Medication info
Rosuvastatin/Amlodipine Tablet 20/5 mg

Rosuvastatin/Amlodipine Tablet 20/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 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 201803561 · Approved 2018.08.31 · Insurance code 642105220

Summary

Main use
(Hypertension, Angina) Improvement of myocardial ischemia and (Hypercholesterolemia) Delayed progression of atherosclerosis
Who takes it
Adults
Adult dose
This medication is administered only to adults, and the dosage should be individualized based on the efficacy and tolerability of each component, amlodipine/rosuvastatin. ○ Amlodipine Adults: Administer 5 mg orally once daily, and the dose may be increased up to 10 mg daily based on patient response. ○ Rosuvastatin - The initial dose is 5 mg orally once daily. - The maintenance dose is 10 mg orally once daily for most patients.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

(Hypertension, Angina) Improvement of myocardial ischemia and (Hypercholesterolemia) Delayed progression of atherosclerosis

  • Hypertension
  • fixed blockage of coronary artery
  • coronary artery vasospasm
  • vascular constriction
  • myocardial ischemia
  • hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • stroke
  • myocardial infarction
View approved original text

This medication is used only for patients who require simultaneous administration of two drugs, amlodipine and rosuvastatin. Amlodipine is primarily used to treat hypertension and angina, especially ischemia due to coronary artery spasms or contractions. Additionally, it helps reduce the risk of hospitalization due to angina and the risk related to vascular interventions in patients with coronary artery disease who do not have heart failure. In contrast, rosuvastatin is used as an adjunct when dietary and exercise controls are insufficient for treating dyslipidemia such as hypercholesterolemia and mixed dyslipidemia. This medication effectively lowers cholesterol, slows the progression of atherosclerosis, and reduces the risk of cardiovascular disease, particularly helping to decrease the risks associated with stroke, myocardial infarction, and vascular revascularization. Therefore, this medication is used to improve cardiovascular health by managing blood pressure and lipid levels.

How to take

Adult dose

This medication is administered only to adults, and the dosage should be individualized based on the efficacy and tolerability of each component, amlodipine/rosuvastatin. ○ Amlodipine Adults: Administer 5 mg orally once daily, and the dose may be increased up to 10 mg daily based on patient response. ○ Rosuvastatin - The initial dose is 5 mg orally once daily. - The maintenance dose is 10 mg orally once daily for most patients.

Precautions

This medication should not be used by patients who are allergic to its components or similar types of medication. Women who are pregnant, may become pregnant, do not employ adequate contraceptives, or are breastfeeding should not use this medication and should consult a physician if necessary. Patients with severely impaired liver function, unexplained increased liver enzyme levels, or active liver disease should not take this medication. Patients with heart valve disease, in shock, or with muscle disorders, as well as those taking specific immunosuppressants, should also not use this medication. Patients with severely reduced kidney function (especially those with a creatinine clearance of less than 30 mL/min) are prohibited from using this medication. Patients at high risk of muscle disorder should especially avoid high doses of this medication, including those with kidney impairment, hypothyroidism, a family history of muscle disorders, alcoholism, Asians, and interactions with other specific medications. Patients with severe hypotension, those undergoing dialysis, elderly patients, and those with symptoms of muscle weakness should use this medication cautiously, regularly checking liver function and muscle-related symptoms. If symptoms such as muscle pain, weakness, cramps, fatigue, or fever occur while taking this medication, notify a physician immediately and stop the medication if necessary. This medication may affect liver function, so patients with a history of liver disease should be particularly careful and regularly monitor liver enzyme levels. This medication can rarely cause allergic reactions such as skin rashes, hives, and severe skin reactions, so consult medical staff immediately if any skin symptoms appear. Pregnant or breastfeeding women should refrain from using this medication to protect the health of the fetus and baby, and women planning to become pregnant should use proper contraceptive methods. The safety and efficacy of this medication have not been established in children; it is advisable not to use it in pediatric patients. In case of overdose, severe hypotension or cardiac problems may occur, requiring immediate medical treatment; as there is no specific antidote, symptomatic treatment will be necessary. This medication should be kept out of reach of children, stored in its original container, to prevent misuse or quality deterioration.

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, skin peeling, oral/ocular mucosal pain, dyspnea or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine changes

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • fatigue
Show 28 more
  • arthralgia
  • numbness
  • paresthesia
  • discomfort in chest
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • dysuria
  • diarrhea
  • cough
  • rhinitis
  • hair loss
  • sweating
  • purpura
  • thrombocytopenia
  • increased urination frequency
  • nocturia
  • tension increase
  • sensory loss
  • sensory disturbances
  • peripheral neuropathy
  • taste alterations
  • tremors
  • extrapyramidal symptoms

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

Storage

This medication should be kept in a tightly closed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 degree and 30 degrees.

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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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.