Medication info
Durotel Tablets 40/10 mg

Durotel Tablets 40/10 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Light orange oval film-coated tablets
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202103316 · Approved 2021.04.22 · Insurance code 660703600

Summary

Main use
(Hypertension, cardiovascular disease risk) reduction and (hypercholesterolemia) improvement effect
Who takes it
Adults
Adult dose
Telmisartan is administered orally once daily at doses ranging from 20 mg to 80 mg. For essential hypertension, a dose of 40 mg once daily is recommended, and 80 mg once daily is advised for reducing the risk of cardiovascular disease. Rosuvastatin is initiated at a dose of 5 mg once daily, and may be maintained at 10 mg once daily as needed, with a maximum increase up to 20 mg once daily. This can be taken at any time of day regardless of meals.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

(Hypertension, cardiovascular disease risk) reduction and (hypercholesterolemia) improvement effect

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

This medication is used for patients who need to take telmisartan and rosuvastatin simultaneously. Firstly, telmisartan is mainly used for the treatment of essential hypertension and to reduce the risk of cardiovascular disease. In particular, it helps reduce the risk of myocardial infarction, stroke, and death due to cardiovascular disease in high-risk patients who cannot use ACE inhibitors. Rosuvastatin is used as an adjunct when dietary management for conditions like hypercholesterolemia, familial hypercholesterolemia, and mixed hyperlipidemia is insufficient, lowering LDL cholesterol and delaying the progression of atherosclerosis. Moreover, it is effective in reducing the risk of stroke, myocardial infarction, and the need for revascularization in patients at high risk for cardiovascular diseases. By administering these two medications together, hypertension and hyperlipidemia can be managed concurrently, improving the risk of cardiovascular diseases.

How to take

Adult dose

Telmisartan is administered orally once daily at doses ranging from 20 mg to 80 mg. For essential hypertension, a dose of 40 mg once daily is recommended, and 80 mg once daily is advised for reducing the risk of cardiovascular disease. Rosuvastatin is initiated at a dose of 5 mg once daily, and may be maintained at 10 mg once daily as needed, with a maximum increase up to 20 mg once daily. This can be taken at any time of day regardless of meals.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Do not take this medication if you are allergic to it, are pregnant or may become pregnant, or are breastfeeding. It is not safe to use this medication in patients with severe liver impairment or with problems in bile excretion, and in patients with significantly reduced kidney function. Patients with a history of muscle disease or angioedema should also avoid this medication. Elderly patients, those with hyperkalemia, patients with mildly impaired liver function, and patients with cardiovascular diseases require special caution when taking this medication. This medication may cause muscle-related side effects such as myalgia or muscle weakness, so if abnormal symptoms occur in the muscles, consult a doctor immediately. Before taking, it's important to check blood tests for muscle damage indicators and liver function, and to have regular tests during treatment. This medication may interact with other drugs, so inform your healthcare provider about any medications you are taking. In case of overdose, symptoms like hypotension, dizziness, and acute renal failure may occur, requiring immediate treatment at a medical facility. Caution is needed when driving or operating machinery as dizziness or drowsiness may occur. Children should not use this medication as its safety and efficacy have not been established in this population. This medication should be stored out of reach of children, and transferring to another container may pose risks of accidents or deterioration in quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, angioedema (with fatal outcomes), anaphylactic reactions, sepsis (including fatal outcomes), thrombocytopenia, acute renal failure including kidney impairment, liver dysfunction/liver injury, hepatic disorder, jaundice, shock, loss of consciousness, interstitial pneumonia, rhabdomyolysis, Stevens-Johnson syndrome, DRESS syndrome, immune-mediated necrotizing myopathy, severe

Mild side effects

  • Dyspepsia
  • oral paresthesia
  • musculoskeletal stiffness
  • acne
  • itching
  • dizziness
  • nasopharyngitis
  • dysuria
  • rhinitis
  • discomfort in the oral cavity
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  • respiratory diseases
  • nonspecific gastrointestinal diseases
  • benign gastrointestinal tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • fainting
  • visual disturbances
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • abdominal pain

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Light orange oval film-coated tablets

Package unit

30 tablets/box [10 tablets/Alu-Alu x 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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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.