Medication info
Amstel Tablet 80/5 mg

Amstel Tablet 80/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
아이큐어(주)
Appearance
White and light blue, double-sided, convex oval tablet
Packaging
30 tablets (10 tablets/PTP*3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201605746 · Approved 2016.09.30 · Insurance code 674401360

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage 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). For patients with renal impairment, dose adjustments are not necessary for mild to moderate impairment; however, patients with severe renal impairment should start treatment at a lower dose and gradually increase it. The daily dose of telmisartan should not exceed 40 mg for patients with liver impairment.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years, so the administration of this medication is not recommended.

Ingredients

Manufacturer
아이큐어(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Used in patients with essential hypertension when blood pressure cannot be adequately controlled by monotherapy with telmisartan or amlodipine. This medication helps to more effectively control blood pressure, thereby reducing the risk of complications associated with hypertension. Safe and consistent use aids in blood pressure management and contributes to maintaining cardiovascular health. As a result, it improves blood pressure control in essential hypertension.

How to take

Adult dose

The recommended dosage 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). For patients with renal impairment, dose adjustments are not necessary for mild to moderate impairment; however, patients with severe renal impairment should start treatment at a lower dose and gradually increase it. The daily dose of telmisartan should not exceed 40 mg for patients with liver impairment.

Child dose

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

Precautions

This medication can cause serious effects on the fetus when taken during pregnancy, especially in the second and third trimesters; therefore, it should not be used by women who are pregnant or may become pregnant. Additionally, individuals allergic to any of the active ingredients or similar components, lactating women, patients with severe liver or heart issues, and those with certain kidney diseases should not take this medication. Patients with specific heart valve diseases, liver function impairment, gastrointestinal issues, renal artery hypertension, those undergoing dialysis, and the elderly require special caution when using this medication. Common side effects like dizziness and peripheral edema may occur, and severe side effects such as fainting or cardiac issues may rarely arise, so patients should consult a doctor immediately if any abnormal symptoms occur. Blood pressure may decline too low, especially in patients who are dehydrated or taking diuretics; therefore, they should assess their condition carefully before taking the medication and follow medical advice. There is a risk of elevated potassium levels in the blood, so caution is necessary when taking potassium supplements or medications containing potassium, and regular blood tests to check potassium levels are recommended. Patients with impaired kidney function should periodically receive kidney function tests while on this medication, and the safety for kidney transplant patients has not been established. Patients with heart disease may have an increased risk of angina or myocardial infarction when taking this medication, so they should inform their healthcare provider immediately if their symptoms worsen. Pregnant or breastfeeding women should not take this medication, and if planning pregnancy, it is recommended to switch to another safe antihypertensive. This medication may cause drowsiness or dizziness; caution is advised when driving or operating hazardous machinery. Interactions may occur when taken with other medications, so inform the healthcare provider or pharmacist about all medications being taken, especially certain heart medications, diuretics, potassium supplements, specific antibiotics, grapefruit juice, etc. In case of overdose, symptoms like hypotension, dizziness, or cardiac abnormalities may occur, so immediate medical attention is required. This medication is not recommended for children, and elderly patients should start with a lower dose and gradually increase it for safety.

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 high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucous membranes
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  • dyspnea or difficulty breathing
  • asthma attacks
  • respiratory issues with cough and fever
  • jaundice (yellowing of the skin or eyes)
  • extreme fatigue
  • sudden and severe headache
  • lightning-like headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • urination issues

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infections
  • urinary tract infections
  • cystitis
  • anemia
  • hypersensitivity
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
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  • hyperglycemia
  • depression
  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • headache
  • sensory disturbance
  • visual impairment
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • indigestion
  • nausea
  • vomiting
  • dry mouth
  • itching
  • rash
  • hair loss
  • eczema
  • angioedema
  • toxicity

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

Storage

Store this medication in an airtight container that protects it from light, at a temperature between 1 and 30 degrees Celsius, to maintain its effectiveness and safety.

Appearance and packaging

Appearance

White and light blue, double-sided, convex oval tablet

Package unit

30 tablets (10 tablets/PTP*3), 30 tablets/bottle, 100 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.