Medication info

Exator Tablet 5/160/20mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tabletAtorvastatin Calcium Hydrate›21.7mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Light pink oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202105298 · Approved 2021.07.12

Summary

Main use
Treatment of essential hypertension and dyslipidemia (such as hypercholesterolemia)
Who takes it
Adults
Adult dose
This medication is to be taken once daily, one tablet with water. It is recommended to take it at the same time each day (for example, in the morning). The dosage of amlodipine/valsartan combination should be individualized based on effectiveness and tolerability, and conversion to a combination therapy can be considered in cases where monotherapy does not adequately control blood pressure. ㆍ5/80mg: mg amlodipine 5mg or valsartan 80mg monotherapy does not adequately control blood pressure, it can be administered.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Treatment of essential hypertension and dyslipidemia (such as hypercholesterolemia)

  • Essential hypertension
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • dyslipidemia
  • hypercholesterolemia
  • mixed dyslipidemia
  • abnormal beta-lipoproteinemia
  • increased serum triglycerides
  • homozygous familial hypercholesterolemia.
View approved original text

This medication is applied to patients with essential hypertension whose blood pressure is not well controlled using a combination of amlodipine and valsartan, while atorvastatin is administered to reduce the risk of cardiovascular diseases. Atorvastatin effectively reduces the risk of myocardial infarction and stroke in patients at risk for coronary heart disease or stroke, and decreases the risk of revascularization procedures and angina. Additionally, it is used as an adjunct therapy to improve cholesterol and triglyceride levels in patients with dyslipidemia. In summary, this medication effectively improves patient health by aiding in the management of hypertension, improving cardiovascular risk factors, and treating dyslipidemia.

How to take

Adult dose

This medication is to be taken once daily, one tablet with water. It is recommended to take it at the same time each day (for example, in the morning). The dosage of amlodipine/valsartan combination should be individualized based on effectiveness and tolerability, and conversion to a combination therapy can be considered in cases where monotherapy does not adequately control blood pressure. ㆍ5/80mg: mg amlodipine 5mg or valsartan 80mg monotherapy does not adequately control blood pressure, it can be administered.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately if pregnancy is confirmed. If muscle problems develop or muscle enzyme levels rise significantly, this medication should be discontinued, especially for patients at risk of serious myopathy. Patients with allergies to any of the ingredients, those with specific liver or kidney diseases, pregnant or nursing women should not take this medication. Patients with insufficient sodium or body fluids may experience low blood pressure, so their condition should be carefully assessed before starting treatment and blood pressure should be monitored frequently while taking the medication. Patients with high levels of potassium in the blood or reduced kidney function should monitor their potassium levels regularly and take this medication with caution. Patients with heart failure or those who have had a myocardial infarction should closely monitor their kidney function and blood pressure while taking this medication, and extreme caution is advised in cases of severe heart disease. This medication may affect liver function, so patients with a history of liver disease should undergo regular liver function tests, and should consult a physician immediately if any abnormal symptoms occur. When driving or operating machinery, caution is advised as dizziness or fatigue may occur. This medication may interact with other drugs, so if other medications are being taken, you must inform your doctor or pharmacist, especially caution is needed when combined with certain antibiotics, antifungals, and antivirals. If symptoms such as muscle pain, weakness, or fever occur during the use of this medication, inform healthcare professionals immediately, and muscle enzyme testing may be required to evaluate the situation. Women who are pregnant or planning to become pregnant should consult healthcare providers before taking this medication, and women of childbearing age should use appropriate contraception. Nursing mothers should avoid taking this medication, and it is recommended to stop breastfeeding while taking it.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, disorientation, visual disturbances, paralysis, urination abnormalities.

Mild side effects

  • Visual disturbances
  • dry eyes
  • nausea
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensory disturbances
  • tinnitus
  • tachycardia
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  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • muscle cramps
  • weakness
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial edema
  • generalized fatigue
  • flushing
  • asthenia

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 the storage temperature between 1 to 30 degrees Celsius to keep the medication safe and effective for a long time.

Appearance and packaging

Appearance

Light 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.