Medication info

Telok 40/5 mg Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
Bright pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Expired

MFDS item code 202005514 · Approved 2020.07.29

This product's status changed to Expired on 2025.10.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of (hypertension, cardiovascular disease risk) and improvement of (hypercholesterolemia)
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension, the recommended dose is 40 mg orally once daily, which may be effective at 20 mg once daily depending on the patient. If needed, it can be increased up to 80 mg once daily. For reducing the risk of cardiovascular disease, 80 mg orally once daily is recommended. In patients with liver impairment, it should not exceed 40 mg once daily. Rosuvastatin Calcium: For primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (type IIa), combined hyperlipidemia (type IIb), primary dysbetalipoproteinemia (type III) and homozygous familial hypercholesterolemia, patients should follow a standard cholesterol-lowering diet before and during treatment, which should be maintained throughout the treatment period. This medication can be administered at any time of the day without regard to meals. The initial dosage is 5 mg once daily, which can be adjusted to a maintenance dosage that requires greater LDL-cholesterol reduction. The maintenance dose is most commonly adjusted to 10 mg once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum increase up to 20 mg daily at intervals of 4 weeks or longer. Elderly: No dose adjustment is necessary. Renal impairment: No dose adjustment is needed for mild to moderate renal impairment. Not to be administered to patients with severe renal impairment. Caution is required when administering 20 mg to patients with moderate renal impairment. Liver failure: In patients with a Child-Pugh score of 7 or less, an increase in systemic exposure to rosuvastatin was not observed, but it was increased in patients with scores of 8 or 9. Kidney function testing should be considered in these patients. There is no experience administering to patients with a Child-Pugh score above 9. This medication should not be administered to patients with active liver disease. Ethnicity: Because an increase in systemic exposure to this medication has been observed in Asian patients, the recommended initial dose is 5 mg. A dose of 40 mg is contraindicated. Patients predisposed to myopathy: The recommended initial dose for patients predisposed to myopathy is 5 mg. Dosage of 40 mg is contraindicated in some of these patients. Patients taking telmisartan and rosuvastatin in combination may switch to this combination drug (with the same component content for ease of administration).

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

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

  • Essential hypertension
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of premature coronary artery disease
View approved original text

This medicine is administered only to patients who require the combination of telmisartan and rosuvastatin. Telmisartan helps in treating essential hypertension and reducing the risk of cardiovascular disease. It is particularly effective in reducing the incidence of myocardial infarction, stroke, and cardiovascular mortality in patients aged 55 years and older at high risk for cardiovascular disease. Rosuvastatin is used to manage various forms of hypercholesterolemia and dyslipidemia in conjunction with dietary therapy and delays the progression of atherosclerosis. It is also effective in reducing risks associated with myocardial infarction, stroke, and arterial revascularization in men over 50 years and women over 60 years with cardiovascular risk factors. The combination of these two medications is used to improve cardiovascular health and reduce associated risks.

How to take

Adult dose

Telmisartan: For essential hypertension, the recommended dose is 40 mg orally once daily, which may be effective at 20 mg once daily depending on the patient. If needed, it can be increased up to 80 mg once daily. For reducing the risk of cardiovascular disease, 80 mg orally once daily is recommended. In patients with liver impairment, it should not exceed 40 mg once daily. Rosuvastatin Calcium: For primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (type IIa), combined hyperlipidemia (type IIb), primary dysbetalipoproteinemia (type III) and homozygous familial hypercholesterolemia, patients should follow a standard cholesterol-lowering diet before and during treatment, which should be maintained throughout the treatment period. This medication can be administered at any time of the day without regard to meals. The initial dosage is 5 mg once daily, which can be adjusted to a maintenance dosage that requires greater LDL-cholesterol reduction. The maintenance dose is most commonly adjusted to 10 mg once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum increase up to 20 mg daily at intervals of 4 weeks or longer. Elderly: No dose adjustment is necessary. Renal impairment: No dose adjustment is needed for mild to moderate renal impairment. Not to be administered to patients with severe renal impairment. Caution is required when administering 20 mg to patients with moderate renal impairment. Liver failure: In patients with a Child-Pugh score of 7 or less, an increase in systemic exposure to rosuvastatin was not observed, but it was increased in patients with scores of 8 or 9. Kidney function testing should be considered in these patients. There is no experience administering to patients with a Child-Pugh score above 9. This medication should not be administered to patients with active liver disease. Ethnicity: Because an increase in systemic exposure to this medication has been observed in Asian patients, the recommended initial dose is 5 mg. A dose of 40 mg is contraindicated. Patients predisposed to myopathy: The recommended initial dose for patients predisposed to myopathy is 5 mg. Dosage of 40 mg is contraindicated in some of these patients. Patients taking telmisartan and rosuvastatin in combination may switch to this combination drug (with the same component content for ease of administration).

Precautions

This medicine can pose a serious risk to the fetus during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. It should not be taken by women who are pregnant or may become pregnant, or by nursing mothers, and appropriate contraceptive methods should be used. It is generally unsafe for patients with severely impaired liver or kidney function, or those with specific genetic diseases. Elderly patients or those with hyperkalemia, liver disease, etc., should use this medicine cautiously and may require regular monitoring. If symptoms of muscle pain or weakness occur, consultation with a physician should be sought immediately, and blood tests may be needed to check for muscle damage. This medicine can affect liver function, so regular liver function tests should be conducted before and during treatment. There may be interactions when taken with other medications, so if any medications are currently in use, it is essential to consult with a physician or pharmacist. Symptoms such as dizziness, drowsiness, or low blood pressure may arise during treatment, requiring caution when driving or operating machinery. In case of overdose, symptoms such as hypotension, dizziness, or kidney function decline may occur, necessitating immediate medical assistance. Store it 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, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties combined with cough and fever, jaundice, extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significant decrease in urine output

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleep paralysis
  • increased blood pressure
  • hypotension
  • ALT elevation
  • dysuria
  • rhinitis
  • oropharyngeal discomfort
  • lung disease
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  • unspecified gastrointestinal disorders
  • benign gastrointestinal tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing reduction
  • 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 medicine should be kept in a tightly closed container to avoid exposure to air or moisture. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

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.

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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.