Medication info
Robelito Tablet 300/10 mg (Irbesartan, Atorvastatin)

Robelito Tablet 300/10 mg (Irbesartan, Atorvastatin)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletIrbesartan›300mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Pale pink oval film-coated tablet
Packaging
30 tablets/ bottle, 30 tablets/ box [10 tablets/PTPX3]
Approval status
Active

MFDS item code 201401984 · Approved 2014.04.24 · Insurance code 643506880

Summary

Main use
Treatment for reduction of hypertension (essential, diabetic nephropathy) and cardiovascular risk (myocardial infarction, stroke)
Who takes it
Adults
Adult dose
This medication is administered to adults only, and the dosage should be individualized based on the efficacy and tolerability of Irbesartan/Atorvastatin each component. For Irbesartan, adults with essential hypertension should take 150 mg orally once a day, and this can be increased to 300 mg if the effect is insufficient. In the initial treatment, in patients on blood dialysis or those over 75 years old, 75 mg may be considered.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Treatment for reduction of hypertension (essential, diabetic nephropathy) and cardiovascular risk (myocardial infarction, stroke)

  • Essential hypertension
  • hypertension
  • nephropathy
  • myocardial infarction
  • stroke
  • vascular intervention
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • angina
  • hyperlipidemia
View approved original text

This medication contains two ingredients, Irbesartan and Atorvastatin, for use when combination therapy is needed in specific patients. First, Irbesartan is effective for the treatment of essential hypertension and helps prevent nephropathy in patients with Type 2 diabetes who have hypertension. Atorvastatin is used to reduce the risk of cardiovascular disease by lowering the risk of myocardial infarction and stroke in adults with multiple risk factors for coronary artery disease and in patients with Type 2 diabetes. Additionally, it helps reduce various risks related to myocardial infarction, stroke, vascular interventions, and congestive heart failure in patients who already have coronary artery disease. It is also effective in treating hyperlipidemia and is used to reduce total cholesterol and LDL cholesterol levels and increase HDL cholesterol levels in patients with various types of dyslipidemia that are difficult to control with diet. Thus, this medication helps improve heart and vascular health by controlling blood pressure and blood lipid levels.

How to take

Adult dose

This medication is administered to adults only, and the dosage should be individualized based on the efficacy and tolerability of Irbesartan/Atorvastatin each component. For Irbesartan, adults with essential hypertension should take 150 mg orally once a day, and this can be increased to 300 mg if the effect is insufficient. In the initial treatment, in patients on blood dialysis or those over 75 years old, 75 mg may be considered.

Precautions

This medication should not be used during pregnancy. If pregnancy is confirmed, use should be immediately discontinued as it can cause severe harm to the fetus and newborn. If severe muscle pain or weakness occurs, or if there is a significant increase in creatine kinase levels, use should be immediately discontinued and consulted with a physician. Patients with poor liver function or a history of liver disease should use this medication with caution and undergo regular liver function tests. Patients undergoing treatment for hypertension should closely monitor for changes in symptoms, as hypotension or symptoms such as dizziness or fainting may occur. The risk of side effects can increase when used with specific medications, so inform your physician or pharmacist if you are taking other medications. Since there is a risk of elevated potassium levels, patients with hyperkalemia or those taking potassium supplements should regularly check their serum potassium levels. This medication is not recommended for children, especially those under 18 years of age, as the safety and efficacy have not been established. For elderly patients, there is a risk of excessively low blood pressure, so treatment should start at a low dose, and patients should be carefully monitored. Overdosage can cause hypotension, tachycardia, and other symptoms, so strict adherence to the dosage is necessary, and immediate medical consultation is needed if abnormal symptoms occur. Store in a place out of reach of children and keep in the original container to avoid degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough + fever associated respiratory abnormalities, jaundice (yellowing of skin or eyes), general malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Palpitations
  • chest discomfort
  • headache
  • elevated blood triglycerides
  • diarrhea
  • dyspepsia
  • vomiting
  • gastrointestinal disturbances
  • gastritis
  • toothache
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  • dizziness
  • back pain
  • muscle pain
  • nasal bleeding
  • rhinitis
  • visual disturbances
  • macular degeneration
  • chest pain
  • fatigue
  • edema
  • weakness
  • nasopharyngitis
  • upper respiratory infection
  • sprains
  • hyponatremia
  • elevated creatine phosphokinase levels
  • hematuria
  • elevated γ-GTP
  • flushing
  • musculoskeletal trauma
  • anxiety
  • renal failure
  • weakness

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

Storage

This medication should be stored in a tightly sealed container to protect it from air or moisture. The storage temperature should be between 1 to 30 degrees Celsius, and it is advisable to avoid excessively hot or cold places.

Appearance and packaging

Appearance

Pale pink oval film-coated tablet

Package unit

30 tablets/ bottle, 30 tablets/ box [10 tablets/PTPX3]

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

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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.