Medication info
Amoratanal Tablet 5/80/10 mg

Amoratanal Tablet 5/80/10 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Pink oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202108064 · Approved 2021.12.21 · Insurance code 648604380

Summary

Main use
Improves (hypertension, dyslipidemia) and reduces the risk of cardiovascular diseases.
Who takes it
Adults
Adult dose
Take 1 tablet once daily with water. It is recommended to take it at the same time each day (e.g., before breakfast). The amlodipine/valsartan combination is administered in doses of 5/80 mg, 5/160 mg, or 10/160 mg according to blood pressure control status. Rosuvastatin can be taken at any time of the day regardless of meals, starting with an initial dose of 5 mg, with a maintenance dose of.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Improves (hypertension, dyslipidemia) and reduces the risk of cardiovascular diseases.

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary atypical beta-lipoproteinemia
  • coronary heart disease risk factors
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • early family history of coronary heart disease
View approved original text

This drug is used for patients with essential hypertension whose blood pressure is not well controlled, combining amlodipine and valsartan. It is also suitable for patients receiving rosuvastatin simultaneously. Rosuvastatin is used as an adjunctive treatment when dietary therapy is ineffective for patients with hypercholesterolemia and dyslipidemia, and particularly helps patients with familial hypercholesterolemia. In addition, rosuvastatin contributes to delaying the progression of atherosclerosis and reducing the risk of cardiovascular diseases, strokes, and myocardial infarctions. Therefore, this drug effectively improves cardiovascular health through the management of blood pressure and cholesterol.

How to take

Adult dose

Take 1 tablet once daily with water. It is recommended to take it at the same time each day (e.g., before breakfast). The amlodipine/valsartan combination is administered in doses of 5/80 mg, 5/160 mg, or 10/160 mg according to blood pressure control status. Rosuvastatin can be taken at any time of the day regardless of meals, starting with an initial dose of 5 mg, with a maintenance dose of.

Precautions

This drug can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, and should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to this drug or similar medications, pregnant or breastfeeding women, patients with severe liver or kidney diseases, or those with a history of certain heart diseases or angioedema should not take this medication. Patients with sodium or fluid depletion must correct their condition before taking this drug, as hypotension may occur during treatment necessitating careful observation. Patients with high potassium levels or taking other medications that may increase potassium should frequently monitor their potassium levels. Patients with kidney problems or kidney transplant recipients should closely monitor their kidney function when taking this drug. If symptoms of angioedema occur, discontinue use immediately and do not re-administer. Patients with heart failure or those post-myocardial infarction require kidney function evaluation when taking this medication. There is no special dose adjustment needed for the elderly, but those over 75 years old should start at a lower dose and gradually increase. Dizziness or fatigue may occur during treatment, so take care when driving or operating machinery. This drug may affect the liver and muscles, necessitating periodic observation of liver function tests and muscle-related symptoms, and immediate consultation with a doctor if symptoms like muscle pain or weakness appear. Drug interactions may occur when combined with other medications, especially with diuretics, potassium-sparing agents, certain antibiotics or antifungals, and immunosuppressants. Therefore, adhere to professional guidance. Pregnant women or those planning a pregnancy should not take this medication, and breastfeeding mothers should avoid it or discontinue breastfeeding. This medication is not recommended for children under 18 years old. In the event of an overdose, symptoms such as hypotension, shock, and impaired cardiac function may appear, so immediate medical assistance should be sought, and emergency treatment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urine.

Mild side effects

  • Peripheral edema
  • warmth
  • increased ALT
  • increased AST
  • increased blood creatinine
  • flank pain
  • throat pain
  • dizziness
  • sensory loss
  • nasopharyngitis
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  • rash
  • rhinitis
  • influenza
  • anxiety
  • drowsiness
  • positional dizziness
  • sensory abnormalities
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • oropharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • erythema
  • sweating
  • itching.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature to preserve the drug's efficacy.

Appearance and packaging

Appearance

Pink oval film-coated tablets

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.