Medication info

Telmisartan and Rosuvastatin Tablets 80/20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
일양바이오팜(주)
Appearance
Pale pink oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTPX3]
Approval status
Expired

MFDS item code 202101821 · Approved 2021.02.24

This product's status changed to Expired on 2026.02.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypertension and hyperlipidemia, reduced risk of cardiovascular disease treatment
Who takes it
Adults
Adult dose
Telmisartan: The recommended oral dose for adults with essential hypertension is 40 mg once daily, which may also be effective at 20 mg once daily for some patients. If necessary, dosage can be increased up to 80 mg once daily. For reduction of cardiovascular risk, an oral dose of 80 mg once daily is recommended. In patients with liver impairment, mild to moderate cases should not exceed 40 mg once daily. Rosuvastatin Calcium: For primary hypercholesterolemia (including heterozygous familial hypercholesterolemia - type IIa), mixed dyslipidemia (type IIb), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia, patients should be on a standard cholesterol-lowering diet before and during treatment, which should be maintained throughout the treatment period. This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, and for greater reduction of LDL cholesterol levels, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily for most patients. The maintenance dose should be adjusted according to LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Ingredients

Manufacturer
일양바이오팜(주)

Efficacy & effects

Improvement of hypertension and hyperlipidemia, reduced risk of cardiovascular disease treatment

  • Essential hypertension
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • stroke
  • myocardial infarction
View approved original text

This medication is used for patients who require concomitant administration of the two components, telmisartan and rosuvastatin. Telmisartan is primarily used to reduce the risk of myocardial infarction, stroke, and death from cardiovascular disease in patients with essential hypertension and those over 55 years old who are at high risk for cardiovascular disease. Rosuvastatin helps lower cholesterol levels in patients with hypercholesterolemia and mixed dyslipidemia, and primary dysbetalipoproteinemia, in conjunction with dietary therapy, while delaying the progression of atherosclerosis. Additionally, it helps reduce the risk of stroke and myocardial infarction in middle-aged and older patients with cardiovascular risk factors. This medication is used to protect cardiovascular health and reduce the risk of related diseases.

How to take

Adult dose

Telmisartan: The recommended oral dose for adults with essential hypertension is 40 mg once daily, which may also be effective at 20 mg once daily for some patients. If necessary, dosage can be increased up to 80 mg once daily. For reduction of cardiovascular risk, an oral dose of 80 mg once daily is recommended. In patients with liver impairment, mild to moderate cases should not exceed 40 mg once daily. Rosuvastatin Calcium: For primary hypercholesterolemia (including heterozygous familial hypercholesterolemia - type IIa), mixed dyslipidemia (type IIb), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia, patients should be on a standard cholesterol-lowering diet before and during treatment, which should be maintained throughout the treatment period. This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, and for greater reduction of LDL cholesterol levels, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily for most patients. The maintenance dose should be adjusted according to LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Women of childbearing potential must use appropriate contraception before taking this medication, and it should not be taken during pregnancy or while breastfeeding. Patients with severely impaired liver or kidney function, certain liver diseases or muscle disorders, and those allergic to this medication or its components should not take it. Elderly patients or those with high blood potassium levels or mildly impaired liver function should use this medication with caution, requiring regular blood tests and monitoring of health status. Muscle-related side effects such as muscle pain or weakness can occur with this medication; if these symptoms arise, consult a doctor immediately. Additionally, this medication may affect liver function; therefore, liver function tests should be performed periodically before and during treatment. This medication may interact with other drugs; inform your doctor or pharmacist of any other medications you are taking, especially blood pressure medications, diuretics, potassium supplements, certain antibiotics, and antifungals. Overdosage may result in hypotension, dizziness, and decreased kidney function, necessitating immediate contact with a medical facility for appropriate treatment. Dizziness or drowsiness may occur during driving or operating machinery while taking this medication, so caution is advised. Finally, it is not recommended for children as safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mucous membrane pain in the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination problems

Mild side effects

  • Dyspepsia
  • oral paresthesia
  • musculoskeletal stiffness
  • acne
  • pruritus
  • dizziness
  • nasopharyngitis
  • dysuria
  • rhinitis
  • oral discomfort
Show 24 more
  • pulmonary disease
  • unspecified gastrointestinal disease
  • benign gastrointestinal neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • decreased sensation
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • headache
  • facial spasms
  • paresthesia
  • paralysis
  • cough
  • hyperventilation
  • pneumonia
  • flushing
  • erectile dysfunction
  • eating disturbances

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This ensures that the medication's efficacy and safety are preserved over time.

Appearance and packaging

Appearance

Pale pink oval film-coated tablets

Package unit

30 tablets/box [10 tablets/PTPX3]

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.

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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.