Medication info

Telmisartan/Esamlodipine Tablet 80/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletS-Amlodipine Besylate Dihydrate›7.38mg / 1 tablet
Manufacturer / importer
(주)비씨월드제약
Appearance
Oblong tablet consisting of a light yellow layer and a light blue layer
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202203377 · Approved 2022.08.25

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet once daily, to be taken with water irrespective of meals. It is recommended to take it at the same time every day (e.g., in the morning). In patients with mild to moderate renal impairment, dosage adjustment is not necessary; however, patients with severe renal impairment should start treatment with a lower dose and gradually increase it. In patients with hepatic impairment, the daily dose of telmisartan should not exceed 40 mg for those with mild or moderate hepatic impairment.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with either telmisartan or esamlodipine (amlodipine). It helps to stabilize and lower blood pressure, thereby reducing the risk of complications associated with hypertension.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, to be taken with water irrespective of meals. It is recommended to take it at the same time every day (e.g., in the morning). In patients with mild to moderate renal impairment, dosage adjustment is not necessary; however, patients with severe renal impairment should start treatment with a lower dose and gradually increase it. In patients with hepatic impairment, the daily dose of telmisartan should not exceed 40 mg for those with mild or moderate hepatic impairment.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Precautions

This medication can cause serious side effects to the fetus or newborn if taken during pregnancy, particularly in the second and third trimesters, so it must not be taken by women who are pregnant or who may become pregnant. Individuals allergic to any of the ingredients or similar class of medication, those with cholestatic liver disease, severe hepatic impairment, aortic stenosis, patients in shock, and nursing women should not use this medication. Caution is required for patients with severely impaired renal function or diabetic patients with diminished renal function when taking this medication alongside certain other medications. Patients with primary aldosteronism, aortic or mitral stenosis, hepatic impairment, active gastrointestinal diseases, renal artery hypertension, severe hypotension, patients undergoing dialysis for renal failure, and elderly patients should be monitored closely when taking this medication. Possible side effects include headaches, edema, dizziness, palpitations, and nausea, and rare occurrences of changes in blood test results or liver function abnormalities may occur. It is safest to avoid using this medication during pregnancy, and if pregnancy is confirmed, it should be discontinued promptly, and alternative treatments should be sought. This medication lowers blood pressure, and therefore when there is a deficiency in fluid or salt, symptoms of hypotension may occur, so it is important to check the condition before administration. Patients with impaired renal function should have their potassium levels and indicators of renal function checked regularly, and caution is needed when taking potassium supplements or potassium-containing medications due to the risk of hyperkalemia. During treatment with this medication, drowsiness or dizziness may occur; hence caution is necessary while driving or operating hazardous machinery. Like other antihypertensive drugs, patients with heart disease should be careful to avoid excessively low blood pressure, and when combined with similar class medications, the risk of hypotension, hyperkalemia, and deteriorated renal function may increase, so regular blood pressure and blood tests should be done as per the physician's recommendations. This medication may interact with specific drugs, so patients must inform healthcare providers of any other medications they are taking, particularly caution is needed when combined with digoxin, lithium, warfarin, non-steroidal anti-inflammatory drugs, and simvastatin. In cases of overdose, severe hypotension, tachycardia, dizziness, and renal failure may occur, so a medical facility should be visited immediately and appropriate emergency treatment is required. Finally, this medication is not recommended for children as safety and efficacy have not been adequately established, and for the elderly, it is advisable to adjust the dosage and gradually increase it.

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 fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urinate.

Mild side effects

  • Headache
  • peripheral edema
  • swelling
  • palpitations
  • dizziness
  • increased SGOT
  • nausea
  • increased platelet count
  • flushing
  • local edema
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  • orthostatic hypotension
  • lower back pain
  • upper respiratory infection
  • sinusitis
  • diarrhea
  • pharyngitis
  • influenza-like symptoms
  • dyspepsia
  • muscle pain
  • urinary tract infection
  • abdominal pain
  • dizziness
  • pain
  • fatigue
  • cough
  • hypertension
  • chest pain
  • nausea
  • erectile dysfunction
  • increased sweating
  • flushing
  • fever
  • leg pain
  • lethargy
  • palpitations

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

Storage

This medication should be stored in an airtight container to prevent air and moisture from entering. It is best kept at room temperature, between 1 to 30 degrees Celsius, to maintain its effectiveness.

Appearance and packaging

Appearance

Oblong tablet consisting of a light yellow layer and a light blue layer

Package unit

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.