Medication info
Robartan Tablet 10/160 mg

Robartan Tablet 10/160 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP) * 3]
Approval status
Active

MFDS item code 202003859 · Approved 2020.05.26 · Insurance code 646005090

Summary

Main use
Effects of reducing the risk of cardiovascular diseases such as treatment of hypertension, heart failure, and improvement of hypercholesterolemia
Who takes it
Adults · Children
Adult dose
This drug is administered only to adults, with Valsartan recommended at an oral dose of 80 mg once daily. In cases of poorly controlled blood pressure, the dose can be increased to 160 mg daily, and can be increased up to a maximum of 320 mg. For elderly patients (75 years and older) and those with kidney impairment, fluid depletion, or liver impairment, starting dose is 40 mg once daily. In cases of heart failure, the initial dose is recommended at 40 mg orally twice daily.
Child dose
Safety and effectiveness have not been established in children and adolescents under 18 years of age, and it should not be administered.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Effects of reducing the risk of cardiovascular diseases such as treatment of hypertension, heart failure, and improvement of hypercholesterolemia

  • 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 drug is used for patients who need to take both Valsartan and Rosuvastatin simultaneously. Valsartan helps reduce the risk of essential hypertension, heart failure, and mortality after myocardial infarction. It is especially useful for heart failure patients who are intolerant to ACE inhibitors. Rosuvastatin is used for dyslipidemias such as hypercholesterolemia, combined hyperlipidemia, and dysbetalipoproteinemia, and is administered as an adjunct when dietary control is not sufficient. It also helps lower the risk of cardiovascular diseases and stroke, myocardial infarction, and vascular reconstructive surgery. Therefore, this drug is used to improve blood pressure and blood lipid levels, enhancing cardiovascular health.

How to take

Adult dose

This drug is administered only to adults, with Valsartan recommended at an oral dose of 80 mg once daily. In cases of poorly controlled blood pressure, the dose can be increased to 160 mg daily, and can be increased up to a maximum of 320 mg. For elderly patients (75 years and older) and those with kidney impairment, fluid depletion, or liver impairment, starting dose is 40 mg once daily. In cases of heart failure, the initial dose is recommended at 40 mg orally twice daily.

Child dose

Safety and effectiveness have not been established in children and adolescents under 18 years of age, and it should not be administered.

Precautions

This drug can cause serious harm to the fetus when used during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. Women of childbearing potential should ensure appropriate contraception before taking this drug, and it must not be used during pregnancy. Patients with severe liver or kidney dysfunction, a history of angioedema, or myopathy cannot take this drug. Elderly patients or those with high serum potassium levels or liver impairment should take this drug with special caution and may require regular monitoring. This drug may cause muscular side effects such as myalgia, myopathy, and, rarely, rhabdomyolysis, so if muscle pain or weakness occurs, medical personnel must be informed immediately. Symptoms such as abnormal liver function, dyspepsia, headache, dizziness, and nausea may occur, and if severe symptoms arise, usage should cease and a doctor should be consulted. Interactions may occur when taken with other medications, so if other drugs are being taken, they must be disclosed, especially when used with potassium-sparing diuretics, certain antibiotics, or fibrate class medications. This drug is not recommended for breastfeeding women; during breastfeeding, either the drug should be avoided, or breastfeeding should be stopped. In case of overdose, contact medical personnel immediately and receive needed treatment, as there is no specific antidote and symptom-based treatment is important. Safety for children and adolescents has not been established, and it is advisable not to administer to those under 18 years of age. Patients are advised to regularly monitor blood pressure, liver function, kidney function, and blood tests during treatment. Keep this drug in a place inaccessible to children and avoid transferring it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, difficulty breathing, asthma attacks, respiratory issues along with cough+fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver dysfunction (jaundice), sudden and severe headache, thunderclap headache, seizures.

Mild side effects

Dyspepsia, nausea, dizziness, headache, conjunctival hemorrhage, constipation, asthenia, chest pain, facial edema, peripheral edema, nasopharyngitis, urinary tract infection, bruising, increased serum aminotransferases (AST, ALT), increased serum creatine phosphokinase, increased serum potassium, increased gamma-glutamyl transferase, musculoskeletal stiffness, limb pain, decreased sensation, anxiety, upper respiratory infection, edema, insomnia, redness, decreased libido.

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

Storage

This drug may be sensitive to light, so it should be stored in a tightly sealed container that blocks light. Additionally, it is recommended to store the drug at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help ensure the effectiveness of the drug.

Appearance and packaging

Appearance

Pink oval 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.