pitavastatin calcium 2 mg/1
pitavastatin calcium · TABLET, FILM COATED · XLCare Pharmaceuticals Inc.
Pitavastatin calcium is a prescription tablet taken by mouth to help lower cholesterol levels in the blood. It belongs to a class of medications commonly used to reduce the risk of heart disease and stroke.
Key Facts
- Brand Name
- pitavastatin calcium
- Generic Name
- pitavastatin calcium
- NDC Code (Product)
72865-292- Manufacturer
- XLCare Pharmaceuticals Inc.
- Strength
- 2 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205977
- Marketing Start
- 09/18/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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: ( 1 ) • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Take orally once daily with or without food at the same time each day. ( 2.1 ) • 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. ( 2.1 ) • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of pitavastatin tablets, and adjust the dosage if necessary. ( 2.1 ) • Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended dosage is 4 mg once daily. ( 2.2 ) • Recommended starting dosage for patients with moderate and severe renal impairment and end-stage renal disease on hemodialysis is 1 mg once daily. Maximum recommended dosage is 2 mg once daily. ( 2.3 ) • See full prescribing information for pitavastatin tablets dosage modifications due to drug interactions. ( 2.4 ) 2.1 Important Dosage and Administration Information • Take pitavastatin tablets orally once daily with or without food at the same time each day. • For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pitavastatin tablets 4 mg daily, prescribe alternative LDL-C-lowering treatmen…
Contraindications
4 CONTRAINDICATIONS Pitavastatin tablets are contraindicated in the following conditions: • Concomitant use of cyclosporine [see Drug Interactions (7) ] . • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . • Hypersensitivity to pitavastatin or any excipients in pitavastatin tablets. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with pitavastatin tablets [see Adverse Reactions (6) ] . • Cyclosporine ( 4 , 7 ) • Active liver failure or decompensated cirrhosis ( 4 , 5.3 ) • Hypersensitivity to pitavastatin or any excipients in pitavastatin tablets ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 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 [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] . 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 pitavastatin tablets is contraindicated [see Contraindications (4) ] . Gemfibrozil Clinical Impact: Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including pitavastatin tablets. Intervention: Avoid concomitant use of gemfibrozil with pitavastatin tablets. Erythromycin Clinical Impact: Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking erythromycin, do not exceed pitavastatin tablets 1 mg once da…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in other sections of the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] The most frequent adverse reactions (rate ≥ 2%) were myalgia, constipation, diarrhea, back pain, and pain in extremity. ( 6 ) 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 Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of one drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Primary Hyperlipidemia In 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 adult patients with primary hyperlipidemia were administered pitavastatin tablets 1 m…
Frequently Asked Questions
What is pitavastatin calcium used for?
Pitavastatin calcium is a prescription tablet taken by mouth to help lower cholesterol levels in the blood. It belongs to a class of medications commonly used to reduce the risk of heart disease and stroke.
Is pitavastatin calcium a controlled substance?
pitavastatin calcium is not classified as a controlled substance by the DEA.
What is the generic name for pitavastatin calcium?
The generic name for pitavastatin calcium is pitavastatin calcium. There are 6 other brand versions of pitavastatin calcium.
What is the NDC code for pitavastatin calcium 2 mg/1?
The NDC (National Drug Code) for pitavastatin calcium 2 mg/1 is 72865-292, listed by XLCare Pharmaceuticals Inc..