Medication info

Rostel Plus Tablet 80/5/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Oval-shaped two-layer tablet consisting of a white layer and a light blue layer
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202302814 · Approved 2023.09.25

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (risk reduction of atherosclerosis)
Who takes it
Adults
Adult dose
The usual dosage is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). The dosing of telmisartan/amlodipine combination and rosuvastatin should be individualized based on the effectiveness and tolerability for each patient. - Telmisartan/amlodipine combination: Adjust the dosage according to blood pressure control, and dosage adjustments should be made based on kidney function, liver function, and age.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (risk reduction of atherosclerosis)

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • and family history of premature coronary heart disease.
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure when using telmisartan and amlodipine alone. Additionally, rosuvastatin acts as an adjunct to dietary therapy for patients with hypercholesterolemia and dyslipidemia, helping to lower total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. It is particularly effective in reducing the risks associated with stroke, myocardial infarction, and arterial revascularization in middle-aged patients at high risk for cardiovascular diseases. Therefore, this medication is used to effectively manage blood pressure and lipid levels.

How to take

Adult dose

The usual dosage is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). The dosing of telmisartan/amlodipine combination and rosuvastatin should be individualized based on the effectiveness and tolerability for each patient. - Telmisartan/amlodipine combination: Adjust the dosage according to blood pressure control, and dosage adjustments should be made based on kidney function, liver function, and age.

Precautions

This medication may cause serious harm to the fetus and newborn during pregnancy; therefore, if pregnancy is confirmed, it should be discontinued immediately. Patients with allergies to the components of this medication or similar drugs should not use it. Patients with severe liver or kidney impairment, those with a history of angioedema, or specific heart disease patients should use this medication with caution. This medication should also be administered cautiously to elderly patients or those with very low blood pressure or elevated potassium levels. If symptoms such as muscle pain or muscle weakness occur, immediate consultation with a physician is necessary, and blood tests may be required to assess for muscle damage. This medication can affect liver function; therefore, liver function tests should be conducted regularly before and during treatment. Interactions may occur when taken with other medications, so it is essential to inform the physician or pharmacist about any other medications being taken. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use appropriate contraceptive methods. Use in pediatric patients is not recommended as safety and efficacy have not been sufficiently established. In case of overdose, symptoms such as lowered blood pressure, dizziness, and muscle abnormalities may occur, requiring immediate medical attention. This medication should be kept out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Headache
  • dizziness
  • dyspepsia
  • frequent bowel movements
  • diabetes
  • dizziness
  • dry cough
  • urticaria
  • peripheral edema
  • painful urination
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  • rhinitis
  • discomfort in the oropharynx
  • lung disease
  • unspecified gastrointestinal disease
  • benign gastric neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory disturbance
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • erectile dysfunction
  • constipation
  • abdominal pain
  • nausea
  • diarrhea
  • loss of appetite
  • muscle pain
  • muscle cramps

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

Storage

This medication is sensitive to light; therefore, it should be stored in a container that does not allow light to pass through. Additionally, it is advisable to keep it at a temperature ranging from 1 degree to 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Oval-shaped two-layer tablet consisting of a white layer and a light blue layer

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.