Medication info
Pitavastatin Calcium Hydrate 4mg Tablets

Pitavastatin Calcium Hydrate 4mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›4.409mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Pale yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202103367 · Approved 2021.04.26 · Insurance code 073000140

Summary

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

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia

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

This medication helps to manage blood lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It specifically lowers total cholesterol and LDL cholesterol while reducing Apo-B protein and triglyceride levels, and increases HDL cholesterol to help maintain a healthy lipid balance. This effect supports dietary efforts to reduce the risk of cardiovascular diseases. Taking this medication alongside a healthy diet will significantly aid in improving blood lipid levels. It is used to safely and effectively treat dyslipidemia.

How to take

Adult dose

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

Precautions

This medication is used to lower blood cholesterol levels for the treatment of hyperlipidemia. This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to any of its components, those with active liver disease or severe liver dysfunction, patients taking cyclosporine, those with myopathy, women who are pregnant or may become pregnant, breastfeeding women, and patients with lactose intolerance or allergies to soy, beans, or peanuts. Additionally, patients with renal impairment or a history of liver dysfunction, those who consume alcohol excessively, patients taking certain lipid-lowering drugs, individuals with a history of hypothyroidism or myopathy, elderly patients, and patients with disorders of lipid metabolism should take this medication with caution. This medication may cause side effects such as muscle pain, muscle weakness, liver dysfunction, thrombocytopenia, and allergic reactions, so if any unusual symptoms occur while taking it, immediate consultation with a healthcare provider is necessary. Especially, in cases of muscle pain or weakness and elevated muscle enzyme levels in blood tests, discontinuation of this medication is required. Since this drug is primarily metabolized in the liver, regular liver function tests should be performed, and patients at risk of worsening liver function should have their dose adjusted. Also, serious side effects may occur when taking this medication with certain drugs, so it is essential to inform healthcare providers of any other medications being taken. Elderly patients are at a higher risk of side effects, so caution is necessary, and pregnant or breastfeeding women should not take this medication. The safety and efficacy of this medication in children has not been established, so it is best not to use it in this age group. When taking this medication, do not split the tablet; swallow it whole, and keep it out of reach of children. Lastly, rare side effects such as interstitial lung disease or an increased risk of diabetes have been reported with long-term use of this medication, thus requiring regular health checks and monitoring.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • rhabdomyolysis
  • acute renal failure
  • myopathy
  • liver dysfunction
  • jaundice
  • thrombocytopenia
  • severe allergic reactions
  • severe skin reactions
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  • severe edema or urinary abnormalities
  • difficulty breathing
  • chest tightness
  • elevated blood pressure
  • worsening renal function
  • severe kidney impairment
  • severe neurological symptoms
  • paralysis
  • altered consciousness
  • visual disturbances
  • sudden and severe headaches
  • thunderclap headache
  • seizures
  • liver injury

Mild side effects

  • Abdominal pain
  • rash
  • fatigue
  • paralysis
  • itching
  • extensive myalgia
  • muscle tenderness
  • elevated serum ALT (GPT)
  • elevated serum AST (GOT)
  • elevated γ-GT
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  • elevated ALP
  • elevated LDH
  • stiffness
  • drowsiness
  • insomnia
  • headache
  • heavy head
  • dizziness
  • thirst
  • indigestion
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • thrombocytopenia
  • granulocytopenia
  • leukopenia
  • eosinophilia

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 container that is not permeable to light. It is also advisable to store it at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the efficacy and safety of the medication.

Appearance and packaging

Appearance

Pale yellow round film-coated tablets

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.