VIOKACE- pancrelipase tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O), PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50), PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E)

Available from:

Allergan, Inc.

INN (International Name):

PANCRELIPASE LIPASE

Composition:

PANCRELIPASE LIPASE 10440 [USP'U]

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

      VIOKACE  tablets, in combination with a proton pump inhibitor,  is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.       None.       Risk Summary  Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase.       The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.       Ri

Product summary:

VIOKACE   t ablets       10,440 USP units of lipase; 39,150 USP units of protease; 39,150 USP units of amylase       Each VIOKACE tablet is available as a tan, round, biconvex tablet with VIO9111 engraved on one side and 9111 on the other side supplied in bottles of 100 tablets (NDC 58914-112-10). VIOKACE   t ablets       20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase       Each VIOKACE tablet is available as a tan, oval, biconvex tablet with V1 6  engraved on one side and 9116 on the other side supplied in bottles of 100 tablets (NDC 58914-117-10). Storage a n d Handling       Avoid heat. VIOKACE tablets should be stored in a dry place in the original container. Store at room temperature (20-25°C, 68-77°F), brief excursion permitted up to 40°C (104°F) for up to 24 hrs. After opening, keep the container tightly closed  between uses to protect from moisture .       VIOKACE is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten. The desiccant packet will protect the product from moisture.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

VIOKACE- PANCRELIPASE TABLET
Allergan, Inc.
----------
MEDICATION GUIDE
VIOKACE ® (vye-oh-kase)
(pancrelipase)
tablets
Read this Medication Guide before you start taking VIOKACE and each
time you get a refill. There may
be new information. This information does not take the place of
talking with your doctor about your
medical condition or treatment.
What is the most important information I should know about VIOKACE?
VIOKACE may increase your chance of having a rare bowel disorder
called fibrosing
colonopathy. This condition is serious and may require surgery. The
risk of having this
condition may be reduced by following the dosing instructions that
your doctor gave you.
Call your doctor right away if you have any unusual or severe:
•
stomach area (abdominal) pain
•
bloating
•
trouble passing stool (having bowel movements)
•
nausea, vomiting, or diarrhea
Take VIOKACE exactly as prescribed by your doctor. Do not take more or
less VIOKACE than
directed by your doctor.
What is VIOKACE?
•
VIOKACE is a prescription medicine used with a proton pump inhibitor
medicine (PPI) to
treat adults who cannot digest food normally. Adults with swelling of
the pancreas that lasts a
long time (chronic pancreatitis), or who have had some or all of their
pancreas
removed (pancreatectomy) may not digest food normally because they do
not make
enough enzymes or because their enzymes are not released into the
bowel (intestine).
•
VIOKACE contains a mixture of digestive enzymes (including lipases,
proteases, and
amylases) from pig pancreas.
•
It is not known if VIOKACE is safe and effective in children. Use of
VIOKACE in
children may result in poor nutrition and slowing of growth.
What should I tell my doctor before taking VIOKACE?
Before taking VIOKACE, tell your doctor about all your medical
conditions, including if you:
•
are allergic to pork (pig) products
•
have a history of blockage of your intestines, or scarring or
thickening of your bowel wall
(fibrosing colonopathy)
•
have gout, kidney disease, or a condition

Summary of Product characteristics

VIOKACE- PANCRELIPASE TABLET
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIOKACE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIOKACE
VIOKACE® (PANCRELIPASE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
VIOKACE® is a combination of porcine-derived lipases, proteases, and
amylases. VIOKACE, in combination with a proton
pump inhibitor, is indicated in adults for the treatment of exocrine
pancreatic insufficiency due to chronic pancreatitis or
pancreatectomy. (1)
DOSAGE AND ADMINISTRATION
VIOKACE is not interchangeable with any other pancrelipase product.
VIOKACE tablets should be swallowed whole. Do
not crush or chew tablets. (2.1) Dosing should not exceed the
recommended maximum dosage set forth by the Cystic
Fibrosis Foundation Consensus Conferences Guidelines. (2.2)
Begin with 500 lipase units/kg of body weight per meal to a maximum of
2,500 lipase units/kg of body weight per meal
(or less than or equal to 10,000 lipase units/kg of body weight per
day), or less than 4,000 lipase units/g fat ingested per
day. (2.2)
Individualize dosage based on clinical symptoms, the degree of
steatorrhea present and the fat content of the diet. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 10,440 USP units of lipase; 39,150 USP units of protease;
39,150 USP units of amylase (3)
Tablets: 20,880 USP units of lipase; 78,300 USP units of protease;
78,300 USP units of amylase (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Fibrosing colonopathy is associated with high-dose use of pancreatic
enzyme replacement. Exercise caution when
doses of VIOKACE exceed 2,500 lipase units/kg of body weight per meal
(or greater than 10,000 lipase units/kg of
body weight per day). (5.1)
To avoid irritation of oral mucosa, do not chew VIOKACE or retain in
the mouth. (5.2)
Exercise caution when prescribing VIOKACE to patients with gout, renal
impairment, or hyperuricemia. (5.3)
There is theoretical risk of viral transm