Medication info
Duotelmi Plus Tablet 40/5/5 mg (Telmisartan, Amlodipine, Rosuvastatin)

Duotelmi Plus Tablet 40/5/5 mg (Telmisartan, Amlodipine, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›Strength being verifiedAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202500398 · Approved 2025.02.25 · Insurance code 649106110

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (reduction of atherosclerosis risk)
Who takes it
Adults
Adult dose
This medication should be taken as one tablet once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Dosages should be individualized based on the effectiveness and tolerability of the telmisartan/amlodipine combination and rosuvastatin in each patient. The telmisartan/amlodipine combination should be administered as follows: - 40/5 mg: Amlodipine 5 mg or Telmisartan 40 mg.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (reduction of atherosclerosis risk)

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

This medication is used to treat primary hypertension in patients whose blood pressure is not adequately controlled by the monotherapy of telmisartan and amlodipine. Additionally, rosuvastatin is prescribed, along with a dietary regimen, for various lipid disorders including hypercholesterolemia, mixed dyslipidemia, and familial hypercholesterolemia to lower serum cholesterol levels and delay the progression of atherosclerosis. Furthermore, rosuvastatin helps reduce the risk of myocardial infarction, stroke, and arterial revascularization in men over 50 and women over 60 with elevated high-sensitivity C-reactive protein and additional cardiovascular risk factors. Therefore, this medication is effectively used for the prevention and treatment of cardiovascular diseases in patients with combined hypertension and dyslipidemia.

How to take

Adult dose

This medication should be taken as one tablet once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Dosages should be individualized based on the effectiveness and tolerability of the telmisartan/amlodipine combination and rosuvastatin in each patient. The telmisartan/amlodipine combination should be administered as follows: - 40/5 mg: Amlodipine 5 mg or Telmisartan 40 mg.

Precautions

This medication can cause serious harm to the fetus and neonate during pregnancy, and use should be discontinued immediately upon confirmation of pregnancy. Individuals with allergies to the components of this medication or similar drugs, as well as those with certain hereditary diseases or severe liver/kidney dysfunction, should not use this medication. Elderly patients or patients with low blood pressure, hyperkalemia, and liver impairment should exercise increased caution when using this medication, and should consult a physician immediately if muscle-related abnormal symptoms appear. This medication may cause serious muscle disorders such as myalgia, myopathy, and, rarely, rhabdomyolysis, so it is essential to inform medical staff promptly if muscle pain or weakness occurs. Since this medication may affect liver function, it is necessary to undergo routine liver function tests while taking it. Interactions with other medications may occur while taking this medication, so it is important to inform medical staff about any other medications being taken. Dizziness or drowsiness may occur when driving or operating machinery, so caution is advised. In case of overdose, symptoms such as hypotension, dizziness, and arrhythmia may occur, and immediate medical attention is required. Safety and efficacy in children have not been sufficiently confirmed, so it is not recommended for use in children. This medication must be stored out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, wheezing or difficulty breathing, asthma attacks, respiratory anomalies accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, urination issues.

Mild side effects

  • Headache
  • dizziness
  • low back pain
  • diarrhea
  • pharyngitis
  • dyspepsia
  • rectal bleeding
  • pruritus
  • rash
  • myalgia
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  • weakness
  • fatigue
  • nausea
  • abdominal pain
  • constipation
  • drowsiness
  • vasculitis
  • sensory disturbances
  • muscle cramps
  • nervousness
  • insomnia
  • anxiety
  • depression
  • palpitations
  • bradycardia
  • chest pain
  • epistaxis
  • thrombocytopenia
  • polyuria
  • halitosis
  • fatty liver
  • hearing loss
  • tinnitus
  • orthostatic dizziness
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
  • pulmonary diseases
  • musculoskeletal pain

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

Storage

This medication is sensitive to light and should be stored in a container that protects it from light. Additionally, it is best to store the medication at room temperature, ideally between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pink oval film-coated tablet

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.