Medication info

Abifure Tablet 5/20 Milligrams

Prescription medicationTablet경구Expired
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›20mg / 1 tablet
Manufacturer / importer
태극제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Expired

MFDS item code 201906397 · Approved 2019.09.10

This product's status changed to Expired on 2024.09.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered once daily, one tablet, with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosages are as follows: - 5/20 milligrams: for patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 milligrams or olmesartan medoxomil 20 milligrams. - 10/20 milligrams: for patients whose blood pressure is not adequately controlled with monotherapy of olmesartan medoxomil 20 milligrams.
Child dose
The safety and efficacy of this drug in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
태극제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication can be used to effectively manage blood pressure when blood pressure is not sufficiently controlled with either amlodipine or olmesartan medoxomil alone in patients with essential hypertension. This treatment helps prevent cardiovascular complications and improves the patient's overall health. Therefore, it aids in the stable management of blood pressure in hypertensive patients who have difficulty controlling their blood pressure.

How to take

Adult dose

This medication is administered once daily, one tablet, with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosages are as follows: - 5/20 milligrams: for patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 milligrams or olmesartan medoxomil 20 milligrams. - 10/20 milligrams: for patients whose blood pressure is not adequately controlled with monotherapy of olmesartan medoxomil 20 milligrams.

Child dose

The safety and efficacy of this drug in pediatric patients under 18 years of age have not been established.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimester of pregnancy, so if pregnancy is confirmed, it should be stopped immediately. This medication should not be taken by individuals who are allergic to the active ingredients or similar medications, those who are pregnant or breastfeeding, patients with severe liver impairment, aortic stenosis, biliary obstruction, those undergoing renal dialysis, patients in shock, and certain diabetic patients. Patients with fluid or salt depletion, those with vasodilation, impaired cardiac or renal function, and individuals with liver dysfunction should exercise extreme caution while using this medication and should be closely monitored. This drug can cause various side effects, including dizziness, headache, hypotension, palpitations, indigestion, rash, and swelling; if any abnormal symptoms occur, consult a healthcare professional immediately. This medication may interact with other antihypertensive drugs or certain medications, so any currently taken medications should be disclosed to a doctor or pharmacist. It is safest not to use this drug during pregnancy, especially in the second and third trimesters, as it can cause serious harm to the fetus; therefore, women planning pregnancy or who are pregnant should not take this drug. If breastfeeding, since this drug can be passed into breast milk, one should consult with a doctor about whether to continue breastfeeding or stop taking the medication. It is not recommended for use in children under the age of 18, as its safety and efficacy have not been established in this population. Elderly patients may have diminished kidney and liver function; therefore, starting at a lower dose and careful monitoring is advised. In case of overdose, severe hypotension or symptoms due to vasodilation may occur, necessitating immediate hospital treatment for appropriate care. This medication should be stored in a sealed container to protect it from light and moisture, and should be kept out of reach of children; it is best not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling (edema), difficulty breathing, respiratory distress, liver dysfunction (jaundice), severe skin reactions (severe rash with fever, blistering, skin shedding, pain in oral/ocular mucosa), severe allergic reactions, serious neurological symptoms (dizziness, fainting, worsened stroke), acute renal failure, markedly reduced urine output, edema accompanied by increased blood pressure, abnormal vascular tone, decreased glomerular filtration rate,

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • sensory disturbances
  • orthostatic hypotension
  • palpitations
  • hypotension
  • cough
  • nausea
  • vomiting
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  • indigestion
  • diarrhea
  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle tension
  • limb pain
  • low back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • dependent edema
  • fatigue
  • weakness
  • facial swelling
  • decreased potassium levels in the blood
  • increased creatinine levels in the blood
  • increased uric acid levels in the blood
  • increased gamma-glutamyl transferase
  • hemoglobin and hematocrit changes

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 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.