Medication info
Dualetel Tablet 80/20 mg

Dualetel Tablet 80/20 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Pale pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202104525 · Approved 2021.06.14

Summary

Main use
Improvement of hypertension and hyperlipidemia, and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
Telmisartan: For adults with essential hypertension, it is recommended to take 40 mg orally once daily, and depending on the patient, 20 mg once daily may also be effective. If necessary, the dose can be increased up to 80 mg once daily. For the purpose of reducing the risk of cardiovascular diseases, it is recommended to take 80 mg orally once daily. Patients with liver dysfunction should be cautious not to exceed 40 mg once daily in cases of mild to moderate liver dysfunction.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Improvement of hypertension and hyperlipidemia, and 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
  • myocardial infarction
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
View approved original text

This medication is used for patients who require simultaneous administration of telmisartan and rosuvastatin. Telmisartan primarily helps in treating essential hypertension and reducing the risk of cardiovascular diseases. It is particularly effective in reducing the risk of myocardial infarction, stroke, and death from cardiovascular diseases in high-risk patients aged over 55 years. Rosuvastatin calcium is used to control hypercholesterolemia and hyperlipidemia as an adjunct when diet and exercise are insufficient. Additionally, it contributes to slowing the progression of atherosclerosis and reducing the risk of cardiovascular disease. Thus, this combination of medications effectively manages blood pressure and cholesterol, improving cardiovascular health.

How to take

Adult dose

Telmisartan: For adults with essential hypertension, it is recommended to take 40 mg orally once daily, and depending on the patient, 20 mg once daily may also be effective. If necessary, the dose can be increased up to 80 mg once daily. For the purpose of reducing the risk of cardiovascular diseases, it is recommended to take 80 mg orally once daily. Patients with liver dysfunction should be cautious not to exceed 40 mg once daily in cases of mild to moderate liver dysfunction.

Precautions

This medication may cause serious harm or death to the fetus and newborn during pregnancy; therefore, it should be discontinued immediately if pregnancy is confirmed. Patients with hypersensitivity to this medication or who are pregnant, breastfeeding, or have severe liver or kidney disorders should not take it. Patients with a history of muscular disorders, elderly patients, those with hyperkalemia, or liver disorders should take this medication with caution, and regular monitoring and check-ups from a physician are necessary during treatment. This medication may affect liver and kidney function, so liver function tests and serum creatine kinase (CK) levels should be periodically checked before and during administration. If symptoms such as myalgia, muscle weakness, dizziness, or malaise occur during treatment, consult a physician immediately, and in severe cases, the medication may need to be discontinued. This medication may interact with other antihypertensives or lipid-lowering agents, so patients should inform their physician or pharmacist if they are taking other medications. Women who plan to become pregnant or are potentially pregnant should use appropriate contraceptive methods and avoid taking this medication during pregnancy. The safety and efficacy of this medication have not been established in children, so it is advisable not to use it in this population. In case of overdose, symptoms such as hypotension, dizziness, and renal failure may occur; therefore, patients should seek medical attention for appropriate treatment. Drowsiness or dizziness may occur during treatment, so caution should be exercised when driving or operating hazardous machinery. Store out of reach of children and do not transfer to another container for safety.

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, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever-related respiratory changes, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Dyspepsia
  • oral sensory disturbances
  • musculoskeletal stiffness
  • acne
  • itching
  • dizziness
  • nasopharyngitis
  • dysuria
  • rhinitis
  • pharyngeal discomfort
Show 23 more
  • pulmonary diseases
  • unspecified gastrointestinal disorders
  • benign gastrointestinal neoplasms
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • hyperkinetic movement disorders
  • atherosclerosis
  • increased urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • headache
  • facial spasms
  • sensory alterations
  • cough
  • hyperventilation
  • pneumonia
  • flushing
  • erectile dysfunction
  • loss of appetite

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain ambient temperatures between 1 degree and 30 degrees celsius for storage. Proper storage can help maintain the medication's effectiveness for a longer duration.

Appearance and packaging

Appearance

Pale pink 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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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.