Medication info
DURAB Tablet 60/2.5 mg (Pimasartan potassium, Esamlodipine)

DURAB Tablet 60/2.5 mg (Pimasartan potassium, Esamlodipine)

Prescription medicationTablet경구
Ingredient · strength
Fimasartan Potassium Trihydrate›66.01mg / 1 tabletS-Amlodipine Besylate 2.5 Hydrate›3.74mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Yellow, round-edged square film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202300109 · Approved 2023.01.06 · Insurance code 662504830

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for adults is 1 tablet once a day, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). If blood pressure is not controlled with Pimasartan monotherapy, you may administer 30/2.5 mg, 60/2.5 mg, or 60/5 mg formulations depending on the dosage. Elderly patients (under 70 years old) do not require initial dosage adjustment. Mild to moderate doses are recommended.
Child dose
The safety and efficacy in children and adolescents under 18 years have not been established.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension in whom blood pressure is not adequately controlled by monotherapy with Pimasartan potassium.

How to take

Adult dose

The recommended dosage for adults is 1 tablet once a day, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). If blood pressure is not controlled with Pimasartan monotherapy, you may administer 30/2.5 mg, 60/2.5 mg, or 60/5 mg formulations depending on the dosage. Elderly patients (under 70 years old) do not require initial dosage adjustment. Mild to moderate doses are recommended.

Child dose

The safety and efficacy in children and adolescents under 18 years have not been established.

Precautions

This medicine can cause serious harm to the fetus and newborn when taken during pregnancy, especially in the second and third trimesters, so you should stop taking it immediately once pregnancy is confirmed. Patients who have an allergy to any component of this medication or those with certain kidney and liver diseases, bile duct obstruction, or severe aortic stenosis should not use this medicine. Patients with reduced blood volume or sodium deficiency, impaired kidney function, renal artery hypertension, etc., should be closely monitored while taking this medicine, as there may be occurrences of hypotension or worsening kidney function. While taking this medicine, side effects such as dizziness, headache, facial or peripheral edema, urinary disturbances, insomnia, and flushing may occur. If symptoms are severe or persistent, you should consult a healthcare professional. It is important to regularly check blood pressure and potassium levels as there is a risk of hypotension and electrolyte imbalances, particularly hyperkalemia. This medicine may interact with other antihypertensive agents, diuretics, potassium-sparing diuretics, potassium supplements, etc., so inform your healthcare provider of any other medications you are taking. Pregnant or breastfeeding individuals should consult a healthcare professional before taking this medicine, and if breastfeeding, they are advised to stop breastfeeding or discontinue the medicine. The safety and efficacy in children and adolescents under 18 years old have not been established, thus its use is not recommended. Elderly patients may react more sensitively to this medicine, so caution is needed during administration. In cases of overdose, severe hypotension, palpitations, and shock may occur; immediate medical attention is required.

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, difficulty breathing or feeling short of breath, asthma attacks, respiratory distress accompanied by cough and fever, jaundice of the skin or eyes, severe fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Dizziness
  • orthostatic dizziness
  • headache
  • facial edema
  • peripheral edema
  • urinary disturbances
  • insomnia
  • flushing
  • dyspepsia
  • vomiting
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  • nausea
  • upper abdominal pain
  • weakness
  • foreign body sensation
  • elevated liver enzymes
  • decreased platelet count
  • increased serum creatine phosphokinase
  • cough
  • muscle cramps
  • musculoskeletal stiffness
  • itching
  • localized urticaria
  • erectile dysfunction
  • seizures
  • sedation
  • migraine
  • fainting
  • acute pancreatitis
  • intestinal obstruction
  • bleeding duodenal ulcers
  • constipation.

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

Storage

This medicine is sensitive to light, so it should be stored in a container that protects it from light. Additionally, it is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, round-edged square 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.