Medication info
Pitasthan Tablet 1 mg (Pitavastatin Calcium Hydrate)

Pitasthan Tablet 1 mg (Pitavastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›1.102mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
White round film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle
Approval status
Active

MFDS item code 202102918 · Approved 2021.04.05 · Insurance code 649702670

Summary

Main use
Cholesterol improvement treatment for hypercholesterolemia (primary, familial) and dyslipidemia
Who takes it
Adults · Children
Adult dose
For adults, the usual initial dosage is 1 to 2 mg of Pitavastatin Calcium once daily. If the LDL-cholesterol reduction effect is insufficient, the dose may be increased to a maximum of 4 mg per day. The dosage should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.
Child dose
For pediatric patients (10 to 16 years) with heterozygous familial hypercholesterolemia, take 1 mg of Pitavastatin Calcium once daily. If the LDL-cholesterol reduction effect is insufficient, the dose may be increased to a maximum of 2 mg per day.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Cholesterol improvement treatment for hypercholesterolemia (primary, familial) and dyslipidemia

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • LDL-cholesterol
  • apo-B protein
  • triglyceride levels
  • heterozygous familial hypercholesterolemia
  • family history of early cardiovascular disease
  • risk factors for cardiovascular disease
View approved original text

This medication is used as an adjunct to dietary therapy to lower total cholesterol, LDL-cholesterol, apo-B protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing the good cholesterol known as HDL-cholesterol. It is particularly applicable to pediatric patients aged 10 to 16 years with heterozygous familial hypercholesterolemia, helping to safely manage high cholesterol levels. The drug is more effective in patients with a family history or risk factors for early cardiovascular disease, thus playing an important role in improving cardiovascular health. Overall, this treatment is used to improve blood lipid levels and reduce the risk of cardiovascular disease occurrence.

How to take

Adult dose

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

Child dose

For pediatric patients (10 to 16 years) with heterozygous familial hypercholesterolemia, take 1 mg of Pitavastatin Calcium once daily. If the LDL-cholesterol reduction effect is insufficient, the dose may be increased to a maximum of 2 mg per day.

Precautions

This medication should not be administered to patients with known allergies to certain ingredients. Patients with active liver disease or persistently elevated liver function test results should also avoid this medication. Patients with severe liver disorders or biliary obstruction should not be given this drug, nor should it be used in patients taking cyclosporine. Individuals with myopathy, pregnant women, women who may become pregnant, and nursing mothers should not use this medication. It should also not be administered to patients with genetic issues such as lactose intolerance. Patients with impaired renal function or a history of liver disorders should use this medication with caution. In particular, co-administration with fibrates or niacin should be avoided due to the risk of muscle damage and worsening renal function. Caution is also advised when used in elderly or pediatric patients, particularly in cases of myasthenia. Unusual symptoms such as muscle pain, weakness, abdominal pain, rash, itching, etc. may occur while taking this medication, so it is essential to consult a doctor immediately if any symptoms arise. Regular liver function tests should be performed, and if liver abnormalities are found, the treatment should be discontinued. This medication can cause serious muscle damage known as rhabdomyolysis; therefore, if muscle-related symptoms arise, stop taking it immediately. There are many drug interactions, particularly with cyclosporine, fibrates, niacin, erythromycin, etc., thus increasing the risk of renal function deterioration and muscle damage; caution should be exercised. Pregnant women or those who may become pregnant should not use this medication, and it should be discontinued immediately if pregnancy is confirmed during treatment. In children, this medication should be administered with great care only under the guidance of a specialist for the treatment of familial hypercholesterolemia, and safety in children under the age of 10 has not been established. This medication should be kept out of the reach of children, stored in its original container to prevent misuse or degradation in quality.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • liver dysfunction
  • jaundice
  • rhabdomyolysis
  • acute renal failure
  • severe allergic reactions
  • thrombocytopenic purpura
  • severe swelling or urinary abnormalities
  • severe skin adverse reactions
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  • serious neurological symptoms
  • breathing difficulties
  • shortness of breath
  • chest tightness
  • difficulty in breathing.

Mild side effects

Abdominal pain, fatigue, itching, rash, muscle pain, headache, weakness, dry mouth, indigestion, abdominal bloating, constipation, stomatitis, vomiting, loss of appetite, glossitis, nausea, gastric discomfort, diarrhea, thrombocytopenia, granulocytopenia, leukopenia, eosinophilia, leukocytosis, globulin elevation, palpitations, skin tenderness, flushing, arthralgia, edema, blurred vision, photophobia, hearing loss, hematuria, increased uric acid levels, and elevated serum potassium and phosphorus.

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

Storage

This medication should be stored in a tightly closed container that protects from light, and it is safe to keep at room temperature between 1 to 30 degrees Celsius. Storing it this way can maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

Bottle - 30 tablets/bottle, 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.