Medication info
Ducanova Tablet 30/2.5 mg (Valsartan, Amlodipine)

Ducanova Tablet 30/2.5 mg (Valsartan, Amlodipine)

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

MFDS item code 202300130 · Approved 2023.01.06 · Insurance code 694003960

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication 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 the elderly (under 70 years), initial dosage adjustment is not necessary. For patients with mild to moderate renal impairment (creatinine clearance 30–80 mL/min), dosage adjustment is not necessary, but for severe cases (creatinine clearance < 30 mL/min), treatment should start with this medication at Valsartan 30 mg.
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
대웅바이오(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medicine is used in patients with essential hypertension, whose blood pressure is not sufficiently controlled by monotherapy with Valsartan potassium, helping to effectively lower and control blood pressure.

How to take

Adult dose

The recommended dosage for this medication 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 the elderly (under 70 years), initial dosage adjustment is not necessary. For patients with mild to moderate renal impairment (creatinine clearance 30–80 mL/min), dosage adjustment is not necessary, but for severe cases (creatinine clearance < 30 mL/min), treatment should start with this medication at Valsartan 30 mg.

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 harm to the fetus and newborn if taken during pregnancy, especially during the second and third trimesters; therefore, if pregnancy is confirmed, discontinuation of use should occur immediately. It is safe not to take this medication if there is an allergy to any of the ingredients, if pregnant or breastfeeding, or if the patient has certain conditions such as those undergoing kidney dialysis, severe liver disease, or biliary obstruction. Patients with reduced blood volume or impaired kidney function, renal vascular hypertension patients, patients with severe hypotension, and the elderly should be especially cautious and closely monitored while using this medication. As this medication lowers blood pressure, side effects such as dizziness, headache, edema, urinary disorders, insomnia, and flushing may occur; if symptoms worsen, consult a physician. Patients with hypotension or electrolyte imbalances should correct the condition before taking this medication and continuously monitor blood pressure and electrolyte status during use. Especially for patients with heart failure or kidney impairment, there is a risk of hyperkalemia, so blood potassium levels should be regularly checked. This medication may interact with other antihypertensive drugs, diuretics, potassium-sparing diuretics, and potassium supplements; therefore, if other medications are taken concurrently, it is essential to inform the physician or pharmacist. Pregnant and breastfeeding women are advised to avoid using this drug, and if necessary, should discuss with a physician to find a safe alternative treatment. Safety and efficacy for children and adolescents under 18 years of age have not been established and use is not recommended. Generally, elderly patients do not require dosage adjustment; however, some elderly individuals may be more sensitive to the medication, so caution is necessary. Patients with moderate to severe liver impairment should avoid using this medication and should ensure their liver function condition is well monitored. In case of overdose, severe hypotension, palpitations, and bradycardia can occur; if these symptoms happen, visit a medical institution immediately for appropriate treatment. Store this medication out of the reach of children and avoid transferring it to another container as it may impair its quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe 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 abnormalities accompanied by cough and fever, jaundice of the skin or eyes, extreme lethargy throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output,

Mild side effects

  • Dizziness
  • headache
  • orthostatic dizziness
  • insomnia
  • flushing
  • facial edema
  • peripheral edema
  • urinary disorders
  • nausea
  • vomiting
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  • upper abdominal pain
  • dyspepsia
  • weakness
  • foreign body sensation
  • elevated liver enzyme levels
  • decreased platelet count
  • increased serum creatine phosphokinase
  • cough
  • muscle contractions
  • musculoskeletal stiffness
  • itching
  • localized urticaria
  • erectile dysfunction
  • syncope
  • sedation
  • migraine
  • pruritus
  • rash
  • vascular edema
  • erythema multiforme
  • palpitations

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

Storage

This medication is sensitive to light, so it should be stored in a container that does not allow light to enter. It is also advisable to store the medication at a temperature between 1 and 30 degrees Celsius, which is typically room temperature, to maintain its effectiveness for a longer time.

Appearance and packaging

Appearance

White, 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.