Pitavastatin

Pitavastatin is a prescription medication used to treat high cholesterol in adults. Lowering your cholesterol may help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

• Pitavastatin is available under various brand names: Livalo, Zypitamag

Common side effects of Pitavastatin include:

• muscle pain,
• pain in the arms or legs,
• back pain; or
• diarrhea, constipation.

Serious side effects of Pitavastatin include:

• hives,
• difficult breathing,
• swelling of the face, lips, tongue, or throat,
• confusion, and memory problems,
• kidney problems--vomiting, pain in your side or lower back, little or no urination, swelling, rapid weight gain; or
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Rare side effects of Pitavastatin include:

• unexplained muscle pain,
• tenderness, 
• weakness
• fever, 
• unusual tiredness, and 
• dark-colored urine.

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, Lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 1 mg
• 2 mg
• 4 mg

Primary Hyperlipidemia and Mixed Dyslipidemia Adjunct to Diet

Adult dosage

• Moderate-intensity therapy: 
  • Oral: 1 to 4 mg once daily
  • Heterozygous Familial Hypercholesterolemia

Pediatric dosage

Children below 8 years: Safety and efficacy not established

• Children above 8 years and Adolescents: 
• Recommended starting dose: 2 mg orally every day
  • May increase to 4 mg orally every day if necessary

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pitavastatin has severe interactions with the following drugs:
  • atazanavir
  • cyclosporine
  • gemfibrozil
  • Retrovirir
  • lopinavir
  • red yeast rice
• Pitavastatin has serious interactions with the following drugs:
  • colchicine
  • darolutamide
  • eltrombopag
  • erythromycin base
  • erythromycin ethylsuccinate
  • erythromycin lactobionate
  • erythromycin stearate
  • fenofibrate
  • fenofibrate micronized
  • fenofibric acid
  • gemfibrozil
  • Lasmiditan
  • niacin
  • itraconazole
  • rifampin
• Pitavastatin has moderate interactions with at least 46 other drugs.
• Pitavastatin has minor interactions with the following drugs:
  • coenzyme Q10
  • colestipol
  • isradipine
  • orlistat
  • trazodone
  • voclosporin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to pitavastatin
• liver disease (including abnormal liver enzyme tests).
• if you are pregnant or breastfeeding; or
• if you are taking cyclosporine.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pitavastatin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pitavastatin?”

Cautions

• You should not take pitavastatin if you have liver disease (including abnormal liver enzyme tests), or if you also take cyclosporine.
• Do not take pitavastatin if you are pregnant or breastfeeding.
• Pitavastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have a fever, unusual tiredness, or dark urine.
• Pitavastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
• Do not give this medicine to a child without medical advice.
• Avoid eating foods high in fat or cholesterol, or pitavastatin will not be as effective.
• Drinking alcohol can raise triglyceride levels and may increase your risk of liver damage.

Pregnancy and Lactation

• Do not use pitavastatin if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor right away if you become pregnant.
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment
• FDA MedWatch
  • On July 20, 2021, the FDA request to remove the contraindication against HMG-CoA reductase inhibitors in pregnant females
  • Despite the changes, most females found to be pregnant should stop therapy
• Lactation
  • Do not breastfeed while you are taking pitavastatin.
• FDA MedWatch
  • On July 20, 2021, the FDA request to remove the contraindication against HMG-CoA reductase inhibitors in pregnant females
  • Breastfeeding is still not recommended if taking statins; drug may still pass through milk and pose a risk breastfed children
  • For patients with lower risk, temporarily stop statin therapy until breastfeeding ends
  • Patients who are at high risk of heart attack or stroke who require statins after delivery should not breastfeed and should use alternatives such as infant formula