Medication info

Exator Tablet 5/80/10 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tabletAtorvastatin Calcium Hydrate›10.85mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202105299 · Approved 2021.07.12 · Insurance code 649105330

Summary

Main use
Improvement of essential hypertension and dyslipidemia (such as hypercholesterolemia)
Who takes it
Adults
Adult dose
This medication should be taken once a day, 1 tablet, with water. It is recommended to take it at the same time each day (for example, in the morning). For the Amlodipine/Valsartan combination, 5/80 mg: Administer to patients whose blood pressure is not adequately controlled with monotherapy of either amlodipine 5 mg or valsartan 80 mg. 5/160 mg: Administer to patients whose blood pressure is not adequately controlled with monotherapy of either amlodipine 5 mg or valsartan 160 mg.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improvement of essential hypertension and dyslipidemia (such as hypercholesterolemia)

  • Essential hypertension
  • hypercholesterolemia
  • dyslipidemia
  • primary hyperbetalipoproteinemia
  • elevated serum triglycerides
  • homozygous familial hypercholesterolemia
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure with monotherapy, as a combination of amlodipine and valsartan. Additionally, the atorvastatin component is prescribed for those wishing to reduce the risk of cardiovascular disease. It particularly helps reduce the risk for patients with a high risk of myocardial infarction or stroke, those with diabetes, and patients with symptoms of cardiovascular disease. Atorvastatin is used in conjunction with dietary changes when there is dyslipidemia, that is, high levels of cholesterol and triglycerides in the blood, and is also administered when the effects are not sufficient. By taking both medications simultaneously, it is possible to manage blood pressure and lipid levels together, thereby improving cardiovascular health overall.

How to take

Adult dose

This medication should be taken once a day, 1 tablet, with water. It is recommended to take it at the same time each day (for example, in the morning). For the Amlodipine/Valsartan combination, 5/80 mg: Administer to patients whose blood pressure is not adequately controlled with monotherapy of either amlodipine 5 mg or valsartan 80 mg. 5/160 mg: Administer to patients whose blood pressure is not adequately controlled with monotherapy of either amlodipine 5 mg or valsartan 160 mg.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, particularly in the second and third trimesters, so it must be discontinued immediately upon confirmation of pregnancy. If muscle-related diseases are suspected or if there is a significant increase in creatine kinase levels, the use of this medication should be discontinued, and caution is necessary for patients at risk of severe myopathy. Patients with allergies to any ingredient in this medication or those with severe liver impairment, bile duct obstruction, active liver disease, or severe kidney impairment should not use it. Especially, women who are pregnant or may become pregnant, and nursing mothers should not take this medication, and women planning to become pregnant should use appropriate contraception. Patients with a high risk of hypotension, fluid depletion, hyperkalemia, kidney transplant recipients, etc., require close monitoring and measures by a physician before taking this medication. Patients after heart failure or myocardial infarction, patients with acute myocardial infarction, patients with aortic stenosis, etc., should use this medication cautiously, and those with a history of angioedema should discontinue use immediately if angioedema occurs during treatment. Caution is needed for dizziness or fatigue during driving or operating machinery. This medication may affect liver and kidney function, so patients with liver dysfunction or decreased kidney function require regular testing. If symptoms such as muscle pain or weakness, fever, or fatigue occur while taking this medication, the doctor should be informed immediately, and blood tests may be necessary to check for muscle damage. Additionally, this medication can interact with various other drugs. If there are other medications being taken, it is essential to inform the doctor or pharmacist. Due to the atorvastatin component, hepatitis, liver dysfunction, and rarely liver failure can occur, so liver health should be monitored. Regular checks of blood pressure, blood tests, liver function tests, etc., while taking this medication are important to detect adverse reactions.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions
  • High fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain, severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever
  • Yellowing of the skin or eyes (jaundice), profound systemic lethargy, liver abnormalities (jaundice)
  • Sudden and very severe headache,

Mild side effects

Visual disturbances (dry eye, diplopia, visual impairment), nausea, headache, dizziness, drowsiness, orthostatic dizziness, sensory disturbances, tinnitus, tachycardia, palpitations, syncope, orthostatic hypotension, hypotension, cough, pharyngeal and laryngeal pain, diarrhea, abdominal pain, constipation, thirst, rash, erythema, sweating, itching, joint swelling, low back pain, arthritis, muscle cramps, lethargy, increased urine output, polyuria, erectile dysfunction, edema, facial swelling, peripheral edema,

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White 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.