Medication info
Telmisartan/Atorvastatin Calcium/Ezetimibe (unprocessed)/Amlodipine Besylate Tablets 80/20/10/5 mg

Telmisartan/Atorvastatin Calcium/Ezetimibe (unprocessed)/Amlodipine Besylate Tablets 80/20/10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [6 tablets/PTP X 5]
Approval status
Active

MFDS item code 202203055 · Approved 2022.07.21 · Insurance code 645406210

Summary

Main use
Additional treatment for hypertension and dyslipidemia (cholesterol, etc.) management
Who takes it
Adults
Adult dose
This medication is administered only to adults, and the dosage is one tablet once daily taken with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosage for telmisartan/amlodipine combination is once daily, and the dosage should be adjusted if blood pressure control is inadequate. Patients with liver impairment should not exceed a daily dose of 40 mg of telmisartan, and elderly patients aged over 75 should start at a lower dosage.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Additional treatment for hypertension and dyslipidemia (cholesterol, etc.) management

  • Essential hypertension
  • primary hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication is used for patients who require simultaneous administration of telmisartan and amlodipine combination, as well as atorvastatin and ezetimibe combination. To effectively manage hypertension and dyslipidemia, this medication is recommended for patients who have previously used each drug alone but have not adequately controlled blood pressure or lipid levels. The telmisartan/amlodipine combination helps to appropriately manage blood pressure in patients with essential hypertension, and the atorvastatin/ezetimibe combination is effective in improving cholesterol and lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. This medication works by reducing total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol while increasing HDL cholesterol, thereby improving cardiovascular health in patients. Therefore, it is appropriate for patients who require simultaneous management of blood pressure and lipids and effectively improves these conditions.

How to take

Adult dose

This medication is administered only to adults, and the dosage is one tablet once daily taken with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosage for telmisartan/amlodipine combination is once daily, and the dosage should be adjusted if blood pressure control is inadequate. Patients with liver impairment should not exceed a daily dose of 40 mg of telmisartan, and elderly patients aged over 75 should start at a lower dosage.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the 2nd and 3rd trimesters, so treatment must be stopped immediately upon confirmation of pregnancy. Patients with muscle-related disorders, acute infections, hypotension, or recovering from surgery should temporarily stop or use this medication with caution due to the risk of muscle damage. It should not be administered to patients who have allergies to the components contained in this medication or have severely impaired liver function, and patients with serious kidney function impairment. Patients with diabetes or severe kidney impairment should also avoid concomitant use with specific ingredients, and pregnant or nursing women should not use this medication. Patients with slightly impaired liver function or elderly individuals should exercise caution and may require dose adjustments, and should consult a healthcare provider immediately if symptoms of muscle pain or weakness occur. This medication lowers blood pressure, so patients with hypotension or dehydration must stabilize their condition before starting treatment and regularly monitor blood pressure and kidney function during treatment. There is a risk of increased potassium levels in the blood, so caution is needed when taking it alongside potassium supplements or potassium-containing medications. Regular liver function and muscle-related tests should be conducted during treatment to detect adverse reactions early. Caution is needed while driving or operating machinery as dizziness or drowsiness may occur. When taking this medication with other drugs, it is advisable to consult a healthcare provider or pharmacist regarding potential interactions.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin desquamation, pain of oral/eye mucous membranes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headaches, seizures, confusion, visual disturbances, paralysis

Mild side effects

  • Headache
  • dizziness
  • cough
  • indigestion
  • vomiting
  • abdominal pain
  • diarrhea
  • rash
  • itching
  • alopecia
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  • muscle pain
  • muscle cramps
  • joint pain
  • fatigue
  • weakness
  • hypotension
  • flushing
  • facial swelling
  • increased sweating
  • dermatitis
  • cold sweat
  • chest discomfort
  • urinary difficulty
  • nasal congestion
  • urticaria
  • ear discomfort
  • visual disturbances
  • conjunctivitis
  • dry mouth
  • constipation
  • nocturia
  • dizziness
  • drowsiness
  • depression
  • insomnia
  • anxiety
  • lethargy
  • weight gain/loss
  • heaviness in the head

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 recommended to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the medication’s effectiveness over a longer period.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/box [6 tablets/PTP X 5]

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.