Medication info

Megapibatine Tablet 2 mg (Pitavastatin Calcium)

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 202001859 · Approved 2020.03.17

This product's status changed to Approval withdrawn on 2024.09.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of Hypercholesterolemia and Dyslipidemia
Who takes it
Adults
Adult dose
For adults, the usual initial dose of pitavastatin calcium is 1 to 2 mg once daily. If the LDL cholesterol lowering effect is insufficient, it may be increased up to a maximum of 4 mg daily. The dose should be adjusted appropriately every 4 weeks or longer based on LDL cholesterol levels, therapeutic goals, and patient response.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Improvement of Hypercholesterolemia and Dyslipidemia

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo-B protein
  • triglycerides
View approved original text

This medication helps control blood lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Specifically, it lowers total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels, while increasing HDL cholesterol, which is good cholesterol. This plays a significant role in maintaining cardiovascular health. The effect is further enhanced when used alongside dietary therapy, improving the balance of blood lipids. Therefore, this medication is effectively used in the treatment of hyperlipidemia.

How to take

Adult dose

For adults, the usual initial dose of pitavastatin calcium is 1 to 2 mg once daily. If the LDL cholesterol lowering effect is insufficient, it may be increased up to a maximum of 4 mg daily. The dose should be adjusted appropriately every 4 weeks or longer based on LDL cholesterol levels, therapeutic goals, and patient response.

Precautions

This medication should not be used in patients with allergies to specific ingredients or who have liver function issues. It may be risky to take for patients with active liver disease or consistently elevated liver enzymes, as well as those with severe liver impairment or bile duct obstruction. Patients taking cyclosporine or those with myopathy, pregnant or possibly pregnant women, breastfeeding women, and children should not be given this medication. Patients with renal dysfunction or a history of liver issues should use this medication cautiously, especially if used with fibrate medications or niacin, as there may be risks of muscle damage and worsening renal function. Older adults may also experience adverse reactions more readily when taking this medication. Adverse reactions such as myalgia, weakness, skin rash, itching, dyspepsia may occur when taking this medication, and rhabdomyolysis, where muscle tissue breaks down, can occur rarely; if symptoms of muscle pain or weakness appear, medical consultation should be sought immediately. Liver dysfunction, thrombocytopenia, allergic reactions, etc. may also occur, necessitating regular blood tests and liver function tests. As this medication is used to treat hyperlipidemia, it is essential to check blood lipid levels before administration and conduct regular tests during administration to evaluate the treatment's effectiveness. Patients with weak liver function may require dose adjustments and regular liver function tests must be performed during treatment. This medication can interact with other drugs, so caution is especially needed when taken with cyclosporine, fibrate medications, niacin, or erythromycin, and if symptoms like myalgia or weakness occur during combined usage, administration should be stopped immediately. This medication is not used in pregnant or breastfeeding individuals, and if pregnancy is confirmed, administration should be stopped immediately. Its safety and efficacy in children have not been established, so it is not used in pediatric patients. This medication should be kept out of reach of children and stored in its original container. Older adults and those with renal or liver dysfunction are at increased risk of adverse reactions and should take this medication with caution.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • rhabdomyolysis
  • myopathy
  • liver dysfunction
  • jaundice
  • thrombocytopenia
  • severe allergic reactions
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  • severe edema or urinary issues
  • severe skin reactions
  • serious neurological symptoms
  • liver abnormalities (jaundice)

Mild side effects

  • Abdominal pain
  • rash
  • fatigue
  • numbness
  • itching
  • headache
  • stiffness
  • dizziness
  • thirst
  • dyspepsia
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  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • frequent urination
  • aldosterone decrease
  • aldosterone increase
  • adrenocorticotropic hormone increase
  • cortisol increase
  • muscle cramps
  • palpitations
  • tiredness
  • skin pain
  • flushing
  • joint pain
  • blurred vision
  • photophobia
  • hearing loss
  • hematuria
  • increased uric acid levels

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

Storage

This medication should be stored in a tightly closed container that can block light, at a temperature between 1 and 30 degrees Celsius. Proper storage ensures the medication's effectiveness is maintained and prevents degradation.

Appearance and packaging

Appearance

Very light yellowish-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.