Medication info
Rivaro Tablets 1 mg (Pitavastatin Calcium Hydrate)

Rivaro Tablets 1 mg (Pitavastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›1mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Round white film-coated tablet
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Active

MFDS item code 200500287 · Approved 2005.01.06 · Insurance code 644900790

Summary

Main use
Improvement of cholesterol levels in hypercholesterolemia (primary, familial) and dyslipidemia
Who takes it
Adults · Children
Adult dose
For adults, the usual initial dose of Pitavastatin Calcium is 1-2 mg once daily. If the LDL cholesterol-lowering effect is insufficient, the dose may be increased to a maximum of 4 mg per day. Adjustments to the dose should be made every 4 weeks or more and maintained with continuous administration for therapeutic efficacy.
Child dose
For pediatric patients (10 to 16 years) with heterozygous familial hypercholesterolemia, administer Pitavastatin Calcium 1 mg once daily. If the LDL cholesterol-lowering effect is insufficient, increase to a maximum of 2 mg per day.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement of cholesterol levels in hypercholesterolemia (primary, familial) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo-B protein
  • elevated triglycerides
  • low HDL cholesterol
  • family history of early cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used as an adjunct to diet to lower total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is specifically indicated for pediatric patients aged 10 to 16 years with heterozygous familial hypercholesterolemia, where LDL cholesterol levels are 190 mg/dL or above, or 160 mg/dL or above with a family history or other cardiovascular risk factors. This product helps improve blood lipid levels, thereby reducing the risk of cardiovascular disease.

How to take

Adult dose

For adults, the usual initial dose of Pitavastatin Calcium is 1-2 mg once daily. If the LDL cholesterol-lowering effect is insufficient, the dose may be increased to a maximum of 4 mg per day. Adjustments to the dose should be made every 4 weeks or more and maintained with continuous administration for therapeutic efficacy.

Child dose

For pediatric patients (10 to 16 years) with heterozygous familial hypercholesterolemia, administer Pitavastatin Calcium 1 mg once daily. If the LDL cholesterol-lowering effect is insufficient, increase to a maximum of 2 mg per day.

Precautions

This medication should not be used in patients who have had allergic reactions to any of its components, patients with active liver disease, severe liver impairment or obstructed bile flow, and patients taking cyclosporine. Furthermore, it is contraindicated in women with myopathy, pregnant women or women who may become pregnant, and nursing mothers. This medication contains lactose; therefore, it should not be taken by patients with lactose intolerance or related genetic disorders. Caution is advised in patients with kidney dysfunction or a history of liver disorders, as well as individuals who consume excessive alcohol. In particular, it is advisable to avoid concomitant use with fibrates or niacin due to the risk of muscle injury and impaired kidney function. Elderly patients, children, those with hypothyroidism, and patients with genetic muscle disorders should be administered this drug with care, and special caution is needed in patients with severe myasthenia. During treatment, unusual symptoms such as muscle pain, weakness, abdominal pain, rash, itching, headache, myalgia, stiffness, drowsiness, insomnia, heavy feeling, dizziness, thirst, dyspepsia, abdominal bloating, constipation, stomatitis, vomiting, loss of appetite, glossitis, nausea, gastrointestinal discomfort, diarrhea, thrombocytopenia, granulocytopenia, leukopenia, eosinophilia, leukocytosis, glucocorticoid elevation, Coombs test positivity, anemia, increased urination, increased BUN, and elevated serum creatinine should be reported to healthcare providers immediately. Regular liver function tests are necessary, and the medication may need to be discontinued if liver enzyme levels rise. This medication can cause muscle damage (rhabdomyolysis); if muscle pain or weakness worsens, treatment should be ceased. Additionally, this drug may interact with other medications, particularly when used in conjunction with cyclosporine, fibrates, niacin, or erythromycin. Pregnant or nursing women should not take this medication, and women of childbearing potential should verify pregnancy status before use. In pediatric patients, it should be given cautiously under a specialist's guidance for the treatment of familial hypercholesterolemia, and safety has not been established in children under 10 years of age. This medication should be kept out of reach of children and stored in its original container. Before starting treatment, patients should appropriately implement non-drug therapies such as dietary changes and exercise, and the medication should be discontinued if no therapeutic effect is observed. Elderly patients may experience adverse reactions due to reduced physiological function, so dosage adjustments may be required. During treatment, there may be an increased risk of developing diabetes; therefore, blood glucose monitoring is essential. Long-term use may rarely lead to interstitial lung disease, so patients should immediately inform healthcare providers of any respiratory symptoms like shortness of breath or cough.

Side effects and when to seek care immediately

Serious side effects

Hives, rhabdomyolysis, liver dysfunction, jaundice, paralysis, severe allergic reactions, elevated blood pressure, severe swelling or urination abnormalities, severe skin reactions, serious neurological symptoms, difficulty breathing, respiratory issues

Mild side effects

  • Abdominal pain
  • rash
  • fatigue
  • numbness
  • itching
  • headache
  • myalgia
  • stiffness
  • drowsiness
  • insomnia
Show 25 more
  • heavy feeling
  • dizziness
  • thirst
  • dyspepsia
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • thrombocytopenia
  • granulocytopenia
  • leukopenia
  • eosinophilia
  • leukocytosis
  • globulin elevation
  • Coombs test positivity
  • anemia
  • increased urination
  • elevated BUN
  • rising serum creatinine
  • decreased aldosterone

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

Storage

This medication is sensitive to light and should be stored in a dark container away from light. Additionally, it is best to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Round white film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3)

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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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.