Medication info
DURAB Tablet 30/2.5 mg (Pimasartan Potassium, Esamlodipine)

DURAB Tablet 30/2.5 mg (Pimasartan Potassium, Esamlodipine)

Prescription medicationTablet경구
Ingredient · strength
Fimasartan Potassium Trihydrate›33.005mg / 1 tabletS-Amlodipine Besylate 2.5 Hydrate›3.74mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
White film-coated tablets with rounded edges
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202300087 · Approved 2023.01.06

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 daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients whose blood pressure is not adequately controlled with monotherapy of Pimasartan 30 mg, a dose of 30/2.5 mg should be administered. For patients whose blood pressure is not adequately controlled with monotherapy of Pimasartan 60 mg, a dose of 60/2.5 mg should be administered.
Child dose
The safety and efficacy of this medication in pediatric and adolescent patients under 18 years of age have not been established.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Used in patients with essential hypertension when blood pressure is not sufficiently controlled by monotherapy with Pimasartan Potassium.

How to take

Adult dose

The recommended dosage for adults is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients whose blood pressure is not adequately controlled with monotherapy of Pimasartan 30 mg, a dose of 30/2.5 mg should be administered. For patients whose blood pressure is not adequately controlled with monotherapy of Pimasartan 60 mg, a dose of 60/2.5 mg should be administered.

Child dose

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

Precautions

This medication can cause serious injury or death to the fetus or newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to the main ingredients of this medication or similar drugs, those who are pregnant or breastfeeding, patients undergoing renal dialysis, patients with severely impaired liver function, those with biliary obstruction, certain kidney diseases or diabetes, those with lactose intolerance, patients with severe aortic stenosis, and those in a state of shock should not take this medication. Caution should be exercised when using this medication in patients with a deficient blood volume or low salt levels, impaired renal function, renal artery hypertension, patients with aortic or mitral valve stenosis, primary hyperaldosteronism, severe hypotension, the elderly, and those with allergies to certain pigments, as their condition should be closely monitored. Adverse effects such as dizziness, headache, facial or peripheral edema, urination disorders, insomnia, and flushing may occur; consult a physician if any unusual symptoms arise. There is a risk of serious adverse effects such as sudden drops in blood pressure, severe allergic reactions, and worsening renal function; therefore, caution is necessary. This medication can interact with other antihypertensive agents, diuretics, potassium-sparing drugs, certain anti-inflammatory drugs, antibiotics, lithium, grapefruit juice, etc.; notify your healthcare provider of all medications you are currently taking. It is advisable to avoid taking this medication during pregnancy or breastfeeding, but if necessary, consult a physician thoroughly. The safety and efficacy of this medication in children or adolescents under 18 years of age have not been established. No special dose adjustment is needed for elderly patients, but caution is advised due to potential sensitivity reactions. Patients with severely impaired liver function should not take this medication. In case of overdose, symptoms such as hypotension, palpitations, and in severe cases, shock may occur; immediate medical attention is necessary. This medication should be kept out of reach of children, and transferring it to another container may result in degradation of quality or accidental exposure, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, chest tightness, cold sweats, pallor, severe allergic reactions, severe rashes accompanied by high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe conditions

Mild side effects

  • Dizziness
  • orthostatic dizziness
  • headache
  • facial edema
  • peripheral edema
  • urination disorders
  • insomnia
  • flushing
  • dyspepsia
  • vomiting
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  • nausea
  • upper abdominal pain
  • weakness
  • foreign body sensation
  • elevated liver enzyme levels (ALT, AST)
  • decreased platelet count
  • increased serum creatine phosphokinase
  • cough
  • muscle cramps
  • muscle rigidity
  • itching
  • localized hives
  • erectile dysfunction
  • epilepsy
  • sedation
  • migraine
  • pruritus
  • rash
  • angioedema
  • erythema multiforme

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

Storage

This medication may be sensitive to light and should be stored in a tightly closed container that blocks light. It is important to maintain the storage temperature between 1 to 30 degrees Celsius to preserve the drug's effectiveness and safety for an extended period.

Appearance and packaging

Appearance

White film-coated tablets with rounded edges

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.