Medication info
Rovato 5mg/20mg

Rovato 5mg/20mg

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium›20.72mg / 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 200807377 · Notified 2008.07.03 · Insurance code 660702190

Summary

Main use
Reduction of the risk of hypertension and coronary artery disease (myocardial infarction, stroke) and improvement of dyslipidemia
Who takes it
Adults
Adult dose
For Amlodipine (escalated amlodipine), the standard dose is 5 (2.5) mg orally once a day, and it can be increased to a maximum of 10 (5) mg per day depending on the patient's response. Atorvastatin is initiated at 10 mg once a day and can be administered up to 80 mg, adjusting the dose according to therapeutic goals and responses. It can be taken at any time of the day, regardless of food.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Reduction of the risk of hypertension and coronary artery disease (myocardial infarction, stroke) and improvement of dyslipidemia

  • Hypertension
  • fixed obstruction of the coronary artery
  • vasospasm
  • vasoconstriction
  • myocardial ischemia
  • angina
  • multiple risk factors for coronary heart disease
  • myocardial infarction
  • stroke
  • vascular reconstruction
  • chronic stable angina
  • retinopathy
View approved original text

This medication is suitable for patients who require the combined use of the two drugs, Amlodipine and Atorvastatin. Amlodipine helps improve myocardial ischemia occurring in high blood pressure and stable or variant angina. Additionally, it reduces hospitalization risk for angina and risk for vascular reconstruction in patients with coronary artery disease who do not have heart failure or low cardiac output. Atorvastatin is effective in reducing the risk of myocardial infarction, stroke, and vascular procedures, particularly benefiting patients with multiple risk factors or diabetes. It is also used for the treatment of hypercholesterolemia and dyslipidemia, contributing to the prevention of cardiovascular diseases by improving blood lipid levels. Thus, this medication is used to comprehensively improve cardiovascular health by controlling blood pressure and blood lipid levels.

How to take

Adult dose

For Amlodipine (escalated amlodipine), the standard dose is 5 (2.5) mg orally once a day, and it can be increased to a maximum of 10 (5) mg per day depending on the patient's response. Atorvastatin is initiated at 10 mg once a day and can be administered up to 80 mg, adjusting the dose according to therapeutic goals and responses. It can be taken at any time of the day, regardless of food.

Precautions

This medication should not be used in certain patients. First, patients who are allergic to this medication or have experienced hypersensitivity reactions to similar medications should not take it. Additionally, patients with significantly impaired liver function, active liver disease, bile secretion cessation, or muscle disorders should also avoid taking this medication. Women who are pregnant or potentially pregnant, as well as nursing women, should not use this medication. Patients with muscle disorders, severe aortic stenosis, in shock, within one month post-myocardial infarction, or with unstable angina should also avoid using this medication. Patients receiving certain hepatitis treatments should also avoid this medication. This medication should be used with caution in patients with very poor kidney function, the elderly, those with a history of alcoholism, or liver disease. Patients at high risk for muscle damage, those with hypothyroidism, individuals with a family history of muscle disorders, and patients taking certain medications should undergo muscle enzyme testing before starting therapy. Patients with heart failure or hypertensive crises, mild to moderate liver dysfunction, or severe myasthenia gravis should use caution. This medication generally has good tolerability; however, rare side effects may occur, including skin rash, itching, muscle pain, headache, dizziness, indigestion, and fatigue. If symptoms of liver dysfunction or muscle pain intensify, it is essential to consult a doctor immediately. Patients should routinely undergo liver function tests and muscle-related examinations while on this medication, and if abnormal symptoms appear, they must discontinue the medication and notify healthcare personnel. Women who may become pregnant should use appropriate contraception during medication use, and if pregnancy is confirmed, they should immediately discontinue the medication. Nursing women are advised not to take this medication. The safety of this medication in children and the elderly has not been sufficiently established, so caution is warranted in their use. In the case of overdose, severe hypotension, reflex tachycardia, and shock may occur, which necessitates immediate emergency treatment, and blood dialysis may not be effective. This medication may interact with various other medications, so if the patient is taking other medications, they must inform healthcare providers, especially if the medications affect liver function or increase the risk of muscle damage. Finally, this medication should be stored out of reach of children, and transferring it to other containers is discouraged.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, breathlessness or difficulty in breathing, asthma attacks, respiratory issues accompanied by cough + fever, respiratory problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver dysfunction (jaundice), sudden and extreme

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • muscle tension increase
  • sensory loss/abnormal sensations
  • peripheral neuropathy
  • fainting
  • altered taste
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • indigestion
  • gingival hypertrophy
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • joint pain
  • low back pain
  • muscle cramps

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, preferably at room temperature between 15 to 30 degrees Celsius. This storage will help maintain the medication's effectiveness.

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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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.