Medication info

Telostin Tablet 40/5 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›40mg / 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Approval withdrawn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 202001838 · 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This product's status changed to Approval withdrawn on 2024.12.04.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
(Reduction of hypertension and cardiovascular disease risk) and (Improvement of hypercholesterolemia)
Who takes it
Adults
Adult dose
Telmisartan: The recommended dose is 40 mg orally once a day, and depending on the patient, 20 mg once daily may also be effective. If necessary, the dose may be increased up to 80 mg once daily. For reducing cardiovascular disease risk, 80 mg orally once a day is prescribed. Patients with liver impairment (mild to moderate) should not exceed 40 mg once daily. Rosuvastatin Calcium: Initiate with a dose of 5 mg once daily.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

(Reduction of hypertension and cardiovascular disease risk) and (Improvement of hypercholesterolemia)

  • Essential hypertension
  • hypercholesterolemia
  • abnormal beta-lipoproteinemia
View approved original text

This medication is used for patients who need to take telmisartan and rosuvastatin simultaneously. Telmisartan helps reduce the risk of myocardial infarction, stroke, and cardiovascular disease mortality in adults with hypertension and a high risk of cardiovascular disease. Rosuvastatin lowers cholesterol levels in patients with hypercholesterolemia, particularly familial hypercholesterolemia and mixed dyslipidemia, delays the progression of atherosclerosis, and reduces cardiovascular disease risk. It is also used to lower the risk of stroke, myocardial infarction, and revascularization in high-risk patients with elevated high-sensitivity C-reactive protein levels. By administering these two components together, it effectively controls blood pressure and blood lipids, improving cardiovascular health.

How to take

Adult dose

Telmisartan: The recommended dose is 40 mg orally once a day, and depending on the patient, 20 mg once daily may also be effective. If necessary, the dose may be increased up to 80 mg once daily. For reducing cardiovascular disease risk, 80 mg orally once a day is prescribed. Patients with liver impairment (mild to moderate) should not exceed 40 mg once daily. Rosuvastatin Calcium: Initiate with a dose of 5 mg once daily.

Precautions

This medication can cause serious harm to the fetus and newborn during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. This medication should not be taken by individuals allergic to this drug or its ingredients, pregnant or potentially pregnant women, or nursing mothers. Patients with severe hepatic impairment or issues with bile excretion need to exercise caution when taking this medication. Patients with a history of muscle disorders or severe kidney dysfunction should also be cautious when taking this medication. Caution is necessary when administering this drug to the elderly, patients with high potassium levels, or those with mild hepatic impairment. If symptoms such as myalgia, muscle weakness, or muscle cramps occur, consult a physician immediately, and muscle enzyme levels may need to be checked if necessary. This medication requires regular monitoring of liver function tests, and if there is a significant increase in liver enzymes, it should be discontinued. Due to its blood pressure-lowering effects, dizziness or hypotension may occur, so special caution is needed for those taking high doses of diuretics or with low blood volume. As there may be interactions with other drugs, inform healthcare professionals of all medications being taken, particularly when combined with drugs that may increase muscle toxicity. This medication has not been sufficiently proven to be safe and effective in children and is not recommended for pediatric use. Overdose may lead to hypotension, dizziness, and deterioration of kidney function, requiring immediate medical attention. During treatment, be cautious of dizziness or drowsiness when driving or operating dangerous machinery. 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 (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significant decrease in urine output, systemic symptoms.

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleep paralysis
  • elevated blood pressure
  • hypotension
  • ALT elevation
  • painful urination
  • rhinitis
  • discomfort in the oropharynx
  • respiratory diseases
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  • unspecified gastrointestinal diseases
  • benign gastrointestinal neoplasms
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • fainting
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • respiratory issues.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is safe to store the medication at room temperature between 1 to 30 degrees Celsius, avoiding extremes of heat or cold.

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.