Medication info

Rovax 10/160 mg Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP) x 3]
Approval status
Expired

MFDS item code 202006067 · 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
(Hypertension, heart failure) treatment and improvement of hypercholesterolemia
Who takes it
Adults · Children
Adult dose
◆ Valsartan 1. Essential Hypertension Take with water during meals or between meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended oral dosage for adults regardless of sex or race is once daily 80 mg of Valsartan. The antihypertensive effect gradually appears within 2 weeks and reaches maximum effect after 4 weeks. In patients whose blood pressure is not adequately controlled, the dosage may be increased to 160 mg per day.
Child dose
Safety and effectiveness have not been established in children and adolescents under 18 years of age.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

(Hypertension, heart failure) treatment and improvement of hypercholesterolemia

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

This medication is used for patients who need to take two components, Valsartan and Rosuvastatin, together. Valsartan is effective primarily for essential hypertension, heart failure, and reducing the risk of death after myocardial infarction. It is especially suitable for heart failure patients with side effects from ACE inhibitors. Rosuvastatin helps improve hypercholesterolemia and dyslipidemia and is used as an adjunct when dietary management is insufficient. Additionally, it contributes to lowering the risk of cardiovascular diseases, reducing the risk of stroke, myocardial infarction, and recurrence after vascular revascularization. Therefore, this medication is used to improve cardiovascular health in patients with both hypertension and hyperlipidemia.

How to take

Adult dose

◆ Valsartan 1. Essential Hypertension Take with water during meals or between meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended oral dosage for adults regardless of sex or race is once daily 80 mg of Valsartan. The antihypertensive effect gradually appears within 2 weeks and reaches maximum effect after 4 weeks. In patients whose blood pressure is not adequately controlled, the dosage may be increased to 160 mg per day.

Child dose

Safety and effectiveness have not been established in children and adolescents under 18 years of age.

Precautions

This medication can cause serious harm to the fetus during pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Women who are pregnant or may become pregnant and breastfeeding women should not take this medication and should use appropriate contraceptive methods. Patients with severely impaired liver or kidney function, muscle diseases, or certain liver diseases should not take this medication due to potential risks. Caution is advised for elderly patients, patients with hyperkalemia, and those with liver impairment, who should undergo regular liver function tests and kidney function tests. This medication can cause muscle-related adverse reactions, such as muscle pain, myopathy, and rarely rhabdomyolysis; if symptoms like muscle pain or weakness occur, consult a doctor immediately. Blood pressure may drop sharply, leading to dizziness or fainting; therefore, start at a low dose and monitor the condition. This medication can affect liver and kidney function; thus, patients with impaired function of these organs must consult a physician before taking it. There may be interactions when taken with other drugs, so if you are taking other medications, you must inform your doctor, especially caution is needed when used in conjunction with potassium-sparing diuretics, potassium supplements, certain antibiotics, antifungals, immunosuppressants, etc. It is advisable to avoid or limit alcohol intake during the use of this medication, and if signs of liver dysfunction occur, contact a physician immediately. The safety and effectiveness in children and adolescents have not been established, so it is generally not recommended for this age group. There is no specific antidote for overdose, and immediate medical attention is required for appropriate treatment, as hypotension or altered consciousness may occur. Store this medication out of the reach of children, and be careful not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, peeling skin, pain of oral/ocular mucosa, severe skin reactions, difficulty breathing or shortness of breath, asthma attack, respiratory problems associated with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache.

Mild side effects

Dyspepsia, nausea, dizziness, headache, conjunctival hemorrhage, constipation, weakness, chest pain, facial edema, peripheral edema, nasopharyngitis, urinary tract infection, bruising, increased blood liver transaminases (AST, ALT), increased blood creatine phosphokinase, increased blood potassium, elevated gamma-glutamyl transpeptidase, musculoskeletal stiffness, limb pain, paresthesia, anxiety, upper respiratory tract infection, pharyngitis, tonsillitis, spinal stenosis, insomnia.

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

Storage

This medication should be stored in a container that blocks light and air, and the storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Pink oval 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.