Medication info
Enpistar Tablet 80/5mg

Enpistar Tablet 80/5mg

Prescription medication경구
Ingredient · strength
Telmisartan Powder 23.9%›334.72mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
It is a double tablet that is oval-shaped and biconvex in appearance, colored white and light gray.
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201605824 · Approved 2016.09.30 · Insurance code 669906980

Summary

Main use
Improvement in blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., morning). It is recommended to adjust the individual components (telmisartan or amlodipine) before administration, and if blood pressure is not controlled, the following doses should be administered. - 40/5 milligrams: for patients whose blood pressure is not controlled with 5 milligrams of amlodipine or 40 milligrams of telmisartan.
Child dose
Safety and efficacy have not been established in pediatric patients under 18 years of age, so the use of this medication is not recommended.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for effectively controlling blood pressure in patients with essential hypertension who do not achieve adequate blood pressure control with monotherapy of telmisartan or amlodipine.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., morning). It is recommended to adjust the individual components (telmisartan or amlodipine) before administration, and if blood pressure is not controlled, the following doses should be administered. - 40/5 milligrams: for patients whose blood pressure is not controlled with 5 milligrams of amlodipine or 40 milligrams of telmisartan.

Child dose

Safety and efficacy have not been established in 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, especially during the second and third trimesters of pregnancy, so it should not be used by pregnant women or women who may become pregnant. This medication should not be administered to patients with certain conditions, such as liver impairment, obstructive biliary disease, severe hypotension, cardiogenic shock, and unstable heart failure after acute myocardial infarction. Patients with primary aldosteronism or aortic stenosis, and hypertrophic obstructive cardiomyopathy require special caution when using this medication. As this medication is metabolized by the liver and excreted in bile, dosage adjustment and caution are necessary in patients with impaired liver function. Patients with gastrointestinal disorders may experience gastrointestinal-related side effects, so it should be administered cautiously. In patients with renal function impairment or renal artery hypertension, there is a risk of worsening kidney function or hypotension, necessitating regular blood tests and monitoring. Elderly patients may exhibit sensitive reactions, so dosing should be adjusted slowly with caution. This medication can significantly reduce blood pressure; if hypotensive symptoms occur, the patient should be laid down immediately and receive fluid therapy if necessary. Hyperkalemia may occur, hence, caution is necessary if potassium supplements or medications containing potassium are taken concurrently. This medication can cause drowsiness or dizziness; therefore, caution should be exercised while driving or operating machinery. There may be interactions with other medications, so it is important to inform healthcare providers of any medications currently being taken. Safety and efficacy have not been established in children, so use is not recommended. In case of overdose, severe hypotension and cardiovascular side effects may occur, so appropriate treatment should be sought immediately at a medical facility. When storing this medication, keep it out of reach of children, away from moisture, and take it immediately after opening the package.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
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  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • headache
  • sensory disturbance
  • syncope
  • tremors
  • visual impairment
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • liver dysfunction
  • pruritus
  • sweating
  • rash
  • hair loss
  • purpura

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

Storage

This medication is sensitive to light and should be stored in a container that prevents light exposure. Additionally, it is important to store it at room temperature between 1 degree and 30 degrees Celsius to avoid damage.

Appearance and packaging

Appearance

It is a double tablet that is oval-shaped and biconvex in appearance, colored white and light gray.

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.