Medication info
Rostel Tablet 40/10 mg

Rostel Tablet 40/10 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 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 x 3)
Approval status
Active

MFDS item code 201506820 · Approved 2015.09.25 · Insurance code 651204420

Summary

Main use
Improves hypertension and hyperlipidemia and reduces the risk of cardiovascular diseases
Who takes it
Adults
Adult dose
It is recommended to administer 40 mg of telmisartan orally once daily; a dosage of 20 mg once daily may be effective depending on the patient. If necessary, it can be increased up to 80 mg once daily. For the purpose of reducing the risk of cardiovascular diseases, 80 mg of this medication is recommended to be taken orally once daily. Patients with liver impairment should not exceed 40 mg once daily. The initial dose of rosuvastatin is 5 mg once daily.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improves hypertension and hyperlipidemia and reduces the risk of cardiovascular diseases

  • Essential hypertension
  • coronary artery disease
  • peripheral artery disease
  • stroke
  • transient ischemic attacks
  • clinical evidence of damage to peripheral organs
  • high-risk diabetes
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed-type hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
View approved original text

This medication is used for patients who need to take both telmisartan and rosuvastatin. Telmisartan is primarily indicated for patients with essential hypertension and for individuals over 55 years who are at high risk of cardiovascular diseases, helping to reduce the risks of conditions such as myocardial infarction and stroke. Rosuvastatin is used in conjunction with dietary and exercise regimens to lower cholesterol levels in cases of primary hypercholesterolemia, mixed-type hyperlipidemia, and familial hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is also used to reduce the risks of stroke, myocardial infarction, and vascular reconstruction surgeries in patients aged 50 years or older who are at high risk of cardiovascular diseases. Combining these two medications manages both hypertension and hyperlipidemia simultaneously, preventing and improving cardiovascular diseases.

How to take

Adult dose

It is recommended to administer 40 mg of telmisartan orally once daily; a dosage of 20 mg once daily may be effective depending on the patient. If necessary, it can be increased up to 80 mg once daily. For the purpose of reducing the risk of cardiovascular diseases, 80 mg of this medication is recommended to be taken orally once daily. Patients with liver impairment should not exceed 40 mg once daily. The initial dose of rosuvastatin is 5 mg once daily.

Precautions

This medication may cause serious harm to the fetus during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not use this medication and should employ appropriate contraceptive methods if necessary. Patients with severely impaired liver function, those with problems in bile excretion, or those with muscle disorders should avoid using this medication. Patients with very poor kidney function or those using it in combination with specific immunosuppressants, as well as diabetic patients with moderate to severe renal impairment, should also avoid this medication. High-dose usage is prohibited for patients vulnerable to muscle disorders, and those with genetic lactase deficiency should avoid this medication. Caution is advised for elderly patients or those with hyperkalemia, as well as patients with slightly impaired liver function, and those who consume alcohol excessively or have hypothyroidism. Patients with heart valve diseases, ischemic heart diseases, gastrointestinal disorders, or renal vascular diseases should also take caution when using this medication. This medication can cause muscle-related side effects such as myalgia, myopathy, or rhabdomyolysis; if experiencing muscle pain or weakness, consult a doctor immediately. Additionally, liver function abnormalities may occur, so regular liver function tests are recommended. This medication can interact with various other drugs, so if taking other medications, consult a doctor or pharmacist. In case of overdose, hypotension, dizziness, or acute kidney failure may occur, requiring immediate treatment. Drowsiness or dizziness may occur while taking this medication, so exercise caution when driving or operating dangerous machinery. The safety and effectiveness of this medication in children have not been established; therefore, it is not recommended. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reaction, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache,

Mild side effects

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

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Doing so will help preserve the drug's effectiveness over time.

Appearance and packaging

Appearance

Bright blue oval film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu 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.