Medication info

Exator Tablet 5/80/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tabletAtorvastatin Calcium Hydrate›21.7mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Light orange oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202105301 · Approved 2021.07.12

Summary

Main use
Improvement of essential hypertension and dyslipidemia (hypercholesterolemia, etc.)
Who takes it
Adults
Adult dose
This medication is taken orally once daily as 1 tablet, with water. It is recommended to take it at the same time each day, if possible (e.g., in the morning). For the Amlodipine/Valsartan combination: - 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5 mg or Valsartan 80 mg. - 5/160 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5 mg or Valsartan 160 mg.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improvement of essential hypertension and dyslipidemia (hypercholesterolemia, etc.)

  • Essential hypertension
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • primary hyper-beta-lipoproteinemia
  • elevated serum triglycerides
  • homozygous familial hypercholesterolemia.
View approved original text

This medication is used for patients with essential hypertension who struggle to achieve blood pressure control with monotherapy, as a combination of amlodipine and valsartan. The inclusion of atorvastatin also reduces the risk of myocardial infarction, stroke, vascular interventions, and angina in patients at high risk for cardiovascular diseases, and helps treat dyslipidemia. Atorvastatin is particularly effective for patients with hypercholesterolemia, mixed dyslipidemia, and genetic lipid disorders, and can be used when dietary therapy alone is insufficient or where alternative treatments are not feasible. This medication is used to effectively reduce the risk of cardiovascular diseases by managing both blood pressure and blood lipid levels.

How to take

Adult dose

This medication is taken orally once daily as 1 tablet, with water. It is recommended to take it at the same time each day, if possible (e.g., in the morning). For the Amlodipine/Valsartan combination: - 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5 mg or Valsartan 80 mg. - 5/160 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5 mg or Valsartan 160 mg.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. If there are any symptoms related to muscles or if there is a significant increase in creatine kinase levels, this medication should be discontinued. Caution is especially necessary when severe myopathy is suspected, as it may lead to renal function deterioration. This medication should not be administered to patients with certain diseases or conditions. For example, patients with allergies to the drug's components, pregnant or nursing women, patients with severe liver or kidney function impairment, and those who may experience problems when taking it alongside specific drugs should not use this medication. Patients with low sodium or fluid levels in the body should correct their condition prior to taking this medication, and if symptoms of low blood pressure occur during use, immediate action such as lying down and administering saline if necessary is required. Patients with high potassium levels should frequently monitor their potassium levels while taking this medication, as hyperkalemia may worsen. Patients with renal vascular issues, those who have received kidney transplants, those with a history of angioedema, and patients after heart failure or myocardial infarction must take this medication with caution and be closely monitored. While taking this medication, regular tests for liver and kidney function should be completed, and symptoms such as muscle pain, weakness, fatigue, or fever should be reported to a physician immediately. Caution may be needed while driving or operating machinery as dizziness or fatigue may occur. There may be interactions with other drugs, so if you are taking any other medications, you must inform your doctor or pharmacist, especially when using certain antibiotics, antifungals, immunosuppressants, or some antiviral medications. Pregnant or nursing women should not use this medication, and fertile women should utilize appropriate contraception methods while taking this medication. This medication is not recommended for children, so consultation with a specialist is required before administering it to pediatric patients.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, dyspnea or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough+fever, jaundice (yellowing of skin or eyes), severe malaise, sudden and very intense headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • nausea
  • anxiety
  • dizziness
  • drowsiness
  • sensory disturbances
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
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  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • weakness
  • facial flushing
  • diplopia

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. Avoid excessively hot or cold locations, and it is best to keep it in a cool place away from direct sunlight.

Appearance and packaging

Appearance

Light orange 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.