ZYPITAMAG 2 mg/1
Pitavastatin Magnesium · TABLET, FILM COATED · Zydus Lifesciences Limited
Zypitamag is a prescription medication that contains pitavastatin magnesium, a statin used to help lower cholesterol levels in the blood. It works by reducing the production of cholesterol in your body and may help reduce the risk of heart disease.
Key Facts
- Brand Name
- ZYPITAMAG
- Generic Name
- Pitavastatin Magnesium
- NDC Code (Product)
70771-1117- Manufacturer
- Zydus Lifesciences Limited
- Strength
- 2 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA208379
- Drug Class
- HMG-CoA Reductase Inhibitor [EPC]
- Marketing Start
- 03/09/2018
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 ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information. ZYPITAMAG is 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 ( 1 ).
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 ZYPITAMAG 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 ZYPITAMAG, 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. ZYPITAMAG is not available in a 1 mg dose; use an alternative formulation of pitavastatin. Maximum recommended dosage is 2 mg once daily. ( 2.3 ) See full prescribing information for ZYPITAMAG dosage modifications due to drug interactions. ( 2.4 ) 2.1 Important Dosage and Administration Information Take ZYPITAMAG 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 ZYPITAMAG 4 mg daily, prescribe alternative LD…
Contraindications
4 CONTRAINDICATIONS ZYPITAMAG is 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 ZYPITAMAG. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with pitavastatin [see Adverse Reactions ( 6 )] . Cyclosporine ( 4 , 7 ) Active liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to pitavastatin or any excipients in ZYPITAMAG ( 4 )
Drug Interactions
7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of ZYPITAMAG with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 2.4 , 7 ). Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with ZYPITAMAG 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 ZYPITAMAG Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis . Intervention: Concomitant use of cyclosporine with ZYPITAMAG 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. Intervention: Avoid concomitant use of gemfibrozil with ZYPITAMAG. Erythromycin Clinical Impact: Erythromycin significantly increases pitavastatin exposure and increases the risk of myo…
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 Medicure at 1-800-509-0544 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 1 mg to 4 mg daily. The mea…
Frequently Asked Questions
What is ZYPITAMAG used for?
Zypitamag is a prescription medication that contains pitavastatin magnesium, a statin used to help lower cholesterol levels in the blood. It works by reducing the production of cholesterol in your body and may help reduce the risk of heart disease.
Is ZYPITAMAG a controlled substance?
ZYPITAMAG is not classified as a controlled substance by the DEA.
What is the generic name for ZYPITAMAG?
The generic name for ZYPITAMAG is Pitavastatin Magnesium. There are no other listed brand versions of Pitavastatin Magnesium.
What is the NDC code for ZYPITAMAG 2 mg/1?
The NDC (National Drug Code) for ZYPITAMAG 2 mg/1 is 70771-1117, listed by Zydus Lifesciences Limited.
Other ZYPITAMAG Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)