Medication info
Rostel Tablet 80/10 mg

Rostel Tablet 80/10 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Bright blue oval film-coated tablet
Packaging
30 tablets ((10 tablets/Alu-Alu)x3)
Approval status
Active

MFDS item code 201506818 · Approved 2015.09.25 · Insurance code 651204400

Summary

Main use
Reduction of (hypertension, cardiovascular disease risk) and improvement of (hypercholesterolemia)
Who takes it
Adults
Adult dose
Telmisartan: Recommended oral dose of 40 mg once daily, with efficacy possible at 20 mg depending on the patient, and can be increased to 80 mg if needed. For risk reduction of cardiovascular disease: Recommended oral dose of 80 mg once daily. Patients with liver dysfunction: Do not exceed 40 mg once daily. Rosuvastatin: Initial dose of 5 mg once daily, maintenance dose of 10 mg once daily, can be increased up to a maximum of 20 mg. Elderly: No dose adjustment required.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Reduction of (hypertension, cardiovascular disease risk) and improvement of (hypercholesterolemia)

  • Essential Hypertension
  • Primary Hypercholesterolemia
  • Heterozygous Familial Hypercholesterolemia
  • Mixed Dyslipidemia
  • Homozygous Familial Hypercholesterolemia
  • Hypercholesterolemia
  • Primary Dysbetalipoproteinemia
View approved original text

This medication is used for patients who need to take telmisartan and rosuvastatin simultaneously. Telmisartan helps reduce the risk of essential hypertension and cardiovascular diseases. It particularly reduces the risk of myocardial infarction, stroke, and death due to cardiovascular diseases in patients at high risk for cardiovascular events. Rosuvastatin is used for managing hypercholesterolemia and mixed dyslipidemia and is utilized as an adjunctive treatment when dietary and exercise changes are inadequate. It also helps slow the progression of atherosclerosis and contributes to reducing the risk of complications associated with cardiovascular diseases, stroke, myocardial infarction, and vascular reintervention. The combination therapy of these two medications is used to manage blood pressure and cholesterol simultaneously, improving cardiovascular health.

How to take

Adult dose

Telmisartan: Recommended oral dose of 40 mg once daily, with efficacy possible at 20 mg depending on the patient, and can be increased to 80 mg if needed. For risk reduction of cardiovascular disease: Recommended oral dose of 80 mg once daily. Patients with liver dysfunction: Do not exceed 40 mg once daily. Rosuvastatin: Initial dose of 5 mg once daily, maintenance dose of 10 mg once daily, can be increased up to a maximum of 20 mg. Elderly: No dose adjustment required.

Precautions

This medication can cause severe harm to the fetus during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used in individuals with hypersensitivity to this medication, pregnant or breastfeeding women, and fertile women who are not using appropriate contraception. Patients with severely impaired liver function or cholestasis should use this medication cautiously. Its use is contraindicated or should be carried out with caution in patients with a history of muscle diseases, severe renal impairment, or in cases of concomitant use with specific medications. Elderly patients, those with hyperkalemia, and patients with mildly impaired liver function require careful monitoring during administration. This medication can affect the liver and muscles, so regular blood tests for liver enzymes and muscle-related parameters should be conducted before and during administration. If symptoms such as muscle pain, weakness, or cramps occur, consult a physician immediately, and if severe, drug administration may need to be stopped. This medication can interact with other drugs, so it's essential to inform your doctor or pharmacist about any other medications being taken. Caution is necessary when driving or operating machinery due to the possibility of dizziness or drowsiness. It is not recommended for children as safety and efficacy have not been established. In the case of overdose, symptoms such as hypotension, renal failure, and muscle abnormalities may occur; immediate medical attention is necessary. This medication contains lactose; therefore, it should not be taken by patients with lactose intolerance. Store the medication out of reach of children and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by high fever, blistering, peeling skin, pain in the mucous membranes of the mouth/eyes, difficulty or trouble breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary retention

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleep paralysis
  • elevated blood pressure
  • decreased diastolic blood pressure
  • hypotension
  • urinary pain
  • rhinitis
  • discomfort in the oropharynx
  • pulmonary disease
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  • unspecified gastrointestinal disease
  • benign gastrointestinal neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • fainting
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • orthostatic hypotension
  • abdominal pain

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the effectiveness of the drug.

Appearance and packaging

Appearance

Bright blue oval film-coated tablet

Package unit

30 tablets ((10 tablets/Alu-Alu)x3)

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.