Medication info
Amstel Tablet 40/5 mg

Amstel Tablet 40/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
아이큐어(주)
Appearance
White and light blue, double convex oval bilayer tablet.
Packaging
30 tablets (10 tablets/PTP*3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201605745 · Approved 2016.09.30 · Insurance code 674401350

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). Patients with renal impairment do not need dose adjustments in cases of mild or moderate renal impairment, but patients with severe renal impairment should start with a lower dose and gradually increase it. In cases of liver impairment, the daily dose of telmisartan should not exceed 40 mg in patients with mild to moderate liver impairment.
Child dose
Safety and efficacy in pediatric patients under 18 years have not been established; therefore, use in this population is not recommended.

Ingredients

Manufacturer
아이큐어(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively manage and control blood pressure when telmisartan or amlodipine monotherapy does not sufficiently control blood pressure due to essential hypertension.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). Patients with renal impairment do not need dose adjustments in cases of mild or moderate renal impairment, but patients with severe renal impairment should start with a lower dose and gradually increase it. In cases of liver impairment, the daily dose of telmisartan should not exceed 40 mg in patients with mild to moderate liver impairment.

Child dose

Safety and efficacy in pediatric patients under 18 years have not been established; therefore, use in this population is not recommended.

Precautions

This drug can cause serious harm to the fetus, especially in the second and third trimesters of pregnancy; therefore, it should not be taken by women who are pregnant or may become pregnant. This drug should not be administered to patients with certain conditions, such as severe liver impairment, biliary obstruction, severe hypotension, or severely impaired cardiac function. Patients with primary aldosteronism or aortic stenosis, as well as those with obstructive hypertrophic cardiomyopathy, should use this drug cautiously, and patients with liver impairment should also take it with care. Patients with gastrointestinal diseases should be cautious while taking this medication due to the risk of gastrointestinal bleeding. Patients with impaired kidney function, dialysis patients, or elderly individuals should be carefully monitored for potential worsening of kidney function or adverse effects when taking this medication. This drug lowers blood pressure, which may cause hypotensive symptoms, and side effects like dizziness or drowsiness; hence caution is advised when driving or operating machinery. Additionally, this drug may interact with certain medications, so it is essential to consult a physician or pharmacist if you are taking other medications. It is advisable for nursing women not to take this medication; if pregnant or planning to become pregnant, consultation with healthcare professionals is necessary. In case of overdose, severe symptoms such as hypotension and arrhythmia may occur, requiring immediate medical attention. This medication is not recommended for children as safety and efficacy in this patient population have not been sufficiently established.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), profound fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Dizziness, peripheral edema, headache, drowsiness, migraine, paresthesia, visual disturbances, vertigo, tinnitus, palpitations, bradycardia, tachycardia, flushing, hypotension, orthostatic hypotension, cough, rhinitis, changes in bowel habits (including diarrhea and constipation), abdominal pain, indigestion, nausea, vomiting, dry mouth, itching, rash, hair loss, purpura, skin discoloration, sweating, eczema, erythema, thrombocytopenia, increased serum uric acid, increased serum creatinine, weight gain,

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

Storage

This drug is sensitive to light and should be stored in a light-proof container. It is also important to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's efficacy.

Appearance and packaging

Appearance

White and light blue, double convex oval bilayer 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.