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Zypitamag Generic Name & Formulations
Legal Class
Rx
General Description
Pitavastatin 2mg, 4mg; tabs.
Pharmacological Class
HMG-CoA reductase inhibitor.
How Supplied
Tabs—30, 90, 100, 500, 1000
Manufacturer
Generic Availability
NO
Zypitamag Indications
Indications
Adjunct to diet to reduce elevated total-C, LDL-C, ApoB, and TG, and to increase HDL-C in primary hyperlipidemia and mixed dyslipidemia.
Limitations of Use
Effect on cardiovascular morbidity and mortality has not been determined.
Zypitamag Dosage and Administration
Adult
Individualize. Initially 2mg once daily; may increase after 4 weeks to max 4mg once daily. Moderate to severe renal impairment (CrCl 15–59mL/min, or ESRD with hemodialysis): initially 1mg once daily; max 2mg once daily. Concomitant erythromycin: max 1mg daily. Concomitant rifampin: max 2mg daily.
Children
Not established.
Zypitamag Contraindications
Contraindications
Active liver disease. Unexplained, persistent elevated serum transaminases. Concomitant cyclosporine. Pregnancy. Nursing mothers.
Zypitamag Boxed Warnings
Not Applicable
Zypitamag Warnings/Precautions
Warnings/Precautions
Increased risk of myopathy and rhabdomyolysis esp. in renal impairment, uncontrolled hypothyroidism, age ≥65yrs, higher dose. Discontinue if markedly elevated CK levels occur or myopathy is confirmed or suspected; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Immune-mediated necrotizing myopathy; monitor. Monitor liver function prior to initiation and as clinically indicated. Discontinue immediately if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. Substantial alcohol ingestion. Advise females of reproductive potential to use effective contraception during treatment.
Zypitamag Pharmacokinetics
See Literature
Zypitamag Interactions
Interactions
See Contraindications. Avoid gemfibrozil. Potentiated by erythromycin, rifampin (see Adults). Increased risk of myopathy with concomitant fibrates, colchicine, niacin (≥1g/day); consider risk/benefit.
Zypitamag Adverse Reactions
Adverse Reactions
Myalgia, back/extremity pain, diarrhea, constipation; myopathy, rhabdomyolysis, increases in CK, liver enzymes, HbA1c and fasting serum glucose; rare: cognitive impairment, fatal/non-fatal hepatic failure.
Zypitamag Clinical Trials
See Literature
Zypitamag Note
Not Applicable
Zypitamag Patient Counseling
See Literature
