Medication info
Rosuvastatin Tablets 10/80 mg

Rosuvastatin Tablets 10/80 mg

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

MFDS item code 202003912 · Approved 2020.05.27 · Insurance code 649104910

Summary

Main use
(Improvement of hypertension, heart failure) and (reduction of hyperlipidemia, cardiovascular disease risk)
Who takes it
Adults
Adult dose
Rosuvastatin Tablets 10/80 mg is indicated for adults only, and the dosage should be individualized based on the effects and tolerability of valsartan and rosuvastatin in each patient. ◆ Valsartan 1. Essential hypertension: The recommended dose is 80 mg orally once daily; it can be increased to a maximum of 320 mg daily if blood pressure control is challenging. 2. Heart failure: Start with 40 mg orally twice daily and can increase to 80 mg or 160 mg.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

(Improvement of hypertension, heart failure) and (reduction of hyperlipidemia, cardiovascular disease risk)

  • Essential hypertension
  • heart failure
  • left ventricular failure
  • left ventricular systolic dysfunction
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hyperlipidemia
  • primary dysbetalipoproteinemia
  • risk factors for coronary artery disease
  • hypertension
View approved original text

This medication is used for patients who require simultaneous administration of two drugs: valsartan and rosuvastatin. Valsartan is administered to treat essential hypertension, heart failure patients who cannot take ACE inhibitors, and to reduce mortality risk after myocardial infarction. Rosuvastatin is used as an adjunct therapy for patients with hyperlipidemia and familial hypercholesterolemia when diet and exercise are insufficient. Furthermore, it helps delay the progression of atherosclerosis and reduce the risk of cardiovascular diseases. By using these two drugs together, it improves blood pressure control, lipid management, and cardiovascular disease prevention.

How to take

Adult dose

Rosuvastatin Tablets 10/80 mg is indicated for adults only, and the dosage should be individualized based on the effects and tolerability of valsartan and rosuvastatin in each patient. ◆ Valsartan 1. Essential hypertension: The recommended dose is 80 mg orally once daily; it can be increased to a maximum of 320 mg daily if blood pressure control is challenging. 2. Heart failure: Start with 40 mg orally twice daily and can increase to 80 mg or 160 mg.

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 upon confirmation of pregnancy. Additionally, it is contraindicated in patients with allergies to this drug or severely impaired liver or kidney function, and those with certain genetic disorders. Elderly patients, those with compromised liver function, and heart disease patients require special attention during use, and dosage adjustment or frequent monitoring is necessary. This medication can cause serious side effects related to muscles, such as myalgia or muscle weakness, and rarely muscle rupture, so if muscle pain worsens, consult a doctor immediately. Side effects such as abnormal liver function, dyspepsia, headache, and dizziness may occur, so if symptoms persist or worsen, inform a healthcare professional. Interactions with other medications may occur; therefore, inform your healthcare provider if you are taking any other medications, especially potassium-sparing diuretics, certain antibiotics, and immunosuppressants. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women should stop breastfeeding while taking this medication. The safety and efficacy in pediatric patients under 18 years of age have not been established, so it is preferable not to use it in this population. In case of overdose, since there is no specific antidote, you should visit a medical institution immediately for appropriate treatment. This medication should be stored out of the reach of children, and it is advisable to avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), difficulty breathing, chest tightness, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizures, consciousness confusion, vision abnormalities, paralysis, etc.

Mild side effects

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

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

Storage

This medication should be stored in a tightly sealed container that blocks light, at a temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the efficacy of the drug.

Appearance and packaging

Appearance

Pink round film-coated tablet

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.