Medication info
Pitasan Tablet 2mg (Pitavastatin Calcium Hydrate)

Pitasan Tablet 2mg (Pitavastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›2.205mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Very pale yellow-red round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202003208 · Approved 2020.04.29 · Insurance code 649702690

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia
Who takes it
Adults
Adult dose
For adults, the initial dose of pitavastatin calcium is 1 to 2 mg taken once daily. If the LDL cholesterol-lowering effect is insufficient, the dose may be increased to a maximum of 4 mg per day. Adjust the dosage appropriately with an interval of at least 4 weeks.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • apolipoprotein B
  • triglyceride levels
View approved original text

This medicine is used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia to lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels, while increasing HDL cholesterol, the good cholesterol. It helps improve blood lipid levels and enhance cardiovascular health.

How to take

Adult dose

For adults, the initial dose of pitavastatin calcium is 1 to 2 mg taken once daily. If the LDL cholesterol-lowering effect is insufficient, the dose may be increased to a maximum of 4 mg per day. Adjust the dosage appropriately with an interval of at least 4 weeks.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to any ingredient of this medication, have active liver disease, or consistently high liver enzyme levels of unknown cause, severe liver dysfunction, cholestasis, patients taking cyclosporine, those with myopathy, women who are pregnant or may become pregnant, nursing mothers, and there is no experience in administering it to children. Additionally, patients with renal impairment or a history of liver dysfunction, patients who consume excessive amounts of alcohol, individuals taking certain medications (such as fibrates or nicotinic acid), patients with hypothyroidism or genetic muscle diseases or a history of muscle-related conditions, elderly patients, and those with severe muscle weakness should use this medication with caution. This medication may have various adverse reactions including muscle pain, weakness, liver function abnormalities, skin rash, itching, and gastrointestinal disturbances. In particular, rhabdomyolysis, a condition in which muscle tissue is damaged, can occur, so if there is severe muscle pain or weakness, use should be discontinued immediately. Regular liver function tests should be performed before and during treatment to monitor for any liver dysfunction, and blood lipid levels should be evaluated periodically to assess treatment effectiveness. Since this medication is primarily metabolized in the liver, the dosage should be reduced in patients with liver dysfunction, and due to multiple drug interactions, especially when combined with cyclosporine or fibrates, the risk of rhabdomyolysis and renal function deterioration is high, so such combinations should be avoided or closely monitored. Elderly patients may experience adverse reactions more readily due to diminished physiological function; therefore, caution is advised during administration. Pregnant and nursing mothers should avoid this medication due to potential risks to the fetus or newborn, and if pregnancy is confirmed, the medication should be discontinued immediately. Children are not to be used as safety and efficacy have not been established. Finally, this medication should be stored out of reach of children and kept in its original container to prevent misuse or deterioration of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, jaundice, liver dysfunction, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output, severe systemic edema, edema associated with elevated blood pressure, rhabdomyolysis, myopathy, thrombocytopenia, severe renal impairment

Mild side effects

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

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

Storage

This medication is sensitive to light and should be stored in a special container that does not allow light to enter. It is also safe to store the medication at cool room temperature, that is, between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Very pale yellow-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.