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Rx Item-Viokace 20.9 78.3K Tab 100 By Actavis Pharma

NDC 58914-0117-10 UPC/GTIN No.3-58914-11710-2 Mfg.Part No.11710BRAND: VIOKACE NDC: 58914-0117-10,58914011710 UPC: 3-58914-11710-2,358914117102 Actavis PharmaOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Viokace 20.9 78.3K Tab 100 By Actavis Pharma

$761.84$725.57

Item No.: RX186078 NDC No.58914011710 UPC No.:358914117102 NDC No.58914-0117-10 UPC/GTIN No.3-58914-11710-2 MPN 11710 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx186078 Viokace 20.9/78.3K Tab 100 by Actavis Pharma Item No.3186078 NDC No.58914011710 UPC No.358914117102 Other Name Viokace, LIP

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VIOKACE - pancrelipase lipase, pancrelipase protease and pancrelipase amylase tablet
Aptalis Pharma US, Inc
1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION



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 [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].

2.1 Administration
Since VIOKACE is not enteric-coated, it should be taken in combination with a proton pump inhibitor [see Indications and Usage (1) ].

VIOKACE should be taken during meals or snacks, with sufficient fluid. Tablets should be swallowed whole. Do not crush or chew tablets. Care should be taken to ensure that no drug is retained in the mouth to avoid mucosal irritation.

2.2 Dosage
Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1,2,3 VIOKACE should be administered in a manner consistent with the recommendations of the Conferences provided in the following paragraph. Only the adult dosing guidelines are shown below. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.

Additional recommendations for pancreatic enzyme therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy are based on a clinical trial conducted in these populations.

Enzyme dosing should 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.

Usually, half of the prescribed VIOKACE dose for an individualized full meal should be given with each snack. The total daily dosage should reflect approximately three meals plus two or three snacks per day.

In one clinical trial, patients received VIOKACE at a dose of 125,280 lipase units per meal while consuming 100 g of fat per day [see Clinical Studies (14) ]. Lower starting doses recommended in the literature are consistent with the 500 lipase units/kg of body weight per meal lowest starting dose recommended for adults in the Cystic Fibrosis Foundation Consensus Conferences Guidelines.1,2,3,4 The initial starting dose and increases in the dose per meal should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.

Limitations on Dosing

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.1,2,3 If symptoms and signs of steatorrhea persist, the dosage may be increased by the healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted. 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. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture, indicative of fibrosing colonopathy, in children less than 12 years of age [ see Warnings and Precautions (5.1) ]. Patients currently 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.

3 DOSAGE FORMS AND STRENGTHS

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:

10,440 USP units of lipase; 39,150 USP units of protease; 39,150 USP units of amylase tablets are tan, round, biconvex and have VIO9111 engraved on one side and 9111 on the other side.
20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase tablets are tan, oval, biconvex with V16 engraved on one side and 9116 on the other side.
DESCRIPTION



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; 39,150 USP units of protease; 39,150 USP units of amylase tablets are tan, round biconvex and have VIO9111 engraved on one side and 9111 on the other side.

20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase tablets are tan, oval, biconvex with V16 engraved on one side and 9116 on the other side.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
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.

NDC 58914-0117-10 UPC/GTIN No.3-58914-11710-2 Mfg.Part No.11710
RX ITEM-Viokace 20.9 78.3K Tab 100 By Ac
NDC 58914-0117-10 UPC/GTIN No.3-58914-11710-2 Mfg.Part No.11710

BRAND: VIOKACE NDC: 58914-0117-10,58914011710 UPC: 3-58914-11710-2,358914117102 Actavis Pharma
Viokace 20.9 78.3K Tab 100 By Actavis Ph
BRAND: VIOKACE NDC: 58914-0117-10,58914011710 UPC: 3-58914-11710-2,358914117102 Actavis Pharma

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
LIPASE/PROTEASE/AMYLASE O
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.