MedCallyLooking up the FDA label…
Looking up the FDA label…
Also sold as Pitavastatin Calcium, Livalo
Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
Myopathy and Rhabdomyolysis: Advise patients that pitavastatin tablets may cause myopathy and rhabdomyolysis. Inform patients that the risk is increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever. Hepatic Dysfunction: Inform patients that pitavastatin tablets may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. Increases in HbA1c and Fasting Serum Glucose Levels: Inform patients that increases in HbA1c and fasting serum glucose levels may occur with pitavastatin tablets. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices. Pregnancy: Advise pregnant patients and patients who become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if pitavastatin tablets should be discontinued. Lactation: Advise patients that breastfeeding is not recommended during treatment with pitavastatin tablets. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad—500 096, India 75105849 Revised: 8/2024 MX:PITA:R5
The following serious adverse reactions are discussed in other sections of the labeling: • Myopathy and Rhabdomyolysis • Immune-Mediated Necrotizing Myopathy • Hepatic Dysfunction • Increases in HbA1c and Fasting Serum Glucose Levels The most frequent adverse reactions (rate ≥ 2%) were myalgia, constipation, diarrhea, back pain, and pain in extremity. To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experi…
Having one of these?
A doctor will tell you whether it matters and what to do about it. Written answer, a week of free follow-ups.
Ask a doctor — $19.99Pitavastatin tablets are contraindicated in the following conditions: • Concomitant use of cyclosporine. • Acute liver failure or decompensated cirrhosis. • Hypersensitivity to pitavastatin or any excipients in pitavastatin tablets. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with pitavastatin tablets. • Cyclosporine • Active liver failure or decompensated cirrhosis • Hypersensitivity to pitavastatin or any excipients in pitavastatin tablets
2 DOSAGE AND ADMINISTRATION • Take orally once daily with or without food at the same time each day. • For patients requiring a high-intensity statin or are unable to achieve their LDL-C goal receiving pitavastatin tablets 4 mg daily, prescribe alternative LDL-C-lowering treatment. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of pitavastatin tablets, and adjust the dosage if necessary. • Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended dosage is 4 mg once daily.…
Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with pitavastatin tablets and instructions for preventing or managing drug interactions. Table 2. Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Pitavastatin Tablets Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: Concomitant use of cyclosporine with pitavastat…
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationSame medicine, sold as
Works in a similar way — hmg coa reductase inhibitors
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.