Medication info
Duroltel 40/5 mg Tablets

Duroltel 40/5 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Pale yellow oval film-coated tablets
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202103317 · Approved 2021.04.22 · Insurance code 660703590

Summary

Main use
Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)
Who takes it
Adults
Adult dose
It is recommended to orally administer telmisartan at a dose of 40 mg once daily; for some patients, 20 mg once daily may be effective. If necessary, the dose may be increased to a maximum of 80 mg once daily. For the reduction of cardiovascular disease risk, it is recommended to administer 80 mg orally once daily. Rosuvastatin calcium initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

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

  • Essential hypertension
  • hypercholesterolemia
  • dysbetalipoproteinemia
  • high sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary heart disease
View approved original text

This medication is used for patients who need to take both telmisartan and rosuvastatin simultaneously. Telmisartan primarily reduces the risk of myocardial infarction, stroke, etc., in patients with essential hypertension and those over 55 years old with a high risk of cardiovascular disease. Rosuvastatin lowers blood cholesterol levels in patients with hypercholesterolemia and dyslipidemia, slowing the progression of atherosclerosis and reducing the risk of stroke and myocardial infarction associated with cardiovascular disease. The combination of these two components aids in the management of hypertension and hyperlipidemia and helps prevent cardiovascular diseases.

How to take

Adult dose

It is recommended to orally administer telmisartan at a dose of 40 mg once daily; for some patients, 20 mg once daily may be effective. If necessary, the dose may be increased to a maximum of 80 mg once daily. For the reduction of cardiovascular disease risk, it is recommended to administer 80 mg orally once daily. Rosuvastatin calcium initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily.

Precautions

This medication can seriously harm the fetus if taken during pregnancy, so it should be immediately discontinued if pregnancy is confirmed. Individuals with allergies to this medication or its components, pregnant or potentially pregnant women, and nursing mothers should not take it. It should not be used in patients with severe liver dysfunction or biliary excretion issues, and caution is warranted in cases of liver disease. Patients with muscle disorders or a history of myopathy should be particularly cautious as there is an increased risk of muscle damage when taking this medication. The use of this medication is prohibited in patients with severely reduced renal function, those using certain immunosuppressants, and diabetic patients with impaired kidney function. Elderly patients, those with high potassium levels in the blood, and patients with mildly impaired liver function should be closely observed when using this medication. This medication can cause side effects related to muscles, such as myalgia or muscle weakness, so patients should consult a doctor immediately if symptoms occur. This medication may affect liver function, necessitating regular liver function tests before and during treatment. Because it has blood pressure-lowering effects, dizziness or symptoms of hypotension may occur, so caution is needed when driving or operating machinery. There may be interactions with other medications, so patients must inform their doctor or pharmacist about all medications they are taking, particularly if using potassium-sparing diuretics or certain antibiotics and antifungal agents. Safety and efficacy in children have not been established, and it is not recommended for use in this population. In case of overdose, symptoms such as hypotension, dizziness, and acute renal failure may occur, and immediate medical attention is necessary. Store in a place out of reach of children, and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or dyspnea, asthma attack, cough with fever accompanied respiratory issues, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, numbness, urination

Mild side effects

  • Dyspepsia
  • oral paresthesia
  • musculoskeletal rigidity
  • acne
  • pruritus
  • dizziness
  • nasopharyngitis
  • dysuria
  • rhinitis
  • oropharyngeal discomfort
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  • pulmonary disease
  • unspecified gastrointestinal disease
  • benign gastrointestinal neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • pollakiuria
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • syncope
  • visual disturbances
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture, and it is safest to store it at a temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow 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.