Medication info

Pitavastatin Calcium 2mg Tablet

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Pitavastatin Calcium›2mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201103468 · Approved 2011.05.26

This product's status changed to Approval withdrawn on 2024.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (cholesterol, LDL, triglycerides)
Who takes it
Adults
Adult dose
For adults, the usual initial dosage of pitavastatin calcium is 1 to 2 mg once daily. If the LDL cholesterol-lowering effect is insufficient, the dose may be increased to a maximum of 4 mg once daily. The dosage should be adjusted appropriately at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (cholesterol, LDL, triglycerides)

View approved original text

This medication is used for the treatment of primary hypercholesterolemia and mixed dyslipidemia patients. It helps reduce total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels while increasing HDL cholesterol, the 'good' cholesterol. It is effective in improving blood lipid levels when used alongside a diet. Therefore, it can contribute to reducing the risk of cardiovascular diseases. For these reasons, this medication is actively used to treat dyslipidemia.

How to take

Adult dose

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

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to this medication, those with active liver disease, patients with severe liver impairment or bile duct obstruction, and patients currently taking cyclosporine. Additionally, this medication is not to be given to individuals with myopathy, women who are pregnant or may become pregnant, nursing mothers, and children. Patients with lactose intolerance should also use caution. Patients with impaired kidney function or a history of liver disease, and those who consume alcohol excessively should use this medication with caution. Particularly when used in conjunction with fibrates or niacin, there is an increased risk of muscle damage and renal function deterioration. During the use of this medication, symptoms such as muscle pain or weakness may occur, and if these symptoms appear, immediate consultation with healthcare professionals is advisable. Liver function abnormalities and abnormal blood test results should also be monitored regularly, and if abnormalities are found, discontinuation of the medication may be necessary. Rarely, side effects such as skin rash, itching, headaches, indigestion, and thrombocytopenia may occur, so any abnormal symptoms should be reported immediately. As this medication is primarily metabolized in the liver, it is important to conduct regular liver function tests and to combine it with adequate examination, dietary regimen, and exercise therapy before administering. Moreover, this medication may interact with other drugs, so special care is required, especially when taken with cyclosporine, fibrates, niacin, and erythromycin. Older patients may experience a higher risk of side effects due to decreased physiological function, therefore dosage adjustment and close observation are necessary. Pregnant or nursing women should not take this medication, and women who may become pregnant must verify their pregnancy status before taking it. Finally, this medication should be stored out of reach of children and should not be transferred to another container from its original packaging.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rashes with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Abdominal pain
  • rash
  • malaise
  • numbness
  • itching
  • stiffness
  • drowsiness
  • insomnia
  • headache
  • heavy-headedness
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  • dizziness
  • thirst
  • indigestion
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • thrombocytopenia
  • agranulocytosis
  • leukopenia
  • eosinophilia
  • leukocytosis
  • globulin elevation
  • positive Coombs test
  • anemia
  • polyuria
  • elevated BUN
  • increased serum creatinine
  • decreased aldosterone.

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

Storage

This medication may be sensitive to light, so it should be stored in a light-resistant, tightly closed container. Additionally, it is important to maintain a room temperature of between 1 and 30 degrees Celsius when storing the medication. Proper storage will help maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

White 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.