Pertzye and Pitavastatin Calcium, Pitavastatin Magnesium

• Generic Name: pancrelipase
• Dosage Forms: capsule, delayed release
• Other Brand Names: Creon, Pancreaze, Pertzye, Ultresa, Viokace, Zenpep, Cotazym, Viokase, Zymase, Pancrease MT 4, Pancrease MT 16, Protilase, Panase, Ku-Zyme HP, Cotazym-S, Creon 10, Creon 20, Ultrase MT 20, Protilase MT-16, Creon 5, Pancrease, Pancrease MT 10, Vio-Moore, Panokase, Ilozyme, Pancrease MT 20, Ultrase, Ultrase MT 12, Pancron D/R, Encron-10, Ultrase MT 18, Arco-Lase, Lipram, Pancrecarb MS-8, Pancrecarb MS-4, Lipram-UL 18, Lipram-CR20, Lipram-UL 12, Lipram-UL 20, Viokase 16, Pancreatil-UL 12, Pangestyme CN 10, Pangestyme CN 20, Pangestyme MT 16, Pangestyme UL 18, Pangestyme EC, Kutrase, Ku-Zyme, Lipram-CR, Plaretase, Viokase 8, Lipram-CR5, Lapase, Dygase, Pancrecarb MS-16, Pangestyme UL 20, Panocaps, Panocaps MT 16, Lipram-CR10, Palcaps 10, Lipram-PN10, Lipram-PN16, Lipram-PN20, Panokase 16

Pertzye is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.

Pertzye capsules contain a mixture of digestive enzymes including lipases, proteases and amylases from pig pancreas.

Pertzye is safe and effective in children when taken as prescribed by your doctor.

• Generic Name: pitavastatin
• Dosage Forms: n.a.
• Other Brand Names: Livalo, Zypitamag

Available as pitavastatin calcium (e.g., Livalo) and pitavastatin magnesium (i.e., Zypitamag). FDA considers pitavastatin magnesium tablets to be a pharmaceutical alternative (as described in section 505[b][2] of the Federal Food, Drug, and Cosmetic Act) and not a pharmaceutical (generic) equivalent to pitavastatin calcium tablets, since both contain the same active moiety (pitavastatin) but have different salts. Clinical efficacy and safety expected to be similar between the 2 salt forms of the drug.

Dyslipidemias

Adjunct to nondrug therapies (e.g., dietary management) to decrease elevated serum total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations, and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia or mixed dyslipidemia. Also used in combination with fenofibrate to decrease triglyceride concentrations and increase HDL-cholesterol concentrations in patients with mixed dyslipidemia and CHD (or CHD risk equivalents) who are on optimal statin therapy; however, no incremental benefit on cardiovascular morbidity and mortality beyond that provided by statin monotherapy.

Reductions in LDL-cholesterol concentrations achieved with usual dosages (1–4 mg daily) of pitavastatin are similar to or greater than those achieved with low to medium dosages of certain other statins (i.e., atorvastatin, pravastatin, simvastatin).

Safety and efficacy not established in patients with Fredrickson type I, III, or V dyslipidemia. Effect on cardiovascular morbidity and mortality not established.

Prevention of Cardiovascular Events

ACC/AHA cholesterol management guideline recommends statins as first-line therapy for prevention of atherosclerotic cardiovascular disease (ASCVD) in adults; extensive evidence demonstrates that statins can substantially reduce ASCVD risk when used for secondary prevention or primary prevention (in high-risk patients). Relative reduction in ASCVD risk is correlated with degree of LDL-cholesterol lowering; therefore, use maximum tolerated statin intensity to achieve optimum ASCVD benefits. According to ACC/AHA, pitavastatin may be used for primary or secondary prevention in adults when moderate-intensity statin therapy is indicated.