Medication info
Pitasan Tablet 4 mg (Pitavastatin Calcium Hydrate)

Pitasan Tablet 4 mg (Pitavastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›4.409mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Light yellow, round film-coated tablet
Packaging
Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202103533 · Approved 2021.04.30

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia
Who takes it
Adults
Adult dose
For adults, the usual initial dose is 1 to 2 mg of Pitavastatin Calcium taken once daily. If the LDL cholesterol-lowering effect is insufficient, the dose can be increased up to a maximum of 4 mg per day. The dose should be adjusted appropriately at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • apo-B protein
  • triglyceride levels
View approved original text

This medication helps to control cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It specifically reduces total cholesterol, LDL cholesterol, apo-B protein, and triglyceride levels, while increasing levels of HDL cholesterol, the good cholesterol. It improves blood lipid levels when used as an adjunct to dietary therapy, contributing to a reduced risk of cardiovascular disease. For these reasons, this drug is effectively used in the treatment of dyslipidemia.

How to take

Adult dose

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

Precautions

This drug should not be used in patients with allergies to specific components or severe liver disease. It should also not be administered in cases of active liver disease or persistently elevated liver enzyme levels. Patients taking cyclosporine or with myopathy, pregnant women, women who may become pregnant, and breastfeeding women should not use this drug. There is no experience using this medication in pediatric patients, so it should not be administered to children. Patients with lactose intolerance or specific genetic conditions, as well as those allergic to soybean oil, beans, or peanuts, should also avoid this drug. Patients with renal function abnormalities or a history of liver disorders should use this medication with caution. Care should be taken, especially when taken with fibrates or niacin, as the risk of muscle damage increases. Patients who excessively consume alcohol should use this drug cautiously. Elderly patients, those with hypothyroidism, genetic muscle diseases, hyperlipidemia, diabetes, and severe myasthenia gravis also require caution. This drug can cause a variety of adverse reactions such as muscle pain, liver dysfunction, skin rashes, and digestive disturbances, so immediate consultation with a doctor is necessary if symptoms occur. Particularly, if muscle pain, weakness, or changes in urine color are observed, treatment should be discontinued due to the possibility of rhabdomyolysis. Regular liver function tests and blood lipid level assessments should be conducted before and during treatment to evaluate therapeutic efficacy. This drug is used for the treatment of hypercholesterolemia, and it is recommended to accompany dietary therapy and exercise. It should not be crushed or divided when taken, and must be kept out of reach of children. Pregnant or breastfeeding women should not take this drug, and if pregnancy is confirmed, treatment should be discontinued immediately. When taken with other medications, attention should be paid to interactions, especially avoiding co-administration with cyclosporine, fibrates, and niacin. Elderly patients may experience adverse effects due to decreased physical function, so dose adjustment and caution are necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, vascular edema, rhabdomyolysis after administration, muscle pain due to myopathy, weakness, elevated CPK levels, severe renal impairment such as acute renal failure, liver dysfunction, jaundice, thrombocytopenia, severe allergic reactions, severe skin reactions, severe edema, deterioration of kidney function, rapid decline in kidney function, acute renal failure, severe myasthenia gravis, ocular myasthenia associated with a rapid decline in kidney function.

Mild side effects

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

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

Storage

This drug should be stored in a tightly closed container that blocks light, and the storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

Light yellow, round film-coated tablet

Package unit

Bottle - 30 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.

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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.