Medication info
Rostel Plus Tablet 80/5/10 Milligrams

Rostel Plus Tablet 80/5/10 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Oval bilayer tablet consisting of a white layer and a light blue layer
Packaging
For domestic use - 30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202302008 · Approved 2023.06.29 · Insurance code 651206070

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (atherosclerosis, etc.)
Who takes it
Adults
Adult dose
Take one tablet once a day with water, regardless of meals. Dosage should be individualized for each patient based on the efficacy and tolerability of telmisartan/amlodipine and rosuvastatin. Examples of telmisartan/amlodipine combination doses are as follows: - 40/5 milligrams: Administered to patients whose blood pressure is not adequately controlled with 5 milligrams of amlodipine or 40 milligrams of telmisartan. - 80/5

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (atherosclerosis, etc.)

  • Essential hypertension
  • primary hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • mixed hyperlipidemia
  • familial homozygous hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol level
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used for patients with hypertension whose blood pressure is not well controlled with telmisartan and amlodipine monotherapy, and should only be used when rosuvastatin needs to be administered simultaneously. The telmisartan/amlodipine combination effectively controls essential hypertension, while rosuvastatin is used as an adjunct to diet in patients with hypercholesterolemia and dyslipidemia not controlled by diet and exercise. It also helps delay the progression of atherosclerosis and reduce the risk of cardiovascular disease. Particularly, in high-risk patients aged midlife and above, it plays a significant role in lowering the risk of stroke, myocardial infarction, and arterial revascularization procedures. This medication effectively manages hypertension and dyslipidemia, improving cardiovascular health.

How to take

Adult dose

Take one tablet once a day with water, regardless of meals. Dosage should be individualized for each patient based on the efficacy and tolerability of telmisartan/amlodipine and rosuvastatin. Examples of telmisartan/amlodipine combination doses are as follows: - 40/5 milligrams: Administered to patients whose blood pressure is not adequately controlled with 5 milligrams of amlodipine or 40 milligrams of telmisartan. - 80/5

Precautions

This medication should not be used in pregnant women. Particularly in early pregnancy, it can cause serious harm to the fetus, so if pregnancy is confirmed, it should be discontinued immediately. This medication should not be administered to patients with allergies to the ingredients or similar medications, patients with hereditary angioedema or a related history. It should also not be used in patients with severe liver or kidney dysfunction, severe heart valve disease, or in shock. Before taking this medication, it is essential to consult with a doctor, especially for elderly patients, those with low blood pressure, hyperkalemia, or liver or kidney issues who require extra caution. During treatment, if muscle pain, weakness, or severe fatigue occurs, notify a doctor immediately, and muscle damage can be checked through blood testing. If liver function abnormalities are suspected, discontinue use and consult a healthcare professional. Since interactions may occur with other medications, be sure to inform your doctor or pharmacist of any other medicines you are taking. This medication is also not recommended for breastfeeding women; if taken, breastfeeding should be discontinued. Safety and efficacy have not been adequately established for children, so it is preferable to avoid use in pediatric patients. In case of overdose, symptoms such as low blood pressure, dizziness, and kidney dysfunction may occur, thus timely medical treatment should be sought. This medication should be stored away from direct sunlight and kept out of the reach of children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, high fever, severe rashes, blisters, skin peeling, pain in oral/ocular mucosa, severe allergic reactions, severe cutaneous adverse reactions, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities accompanied by cough and fever, jaundice (skin or eyes turning yellow), significant lethargy, liver abnormalities (jaundice), sudden and severe headache, lightning-like pain

Mild side effects

  • Dyspepsia
  • frequent bowel movements
  • diabetes
  • dizziness
  • dry vesicular sound
  • hives
  • peripheral edema
  • dyspepsia
  • gastrointestinal disturbances
  • chronic gastritis
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  • various gastrointestinal problems
  • hiatal hernia
  • rhinitis
  • oropharyngeal discomfort
  • pulmonary disorders
  • unspecified gastrointestinal diseases
  • benign gastrointestinal neoplasms
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • erectile dysfunction
  • nausea
  • abdominal pain

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

Storage

This medication is sensitive to light and should be stored in a light-resistant container. Additionally, it should be stored at room temperature between 1 degree and 30 degrees Celsius, avoiding excessively hot or cold conditions.

Appearance and packaging

Appearance

Oval bilayer tablet consisting of a white layer and a light blue layer

Package unit

For domestic use - 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.