Medication info

TRDUO Tablet 80/5 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
Bright pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Approval withdrawn

MFDS item code 201906978 · Approved 2019.09.30

This product's status changed to Approval withdrawn on 2024.08.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of (hypertension, cardiovascular disease risk) and improvement of hypercholesterolemia
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension, adults should take 40 mg orally once daily, although 20 mg once daily may be effective for some patients. If necessary, the dose may be increased to 80 mg once daily. For reducing the risk of cardiovascular diseases, it is recommended to take 80 mg orally once daily. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin: For primary hypercholesterolemia

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Reduction of (hypertension, cardiovascular disease risk) and improvement of hypercholesterolemia

  • Essential hypertension
  • hypercholesterolemia
  • hyperlipidemia
  • dysbetalipoproteinemia
View approved original text

This medication is used for patients who need to take both telmisartan and rosuvastatin. Telmisartan helps reduce the risk of heart attack, stroke, and death due to cardiovascular diseases in patients with essential hypertension and high-risk groups with a high risk of cardiovascular diseases. Rosuvastatin is used when diet alone is insufficient to control primary or familial hypercholesterolemia and combined hyperlipidemia, lowering total cholesterol and LDL cholesterol while delaying the progression of atherosclerosis. Additionally, rosuvastatin is effective in reducing the risk of stroke, heart attack, and vascular reintervention in high-risk groups with elevated high-sensitivity C-reactive protein levels. The combination of both drugs effectively manages cardiovascular health.

How to take

Adult dose

Telmisartan: For essential hypertension, adults should take 40 mg orally once daily, although 20 mg once daily may be effective for some patients. If necessary, the dose may be increased to 80 mg once daily. For reducing the risk of cardiovascular diseases, it is recommended to take 80 mg orally once daily. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin: For primary hypercholesterolemia

Precautions

This medication can cause serious harm to the fetus and newborn if administered to pregnant women; therefore, it must be stopped immediately upon confirmation of pregnancy. This medication should not be used by individuals allergic to it or its ingredients, pregnant women or those who may become pregnant, breastfeeding mothers, and patients with certain liver or kidney diseases. Patients with severe liver dysfunction or problems with bile excretion should use caution, as this medication's metabolism may be difficult, increasing the risk of side effects. It should also not be given to patients with a history of muscle disorders, those prone to muscle issues, patients with a history of angioedema, and those with severe renal failure. Elderly patients, those with elevated blood potassium levels, patients with mild liver dysfunction, and individuals with heart or gastrointestinal diseases should use this medication cautiously, with regular blood tests and monitoring of their condition. This medication may cause serious side effects such as muscle pain, muscle weakness, and rarely, rhabdomyolysis resulting from muscle tissue damage; therefore, patients should consult their physician immediately if they experience any abnormal muscle symptoms. Also, liver dysfunction may occur, so liver enzyme levels should be regularly checked, and treatment should be stopped if abnormalities are found. This medication may interact with other drugs, so patients must inform their physician or pharmacist about any current medications, especially when combining with certain diuretics, potassium supplements, antihypertensives, antibiotics, and antifungals. Women who are pregnant or breastfeeding should not use this medication, and women planning to become pregnant should use adequate contraception. Safety and efficacy in children have not been established; therefore, it is not recommended. In case of overdose, symptoms such as hypotension, dizziness, and impaired kidney function may occur, requiring immediate medical attention. During the medication period, caution is advised when driving or operating machinery, as dizziness or drowsiness may occur. Finally, this medication 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 (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), generalized severe lethargy, sudden and very severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, changes in urine output

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleepiness
  • elevated blood pressure
  • decreased blood pressure
  • hypotension
  • elevated ALT
  • painful urination
  • rhinitis
  • discomfort in the oropharynx
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  • pulmonary diseases
  • gastrointestinal disorders
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory impairment
  • dyskinesia
  • atherosclerosis
  • increased urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • fainting
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • abdominal pain
  • diarrhea
  • indigestion

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

Storage

This medication may be sensitive to air or moisture; therefore, it must be stored in a sealed container. It is preferable to maintain the storage temperature between 1 degree and 30 degrees Celsius to preserve the drug's efficacy and safety.

Appearance and packaging

Appearance

Bright pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP*3]

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.

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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.