Medication info

Rovax 5/80 mg Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletValsartan›80mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP) x 3]
Approval status
Expired

MFDS item code 202006073 · Approved 2020.08.28

This product's status changed to Expired on 2025.08.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension and heart failure, improvement of hypercholesterolemia, reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Essential Hypertension: It is recommended to administer 80 mg of valsartan orally once daily. Patients whose blood pressure is not well controlled may increase to 160 mg daily or combine with a diuretic. If additional blood pressure reduction is needed, it may be increased to a maximum of 320 mg daily. For elderly patients (75 years and older) and patients with kidney impairment, fluid depletion, mild to moderate liver impairment, the starting dose is 40 mg once daily.
Child dose
Safety and efficacy have not been established in children and adolescents under 18 years of age, so it is not administered.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Treatment of hypertension and heart failure, improvement of hypercholesterolemia, reduction of cardiovascular disease risk

  • Essential hypertension
  • heart failure
  • left ventricular failure
  • left ventricular systolic dysfunction
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
View approved original text

This medication is prescribed to patients who require the simultaneous use of valsartan and rosuvastatin. Valsartan is used to reduce the risk of essential hypertension, heart failure, and mortality after myocardial infarction. It is particularly effective in heart failure patients who are intolerant to ACE inhibitors. Rosuvastatin regulates hypercholesterolemia and dyslipidemia, delays the progression of atherosclerosis, and reduces the risk of cardiovascular disease. Additionally, it helps lower the risk of myocardial infarction, stroke, and revascularization procedures. Therefore, this medication is used to improve the health status of patients with hypertension and cardiovascular risks.

How to take

Adult dose

Essential Hypertension: It is recommended to administer 80 mg of valsartan orally once daily. Patients whose blood pressure is not well controlled may increase to 160 mg daily or combine with a diuretic. If additional blood pressure reduction is needed, it may be increased to a maximum of 320 mg daily. For elderly patients (75 years and older) and patients with kidney impairment, fluid depletion, mild to moderate liver impairment, the starting dose is 40 mg once daily.

Child dose

Safety and efficacy have not been established in children and adolescents under 18 years of age, so it is not administered.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters; it should be discontinued immediately upon confirmation of pregnancy. It is not safe to use this medication in women who are pregnant or may become pregnant, nursing mothers, patients with severe liver or kidney impairment, and those with muscle disorders. Elderly patients, patients with high potassium levels, patients with slight liver impairment, patients with heart or vascular disease should use this medication carefully, and regular blood tests and kidney function tests may be necessary as required. This medication can cause muscle pain, weakness, and, rarely, rhabdomyolysis (muscle destruction); if symptoms of muscle pain or weakness occur, the healthcare provider should be notified immediately. Furthermore, this medication may affect liver function, so if symptoms of liver dysfunction occur, it should be discontinued and a doctor consulted. There may be interactions with other medications, so if other medications are being taken, be sure to inform a doctor or pharmacist. In the case of overdose, there is no specific antidote, so immediate hospitalization for appropriate treatment is necessary, and appropriate measures are needed if blood pressure becomes excessively low. This medication is not recommended for use in children as safety and effectiveness have not been established. During treatment, driving or operating machinery may cause dizziness, so care should be taken. Lastly, this medication should be kept out of reach of children and not transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema (swelling of face, lips, pharynx, tongue), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory distress accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme fatigue, severe liver dysfunction (jaundice), sudden and severe symptoms.

Mild side effects

Dyspepsia, nausea, dizziness, headache, conjunctival hemorrhage, constipation, weakness, chest pain, facial swelling, peripheral edema, nasopharyngitis, urinary tract infection, bruising, increased serum liver aminotransferase (AST, ALT) levels, increased serum creatine phosphokinase, increased serum potassium, increased gamma-glutamyl transferase, musculoskeletal stiffness, limb pain, sensory disturbance, anxiety, upper respiratory infection, pharyngitis, tonsillitis, spinal stenosis.

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 tightly sealed container that prevents light exposure. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP) x 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.