Medication info
Rosuvastatin/Amlodipine 5/5 mg Tablet

Rosuvastatin/Amlodipine 5/5 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
Orange, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201803562 · Approved 2018.08.31 · Insurance code 642105230

Summary

Main use
Treatment for improvement of hypertension and angina, reduction of risks for hyperlipidemia and cardiovascular diseases
Who takes it
Adults
Adult dose
Adults: Amlodipine is taken orally once a day at a starting dose of 5 mg, which may be increased up to a maximum of 10 mg per day according to the patient's response. Adjust the dosage appropriately according to symptoms. Rosuvastatin: The initial dose is 5 mg taken once a day, and the maintenance dose is 10 mg once a day, where most patients are adjusted at this dose. The maintenance dose should be adjusted every 4 weeks or longer based on LDL cholesterol levels, treatment goals.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Treatment for improvement of hypertension and angina, reduction of risks for hyperlipidemia and cardiovascular diseases

  • Hypertension
  • fixed occlusion of coronary arteries
  • coronary vasospasm
  • vascular contraction
  • ischemic heart disease
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hyperlipidemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
View approved original text

This medicine is used for patients who need to take both amlodipine and rosuvastatin simultaneously. Amlodipine helps improve blood flow disorders in the heart and blood vessels due to hypertension, stable angina, and variant angina, and reduces the risk of hospitalization due to angina and the risk associated with coronary artery revascularization. Rosuvastatin is primarily used to improve hyperlipidemia and dyslipidemia, and is utilized as an adjunctive treatment when dietary or exercise control is insufficient. Additionally, it effectively reduces cardiovascular disease risk, lowering the risks of stroke, myocardial infarction, and arterial revascularization procedures. The combination of these two medications effectively manages both hypertension and dyslipidemia, improving the occurrence and progression of cardiovascular diseases.

How to take

Adult dose

Adults: Amlodipine is taken orally once a day at a starting dose of 5 mg, which may be increased up to a maximum of 10 mg per day according to the patient's response. Adjust the dosage appropriately according to symptoms. Rosuvastatin: The initial dose is 5 mg taken once a day, and the maintenance dose is 10 mg once a day, where most patients are adjusted at this dose. The maintenance dose should be adjusted every 4 weeks or longer based on LDL cholesterol levels, treatment goals.

Precautions

This medicine should not be used by individuals who are allergic to any ingredients included in this medication or to similar classes of drugs. It is safer for women who are pregnant or may become pregnant, as well as those who are breastfeeding, to avoid using this medicine. Patients with severe liver dysfunction or active liver disease should not take this medicine. Patients with severe aortic stenosis, those in a state of shock, and patients with muscle disorders should avoid this medicine. Patients with very poor kidney function or those taking certain medications should exercise caution, particularly those at higher risk for muscle-related side effects should avoid this medicine. Patients with very low blood pressure, patients undergoing dialysis for renal failure, elderly patients, and patients with muscle weakness should use this medicine with caution. This medicine can affect liver function, so it is important to regularly check liver function before and during treatment. If symptoms of muscle pain or weakness occur, consult a doctor immediately, and in severe cases, discontinuing the medication may be necessary. This medicine may interact with certain medications, so inform your healthcare provider if you are taking other drugs. Pregnant or breastfeeding women should not use this medicine, and women who may become pregnant should use appropriate contraceptive methods. There is no established safety and effectiveness for pediatric use, thus it is not recommended for children. The general dosage is recommended for the elderly, but caution may be needed depending on their condition. In the case of overdose, hypotension and heart-related problems may occur, so visit a medical institution immediately and receive appropriate emergency treatment. Store the medicine out of reach of children, and keep it in its original container, as transferring it to another container could lead to accidents or degradation of 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 fever, blisters, peeling skin, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities associated with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • muscle pain
  • weakness
  • fatigue
  • lethargy
  • joint pain
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  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • diarrhea
  • heaviness in the head
  • flushing
  • decreased tolerance to glucose
  • weakness
  • hair loss
  • excessive sweating
  • purpura
  • skin discoloration
  • thrombocytopenia
  • cough
  • rhinitis
  • urinary disorders
  • increased frequency of urination
  • nocturia
  • erectile dysfunction
  • taste disturbances
  • tremors
  • extrapyramidal disorders
  • rash
  • itching
  • skin redness
  • spots

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

Storage

Store this medicine in a sealed container to protect it from air and moisture. It is recommended to keep the storage temperature between 1°C and 30°C. This way, the effectiveness and safety of the medicine can be well maintained.

Appearance and packaging

Appearance

Orange, round 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.