Medication info

Entiatopin Tablets 5/10 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Atorvastatin Calcium›10.36mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 202002813 · Approved 2020.04.21

This product's status changed to Expired on 2025.04.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypertension and angina (myocardial ischemia), treatment to reduce cardiovascular risk
Who takes it
Adults
Adult dose
Amlodipine (S-Amlodipine) should be administered orally once daily at 5 (2.5) mg, and the dose may be increased up to a maximum of 10 (5) mg per day based on the patient's response. Adjustments should be made appropriately according to symptoms. The recommended starting dose of atorvastatin is 10 mg once daily, but in patients requiring a significant reduction in LDL cholesterol levels, doses of 20 mg or 40 mg (if a reduction of 45% or more in LDL cholesterol is required) can be initiated.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Improvement of hypertension and angina (myocardial ischemia), treatment to reduce cardiovascular risk

  • Hypertension
  • fixed closure of coronary arteries
  • vasospasm of coronary blood vessels
  • vasoconstriction
  • myocardial ischemia
  • angina
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • elevated serum triglycerides
  • primary dysbetalipoproteinemia
  • homozymous familial hypercholesterolemia
View approved original text

Amlodipine (S-Amlodipine) is used to improve symptoms of myocardial ischemia caused by hypertension and stable angina, as well as variant angina. It has been shown to reduce the risk of hospitalization due to angina and the risk related to coronary artery revascularization in patients with recent coronary artery disease. Atorvastatin helps to reduce the risks of myocardial infarction, stroke, angina, and risks related to revascularization in patients with several risk factors associated with coronary artery disease. It also improves lipid levels in patients with hypercholesterolemia and dyslipidemia, enhancing cardiovascular health, and is applicable to patients with familial hypercholesterolemia who require intensive treatment. Both medications are effectively used for the prevention and treatment of cardiovascular diseases.

How to take

Adult dose

Amlodipine (S-Amlodipine) should be administered orally once daily at 5 (2.5) mg, and the dose may be increased up to a maximum of 10 (5) mg per day based on the patient's response. Adjustments should be made appropriately according to symptoms. The recommended starting dose of atorvastatin is 10 mg once daily, but in patients requiring a significant reduction in LDL cholesterol levels, doses of 20 mg or 40 mg (if a reduction of 45% or more in LDL cholesterol is required) can be initiated.

Precautions

This drug should not be used in patients with specific allergic reactions, severe liver dysfunction, active liver disease, or those with serum aminotransferase levels that persist above three times the upper limit of normal. It is also not safe to administer to pregnant or potentially pregnant women and nursing mothers. This drug should not be used in patients with severe aortic stenosis, shock, those within one month after myocardial infarction, or patients with unstable angina. Caution should be exercised in patients with severely impaired kidney function, elderly individuals, alcoholics, or those with a history of liver disease. Patients with a history of muscle disease or those predisposed to rhabdomyolysis should check creatine kinase levels, which indicate muscle damage, before administration and proceed with caution. Caution is also required for patients with acute heart failure, hypertensive crisis, or mild to moderate liver dysfunction. This drug generally has good tolerability; however, mild side effects such as flushing, fatigue, edema, dizziness, headaches, and dyspepsia may occur. Muscle pain, cramps, liver function abnormalities, and allergic reactions are rare but can occur, and any unusual symptoms should be reported immediately to a healthcare provider. This drug may cause liver function abnormalities, so regular liver function tests and monitoring for unusual signs are necessary. Additionally, this drug may interact with various medications, so patients should inform their healthcare provider of any other medications they are taking. Overdose may result in severe hypotension, shock, and heart function abnormalities, necessitating immediate emergency treatment. Pregnant and nursing women should not use this drug, and women planning to become pregnant should use appropriate contraception. Safety in children and elderly patients has not been adequately established, so caution is advised. Patients should exercise caution while driving or operating machinery during treatment as dizziness may occur. This drug should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues along with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, flushing.

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 26 more
  • malaise
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • muscle tone increase
  • sensory loss/anomalies
  • peripheral neuropathy
  • syncope
  • taste disturbances
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hypertrophy
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • myopathy.

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

Storage

This drug may be sensitive to air and humidity, so it should be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage will help retain the drug's efficacy and safety for a longer period.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 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.