Medication info
Telmisartan and Amlodipine Tablets 80/5 mg

Telmisartan and Amlodipine Tablets 80/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan Powder 23.9%›334.72mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Biconvex, oval, double-layered tablet in white and light gray.
Packaging
30 tablets/box [10 tablets/PTPX3]
Approval status
Active

MFDS item code 201908433 · Approved 2019.12.16 · Insurance code 057600440

Summary

Main use
Improvement in blood pressure control in essential hypertension.
Who takes it
Adults · Children
Adult dose
The recommended dosage for adults is 1 tablet once daily, to be taken with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). 40/5 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 40 mg telmisartan. 80/5 mg: Given to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or this medication 40/5 mg.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, so the use of this medication is not recommended.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improvement in blood pressure control in essential hypertension.

  • Essential hypertension
View approved original text

This medication effectively lowers blood pressure in patients with essential hypertension who do not achieve adequate blood pressure control with amlodipine or telmisartan monotherapy. For those who find it difficult to manage their blood pressure, taking this medicine reduces the strain on the heart and blood vessels, thereby improving overall health. This drug is used to stabilize blood pressure management and to reduce the risk of cardiovascular complications.

How to take

Adult dose

The recommended dosage for adults is 1 tablet once daily, to be taken with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). 40/5 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 40 mg telmisartan. 80/5 mg: Given to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or this medication 40/5 mg.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, so the use of this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus if administered during pregnancy, especially in the second and third trimesters, and should not be used by women who are pregnant or may become pregnant. This medication should not be administered to patients with hypersensitivity to the active ingredients, severe liver impairment, hypotension, heart failure, or unstable condition following acute myocardial infarction. Caution is advised for patients with impaired liver function, certain cardiac valve diseases, decreased kidney function, the elderly, etc. During treatment, side effects such as dizziness, peripheral edema, palpitations, and hypotension may occur, and if these symptoms are severe, medical advice should be sought immediately. As this drug lowers blood pressure, appropriate measures must be taken if symptoms of hypotension arise during treatment, particularly for patients who are deficient in fluids or salt. There is a risk of elevated potassium levels in the blood; therefore, regular monitoring of serum potassium levels is necessary when used in conjunction with potassium supplements or potassium-containing medications. Patients with impaired kidney function should undergo frequent monitoring relevant to kidney function while taking this medication, and safety for kidney transplant patients has not been fully established. This medication may interact with other antihypertensives or specific medications, so patients should inform their healthcare providers of any other medications they are taking. Pregnant and breastfeeding women should not take this medication, and if confirmed during pregnancy, it should be discontinued immediately and alternative treatment should be sought. Safety and efficacy have not been sufficiently established for use in children under 18 years of age, so it is not recommended. Elderly patients may respond more sensitively to this medication, so they should take it with caution and adjust the dosage accordingly. In cases of overdose, severe symptoms such as hypotension, dizziness, and cardiac dysfunction may occur; therefore, adherence to the prescribed dosage is essential, and emergency treatment should be sought in case of overdose. Store this medication out of reach of children and keep it in its original packaging for safety. Caution is advised when driving or operating machinery, as dizziness or drowsiness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), difficulty breathing, severe allergic reactions, angioedema (with fatal outcomes), toxic skin rashes, Stevens-Johnson syndrome, exfoliative dermatitis, erythema multiforme, liver abnormalities (hepatitis, jaundice, elevated liver enzymes), acute renal failure, hypotension, syncope, myocardial infarction, ventricular tachycardia, arrhythmia, atrial fibrillation, sepsis, intestinal vascular edema, renal dysfunction, thrombocytopenia, leukopenia.

Mild side effects

  • Dizziness
  • peripheral edema
  • syncope
  • headache
  • drowsiness
  • migraine
  • paresthesia
  • taste disturbance
  • tremors
  • visual disturbances
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  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • abdominal pain
  • diarrhea
  • vomiting
  • dry mouth
  • itching
  • rash
  • hair loss
  • purpura
  • skin discoloration
  • sweating
  • eczema
  • erythema
  • joint swelling
  • muscle cramps
  • arthralgia
  • myalgia
  • low back pain
  • limb pain
  • tendon pain
  • urination disorders
  • frequency.

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

Storage

This medication should be stored in a tightly sealed container protected from light, preferably at room temperature between 1 to 30 degrees Celsius. Storing this way helps maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

Biconvex, oval, double-layered tablet in white and light gray.

Package unit

30 tablets/box [10 tablets/PTPX3]

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.