Medication info
Telmisartan/Amlodipine/Atorvastatin Combined Tablet 80/5/5 mg

Telmisartan/Amlodipine/Atorvastatin Combined Tablet 80/5/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
Oval two-layer tablet consisting of a white layer and a light blue layer
Packaging
30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle
Approval status
Active

MFDS item code 202302811 · Approved 2023.09.25 · Insurance code 649808240

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (reduced risk of atherosclerosis)
Who takes it
Adults
Adult dose
This medication is taken once daily, with one tablet, regardless of meals, and it is recommended to take it at the same time each day (e.g., in the morning). The dosage of the Telmisartan/Amlodipine combination is adjusted based on blood pressure control status, with available doses of 40/5 mg, 80/5 mg, 40/10 mg, and 80/10 mg. In patients with renal impairment, adjustments are made for mild to moderate renal impairment.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (reduced risk of atherosclerosis)

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not sufficiently controlled with Telmisartan and Amlodipine combination. It also contains Atorvastatin Calcium, which helps patients with hypercholesterolemia and mixed dyslipidemia who cannot control their cholesterol levels by diet and exercise alone. It is particularly used as an adjunct to diet for patients with abnormal lipid levels due to family history and lowers total cholesterol and LDL cholesterol, delaying the progression of atherosclerosis. Additionally, it reduces the risk of various conditions such as stroke, myocardial infarction, and arterial revascularization in patients at high risk of cardiovascular disease. Patients taking this medication can simultaneously control their blood pressure and cholesterol levels, improving cardiovascular health.

How to take

Adult dose

This medication is taken once daily, with one tablet, regardless of meals, and it is recommended to take it at the same time each day (e.g., in the morning). The dosage of the Telmisartan/Amlodipine combination is adjusted based on blood pressure control status, with available doses of 40/5 mg, 80/5 mg, 40/10 mg, and 80/10 mg. In patients with renal impairment, adjustments are made for mild to moderate renal impairment.

Precautions

This medication should not be used in pregnant women as it can cause serious harm to the fetus and newborn. If pregnancy is confirmed, take this medication immediately. Patients with allergies to any components or related components of this medication or those with certain hereditary diseases should not take it. In particular, patients with a history of angioedema, severe liver impairment, or severe kidney impairment may be at risk from using this medication. Elderly patients, those with hypotension, hyperkalemia, liver dysfunction, and similar conditions should use caution when administering this medication. Regular testing and monitoring are necessary as this medication can affect liver and kidney function. If symptoms such as muscle pain, muscle weakness, or muscle cramps occur during treatment, consult a physician immediately. If muscle-related problems are severe, discontinuation of the medication may be necessary. Interactions with other medications may occur, especially when taken with antihypertensives, diuretics, immunosuppressants, or certain antibiotics, so consultation with a physician is required. It is also recommended that breastfeeding women not use this medication, and if unavoidable, breastfeeding should be discontinued. In cases of overdose, hypotension, dizziness, and cardiac arrhythmias may occur, requiring immediate treatment. If an overdose is suspected, promptly visit a medical facility. This medication is not recommended for children and should be kept in a safe place out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough + fever, respiratory issues, yellowing of the skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice).

Mild side effects

  • Dyspepsia
  • dizziness
  • frequent bowel movements
  • headache
  • constipation
  • nausea
  • abdominal pain
  • drowsiness
  • fatigue
  • angioedema
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  • itching
  • rash
  • muscle pain
  • weakness
  • low back pain
  • urinary tract infection
  • muscle cramps
  • weight gain
  • weight loss
  • vasculitis
  • peripheral neuropathy
  • tremor
  • diplopia
  • eye pain
  • tinnitus
  • ear pain
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
  • pulmonary disease
  • unspecified gastrointestinal disease
  • benign gastrointestinal neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis.

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

Storage

This medication is packaged in special containers that block light and air. When stored, it should be kept at room temperature between 1 degree and 30 degrees Celsius, and it is important to avoid direct sunlight. This way, the medication's efficacy and safety can be maintained.

Appearance and packaging

Appearance

Oval two-layer tablet consisting of a white layer and a light blue layer

Package unit

30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle

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.