Medication info
K-BARO tablet 4 mg (Pitavastatin Calcium Hydrate)

K-BARO tablet 4 mg (Pitavastatin Calcium Hydrate)

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

MFDS item code 202103313 · Approved 2021.04.22

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, the dose may be increased up to a maximum of 4 mg per day. The dosage should be adjusted appropriately at 4-week intervals or longer based on LDL cholesterol levels, therapeutic goals, and patient response.

Ingredients

Manufacturer
주식회사제뉴원사이언스

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 level
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, apo-B protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It also increases HDL cholesterol levels, improving blood lipid balance. It is more effective when used alongside dietary interventions and contributes to reducing cardiovascular disease risk. Therefore, it plays a significant role in managing 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, the dose may be increased up to a maximum of 4 mg per day. The dosage should be adjusted appropriately at 4-week intervals 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 with impaired liver function. It should also be avoided in cases of active liver disease or persistently elevated liver enzyme levels. Patients with severe liver impairment or bile duct obstruction, as well as those taking the immunosuppressive drug cyclosporine, should not use this medication. It is also contraindicated in women with myopathy, those who are pregnant or may become pregnant, and breastfeeding women. Safety has not been established in pediatric patients, thus it should not be administered to children. This medication contains lactose, so it should not be taken by those with lactose intolerance or specific genetic metabolic disorders. Patients allergic to soybean oil, soy, peanuts, and other allergens should exercise caution. Patients with kidney dysfunction, a history of liver disease, or excessive alcohol consumption should use this medication cautiously. The risk of muscle damage may increase when combined with fibrate medications or niacin, so co-administration should be avoided or closely monitored. Patients with hypothyroidism, hereditary muscle diseases, elderly patients, and those with lipid metabolism disorders should also exercise caution when using this medication. This medication can cause various adverse reactions such as myalgia, muscle weakness, liver function abnormalities, skin rash, and dyspepsia, so consult a doctor immediately if any symptoms appear. In particular, symptoms like myalgia, weakness, or changes in urine color may indicate a serious condition called rhabdomyolysis, and administration should be stopped immediately. During treatment, regular blood tests should monitor liver function and muscle condition, and if there is no therapeutic effect, use of the medication should be discontinued. This medication may interact with other drugs, so be sure to inform healthcare providers of any other medications being taken. Elderly patients may experience adverse reactions more easily due to decreased body function, so dosage adjustments and monitoring are recommended. Pregnant or breastfeeding women should absolutely not take this medication as it may harm the fetus or infant. This medication should be swallowed whole without breaking the tablet and stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • rhabdomyolysis
  • acute renal failure
  • severe liver dysfunction
  • jaundice
  • thrombocytopenia
  • severe allergic reactions
  • liver abnormalities (jaundice)
  • severe edema or urination abnormalities.

Mild side effects

  • Abdominal pain
  • rash
  • fatigue
  • paralysis
  • itching
  • headache
  • dizziness
  • skin prickling
  • stiffness
  • drowsiness
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  • insomnia
  • heaviness in the head
  • thirst
  • dyspepsia
  • bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • cheilitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • granulocytopenia
  • leukopenia
  • eosinophilia
  • leukocytosis
  • hyperglobulinemia
  • positive Coombs test
  • anemia
  • increased urination
  • elevated BUN
  • increased serum creatinine
  • decreased aldosterone
  • elevated aldosterone.

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 tight container that protects against light. Additionally, it is best to store the medication at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Light yellow round film-coated tablet

Package unit

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.

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.