Medication info
Exadipin Tablets 5/160 milligrams

Exadipin Tablets 5/160 milligrams

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Yellow oval film-coated tablet
Packaging
28 tablets (ALU-ALU X 2) / carton
Approval status
Active

MFDS item code 201403415 · Approved 2014.07.25 · Insurance code 645208360

Summary

Main use
Improvement in control of essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 1 tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time each day (for example, in the morning). When blood pressure is not controlled by amlodipine or valsartan monotherapy, adjust to dosages of 5/80 milligrams, 5/160 milligrams, or 10/160 milligrams. For patients with renal impairment, no dosage adjustment is necessary for mild and moderate cases, but for severe patients, dosage adjustment is needed.
Child dose
Safety and efficacy have not been established for pediatric patients under the age of 18, so administration is not recommended.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement in control of essential hypertension

  • Essential hypertension
View approved original text

This medicine is used for patients with essential hypertension who have difficulty controlling blood pressure with monotherapy using amlodipine or valsartan.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time each day (for example, in the morning). When blood pressure is not controlled by amlodipine or valsartan monotherapy, adjust to dosages of 5/80 milligrams, 5/160 milligrams, or 10/160 milligrams. For patients with renal impairment, no dosage adjustment is necessary for mild and moderate cases, but for severe patients, dosage adjustment is needed.

Child dose

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

Precautions

This drug may cause serious harm to the fetus if taken during the second and third trimesters of pregnancy; therefore, women who are pregnant or may become pregnant should avoid taking it. This drug should not be taken if you have an allergy to the ingredients contained in this drug or similar class drugs. Patients with severely impaired kidney function or serious liver dysfunction should also avoid using this drug for safety. Diabetic patients with moderate to severe renal impairment should be cautious as taking this medication with certain other drugs may pose risks. If you have previously experienced facial or neck swelling due to angioedema or have taken related medications, you should not use this drug. Patients with severe aortic stenosis or in a state of shock are prohibited from using this drug. In conditions of sodium or fluid depletion in the body, this drug can cause hypotension, so you should check your status before taking it and supplement if necessary. Patients with high potassium levels may have increased potassium concentration when taking this drug, so frequent blood tests are required. Patients with renal artery stenosis need careful monitoring as there is a risk of worsening kidney function when taking this drug. There is insufficient safety data for patients who have recently undergone kidney transplantation, so use is not recommended. If symptoms of angioedema occur during the use of this drug, discontinue immediately and consult a physician. Patients with heart failure or after myocardial infarction should be closely monitored for changes in kidney function or hypotension when taking this drug. In acute myocardial infarction patients, some components of this drug may worsen angina or myocardial infarction symptoms, so caution is needed. Patients with aortic or mitral valve stenosis and those with obstructive hypertrophic cardiomyopathy require special attention when taking this drug. The risk of hypotension, worsening kidney function, and hyperkalemia may increase when this drug is used with other antihypertensive medications, so regular blood pressure monitoring and blood tests should be conducted as directed by a physician. Caution is needed as dizziness or fatigue may occur when driving or operating machinery. In case of overdose, symptoms such as hypotension, dizziness, and increased heart rate may occur; in such cases, you should visit a medical institution for appropriate treatment immediately. This drug is not recommended for children under 18 years of age, as safety and efficacy have not been sufficiently established. Elderly patients may be administered similar doses as adults, but they should be closely monitored. It is advisable to regularly check kidney function and electrolyte levels through blood tests during treatment with this drug. There may be interactions with other medications during this treatment, so you should consult a physician or pharmacist about all medications you are taking.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
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  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • fatigue
  • polyuria
  • diuresis
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial edema
  • tiredness
  • flushing
  • weakness.

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

Storage

This drug must be stored in a tightly sealed container to prevent exposure to air and moisture, and it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

28 tablets (ALU-ALU X 2) / carton

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.