Medication info

Rostel Plus Tablet 40/5/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Oval, 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 202302815 · Approved 2023.09.25

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (reduction of the risk of atherosclerosis)
Who takes it
Adults
Adult dose
This medication is taken once daily, 1 tablet, with or without food, and is recommended to take at the same time each day (e.g., in the morning). The dosage should be individualized for each patient based on the effect and tolerability of telmisartan/amlodipine combination and rosuvastatin. The dosage of the telmisartan/amlodipine combination can be 40/5 mg, 80/5 mg, or 40/10 mg depending on blood pressure control status.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

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

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

This medication is administered to patients with essential hypertension whose blood pressure is not sufficiently controlled even with the combination of telmisartan and amlodipine, and it is prescribed only when rosuvastatin needs to be used together. The telmisartan/amlodipine combination helps effectively control blood pressure. Rosuvastatin is used as an adjunct to dietary treatment in patients with hypercholesterolemia and dyslipidemia, particularly contributing to slowing the progression of atherosclerosis and reducing the risk of cardiovascular disease. It is also helpful for patients with familial hypercholesterolemia and dysbetalipoproteinemia. This medication is used to manage both hypertension and cholesterol issues simultaneously to improve cardiovascular health.

How to take

Adult dose

This medication is taken once daily, 1 tablet, with or without food, and is recommended to take at the same time each day (e.g., in the morning). The dosage should be individualized for each patient based on the effect and tolerability of telmisartan/amlodipine combination and rosuvastatin. The dosage of the telmisartan/amlodipine combination can be 40/5 mg, 80/5 mg, or 40/10 mg depending on blood pressure control status.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients allergic to the components of this medication or similar components, patients with hereditary angioedema, or patients with severe liver or kidney impairment should not take this medication. Caution is warranted for diabetic patients or patients with decreased kidney function when taking this medication along with certain other drugs. Patients who are elderly, have hypotension, have hyperkalemia, or have impaired liver or kidney function must consult a doctor before taking this medication. This medication may cause musculoskeletal side effects such as muscle pain or weakness, so if severe muscle pain or unusual symptoms occur, immediate consultation with a doctor is necessary. This medication may affect liver function, so regular liver function tests should be conducted before and during treatment. As a blood pressure-lowering agent, symptoms of dizziness or hypotension may occur, so caution is needed when driving or operating machinery. Interactions with other medications are possible; therefore, if you are currently taking any medications, you must inform your doctor, particularly when combining with certain antibiotics, immunosuppressants, or other lipid-lowering agents. If breastfeeding, it is recommended to avoid taking this medication, and if it must be taken, breastfeeding should be discontinued. Safety and efficacy have not been sufficiently confirmed for children and adolescents under 18 years, so it is not recommended. In case of overdose, severe hypotension, dizziness, kidney dysfunction, etc. may occur, necessitating immediate visit to a hospital for appropriate treatment. This medication should be kept out of reach of children and should not be transferred to other containers; caution should be exercised to maintain quality during storage.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Dyspepsia
  • frequent bowel movements
  • diabetes
  • dizziness
  • dry patches
  • urticaria
  • nail fungus
  • lumbar spinal canal stenosis
  • ear discharge
  • dizziness
Show 21 more
  • chronic gastritis
  • hiatal hernia
  • various gastrointestinal disorders
  • dysuria
  • rhinitis
  • discomfort in oropharynx
  • lung disease
  • unspecified gastrointestinal disorders
  • benign gastric neoplasms
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • erectile dysfunction

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

Storage

This medication is sensitive to light, so it should be stored in a container that blocks light. Also, to maintain the medication's effectiveness, it should be stored at a temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Oval, 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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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.