Medication info
Rosuvastatin/ValSartan Tablets 20/160 mg

Rosuvastatin/ValSartan Tablets 20/160 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Brown oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202003910 · Approved 2020.05.27

Summary

Main use
(Improvement of hypertension, heart failure) and effect of (control of hyperlipidemia)
Who takes it
Adults · Children
Adult dose
For hypertension treatment, the recommended oral dose of valsartan is 80 mg once daily. If blood pressure control is needed, it can be increased to 160 mg once daily and can go up to a maximum of 320 mg once daily. For heart failure treatment, the initial dose is 40 mg orally twice daily, and can be increased to 80 mg or 160 mg once. To reduce the risk of death post-myocardial infarction, the recommended initial dose is 20 mg taken orally twice daily.
Child dose
Safety and efficacy have not been established in children and adolescents under 18 years of age, therefore it is not administered.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

(Improvement of hypertension, heart failure) and effect of (control of hyperlipidemia)

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

This medication is used for patients who need both valsartan and rosuvastatin. Valsartan primarily helps treat essential hypertension and heart failure, and reduce the risk of death after myocardial infarction. It is particularly used in heart failure patients who are intolerant to ACE inhibitors. Rosuvastatin is used as an adjunct when dietary changes and exercise cannot adequately control hyperlipidemia and is effective in slowing the progression of atherosclerosis. It also helps reduce the risks of stroke, myocardial infarction, and arterial revascularization in patients with high cardiovascular risk. Therefore, this drug is used to effectively improve hypertension and dyslipidemia.

How to take

Adult dose

For hypertension treatment, the recommended oral dose of valsartan is 80 mg once daily. If blood pressure control is needed, it can be increased to 160 mg once daily and can go up to a maximum of 320 mg once daily. For heart failure treatment, the initial dose is 40 mg orally twice daily, and can be increased to 80 mg or 160 mg once. To reduce the risk of death post-myocardial infarction, the recommended initial dose is 20 mg taken orally twice daily.

Child dose

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

Precautions

This drug can cause severe harm to the fetus during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Women who are pregnant or may become pregnant, and breastfeeding women should not take this medication. Patients with severely impaired liver function or certain liver diseases should not use this medication. Patients with muscle diseases or a history of muscle problems related to similar medications should also avoid taking it. Patients with severe kidney impairment are also advised not to use this medication. Caution should be exercised in elderly patients or those with high blood potassium levels. Patients with heart diseases or dehydration should also be cautious when taking this medication. This drug may cause muscle pain, weakness, and, rarely, severe muscle damage (rhabdomyolysis), thus medical consultation should be sought immediately if muscle pain or weakness occurs. Liver function tests are recommended before and during treatment as liver function problems may develop. It is advisable to avoid or limit alcohol intake during treatment. There may be interactions when taking this medication with other drugs, so inform healthcare providers of any other medications being taken. This medication is not used in children and adolescents as safety and efficacy have not been established. There is no specific antidote for overdose, so seek medical care immediately if symptoms occur. 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

Angioedema, urticaria, Stevens-Johnson syndrome, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties with cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness,

Mild side effects

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

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

Storage

This medication should be stored in a container that shields it from light and prevents air from entering, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain its efficacy for a longer period.

Appearance and packaging

Appearance

Brown 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.