Medication info
Rovelitol Tablet 150/10 mg (Irbesartan, Atorvastatin)

Rovelitol Tablet 150/10 mg (Irbesartan, Atorvastatin)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletIrbesartan›150mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 30 tablets/box [10 tablets/PTPX3], 100 tablets/bottle
Approval status
Active

MFDS item code 201309481 · Approved 2013.09.27 · Insurance code 643506680

Summary

Main use
(Hypertension, diabetic kidney disease) improvement and (myocardial infarction, stroke, etc.) risk reduction
Who takes it
Adults
Adult dose
This medication is for adults only and should be individualized based on the effectiveness and tolerability of each component, Irbesartan/Atorvastatin. Irbesartan - Essential hypertension: Administer 150 mg orally once daily, and if sufficient effect is not achieved, may increase to 300 mg. - Kidney disease in patients with hypertension and type 2 diabetes: Start with 150 mg orally once daily and can increase to 300 mg.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

(Hypertension, diabetic kidney disease) improvement and (myocardial infarction, stroke, etc.) risk reduction

  • Essential hypertension
  • hypertension
  • kidney disease
  • coronary heart disease
  • myocardial infarction
  • stroke
  • angioplasty
  • stable chronic angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • angina
View approved original text

This medication is prescribed only for patients who need to use both Irbesartan and Atorvastatin simultaneously. Irbesartan is primarily used for the treatment of essential hypertension and kidney disease in patients with hypertension and type 2 diabetes. Atorvastatin helps reduce the risk of cardiovascular disease and is used in the treatment of hyperlipidemia. In particular, it lowers the risk of myocardial infarction, stroke, angioplasty, and angina, and also reduces cardiovascular risks in patients with type 2 diabetes. Additionally, it is effective in improving cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Therefore, this medication is used for patients who wish to manage both hypertension and cardiovascular disease risk.

How to take

Adult dose

This medication is for adults only and should be individualized based on the effectiveness and tolerability of each component, Irbesartan/Atorvastatin. Irbesartan - Essential hypertension: Administer 150 mg orally once daily, and if sufficient effect is not achieved, may increase to 300 mg. - Kidney disease in patients with hypertension and type 2 diabetes: Start with 150 mg orally once daily and can increase to 300 mg.

Precautions

This medication must not be taken during pregnancy. If pregnancy is confirmed, discontinue the medication immediately, as it can cause severe damage to the fetus and newborn. This medication should be used with caution in patients with poor liver or kidney function, and it is advisable not to administer it in cases of severe liver or kidney disease. If symptoms of muscle pain or weakness occur, consult a doctor immediately, as severe cases can lead to rhabdomyolysis, which may damage muscle tissue. Hyperkalemia may occur, so potassium levels in the blood should be monitored periodically, and it is advised to avoid co-administration with potassium supplements or potassium-sparing diuretics. This medication can be taken with other antihypertensive medications or antidiabetic agents, but due to potential drug interactions that may increase side effects, a consultation with a doctor or pharmacist is recommended during treatment. Dizziness or fatigue may occur, so caution is needed when driving or operating machinery. If hepatic impairment or jaundice symptoms appear, stop taking the medication immediately and inform healthcare personnel. It is advisable not to use this medication in children and adolescents under 18 years of age, as its safety and efficacy have not been established. In elderly patients, the risk of stroke may increase due to excessively low blood pressure, so it is essential to start with a low dose and monitor the condition closely. Overdose may lead to symptoms such as hypotension and tachycardia, and since no specific antidote exists, treatment should be provided according to symptoms. This medication should be stored out of reach of children and kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral or ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urination problems

Mild side effects

  • Palpitations
  • chest discomfort
  • headache
  • elevated blood triglycerides
  • diarrhea
  • dyspepsia
  • vomiting
  • gastrointestinal disturbances
  • gastritis
  • dental pain
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  • dizziness
  • low back pain
  • muscle pain
  • nasal hemorrhage
  • rhinorrhea
  • chest pain
  • fatigue
  • asthenia
  • nasopharyngitis
  • upper respiratory tract infection
  • sprains
  • hyponatremia
  • elevated serum creatine phosphokinase
  • hematuria
  • elevated γ-GTP
  • elevated blood pressure
  • hypotension
  • localized numbness
  • worsened dizziness
  • worsened headache
  • skin rash
  • intervertebral disc herniation

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a temperature between 1°C and 30°C. This will help preserve the efficacy and safety of the medication for a longer duration.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 30 tablets/box [10 tablets/PTPX3], 100 tablets/bottle

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.