Medication info
Rovaro 4 mg (Pitavastatin Calcium)

Rovaro 4 mg (Pitavastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium›4mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Yellow film-coated tablet with a score line in the center
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202201915 · Approved 2022.05.10 · Insurance code 649105510

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia
Who takes it
Adults
Adult dose
For adults, the usual initial dosage is 1 to 2 mg of Pitavastatin Calcium taken once daily. If the LDL cholesterol-lowering effect is not sufficient, the dose can be increased up to a maximum of 4 mg daily. The dosage may be adjusted appropriately at intervals of 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response.

Ingredients

Manufacturer
한국휴텍스제약(주)

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 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 raising HDL cholesterol. When used in conjunction with dietary changes, it is effective in improving blood lipid concentrations and reducing the risk of cardiovascular diseases. By consistently following a dietary regimen and taking this medication, patients can effectively manage their blood lipid levels. This drug serves as a good adjunct for the treatment of hyperlipidemia.

How to take

Adult dose

For adults, the usual initial dosage is 1 to 2 mg of Pitavastatin Calcium taken once daily. If the LDL cholesterol-lowering effect is not sufficient, the dose can be increased up to a maximum of 4 mg daily. The dosage may be adjusted appropriately at intervals of 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response.

Precautions

This medication is used for treating hyperlipidemia and should not be used in certain patients. It is contraindicated in patients with allergies to the components of this medication, severe liver disease or a persistent unexplained increase in liver enzyme levels, severe hepatic impairment or biliary obstruction, those taking cyclosporine, patients with myopathy, pregnant women or those who may become pregnant, nursing mothers, and children. Additionally, patients with impaired kidney function or liver impairment, excessive alcohol consumption, hypothyroidism, the elderly, and patients with muscle weakness should use this medication with caution. During treatment, adverse reactions such as muscle pain, weakness, abdominal pain, rash, and itching may occur, and although rhabdomyolysis due to muscle damage is rare, it can be a serious side effect, so treatment should be discontinued immediately if symptoms appear. Liver function abnormalities may also occur, so regular liver function tests should be performed both before and during treatment, and if any abnormal findings are detected, medication should be discontinued. This medication may interact with other drugs, particularly cyclosporine, fibrate medications, and niacin, increasing the risk of muscle damage; thus, combined use should be avoided or done with caution. Elderly patients are at higher risk for side effects due to decreased physical function, so dose adjustment and careful monitoring are necessary. Pregnant or nursing women should not take this medication, as it may pose risks to the fetus and newborn. Safety and efficacy in children have not been established, so it should not be used in pediatrics. Tablets should be swallowed whole and should not be crushed, and they should be kept out of reach of children. Transferring the drug from its original container to another can lead to misuse or degradation of quality, so it must be stored in the original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or breathing difficulty, asthmatic attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

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

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

Storage

This medication is sensitive to light, so it should be stored in a special container that does not allow light to penetrate. Furthermore, to maintain its effectiveness, it is important to store it at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow film-coated tablet with a score line in the center

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.