Medication info

Telostin Tablet 80/10 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Bright blue oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP*3)]
Approval status
Approval withdrawn

MFDS item code 202001839 · 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This product's status changed to Approval withdrawn on 2024.12.04.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
(Hypertension, cardiovascular disease) risk reduction and improvement of (hypercholesterolemia)
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension, the recommended oral dose is 40 mg once daily, with 20 mg once daily also possibly effective depending on the patient. If necessary, it can be increased to 80 mg once daily. For reducing the risk of cardiovascular disease, the recommended oral dosage is 80 mg once daily. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: The initial dose is 5 mg once daily,

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

(Hypertension, cardiovascular disease) risk reduction and improvement of (hypercholesterolemia)

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

This medication is used only for patients who need to take both telmisartan and rosuvastatin simultaneously. Telmisartan treats essential hypertension and reduces the risk of cardiovascular diseases, particularly in high-risk groups, reducing the risk of myocardial infarction, stroke, and mortality from cardiovascular diseases. Meanwhile, rosuvastatin helps control blood lipid abnormalities, such as hypercholesterolemia and dyslipidemia, slowing the progression of atherosclerosis and reducing various risks associated with cardiovascular diseases. By working together, these two components effectively manage hypertension and hyperlipidemia, thereby improving cardiovascular health.

How to take

Adult dose

Telmisartan: For essential hypertension, the recommended oral dose is 40 mg once daily, with 20 mg once daily also possibly effective depending on the patient. If necessary, it can be increased to 80 mg once daily. For reducing the risk of cardiovascular disease, the recommended oral dosage is 80 mg once daily. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: The initial dose is 5 mg once daily,

Precautions

This medication can cause severe harm to the fetus if used during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. People allergic to this medication or its components should not use it. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication, and fertile women who do not use adequate contraceptive measures should be cautious. Patients with severely impaired liver function or biliary obstruction, as well as those with active liver disease, should not take this medication. Patients with muscle disorders or a history of angioedema, and those with severe renal impairment, should also avoid using this medication. In particular, patients taking cyclosporine or those with diabetes and moderate to severe renal impairment are contraindicated from coadministration. High-dose administration of this medication is prohibited in patients at high risk for myopathy or rhabdomyolysis, and those patients should consult their doctor before taking it. Patients with genetically determined lactose intolerance should not take this medication due to its lactose content. Elderly patients, those with hyperkalemia, and patients with mildly impaired liver function should use this medication cautiously and undergo regular liver function tests and blood tests. Patients with cardiovascular or gastrointestinal diseases, and renal vascular hypertension should also be cautious when taking this medication. If symptoms like muscle pain, muscle weakness, or muscle cramps occur while taking this medication, consult a physician immediately, and necessary muscle enzyme tests should be conducted to check for abnormalities. This medication can interact with other antihypertensive or lipid-lowering medications, so inform your doctor of any other medications being taken. It is important to check muscle enzymes and liver function through blood tests before starting treatment and regularly during treatment. Women who are pregnant or breastfeeding should avoid taking this medication, and those planning to become pregnant should use adequate contraceptive measures. The safety and efficacy of this medication in children have not been established, so it is not recommended for pediatric use. In case of overdose, symptoms such as hypotension, dizziness, and acute renal failure may occur, requiring immediate visit to a medical institution, as there is no specific antidote and symptomatic treatment is necessary. Be cautious when driving or operating machinery, as dizziness or drowsiness may occur during the course of medication. Finally, store this medication out of reach of children and do not transfer it to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, feeling short of breath or difficulty in breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urine

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleepiness
  • increased blood pressure
  • decreased diastolic blood pressure
  • hypotension
  • painful urination
  • rhinitis
  • discomfort in the oropharynx
  • pulmonary diseases
Show 23 more
  • 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

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. Also, avoid storing it in excessively hot or cold locations, and it is best to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright blue 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.

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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.