Medication info
Dulabr Tablet 60/5 mg (Pimasartan Potassium, Esamlodipine)

Dulabr Tablet 60/5 mg (Pimasartan Potassium, Esamlodipine)

Prescription medicationTablet경구
Ingredient · strength
Fimasartan Potassium Trihydrate›66.01mg / 1 tabletS-Amlodipine Besylate 2.5 Hydrate›7.48mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Orange, rounded square film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202300090 · Approved 2023.01.06 · Insurance code 662504820

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). For patients taking pimasartan and esamlodipine (amlodipine) concurrently, it may be convenient to switch to this medication (combination of active ingredients with the same content). For the elderly (under 70 years), initial dosage adjustment is not necessary. Patients with mild to moderate renal impairment do not require dosage adjustment, but patients with severe renal impairment (creatinine clearance < 30 mL/min) should start treatment with pimasartan 30 mg.
Child dose
The safety and efficacy in pediatric patients aged 18 years and under 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 when controlling blood pressure with pimasartan potassium alone is difficult, by combining with additional treatments or other medications to control blood pressure.

How to take

Adult dose

The recommended dosage for this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). For patients taking pimasartan and esamlodipine (amlodipine) concurrently, it may be convenient to switch to this medication (combination of active ingredients with the same content). For the elderly (under 70 years), initial dosage adjustment is not necessary. Patients with mild to moderate renal impairment do not require dosage adjustment, but patients with severe renal impairment (creatinine clearance < 30 mL/min) should start treatment with pimasartan 30 mg.

Child dose

The safety and efficacy in pediatric patients aged 18 years and under have not been established.

Precautions

This medication can cause serious harm to the fetus or newborn, especially when taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately if pregnancy is confirmed. This medication should not be used by individuals who have allergies to its main ingredients or similar classes of drugs, are pregnant or breastfeeding, are undergoing kidney dialysis, have moderate to severe liver impairment, have biliary obstruction, or have specific kidney diseases or diabetic nephropathy. Patients with low blood volume or reduced sodium levels, impaired kidney function, renovascular hypertension, aortic stenosis, severe hypotension, and the elderly should use this medication with particular caution and be closely monitored during treatment. Side effects such as dizziness, headaches, facial swelling, urinary issues, insomnia, and flushing may occur; if symptoms are severe, consult a physician. Symptoms of hypotension may occur due to excessively low blood pressure, so those taking diuretics or with low sodium intake in their diet should closely monitor for symptoms of hypotension and seek appropriate treatment if necessary. This medication may increase potassium levels in the blood; therefore, patients with heart failure or impaired kidney function should regularly check their potassium levels through blood tests. Interactions may occur if this medication is taken with other antihypertensives or certain medications, so if other medications are being taken, it is crucial to inform healthcare professionals. Pregnant or breastfeeding women are advised to avoid this medication, especially since it may pose risks to the fetus during pregnancy; consultation with healthcare professionals is essential before use. The safety and efficacy in children and adolescents under 18 years have not been established, so it is advisable not to use this medication in this age group. In cases of overdose, severe hypotension or abnormalities in heart function may occur, and immediate contact with a medical institution is necessary for appropriate treatment. This medication should be stored out of reach of children and not transferred to other containers; it is important to carefully check the precautions during use.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Dizziness
  • orthostatic dizziness
  • headaches
  • facial edema
  • peripheral edema
  • urinary issues
  • insomnia
  • flushing
  • dyspepsia
  • vomiting
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  • nausea
  • upper abdominal pain
  • fatigue
  • foreign body sensation
  • elevated liver enzymes
  • decreased platelet count
  • increased serum creatine phosphokinase
  • cough
  • muscle contraction
  • musculoskeletal stiffness
  • pruritus
  • localized urticaria
  • erectile dysfunction
  • sedation
  • migraines
  • syncope
  • pruritus
  • angioedema
  • erythema multiforme
  • vasculitis
  • tension increase.

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

Storage

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, it should be kept at room temperature, preferably between 1 to 30 degrees Celsius, avoiding extremes in temperature.

Appearance and packaging

Appearance

Orange, rounded 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.