Medication info
Ducafin Tablets 60/5 mg

Ducafin Tablets 60/5 mg

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

MFDS item code 202300098 · Approved 2023.01.06

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients whose blood pressure is not adequately controlled with 30 mg Pimasartan monotherapy, a 30/2.5 mg dosage is administered. For patients whose blood pressure is not adequately controlled with 60 mg Pimasartan monotherapy, a 60/2.5 mg dosage is administered.
Child dose
Safety and efficacy in pediatric patients under 18 years have not been established.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

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

Child dose

Safety and efficacy in pediatric patients under 18 years have not been established.

Precautions

This medication can cause serious harm or death to the fetus and newborn if taken during pregnancy, especially in the 2nd and 3rd trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to any of the components, women who are pregnant or breastfeeding, patients undergoing renal dialysis, patients with moderate to severe liver dysfunction, biliary obstruction, diabetic patients with certain renal impairments, certain genetically lactose-intolerant patients, patients with severe aortic stenosis, and patients in shock should not be administered this medication. Extra care should be taken when administering this medication to patients with reduced blood volume or sodium levels, impaired kidney function, renal artery hypertension, aortic and mitral stenosis, primary hyperaldosteronism, severe hypotension, elderly patients, and patients allergic to specific pigment components. Side effects may include dizziness, headache, facial swelling, urination disorders, insomnia, flushing, and in rare cases, severe renal impairment, blood pressure drop, and allergic reactions have been reported. Hypotension or electrolyte imbalances may occur during treatment, especially in patients on high-dose diuretics, who should be closely monitored for signs of hypotension. Patients with heart failure or impaired kidney function should have their potassium levels regularly checked through blood tests due to the risk of elevated serum potassium. In patients with renal artery stenosis, there may be an increased risk of worsening kidney function and hypotension, so administration should be done cautiously. This medication may increase blood pressure-lowering effects or worsen side effects when used in combination with other antihypertensives, so it should be administered according to healthcare professionals' instructions during combined therapy. Due to potential risks to the fetus, women taking this medication should consult with healthcare professionals if planning to become pregnant or if pregnant. Breastfeeding women are advised to either discontinue breastfeeding or the medication, as it may be excreted in breast milk. Safety and efficacy in pediatric patients under 18 years have not been established, thus it is not recommended for this age group. Elderly patients may be more sensitive to this medication, so any changes in symptoms should be closely monitored upon administration. This medication should not be administered to patients with moderate to severe liver dysfunction. In cases of overdose, severe blood pressure drop, heart irregularities, shock, and other symptoms may occur, requiring immediate assistance from healthcare professionals and emergency care if necessary. This medication should be kept out of reach of children, and transferring it to another container is not advisable for quality maintenance and safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rashes with high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities along with cough and fever, yellow discoloration of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, decreased urination.

Mild side effects

  • Dizziness
  • orthostatic dizziness
  • headache
  • facial swelling
  • peripheral edema
  • urination disorders
  • insomnia
  • flushing
  • dyspepsia
  • vomiting
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  • nausea
  • upper abdominal pain
  • weakness
  • foreign body sensation
  • increased liver enzyme levels
  • decreased platelet count
  • increased serum creatine phosphokinase
  • cough
  • muscle cramps
  • musculoskeletal stiffness
  • itching
  • localized hives
  • flushing
  • erectile dysfunction
  • syncope
  • sedation
  • migraine
  • pruritus
  • rash
  • angioedema
  • erythema multiforme.

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

Storage

This medication should be stored in a specially designed container that prevents light and air penetration, and should be kept at a temperature between 1 to 30 degrees Celsius at room temperature. This storage method safely maintains the effectiveness of the medication.

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.