Medication info

Telostin Tablets 80/5 Milligrams

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Bright pink oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP*3)]
Approval status
Approval withdrawn

MFDS item code 202001841 · Approved 2020.03.17

This product's status changed to Approval withdrawn on 2024.12.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk).
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension, the recommended oral dose is 40 mg once daily; in some patients, 20 mg once daily may be effective, and the dose may be increased to a maximum of 80 mg once daily. To reduce the risk of cardiovascular disease, the recommended oral dose is 80 mg once daily. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin: For primary hypercholesterolemia, the initial dose is 5 mg once daily.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk).

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

This medication is used for patients who need to take telmisartan and rosuvastatin together. Telmisartan is primarily used to treat essential hypertension and to reduce the risk of cardiovascular disease, particularly to help lower the risk of myocardial infarction, stroke, and cardiovascular death in high-risk patients who cannot use ACE inhibitors. Rosuvastatin is a dietary supplement for patients with hypercholesterolemia and mixed hyperlipidemia, functioning to lower LDL cholesterol, delay the progression of atherosclerosis, and reduce the risk of cardiovascular disease. The combination of these two medications is effective in managing hypertension and hyperlipidemia, as well as in preventing cardiovascular events. Therefore, this medication is used to reduce the risk of cardiovascular disease in patients who have both hypertension and hyperlipidemia.

How to take

Adult dose

Telmisartan: For essential hypertension, the recommended oral dose is 40 mg once daily; in some patients, 20 mg once daily may be effective, and the dose may be increased to a maximum of 80 mg once daily. To reduce the risk of cardiovascular disease, the recommended oral dose is 80 mg once daily. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin: For primary hypercholesterolemia, the initial dose is 5 mg once daily.

Precautions

This medication can cause serious harm to the fetus and newborn, especially during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. This medication should not be taken by individuals who are allergic to this drug or its components, women who are pregnant or are capable of becoming pregnant, and individuals who are breastfeeding. Patients with severe liver dysfunction or bile flow problems, and those with severe kidney disease or muscular disorders should not use this medication. Elderly individuals, those with high potassium levels, and those with slightly reduced liver function should take this medication with special caution. This medication can cause muscle-related side effects, such as muscle pain or weakness, so if any unusual symptoms arise in the muscles while taking it, consultation with a physician should be sought immediately. Regular liver function and muscle enzyme tests should be conducted before and during the use of this medication, and if abnormalities are found, use should be discontinued. Additionally, this medication may interact with other drugs, so individuals currently taking other medications must inform their healthcare provider. In case of overdose, symptoms such as hypotension, dizziness, and renal impairment may occur, so caution is advised, and prompt treatment from healthcare providers may be necessary in special cases. Finally, it is necessary to be careful during driving or operating machinery as dizziness or drowsiness may occur while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with cough and fever, jaundice of the skin or eyes, extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual abnormalities, paralysis, significantly reduced urination.

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleepiness
  • increased blood pressure
  • decreased blood pressure
  • hypotension
  • increased ALT
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
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  • respiratory disease
  • gastrointestinal disease
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory impairment
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • fainting
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • orthostatic hypotension
  • abdominal pain
  • diarrhea
  • dyspepsia
  • abdomen.

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 recommended to keep the storage temperature between 1 and 30 degrees Celsius to safely maintain the drug's effectiveness.

Appearance and packaging

Appearance

Bright pink oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP*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.