Medication info
Rovastatin 20/80 mg Tablets

Rovastatin 20/80 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletValsartan›80mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Brown, round film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP)*3]
Approval status
Active

MFDS item code 202008931 · Approved 2020.12.17 · Insurance code 671706720

Summary

Main use
(Hypertension, Heart Failure) Treatment and improvement of Hyperlipidemia and reduction of cardiovascular disease risk.
Who takes it
Adults · Children
Adult dose
For the treatment of essential hypertension, the recommended dosage for adults is 80 mg of valsartan taken orally once a day. In cases where blood pressure is difficult to control, the dosage can be increased up to 160 mg or in combination with diuretics, and a maximum of 320 mg can be administered daily. For elderly patients (75 years and older), it is recommended to start with 40 mg once daily. Dosage adjustment may be necessary for patients with renal or liver impairment, and specific circumstances.
Child dose
The safety and efficacy of valsartan and rosuvastatin are not established in children and adolescents under 18 years of age.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

(Hypertension, Heart Failure) Treatment and improvement of Hyperlipidemia and reduction of cardiovascular disease risk.

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

This medication is used for patients who require simultaneous administration of two drugs, valsartan and rosuvastatin. Valsartan is primarily used for the treatment of essential hypertension and heart failure and is especially suitable for heart failure patients who cannot tolerate ACE inhibitors. It also helps reduce the risk of death in stable patients with left ventricular dysfunction after myocardial infarction. Rosuvastatin is used for lipid disorders such as primary and familial hypercholesterolemia, and combined hyperlipidemia, and is utilized as an adjunct therapy when diet and exercise are insufficient. This medication is effective in reducing the risk of stroke, myocardial infarction, and arterial revascularization in patients at high cardiovascular risk. Therefore, this medication improves the prevention and treatment of cardiovascular diseases by controlling blood pressure and cholesterol.

How to take

Adult dose

For the treatment of essential hypertension, the recommended dosage for adults is 80 mg of valsartan taken orally once a day. In cases where blood pressure is difficult to control, the dosage can be increased up to 160 mg or in combination with diuretics, and a maximum of 320 mg can be administered daily. For elderly patients (75 years and older), it is recommended to start with 40 mg once daily. Dosage adjustment may be necessary for patients with renal or liver impairment, and specific circumstances.

Child dose

The safety and efficacy of valsartan and rosuvastatin are not 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, so it should be discontinued immediately if pregnancy is confirmed. This medication should not be administered to patients with allergic reactions, severe liver disease, severe renal failure, or certain muscle diseases. Caution is needed for elderly patients, patients with high potassium levels, and those with compromised liver function, and regular liver function tests should be performed. If symptoms of muscle pain or weakness occur, consult a doctor immediately; in severe cases, medication may be stopped. This medication can affect kidney function or potassium levels when taken with other antihypertensives, diuretics, or potassium supplements, so it should be taken under a doctor's guidance. Adverse effects such as interstitial lung disease, liver function abnormalities, and increased blood sugar may occur, so it is important to notify if symptoms arise. Extra caution should be exercised if consuming alcohol heavily or if there are liver problems during the use of this medication, and liver function tests should be monitored. This medication is not recommended for children or adolescents as its safety and effectiveness have not been established. In case of overdose, since there is no specific antidote, seek immediate medical attention for appropriate treatment. Keep this medication out of the reach of children and do not transfer it to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, fever with severe rash, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory disturbances accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances.

Mild side effects

Dyspepsia, nausea, chest discomfort, dizziness, headache, conjunctival hemorrhage, constipation, asthenia, chest pain, facial swelling, peripheral edema, rhinitis, urinary tract infection, bruising, increased serum aminotransferases (AST, ALT), increased serum creatine phosphokinase, increased potassium, increased gamma-glutamyl transferase, musculoskeletal stiffness, limb pain, sensory impairment, anxiety, upper respiratory tract infection, edema, anemia, tinnitus.

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 an opaque container to prevent light exposure. Additionally, it is important to store the medication at a temperature between 1 and 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Brown, round film-coated tablets

Package unit

30 tablets/box [(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.