Medication info
Dutelta Tablet 40/20 mg

Dutelta Tablet 40/20 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP × 3]
Approval status
Active

MFDS item code 202005521 · Approved 2020.07.29 · Insurance code 649105000

Summary

Main use
(Hypertension, Hyperlipidemia) and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
The recommended oral dosage of Telmisartan is 40 mg once daily; for some patients, 20 mg once daily may be effective. If necessary, the dose can be increased up to 80 mg once daily. For the reduction of cardiovascular disease risk, an oral dose of 80 mg once daily is recommended. The initial dose of Rosuvastatin Calcium is 5 mg once daily, which can be adjusted to 10 mg once daily if needed.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

(Hypertension, Hyperlipidemia) and reduction of cardiovascular disease risk

  • Primary hypertension
  • coronary artery disease
  • peripheral artery disease
  • stroke
  • transient ischemic attack
  • clinical evidence of end-organ damage
  • high-risk diabetes
  • primary hypercholesterolemia
  • familial hypercholesterolemia
  • mixed dyslipidemia
  • familial hypercholesterolemia
  • hypercholesterolemia
View approved original text

This medication is used for patients who need to take Telmisartan and Rosuvastatin simultaneously. Telmisartan is primarily used for the treatment of primary hypertension and helps reduce the risk of myocardial infarction, stroke, and death due to cardiovascular diseases in patients at high risk. Rosuvastatin is used for treating hypercholesterolemia and mixed dyslipidemia, serving as an adjunct when dietary control is inadequate. Additionally, it assists in lipid management for patients with familial hypercholesterolemia and dysbetalipoproteinemia. Rosuvastatin lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis and reducing risks of cardiovascular diseases, strokes, and myocardial infarctions. Therefore, this medication is used to manage both hypertension and hyperlipidemia to reduce the risk of cardiovascular diseases.

How to take

Adult dose

The recommended oral dosage of Telmisartan is 40 mg once daily; for some patients, 20 mg once daily may be effective. If necessary, the dose can be increased up to 80 mg once daily. For the reduction of cardiovascular disease risk, an oral dose of 80 mg once daily is recommended. The initial dose of Rosuvastatin Calcium is 5 mg once daily, which can be adjusted to 10 mg once daily if needed.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Women of childbearing potential should use appropriate contraceptive methods, and it should not be taken during pregnancy or breastfeeding. It is generally unsafe to use this medication in patients with severe liver or kidney impairment, certain genetic disorders, or muscle disorders. Elderly patients or those with elevated potassium levels in the blood, or those with compromised liver function should use this medication cautiously and require regular monitoring of liver function and muscle status. If symptoms such as muscle pain or weakness occur, healthcare professionals should be consulted immediately, and discontinuation of the drug may be necessary in severe cases. This medication can interact with other drugs, so any concurrent medications should be reported to healthcare professionals. Due to its blood pressure-lowering effects, symptoms of hypotension may occur; in such cases, the patient should be reclined and may require appropriate treatment. Common side effects reported in clinical trials and post-marketing studies include headache, dizziness, dyspepsia, and muscle pain; if such symptoms persist, healthcare professionals should be notified. Caution is advised regarding alcohol consumption while taking this medication, and attention is needed when driving or operating dangerous machinery. Keep out of reach of children and do not transfer the medication to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema (may lead to fatal outcomes), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory symptoms accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances

Mild side effects

  • Headache
  • orthostatic dizziness
  • hypersomnia
  • elevated blood pressure
  • decreased diastolic blood pressure
  • hypotension
  • elevated ALT
  • painful urination
  • rhinitis
  • oral pharyngeal discomfort
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  • pulmonary disease
  • unspecified gastrointestinal disease
  • benign gastrointestinal neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory impairment
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • syncope
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • low

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

Storage

This medication must be stored in a tightly sealed container to protect it from exposure to air or moisture. It is essential to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White 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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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.