Medication info

TR Duo Tablet 80/10 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
Bright blue oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Approval withdrawn

MFDS item code 201906979 · 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This product's status changed to Approval withdrawn on 2024.08.22.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 and cardiovascular disease risk) and (Improvement of hypercholesterolemia)
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension, the recommended oral dose is 40 mg once daily, with the potential to increase from 20 mg to 80 mg as necessary. For reducing cardiovascular disease risk, a dose of 80 mg once daily is recommended. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: Start with a dose of 5 mg once daily and adjust to 10 mg as needed, with a maximum of 20 mg.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

(Reduction of hypertension and cardiovascular disease risk) and (Improvement of hypercholesterolemia)

  • Essential hypertension
  • primary hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • abnormal beta-lipoproteinemia
View approved original text

This medication is used for patients who need to administer telmisartan and rosuvastatin together. Telmisartan helps primarily in the treatment of essential hypertension and reduces the risk of cardiovascular disease. It is particularly effective in reducing the risk of myocardial infarction, stroke, and death related to cardiovascular disease in high-risk patients. Rosuvastatin primarily controls hypercholesterolemia and various dyslipidemias, lowering blood cholesterol and LDL levels, and delaying the progression of atherosclerosis. Furthermore, it reduces the risk of cardiovascular disease and the risk associated with stroke, myocardial infarction, and vascular revascularization. Therefore, this medication is used to improve the cardiovascular health of patients with both hypertension and hyperlipidemia.

How to take

Adult dose

Telmisartan: For essential hypertension, the recommended oral dose is 40 mg once daily, with the potential to increase from 20 mg to 80 mg as necessary. For reducing cardiovascular disease risk, a dose of 80 mg once daily is recommended. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: Start with a dose of 5 mg once daily and adjust to 10 mg as needed, with a maximum of 20 mg.

Precautions

This medication may cause serious harm or death to the fetus and newborn, particularly during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Women who are allergic to this medication or its ingredients, pregnant or possibly pregnant, or nursing should not take it. Patients with severe hepatic impairment or biliary obstruction should not take this medication. Patients with muscle disease or hereditary angioedema, severe renal failure, or those taking certain medications should also refrain from taking this medication. Elderly patients, those with hyperkalemia, and patients with mild hepatic impairment should be careful while taking this medication, and regular monitoring is necessary as liver and muscle issues may arise. This medication may cause muscle-related side effects, such as myalgia, myopathy, and rhabdomyolysis. Consult your physician immediately if experiencing symptoms like myalgia or weakness. Be cautious as blood pressure may drop too low, causing dizziness, fainting, etc., and closely monitor symptoms during use. This medication may cause liver dysfunction, so liver enzyme levels should be checked regularly, and discontinuation is necessary if abnormalities are found. Since it can interact with other medications, inform your doctor or pharmacist of any concurrent medications you're taking. Women who are pregnant or nursing should not take this medication, and women planning to become pregnant should use appropriate contraception. Safety and efficacy in children have not been established, hence its use is not recommended. In case of overdose, symptoms like hypotension, dizziness, and abnormal heart rate may occur, requiring immediate medical attention and treatment. During the use of this medication, drowsiness or dizziness may occur when driving or operating machinery, so caution is advised.

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/eye mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, and other symptoms.

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleepiness
  • increased blood pressure
  • decreased blood pressure
  • hypotension
  • urinary pain
  • rhinitis
  • throat discomfort
  • pulmonary disease
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  • unspecified gastrointestinal disease
  • benign gastrointestinal tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory impairment
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • fainting
  • vision abnormalities
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • abdominal pain

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

Storage

This medication is prone to damage from air and moisture, so it must be stored in a sealed container. Additionally, avoid extremely cold or hot places, and store at a safe temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Bright blue 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.

Questions about this medicine

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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.