Medication info

Rovax Tablets 10/80 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletValsartan›80mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Pink round film-coated tablets
Packaging
30 tablets/box [(10/PTP) x 3]
Approval status
Expired

MFDS item code 202006071 · 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) 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 daily (e.g., in the morning). Adults: It is recommended to take 80 mg orally once a day. For patients whose blood pressure is not well controlled, the dose may be increased to 160 mg once daily, or a diuretic may be combined. If additional blood pressure lowering is required, the dosage can be increased to a maximum of 320 mg once daily.
Child dose
◆ Valsartan Pediatrics: Safety and efficacy have not been established in children and adolescents under 18 years of age.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

(Treatment of hypertension and heart failure) and improvement of hypercholesterolemia.

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

This medication is used for patients who need to take both valsartan and rosuvastatin simultaneously. Valsartan is primarily used in the treatment of essential hypertension and heart failure, and is particularly suitable for patients with heart failure who cannot use ACE inhibitors. It also helps reduce the risk of death in patients with left ventricular dysfunction following myocardial infarction. Rosuvastatin improves hypercholesterolemia and dyslipidemia, and is used as an adjunct when dietary measures are insufficient. This medication delays the progression of atherosclerosis in patients with hypercholesterolemia and is effective in reducing the risk of cardiovascular disease. Overall, this medication is used to prevent and treat cardiovascular diseases through blood pressure control and cholesterol improvement.

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 daily (e.g., in the morning). Adults: It is recommended to take 80 mg orally once a day. For patients whose blood pressure is not well controlled, the dose may be increased to 160 mg once daily, or a diuretic may be combined. If additional blood pressure lowering is required, the dosage can be increased to a maximum of 320 mg once daily.

Child dose

◆ Valsartan Pediatrics: Safety and efficacy have not been established in children and adolescents under 18 years of age.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters; therefore, it should be discontinued immediately if pregnancy is confirmed. Women of childbearing potential should use appropriate contraceptive measures before taking this medication and should not use it during pregnancy. Patients with severe liver or kidney impairment, a history of certain genetic diseases, or muscle disorders should safely avoid this medication. Elderly patients, patients with hyperkalemia, and patients with mildly impaired liver function should use this medication with caution and undergo regular liver enzyme tests. This medication can cause muscle pain, muscle weakness, and occasionally severe muscle damage known as rhabdomyolysis, so any muscle-related symptoms should prompt immediate consultation with a physician. Additionally, blood pressure may suddenly drop, leading to dizziness or fainting, so caution is advised when starting the medication or increasing the dosage. There may be interactions with other medications, so any current medications should be disclosed to a doctor or pharmacist. Breastfeeding women are advised not to take this medication unless absolutely necessary, in which case breastfeeding should be discontinued. It is not recommended for children or adolescents as safety and efficacy have not been established in this population. In case of overdose, there is no specific antidote, so immediate medical attention should be sought. This medication should be kept out of reach of children, and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory difficulties, jaundice (yellowing of skin or eyes), profound lethargy, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances.

Mild side effects

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

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 container that does not allow light to penetrate. Additionally, it is important to maintain the drug's effectiveness by storing it in a cool, room temperature, specifically between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/box [(10/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.

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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.