Medication info
Ducal Tablet 60/5 mg

Ducal Tablet 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
에이치엘비제약(주)
Appearance
Orange, rounded square film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202300097 · Approved 2023.01.06 · Insurance code 647304490

Summary

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

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Pimasartan potassium is used in the treatment of essential hypertension and can be used as an adjunct therapy when blood pressure is not adequately controlled with monotherapy, helping to manage blood pressure more effectively.

How to take

Adult dose

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

Child dose

Safety and efficacy for paediatric patients under age 18 have not been established.

Precautions

This medication may pose a risk of serious harm or death to the fetus and newborn if taken during pregnancy, particularly in the second and third trimesters. Discontinue immediately if pregnancy is confirmed. Do not take this medication if you are allergic to any of the active ingredients or similar substances, if you are pregnant or nursing, if you are undergoing kidney dialysis, have moderate to severe liver disease, bile duct obstruction, specific kidney issues in diabetic patients, certain hereditary lactose intolerance, severe aortic stenosis, or in shock state. Patients with reduced blood volume or sodium levels, impaired kidney function, renal artery hypertension, aortic or mitral stenosis, primary aldosteronism, severe hypotension, elderly patients, and those allergic to specific pigments should exercise caution while using this medication. During treatment, side effects like dizziness, headaches, facial or peripheral edema, urinary disorders, insomnia, and flushing may occur; consult healthcare professionals if symptoms are severe or persistent. Regular blood tests and monitoring are needed due to possible hypotension, electrolyte imbalances, especially increased potassium levels. When combined with other antihypertensive medications, the blood pressure-lowering effect may increase or side effects may occur; inform healthcare professionals about other medications being taken. If you are pregnant or planning to become pregnant, consult healthcare professionals before taking this medication, and the same applies if you are breastfeeding. The safety and efficacy in children and adolescents under age 18 have not been established, so it is advisable not to use it. In the event of overdose, serious symptoms such as hypotension and cardiac arrhythmias may occur, requiring immediate emergency treatment. Store this medication out of reach of children and avoid transferring it to other containers to maintain quality and safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, cold sweat, skin shedding, pain of oral/ocular mucosa, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, significant reduction in urine output, severe overall swelling accompanied by increased blood pressure, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice),

Mild side effects

  • Dizziness
  • orthostatic dizziness
  • headache
  • facial edema
  • peripheral edema
  • urinary disorders
  • insomnia
  • flushing
  • syncope
  • sedation
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  • migraine
  • dyspepsia
  • vomiting
  • nausea
  • upper abdominal pain
  • weakness
  • foreign body sensation
  • elevated liver enzyme levels
  • reduced platelet count
  • increased serum creatine phosphokinase
  • cough
  • muscle spasms
  • musculoskeletal stiffness
  • pruritus
  • localized urticaria
  • facial flushing
  • erectile dysfunction
  • fatigue
  • pain
  • weight gain/loss
  • hypotension

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 prevents light exposure. It is also recommended to store the medication at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Orange, rounded square film-coated tablets

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.