Medication info

Trevel 80/10/20 milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White oval film-coated tablet
Packaging
30 tablets (10 tablets x 3)/PTP
Approval status
Active

MFDS item code 201802583 · Approved 2018.06.20

Summary

Main use
(Hypertension, Hyperlipidemia) Effect on blood pressure control and cholesterol improvement, and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
This drug should be taken as 1 tablet once a day with water, regardless of meals. It is recommended to take it at the same time daily (e.g., morning). The telmisartan/amlodipine combination is administered at dosages of 40/5 milligrams, 80/5 milligrams, 40/10 milligrams, and 80/10 milligrams based on blood pressure control status. Moderate and mild renal impairment patients do not require dose adjustments, but severe patients should start with a lower dosage.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

(Hypertension, Hyperlipidemia) Effect on blood pressure control and cholesterol improvement, and reduction of cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol level
  • smoking
  • family history of premature coronary artery disease
View approved original text

This drug is used for patients with essential hypertension who have difficulty controlling blood pressure even when taking a combination of telmisartan and amlodipine. Additionally, it is used in conjunction with rosuvastatin for patients who have high cholesterol levels difficult to control by dietary methods due to hypercholesterolemia or familial hypercholesterolemia. This drug helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis and reducing the risk of cardiovascular diseases. Particularly, it reduces the recurrence risk of stroke, myocardial infarction, and revascularization in middle-aged patients with cardiovascular risk factors such as hypertension, low HDL cholesterol, and smoking. Therefore, this drug is used to improve cardiovascular health by simultaneously controlling blood pressure and cholesterol.

How to take

Adult dose

This drug should be taken as 1 tablet once a day with water, regardless of meals. It is recommended to take it at the same time daily (e.g., morning). The telmisartan/amlodipine combination is administered at dosages of 40/5 milligrams, 80/5 milligrams, 40/10 milligrams, and 80/10 milligrams based on blood pressure control status. Moderate and mild renal impairment patients do not require dose adjustments, but severe patients should start with a lower dosage.

Precautions

This drug may cause serious harm to the fetus and newborn during pregnancy, and should be discontinued immediately upon confirmation of pregnancy. It should not be used in patients with hypersensitivity to any of its components or certain diseases, such as severe liver impairment, severe renal impairment, or a history of angioedema. Special care is required when this drug is used in elderly patients, hypotensive patients, or patients with liver impairment, and liver function and muscle condition should be regularly monitored. If symptoms such as muscle pain, weakness, or cramps occur, consult a physician immediately, and in severe cases, discontinuation of this drug may be necessary. As this drug may interact with other medications, inform your physician or pharmacist of any other medications you are taking. Women of childbearing age should use appropriate contraception and it is recommended not to take this drug while breastfeeding. There is insufficient safety data for pediatric use, so administration is not recommended. In case of overdose, symptoms such as hypotension and dizziness may occur, so visit a medical institution immediately. Store this drug out of reach of children, and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, angioedema, severe allergic reactions, severe rash with high fever, blisters, painful mucous membranes of the mouth/eyes, severe skin adverse reactions, asthma attacks, dyspnea, respiratory problems, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures

Mild side effects

  • Headache
  • dizziness
  • orthostatic hypotension
  • low back pain
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • dyspepsia
  • myalgia
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  • weakness
  • itching
  • rash
  • angioedema
  • atopic dermatitis
  • upper respiratory tract infection
  • viral upper respiratory infection
  • pharyngitis
  • sinusitis
  • asthma
  • cough
  • epistaxis
  • urinary tract infection
  • dysuria
  • frequent urination
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • arthralgia
  • arthritis
  • sensory impairment
  • movement disorder
  • numbness
  • fatigue
  • muscle cramps
  • gout

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

Storage

This drug should be stored in a tightly closed container that is not exposed to light, and it is recommended to keep it at a temperature between 1 and 30 degrees Celsius at room temperature. By storing it this way, you can maintain the drug's efficacy and prevent deterioration.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets (10 tablets x 3)/PTP

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.