Medication info

Eurozartan Tablet 5/100 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›100mg / 1 tablet
Manufacturer / importer
메딕스제약(주)
Appearance
Pale pink, rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201903312 · Approved 2019.05.22

This product's status changed to Approval withdrawn on 2024.01.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in control of essential hypertension and treatment goal blood pressure management
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is one tablet once daily, to be taken with water irrespective of meals. It is advisable to take it at the same time each day (e.g., in the morning). Normally, 5/50 mg is administered once daily, and if blood pressure is not adequately controlled after two weeks, the dosage may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years; therefore, this medication is not recommended.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

Improvement in control of essential hypertension and treatment goal blood pressure management

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used for the treatment of hypertension and is effective for patients with essential hypertension who find it difficult to control blood pressure with monotherapy using amlodipine or losartan. It can also be used as initial therapy in stage 2 hypertensive patients who require combination therapy to reach their treatment goal blood pressure. This medication helps to manage blood pressure reliably, thereby assisting in the prevention of cardiovascular complications.

How to take

Adult dose

The recommended dosage of this medication is one tablet once daily, to be taken with water irrespective of meals. It is advisable to take it at the same time each day (e.g., in the morning). Normally, 5/50 mg is administered once daily, and if blood pressure is not adequately controlled after two weeks, the dosage may be increased to 10/50 mg once daily.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years; therefore, this medication is not recommended.

Precautions

This drug may cause severe harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. There is a risk of decreased fetal kidney function, oligohydramnios, and malformations of the skull and limbs. It may also pose risks during early pregnancy, so women of childbearing potential should consult a doctor before taking this medication. Patients with reduced blood volume, especially those on diuretics, should stabilize their condition before starting this medication and be closely monitored. This medication is not to be administered to patients who are allergic to the active ingredients or those with severe liver dysfunction, severe aortic stenosis, or in shock. Due to the antihypertensive effects, dizziness may occur, thus it is advisable to avoid driving or operating heavy machinery. Patients with compromised liver or kidney function should consult a healthcare professional before taking this medication, and regular monitoring of potassium levels is needed due to the risk of hyperkalemia. When taken with other antihypertensive medications, the effects may be enhanced, so it should be taken as directed by a healthcare professional. Taking this medication with grapefruit juice may increase blood drug concentrations, elevating the risk of side effects, so it is advisable to avoid this combination. Women who are pregnant or nursing should not take this medication, and it is not recommended for children or elderly patients over 75 years. Overdose can cause severe hypotension and cardiac issues, so the dosage must be strictly followed, and immediate medical attention is required for any unusual symptoms. Store out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Rash, chest tightness, difficulty breathing, angioedema (swelling of the larynx or pharynx causing airway obstruction, swelling of the face/lips/tongue), vasculitis (Henoch-Schönlein purpura), anaphylactic reaction, severe rash with high fever, blisters, desquamation, oral/ocular mucosal pain, severe skin adverse reactions, severe swelling, dependent edema, shortness of breath or difficulty breathing, asthma attack, cough with sputum

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • discomfort in the chest
  • chest pain
  • early satiety
  • peripheral edema
  • dependent edema
  • abdominal discomfort
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  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • cough
  • conjunctival hyperemia
  • frequent urination
  • fatigue
  • lethargy
  • blood pressure drop
  • tension increase
  • sensory loss/paresthesia
  • peripheral neuropathy
  • syncope
  • taste alteration
  • tremors
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is important to maintain storage temperatures between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pale pink, rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 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.