Medication info
Durotel 80/10 mg Tablet

Durotel 80/10 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Light orange oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202104526 · Approved 2021.06.14

Summary

Main use
Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)
Who takes it
Adults
Adult dose
Administer 40 mg orally once daily as telmisartan, and for some patients, 20 mg once daily may be effective. If necessary, the dose may be increased up to 80 mg once daily. For the purpose of reducing cardiovascular risk, 80 mg orally once daily is recommended. Patients with liver impairment should not exceed 40 mg once daily. The initial dosage of rosuvastatin calcium is 5 mg orally once daily.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)

  • Essential hypertension
  • coronary artery disease
  • peripheral artery disease
  • stroke
  • transient ischemic attacks
  • clinical evidence of end-organ damage
  • high-risk diabetes
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed-type hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
View approved original text

This medication is indicated for patients who require concomitant therapy with telmisartan and rosuvastatin. Telmisartan primarily helps treat essential hypertension and reduce cardiovascular disease risk. It is particularly effective in reducing the risk of myocardial infarction, stroke, and mortality from cardiovascular diseases in high-risk patients aged 55 years and older. Rosuvastatin is used for the treatment of hypercholesterolemia and mixed-type hyperlipidemia, acting as an adjunct to diet when control through diet and exercise is inadequate. Additionally, it lowers the total cholesterol and LDL cholesterol levels in hypercholesterolemic patients, helping to delay the progression of atherosclerosis and reduce the risk of cardiovascular disease. Therefore, this medication is used to manage both hypertension and hyperlipidemia simultaneously to reduce cardiovascular disease risk.

How to take

Adult dose

Administer 40 mg orally once daily as telmisartan, and for some patients, 20 mg once daily may be effective. If necessary, the dose may be increased up to 80 mg once daily. For the purpose of reducing cardiovascular risk, 80 mg orally once daily is recommended. Patients with liver impairment should not exceed 40 mg once daily. The initial dosage of rosuvastatin calcium is 5 mg orally once daily.

Precautions

This medication can cause serious harm to the fetus and newborn during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Individuals allergic to this medication or its components, pregnant women or women of childbearing potential, and nursing mothers should not use this medication. Patients with severe liver impairment or biliary excretion issues, unexplained increases in liver enzyme levels, myopathy, hereditary angioedema, and severe renal impairment should not take this medication. Particularly, patients with diabetes or moderate to severe renal impairment should not take this medication together with certain other drugs. Elderly patients, patients with high serum potassium levels, those with slightly compromised liver function, and patients with heart or vascular diseases should use this medication cautiously and require regular monitoring during treatment. This medication may cause muscle-related side effects such as myalgia or muscle weakness, so patients should consult a doctor immediately if they experience any abnormal muscle symptoms during treatment. Additionally, liver function abnormalities may occur, so regular liver enzyme tests should be conducted, and if liver function worsens significantly, the medication should be discontinued. This medication may interact with other drugs, so patients taking other medications should inform their doctor or pharmacist. Caution is needed for dizziness or drowsiness when driving or operating machinery. In case of overdose, symptoms such as hypotension, dizziness, and acute renal failure may occur, necessitating immediate medical attention. It is safest for children, pregnant women, and nursing mothers not to take this medication. Regular blood tests and symptom observations are required during the course of treatment, and immediate consultation with healthcare professionals is necessary if any abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, breathing issues with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues

Mild side effects

  • Dyspepsia
  • oral sensory abnormalities
  • musculoskeletal stiffness
  • acne
  • itching
  • dizziness
  • nasopharyngitis
  • dysuria
  • rhinitis
  • oropharyngeal discomfort
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  • pulmonary disorders
  • unspecified gastrointestinal diseases
  • benign gastrointestinal neoplasms
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing reduction
  • halitosis
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • syncope
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is also recommended to store the medication at room temperature, between 1°C and 30°C, rather than in extremely hot or cold conditions.

Appearance and packaging

Appearance

Light orange oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP 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.