Medication info

Pivaro Tablet (Pitavastatin Calcium)

Prescription medicationApproval withdrawn
Ingredient · strength
Pitavastatin Calcium›Strength being verified
Manufacturer / importer
이연제약(주)
Appearance
Very light yellowish-red round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201902357 · Approved 2019.04.17

This product's status changed to Approval withdrawn on 2023.05.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
For adults, the usual initial dose of pitavastatin calcium is 1 to 2 milligrams once daily. If the LDL cholesterol-lowering effect is insufficient, the dose may be increased up to a maximum of 4 milligrams per day. Dosage should be adjusted appropriately at intervals of 4 weeks or more according to LDL cholesterol levels, treatment goals, and patient response.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo-B protein
  • triglyceride levels
View approved original text

This medication aids in lowering total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels by supplementing the dietary therapy of patients with primary hypercholesterolemia and mixed dyslipidemia. It also increases HDL cholesterol levels, improving the balance of blood lipids. This helps reduce the risk of cardiovascular diseases and maintain healthier blood conditions. When used alongside dietary management, it is effective in managing dyslipidemia. This medication is used to improve blood lipid levels.

Dosage and Administration

Adult dosage

For adults, the usual initial dose of pitavastatin calcium is 1 to 2 milligrams once daily. If the LDL cholesterol-lowering effect is insufficient, the dose may be increased up to a maximum of 4 milligrams per day. Dosage should be adjusted appropriately at intervals of 4 weeks or more according to LDL cholesterol levels, treatment goals, and patient response.

Precautions

This medication should not be used by individuals who are allergic to specific ingredients. Patients with active liver disease or persistent liver function abnormalities should also not take this medication. It should not be administered in cases of severe liver damage or bile duct obstruction. Patients taking immunosuppressants like cyclosporine should not use this medication. Patients with muscle disorders should also not take this medication. Pregnant women, women of childbearing potential, and nursing mothers should refrain from taking this medication. There is no experience with use in children, so it is not administered. Patients with lactose intolerance or related genetic disorders should also not take this medication. Patients with renal dysfunction or a history of liver disease should use this medication cautiously. Caution is necessary, especially when taken with fibrates or niacin, as this increases the risk of muscle damage and renal function deterioration. Patients who consume excessive alcohol should also use this medication with care. Caution is warranted in those with hypothyroidism or genetic muscle diseases or a history of muscle damage. Elderly patients may have a higher risk of adverse reactions due to decreased body functions and should take care during administration. While taking this medication, symptoms such as muscle pain, weakness, abdominal pain, rash, and itching may occur, and liver function abnormalities or blood anomalies could arise. Rarely, rhabdomyolysis due to muscle damage may occur, so if muscle pain or weakness occurs, administration should be stopped immediately. It is important to regularly check liver function and blood tests for abnormalities. This medication is used for treating hyperlipidemia, so adequate testing should confirm hypercholesterolemia before administration. Diet and exercise regimens should be combined, and cardiovascular risk factors such as hypertension or smoking should also be managed. While taking this medication, blood lipid levels should be regularly tested to confirm effectiveness, and if there is no effect, administration should be halted. Since this medication is primarily metabolized in the liver, patients with impaired liver function need to adjust their dosage, and the risk of muscle-related side effects increases with higher dosages. This medication can interact with certain drugs, increasing the risk of renal impairment or muscle damage when taken with some medications. Particularly avoid coadministration with cyclosporine, fibrates, niacin, and erythromycin; if unavoidable, strict monitoring by a specialist is necessary. Elderly patients may need dosage adjustments if adverse reactions occur due to decreased physiological functions. Pregnant or nursing women should not take this medication, and if taken during pregnancy, it should be discontinued immediately considering the impact on the fetus. The safety and efficacy in children have not been established, so it should not be used. This medication should be stored out of reach of children and kept in its original container to prevent degradation or misuse. Long-term use may rarely increase the risk of interstitial lung disease or diabetes, so if symptoms occur, consult healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes, extreme lethargy, sudden and severe headache, sudden headache, seizures, confusion of consciousness, vision abnormalities, paralysis, significantly decreased urine output

Mild side effects

  • Abdominal pain
  • rash
  • malaise
  • paralysis
  • itching
  • thrombocytopenia
  • stiffness
  • drowsiness
  • insomnia
  • headache
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  • heaviness in the head
  • dizziness
  • thirst
  • dyspepsia
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • granulocytopenia
  • leukopenia
  • eosinophilia
  • leukocytosis
  • increased globulin
  • positive Coombs test
  • anemia
  • polyuria
  • elevated BUN
  • increased serum creatinine
  • decreased aldosterone
  • aldo

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a special container to protect it from light and air, at a temperature between 1 and 30 degrees Celsius room temperature. Storing it this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Very light yellowish-red round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.