Medication info
Ducanazene Tablet 30/2.5 mg

Ducanazene Tablet 30/2.5 mg

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

MFDS item code 202300131 · Approved 2023.01.06 · Insurance code 698504690

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for adults is 1 tablet once daily, taken with water, irrespective of meals. It is recommended to take it at the same time every day (e.g., in the morning). Elderly patients: Dose adjustment is usually not required for elderly patients aged under 70. Patients with renal impairment: Dose adjustment is not necessary for patients with mild to moderate renal impairment (creatinine clearance 30-80 mL/min).
Child dose
The safety and efficacy in pediatric and adolescent patients under 18 years of age have not been established.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used as an additional therapy for patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with pimasartan potassium. It helps lower blood pressure more effectively in cases where previous blood pressure control has been difficult, thereby reducing the risk of cardiovascular complications. It plays an important role in the treatment of essential hypertension.

How to take

Adult dose

The recommended dosage for adults is 1 tablet once daily, taken with water, irrespective of meals. It is recommended to take it at the same time every day (e.g., in the morning). Elderly patients: Dose adjustment is usually not required for elderly patients aged under 70. Patients with renal impairment: Dose adjustment is not necessary for patients with mild to moderate renal impairment (creatinine clearance 30-80 mL/min).

Child dose

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

Precautions

This drug can cause serious harm to the fetus and newborn when taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used in patients allergic to the main ingredients or similar substances, pregnant or nursing women, patients undergoing renal dialysis, patients with moderate to severe liver impairment, patients with obstructed bile ducts, certain diabetic patients, patients with hereditary lactose intolerance, patients with severe aortic stenosis, or patients in a state of shock. Caution is advised in patients with low blood volume or sodium, patients with impaired kidney function, patients with renovascular hypertension, patients with aortic or mitral valve stenosis, patients with obstructive cardiomyopathy, patients with primary aldosteronism, patients with severe hypotension, elderly patients, and patients hypersensitive to certain dyes. While taking this medication, symptoms such as dizziness, headache, facial or peripheral edema, urination disorders, insomnia, and flushing may occur, so patients should monitor their symptoms closely. Patients with hypotension or electrolyte imbalance may experience excessively low blood pressure at the beginning of treatment, and proper measures should be taken immediately if hypotension occurs. This drug may increase serum potassium levels, so patients with heart failure or kidney disorders should regularly test potassium levels through blood tests. Patients with renal artery stenosis should be cautious as kidney function may deteriorate upon taking this medication. As with other antihypertensive agents, patients with heart or cerebrovascular diseases should be cautious of aggravation due to excessive blood pressure lowering. While taking this medication, drowsiness or dizziness may occur, so caution is advised when driving or operating dangerous machinery. Pregnant or nursing women should avoid taking this medication, especially during pregnancy, as it may pose serious risks to the fetus, and it should be discussed with a doctor. The safety and efficacy in children or adolescents under 18 years of age have not been established, so use is not recommended. Generally, elderly patients do not require dose adjustments; however, some elderly patients may be more sensitive to the medication, so caution is necessary. This medication should not be used in patients with moderate to severe liver dysfunction. In case of overdose, hypotension, or irregular heartbeats may occur, and immediate contact with a medical institution for appropriate treatment is required. This medication should be stored out of reach of children, and transferring it to another container may cause deterioration in quality or accidents, so caution is advised.

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 of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination disorders

Mild side effects

  • Dizziness
  • orthostatic dizziness
  • headache
  • facial edema
  • peripheral edema
  • urination disorders
  • insomnia
  • flushing
  • dyspepsia
  • vomiting
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  • nausea
  • abdominal pain
  • weakness
  • foreign body sensation
  • elevated liver enzyme levels
  • decreased platelet count
  • increased serum creatine phosphokinase
  • cough
  • muscle spasm
  • musculoskeletal rigidity
  • pruritus
  • localized urticaria
  • facial flushing
  • erectile dysfunction
  • fainting
  • sedation
  • migraine
  • headache
  • epilepsy
  • amyotrophic lateral sclerosis
  • neuropathy

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

Storage

This medication should be stored in a tightly closed container that can block light, ideally at room temperature between 1 and 30 degrees Celsius. This helps maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

White rectangular film-coated tablet with rounded corners

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.