Medication info
Valsartan and Rosuvastatin Tablets 5/80 mg

Valsartan and Rosuvastatin Tablets 5/80 mg

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

MFDS item code 202003852 · Approved 2020.05.26 · Insurance code 649807660

Summary

Main use
(Hypertension, heart failure) treatment and improvement of hypercholesterolemia, and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
◆ Valsartan 1. Essential Hypertension Take with water with meals or between meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. Adult: The recommended dose is 80 mg orally once daily. If blood pressure is not well controlled, the dose can be increased to 160 mg daily or diuretics may be added, up to a maximum of 320 mg daily. Elderly (age 75 years and older): Start at 40 mg orally once daily.
Child dose
Pediatric: Safety and efficacy in pediatric patients and adolescents under 18 years of age have not been established.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

(Hypertension, heart failure) treatment and improvement of hypercholesterolemia, and reduction of cardiovascular disease risk

  • Primary hypertension
  • heart failure
  • heart failure intolerant to ACE inhibitors
  • left ventricular failure
  • left ventricular systolic dysfunction
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
View approved original text

This medication is prescribed only for patients who use both valsartan and rosuvastatin together. First, valsartan is used to treat hypertension and heart failure patients, as well as to reduce the risk of death in patients with left ventricular dysfunction following myocardial infarction. Valsartan is also effective in heart failure patients who are intolerant to ACE inhibitors. Rosuvastatin is used primarily as an adjunct in patients with hypercholesterolemia and mixed dyslipidemia when diet and exercise are inadequate. It also helps treat patients with homozygous familial hypercholesterolemia and dysbeta-lipoproteinemia. In patients with hypercholesterolemia, it effectively lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis, and reduces the risk of cardiovascular diseases, strokes, and myocardial infarction. Therefore, this medication is used for hypertension, heart failure, management after myocardial infarction, and reduction of hyperlipidemia and cardiovascular disease risk.

How to take

Adult dose

◆ Valsartan 1. Essential Hypertension Take with water with meals or between meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. Adult: The recommended dose is 80 mg orally once daily. If blood pressure is not well controlled, the dose can be increased to 160 mg daily or diuretics may be added, up to a maximum of 320 mg daily. Elderly (age 75 years and older): Start at 40 mg orally once daily.

Child dose

Pediatric: Safety and efficacy in pediatric patients and adolescents under 18 years of age have not been established.

Precautions

This medication can cause serious harm to the fetus when taken during pregnancy, particularly in the second and third trimesters; therefore, it should be discontinued immediately upon confirmation of pregnancy. Pregnant women, those who may become pregnant, and lactating women should not use this medication, and women of childbearing age not using adequate contraception should also avoid taking it. This medication should not be administered to patients with severely impaired liver function, muscle disorders, or severe renal failure. Caution is advised for the elderly, patients with elevated potassium levels, and those with mildly impaired liver function while using this medication. Because this medication lowers blood pressure, there is a risk of dizziness or fainting when first taking it or increasing the dosage. Regular monitoring of kidney function and electrolyte levels is necessary to check for abnormalities. If symptoms like muscle pain, weakness, fatigue, or fever occur, contact medical personnel immediately. Patients at risk of muscle damage should exercise particular caution. As this medication can affect liver function, regular liver function tests are also recommended. There may be interactions when taking it with other medications, so inform healthcare providers about any other medications being taken, especially potassium-sparing diuretics or potassium supplements, as they may increase serum potassium levels. It is safest not to use this medication during pregnancy or breastfeeding, and women planning to become pregnant should consult with a healthcare provider before taking it. Safety and efficacy for children and adolescents have not been established, so it is recommended not to use it in individuals under 18 years of age. In case of overdose, visit a medical facility immediately for appropriate treatment as there is no specific antidote, and treatment will depend on the symptoms. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pale appearance, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory problems accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headaches, lightning-like headaches, seizures, consciousness disturbances, visual disturbances

Mild side effects

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

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 an opaque container that does not allow light to enter. Additionally, it is best stored at room temperature between 1°C and 30°C. This storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Yellow, 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.