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
(주)한독
Appearance
White and light gray, double convex, oval tablets
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201605770 · Approved 2016.09.30 · Insurance code 652105620

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this drug is one tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., morning). Patients with renal impairment do not require dose adjustments in mild to moderate cases, but patients with severe renal impairment should start with a lower dose and gradually increase it. For patients with hepatic impairment, the daily dose should not exceed 40 mg. Elderly patients should be cautious with dosages.
Child dose
The safety and efficacy of this drug for pediatric patients under 18 years have not been established, so its use is not recommended.

Ingredients

Manufacturer
(주)한독

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure with alone therapy of amlodipine or telmisartan. It helps to lower blood pressure more effectively and reduce cardiovascular risk. In other words, it is a suitable treatment option for hypertensive patients who do not respond to monotherapy.

How to take

Adult dose

The recommended dose of this drug is one tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., morning). Patients with renal impairment do not require dose adjustments in mild to moderate cases, but patients with severe renal impairment should start with a lower dose and gradually increase it. For patients with hepatic impairment, the daily dose should not exceed 40 mg. Elderly patients should be cautious with dosages.

Child dose

The safety and efficacy of this drug for pediatric patients under 18 years have not been established, so its use is not recommended.

Precautions

This medication should not be used by pregnant women, especially during the second and third trimesters, as it can cause serious problems for the fetus. This drug should not be administered to patients with certain diseases, such as severe liver impairment, obstructive biliary disease, severe hypotension, or severe heart diseases. Patients with primary aldosteronism, specific heart valve diseases, liver impairment, gastrointestinal diseases, and renovascular hypertension require special caution while using this medication. Side effects like dizziness and peripheral edema can occur frequently, and serious side effects have been reported rarely, so medical consultation should be sought if unusual symptoms appear. Pregnant women should especially avoid taking this medication, and if pregnancy is confirmed, it must be stopped immediately, and alternative treatment should be arranged. Symptoms of hypotension may occur, so blood pressure and symptoms should be carefully monitored during the initial administration, and appropriate treatment should be sought if necessary. There is a risk of increased serum potassium levels; therefore, patients with impaired renal function or heart failure require regular blood tests. This medication may affect kidney function, so patients with kidney disease should monitor kidney function through blood tests as advised by their physician. Patients with cardiovascular diseases may have an increased risk of angina or myocardial infarction when taking this drug, and it should only be taken under medical supervision. This medication can cause drowsiness or dizziness, so caution is required when driving or operating dangerous machinery. There may be interactions when taken with other medications; therefore, it’s essential to inform the healthcare provider of any existing medications. Breastfeeding women should ideally avoid this medication and consult a doctor if necessary. It is not recommended for children or adolescents under 18 years, as its safety and efficacy have not been adequately confirmed. Elderly patients may respond sensitively to this medication, so it should be used cautiously with dose adjustments. In case of overdose, symptoms like hypotension, dizziness, and cardiac problems may occur, so immediate medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache.

Mild side effects

  • Dizziness
  • peripheral edema
  • fainting
  • drowsiness
  • headache
  • sensory disturbances
  • taste disturbances
  • tremor
  • visual impairment
  • vertigo
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  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • indigestion
  • nausea
  • vomiting
  • dry mouth
  • itching
  • sweating
  • rash
  • hair loss
  • purpura
  • skin discoloration
  • eczema
  • erythema
  • joint swelling
  • muscle cramps
  • joint pain
  • muscle pain
  • back pain
  • limb pain
  • tendon pain
  • urinary disorders
  • frequency urination.

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

Storage

This medication is sensitive to light and should be stored in an airtight container that blocks out light. Additionally, it is best stored at room temperature between 1 and 30 degrees Celsius. This helps to maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White and light gray, double convex, oval tablets

Package unit

30 tablets (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.