Medication info
Amoratanal Tablet 5/160/5 mg

Amoratanal Tablet 5/160/5 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Pale yellow-pink oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202108063 · Approved 2021.12.21 · Insurance code 648604370

Summary

Main use
(Hypertension, dyslipidemia) Improvement and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
This medication should be taken once daily with water. It is recommended to take it at the same time daily (e.g., before breakfast). The amlodipine/valsartan combination is administered at the following doses in patients whose blood pressure is not adequately controlled with amlodipine or valsartan alone: 5/80 mg for patients whose blood pressure is inadequately controlled with 5 mg of amlodipine or 80 mg of valsartan alone, 5/160 mg.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

(Hypertension, dyslipidemia) Improvement and reduction of cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease risk factors
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used in patients with essential hypertension who have difficulty controlling blood pressure with monotherapy and combines amlodipine and valsartan. Additionally, rosuvastatin is administered as an adjunct in patients with hypercholesterolemia and dyslipidemia when diet alone does not suffice, to lower blood cholesterol levels and delay the progression of atherosclerosis. In high-risk cardiovascular disease patients, it also reduces the risks of myocardial infarction, stroke, and vascular revascularization procedures. Therefore, this medication is used to manage hypertension and dyslipidemia together and improve cardiovascular health.

How to take

Adult dose

This medication should be taken once daily with water. It is recommended to take it at the same time daily (e.g., before breakfast). The amlodipine/valsartan combination is administered at the following doses in patients whose blood pressure is not adequately controlled with amlodipine or valsartan alone: 5/80 mg for patients whose blood pressure is inadequately controlled with 5 mg of amlodipine or 80 mg of valsartan alone, 5/160 mg.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during pregnancy, especially in the second and third trimesters; therefore, it should be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to any components of this medication, severe hepatic impairment, biliary obstruction, or severe renal impairment should not use it. Caution is advised in patients with diabetes, reduced renal function, a history of angioedema, severe cardiac valvular disease, etc. Particularly in patients who are sodium- or fluid-depleted, hypotension may occur; therefore, status should be carefully checked before administration, and blood pressure and symptoms should be closely monitored during administration. Patients with high potassium levels should exercise caution when using potassium supplements or potassium-sparing diuretics and should have potassium levels frequently monitored. The safety of this medication has not been established in kidney transplant patients, thus caution is required for its use. If angioedema occurs, administration should be discontinued immediately, and it should not be re-administered. In patients with heart failure or following myocardial infarction, there is a possibility of worsening renal function or hypotension, necessitating regular monitoring of blood pressure and renal function. In patients with acute myocardial infarction or aortic stenosis, caution should be taken as the medication may worsen angina or cardiac symptoms. Some components of this medication may affect liver function, so dosage adjustment may be required for patients with poor liver function. Rosuvastatin can cause muscle pain, myopathy, and, rarely, rhabdomyolysis; hence, if muscle pain or weakness occurs, the doctor should be notified immediately. Dizziness or fatigue may occur when driving or operating machinery during the treatment, so caution is warranted. This medication can interact with various drugs, so inform the doctor or pharmacist of any other medications being taken. Women who are pregnant or breastfeeding should not take this medication, and effective contraception should be used if planning pregnancy. Elderly patients should start at a lower dosage and gradually increase to avoid excessive blood pressure reduction. In case of overdose, severe hypotension, shock, and heart failure may occur, requiring immediate emergency treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pale skin, severe rash with fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice of skin or eyes, extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output, total

Mild side effects

  • Peripheral edema
  • warmth
  • flank pain
  • sore throat
  • dizziness
  • sensory disturbances
  • nasopharyngitis
  • influenza
  • visual impairment
  • anxiety
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  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pain in the throat and larynx
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • diaphoresis
  • pruritus
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • lethargy

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to ensure the prolonged efficacy and safety of the medication.

Appearance and packaging

Appearance

Pale yellow-pink oval film-coated tablet

Package unit

30 tablets/bottle, 100 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.