Medication info
Megateldipin Tablet 40/10 mg

Megateldipin Tablet 40/10 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan Powder 23.9%›167.36mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
A white and light gray, double convex, oval tablet.
Packaging
30 tablets/box [(10 tablets/PTP X 3)]
Approval status
Active

MFDS item code 202000048 · Approved 2020.01.03 · Insurance code 060500180

Summary

Main use
Improvement of blood pressure in essential hypertension not controlled by monotherapy with telmisartan or amlodipine.
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once daily, to be taken with water irrespective of meals. It is advised to take it at the same time each day (e.g., in the morning) if possible. Dosage adjustments may be needed based on the patient's condition, with options of 40/5 mg, 80/5 mg, and 40/10 mg. Dosage adjustments and caution are also recommended for patients with renal impairment, liver impairment, and the elderly.
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
(주)엘앤씨바이오

Efficacy & effects

Improvement of blood pressure in essential hypertension not controlled by monotherapy with telmisartan or amlodipine.

  • Essential hypertension
View approved original text

Used in patients with essential hypertension who have not achieved adequate blood pressure control with monotherapy using telmisartan or amlodipine.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, to be taken with water irrespective of meals. It is advised to take it at the same time each day (e.g., in the morning) if possible. Dosage adjustments may be needed based on the patient's condition, with options of 40/5 mg, 80/5 mg, and 40/10 mg. Dosage adjustments and caution are also recommended for patients with renal impairment, liver impairment, and the elderly.

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, and should not be used during pregnancy. It should not be used in individuals with allergies to the active ingredients or similar substances, in pregnant women or those who may become pregnant, in breastfeeding women, in patients with cholestatic disease, in patients with severe liver dysfunction, in patients with left ventricular outflow tract obstruction, in patients with severe hypotension, in patients in a state of shock, in patients with unstable heart failure after acute myocardial infarction, in individuals with issues related to the excipients, and in patients with diabetes or severe renal impairment who are taking specific medications. Careful use is required in patients with primary aldosteronism, certain heart valve diseases, liver disease, gastrointestinal disease, renovascular hypertension, patients on dialysis due to renal failure, elderly patients, and when used in combination with specific antihypertensive agents. Common side effects include dizziness or peripheral edema, and rare side effects may include fainting or severe allergic reactions. During pregnancy, there is an increased risk of fetal renal impairment, cranial formation abnormalities, decreased amniotic fluid, etc., so this medication should be discontinued immediately if pregnancy is confirmed. Since this drug lowers blood pressure, patients with hypotension or dehydration should manage their conditions well prior to taking it. There is a risk of hyperkalemia; potassium levels in the blood should be monitored regularly, and caution is required when taken with potassium supplements or potassium-containing medications. Patients with impaired renal function should take this medication while periodically monitoring renal function and electrolyte levels. Patients with heart disease should be cautious as this medication may increase the risk of angina or myocardial infarction. This medication may cause drowsiness or dizziness; caution is needed when driving or operating hazardous machinery. There may be interactions with other medications, especially when taken with certain heart medications, diuretics, anti-inflammatory drugs, grapefruit juice, etc., so consult with a doctor or pharmacist. Breastfeeding women should avoid taking this medication, and its safety and efficacy have not been established in children, so it is not recommended for them. In the case of overdose, severe hypotension or heart problems may occur, so contact a medical institution immediately and receive necessary treatment. This medication should be kept out of the reach of children and stored in a sealed container to prevent moisture.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema (may have fatal consequences), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin abnormal reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice),

Mild side effects

Dizziness, peripheral edema, upper respiratory tract infections (including pharyngitis and sinusitis), urinary tract infections (including cystitis), anemia, hyperkalemia, hypoglycemia (in diabetic patients), hyponatremia, hyperglycemia, depression, insomnia, anxiety, confusion, drowsiness, migraine, headache, paresthesia, visual disturbances (including double vision), dizziness, tinnitus, palpitations, bradycardia, tachycardia, flushing, hypotension, orthostatic hypotension, cough, abdominal pain, dyspepsia, nausea, vomiting

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

Storage

This medication is sensitive to light, so it should be stored in a container that does not let light in. Additionally, it is recommended to store it at room temperature, between 1 to 30 degrees Celsius, for safe storage.

Appearance and packaging

Appearance

A white and light gray, double convex, oval tablet.

Package unit

30 tablets/box [(10 tablets/PTP X 3)]

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.