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Viokace

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Overview

What is Viokace?

VIOKACE is a pancreatic enzyme preparation for oral administration consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, amylases, and proteases.

Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble in alcohol.

The active ingredient evaluated in clinical trials is lipase. VIOKACE is dosed by lipase units.

Other active ingredients include protease and amylase.

Inactive ingredients in VIOKACE include: colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc.

10,440 USP units of lipase

20,880 USP units of lipase



What does Viokace look like?



What are the available doses of Viokace?

The active ingredient in VIOKACE evaluated in clinical trials is lipase. VIOKACE is dosed in lipase units.

Other active ingredients include protease and amylase. Each VIOKACE tablet strength contains the specified amounts of lipase, protease, and amylase as follows:

What should I talk to my health care provider before I take Viokace?

How should I use Viokace?

VIOKACE (pancrelipase) 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.

VIOKACE is not interchangeable with any other pancrelipase product.

VIOKACE is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of VIOKACE should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet as described in the Limitations on Dosing below [].


What interacts with Viokace?

Sorry No Records found


What are the warnings of Viokace?

Sorry No Records found


What are the precautions of Viokace?

Sorry No Records found


What are the side effects of Viokace?

Sorry No records found


What should I look out for while using Viokace?

None.


What might happen if I take too much Viokace?

There have been no reports of overdose in clinical trials or post-marketing surveillance with VIOKACE. Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures . High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment .


How should I store and handle Viokace?

Storage and 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. between uses to . VIOKACE is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten. The desiccant packet will protect the product from moisture. Storage and 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. between uses to . VIOKACE is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten. The desiccant packet will protect the product from moisture. Storage and 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. between uses to . VIOKACE is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten. The desiccant packet will protect the product from moisture. Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08Metaproterenol sulfate tablets are supplied as follows: 10 mg: white, compressed, round, scored tablets, debossed "PAR 258" available in bottles of 100 (NDC #49884-258-01). 20 mg: white, compressed, round, scored tablets, debossed "PAR 259" available in bottles of 100 (NDC #49884-259-01). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, New York 10977Revised: 04/2016OS258-01-1-08


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The pancreatic enzymes in VIOKACE catalyze the hydrolysis of fats to monoglycerides, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Non-Clinical Toxicology
None.

Beta adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta adrenergic agonists on the vascular system may be potentiated.

Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture in children less than 12 years of age. Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day

Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Patients receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions [].

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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