectomy, post-pancreatectomy. Viokase is helpful in functional dyspepsias.

CONTRA-INDICATIONS:
None.

DOSAGE AND DIRECTIONS FOR USE:
Patients with cystic fibrosis or chronic pancreatitis:
1 to 3 tablets with meals.
For aiding digestion in patients with pancreatectomy or gastrectomy:
1 to 2 tablets taken at 2 hour intervals, or as directed by a physician.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
None. Use with caution in patients known to be allergic to pork protein.

IDENTIFICATION:
Viokase is a white to cream biconvex uncoated tablet, mottled with brown spots. It is embossed with "CE" on the one side.

PRESENTATION;
Bottles of 100 and 500 tablets.

STORAGE INSTRUCTIONS;
Store below 25°C in well-closed container.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
H2870 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19.1.1978.

                D028
A & S PRINTERS

Updated on this site November 1999
Current: March 2005
Source: Hospital Pharmacy

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