Medication info
Rosuvastatin and Amlodipine Tablets 10/10 mg

Rosuvastatin and Amlodipine Tablets 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletAmlodipine Besylate›13.889mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
Pale orange round film-coated tablet
Packaging
30 tablets / bottle
Approval status
Active

MFDS item code 201901087 · Approved 2019.02.21 · Insurance code 642105400

Summary

Main use
Reduction of cardiovascular disease risk through improvement of myocardial ischemia due to hypertension and angina and control of hypercholesterolemia.
Who takes it
Adults
Adult dose
This medication is for adults only. Amlodipine: Take 5 mg orally once daily, with the maximum dose incrementally increased to 10 mg per day based on the patient's response. Rosuvastatin: The initial dose is 5 mg taken orally once daily, with the maintenance dose adjusted as needed to 10 mg once daily. The maintenance dosage should be adjusted according to the patient's response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Reduction of cardiovascular disease risk through improvement of myocardial ischemia due to hypertension and angina and control of hypercholesterolemia.

  • Hypertension
  • fixed closure of coronary arteries
  • coronary vasospasm
  • vasoconstriction
  • myocardial ischemia
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
View approved original text

This medication is used for patients who require simultaneous treatment with both amlodipine and rosuvastatin. Amlodipine treats hypertension and myocardial ischemia caused by stable and variant angina, reducing the risk of hospitalization due to angina and coronary artery revascularization. Rosuvastatin is used as an adjunct in cases of hypercholesterolemia and familial hypercholesterolemia where dietary control is difficult. Additionally, it helps to delay the progression of atherosclerosis in patients with hypercholesterolemia and reduces the risk of stroke, myocardial infarction, and revascularization in patients at high risk for cardiovascular disease. Therefore, this medication is used to manage hypertension, angina, and the combined risks of hyperlipidemia and cardiovascular disease.

How to take

Adult dose

This medication is for adults only. Amlodipine: Take 5 mg orally once daily, with the maximum dose incrementally increased to 10 mg per day based on the patient's response. Rosuvastatin: The initial dose is 5 mg taken orally once daily, with the maintenance dose adjusted as needed to 10 mg once daily. The maintenance dosage should be adjusted according to the patient's response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Precautions

This medication should not be used in patients with allergies to any of its specific components. Pregnant or potentially pregnant women and nursing mothers should not take this medication, and effective contraception should be used if treatment is necessary. Patients with severe liver dysfunction or active liver disease should not take this medication either. Caution is also required in patients with severe aortic stenosis, those in shock, or with muscle diseases. Furthermore, it is prohibited for patients on specific immunosuppressants or those with severe kidney failure. Patients with a history of muscle disorders, alcoholism, hypothyroidism, etc., should be particularly cautious with high doses. Severe hypotension patients, dialysis patients, elderly patients, and those with severe muscle weakness should use this medication with caution. Patients with a history of liver disease or excessive alcohol consumption should have regular liver function tests. If symptoms related to muscle such as muscle pain, weakness, or cramps occur, consult a doctor immediately, and discontinuation and blood testing may be necessary. Caution is required during testing as muscle enzymes may elevate due to exercises or other reasons. This medication may rarely cause side effects such as headaches, dizziness, constipation, muscle pain, and swelling. Discontinuation of the drug and consultation with medical professionals is required if severe skin rashes or allergic reactions occur. This medication can interact with other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Particular caution is required when taking it with specific antibiotics, immunosuppressants, and fibrate drugs. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use effective contraception during treatment. Safety in children has not been established, so it should not be used in pediatric patients. In cases of overdose, symptoms such as severe hypotension, increased heart rate, and shock may occur, requiring immediate medical attention and appropriate emergency treatment. This medication should be kept out of reach of children and stored in its original container to prevent misuse and deterioration of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, mouth/eye mucosal pain, jaundice (yellowness of skin or eyes), extreme lethargy, sudden severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, markedly reduced urine output, severe swelling with increased blood pressure, angioedema.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • weakness
  • fatigue
  • malaise
  • weight gain or loss
  • vasculitis
Show 26 more
  • tension elevation
  • sensory loss
  • sensory abnormalities
  • taste abnormalities
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hypertrophy
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • muscle pain
  • cough
  • rhinitis
  • hair loss
  • sweating
  • purpura
  • skin discoloration
  • toxicity.

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

Storage

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly closed container. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius. This way, the efficacy of the medication can be preserved for a long time.

Appearance and packaging

Appearance

Pale 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.