Medication info
Rovato 5mg/10mg

Rovato 5mg/10mg

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium›10.36mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200807374 · Notified 2008.07.03 · Insurance code 660702180

Summary

Main use
(Hypertension, Angina) Improvement of myocardial ischemia and reduction of risk for (cardiovascular diseases)
Who takes it
Adults
Adult dose
This medication is administered only to adults, and the dosing should be individualized based on the efficacy and tolerability of amlodipine/atorvastatin in each patient. Amlodipine (S-amlodipine): Take 5 (2.5) mg orally once daily, and may be increased up to 10 (5) mg daily based on patient response. Atorvastatin: Recommended initial dose for patients with primary hypercholesterolemia and mixed dyslipidemia.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

(Hypertension, Angina) Improvement of myocardial ischemia and reduction of risk for (cardiovascular diseases)

  • Hypertension
  • fixed obstructive coronary artery disease
  • coronary vasospasm
  • vascular contraction
  • myocardial ischemia
  • angina
  • cardiovascular disease
  • coronary artery heart disease
  • myocardial infarction
  • stroke
  • revascularization
  • chronic stable angina
View approved original text

This medication is used for patients who need to take both amlodipine (S-amlodipine), used to treat hypertension and angina, and atorvastatin, which regulates blood cholesterol levels to lower the risk of cardiovascular diseases. Amlodipine helps alleviate heart ischemia caused by hypertension and coronary artery disease, and reduces the risk of hospitalization and revascularization due to angina. Atorvastatin is effective in reducing the risk of cardiovascular events such as myocardial infarction, stroke, and angina, and is effective in treating hypercholesterolemia and dyslipidemia. The combination of these two medications helps improve the condition of patients at high risk for cardiovascular diseases. Therefore, this medication is used to improve cardiovascular health by managing blood pressure and blood lipids.

How to take

Adult dose

This medication is administered only to adults, and the dosing should be individualized based on the efficacy and tolerability of amlodipine/atorvastatin in each patient. Amlodipine (S-amlodipine): Take 5 (2.5) mg orally once daily, and may be increased up to 10 (5) mg daily based on patient response. Atorvastatin: Recommended initial dose for patients with primary hypercholesterolemia and mixed dyslipidemia.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication or similar class medications, have severe liver dysfunction, pregnant women or those who may become pregnant, breastfeeding women, patients with muscle disorders, patients with severe aortic stenosis, patients in cardiogenic shock, and patients within one month of a myocardial infarction should not take this medication. Additionally, patients with severely impaired kidney function, elderly patients, alcoholics, patients with a history of liver disease, and patients at risk for muscle disorders should exercise extra caution when taking this medication, and when necessary, blood tests should be conducted to check for muscle damage. This medication generally has good tolerability, but various side effects such as fatigue, edema, dizziness, headache, dyspepsia, and myalgia can occur. Especially if symptoms of myalgia or muscle weakness appear, consultation with a physician should be sought immediately. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use appropriate contraception while taking it. This medication may interact with other drugs; therefore, if patients are currently taking other medications, they must inform their physician or pharmacist. Special caution is needed when used in combination with certain antibiotics, antifungals, immunosuppressants, and some antiviral medications. In case of overdose, serious symptoms such as decreased blood pressure and impaired heart function may occur, so immediate medical attention is required, and this medication is not eliminated by dialysis, hence special treatment may be needed. The safety and efficacy of this medication in children and the elderly have not been sufficiently established, so it should be used cautiously under the guidance of a physician in these age groups. Finally, this medication should be kept out of the reach of children and should not be transferred to another container for safety.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • toxic epidermal necrolysis
  • severe allergic reaction
  • severe skin adverse reactions
  • difficulty breathing
  • asthma attacks
  • yellowing of the skin or eyes (jaundice)
  • liver abnormalities (jaundice)
  • sudden and severe headache
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  • seizures
  • confusion
  • vision changes
  • paralysis
  • severe neurological symptoms
  • drastically reduced urine output
  • severe generalized swelling
  • elevated blood pressure
  • severe edema
  • or urinary abnormalities.

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • malaise
  • pain
  • weight increase/decrease
  • hypotension
  • vasculitis
  • muscle tension
  • sensory loss/abnormal sensation
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • tremor
  • extrapyramidal disorder
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia (gastritis)
  • gingival hypertrophy
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • joint pain
  • low back pain
  • muscle

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. Also, it is best to store the medication at room temperature between 1°C and 30°C. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 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.