Medication info
Rosuvastatin/Amlodipine Tablets 20/10 mg

Rosuvastatin/Amlodipine Tablets 20/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletAmlodipine Besylate›13.889mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201803559 · Approved 2018.08.31

Summary

Main use
(Hypertension, angina) Improvement of myocardial ischemia and (hypercholesterolemia) inhibition of the progression of atherosclerosis
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 rosuvastatin/amlodipine components for each patient. Amlodipine: For adults, administer 5mg orally once daily, with the dose able to be increased to a maximum of 10mg per day based on patient's response. Rosuvastatin: The initial dose is 5mg once daily, and the maintenance dose is 10mg once daily for most patients.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

(Hypertension, angina) Improvement of myocardial ischemia and (hypercholesterolemia) inhibition of the progression of atherosclerosis

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

This medication is used for patients who need to take both amlodipine and rosuvastatin. Amlodipine helps treat hypertension and myocardial ischemia caused by stable and variant angina, and reduces the risk of angina and coronary revascularization in patients with coronary artery disease. Rosuvastatin is effective in improving hypercholesterolemia and dyslipidemia, and is used as an adjunct to dietary therapy, especially in patients with familial hypercholesterolemia. It also plays a role in reducing the risk of cardiovascular events, including stroke, myocardial infarction, and revascularization procedures. Thus, both medications are used to improve cardiovascular health by controlling blood pressure and cholesterol levels.

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 rosuvastatin/amlodipine components for each patient. Amlodipine: For adults, administer 5mg orally once daily, with the dose able to be increased to a maximum of 10mg per day based on patient's response. Rosuvastatin: The initial dose is 5mg once daily, and the maintenance dose is 10mg once daily for most patients.

Precautions

This medication should not be used in patients who are allergic to specific ingredients. It should not be administered to pregnant or potentially pregnant women, or nursing mothers, and should only be used with caution in cases where the likelihood of pregnancy is deemed low. It should be avoided in patients with severely impaired liver function or active liver disease, severe aortic stenosis, shock state, myopathy, and in patients who are taking certain medications concurrently. This medication is also not recommended for patients with severely impaired kidney function. Particular caution is required for patients with a history of muscle disease or at risk of muscle toxicity, and should a patient experience muscle pain or weakness, immediate consultation with a healthcare professional is necessary. During treatment, it is advisable to regularly monitor liver enzyme tests, and if symptoms of liver dysfunction arise, the medication should be immediately discontinued. Dosing adjustments and monitoring should be done carefully for the elderly, those with renal failure, and patients with low blood pressure. This medication may interact with other drugs, so it is essential to inform healthcare providers of any current medications being taken. It should not be used during pregnancy or nursing, and appropriate contraceptive measures should be taken if planning to conceive. Safety and efficacy have not been established for pediatric use, so it is advisable not to administer it to children. In case of overdose, immediate visit to a medical institution for appropriate treatment is necessary, and the medication should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (including angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions
  • Severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions (Stevens-Johnson syndrome, DRESS, etc.)
  • Shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever
  • Yellowing of the skin or eyes (jaundice), severe systemic reaction

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • muscle pain
  • weakness
  • fatigue
  • sensory disturbances
  • itching
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  • rash
  • hair loss
  • sweating
  • purpura
  • urinary difficulty
  • cough
  • dyspnea
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • erectile dysfunction
  • joint pain
  • muscle cramping
  • musculoskeletal pain
  • dry mouth
  • pruritus
  • hypotension
  • vasculitis
  • palpitations
  • drowsiness
  • heaviness
  • warmth
  • impaired glucose tolerance
  • weakness
  • heightened tension
  • sensory reduction
  • sensory disturbances
  • peripheral neuropathy

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow 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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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.