Medication info

Napdil Tablet 50 Milligrams (Naftopidil)

Prescription medicationApproval withdrawn
Ingredient · strength
Naftopidil›Strength being verified
Manufacturer / importer
Genewon Science Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201804952 · Approved 2018.12.07

This product's status changed to Approval withdrawn on 2023.06.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of urinary symptoms caused by benign prostatic hyperplasia
Who uses it
Adults
Adult dosage
In adults, start with naftopidil 25mg once daily. If the effect is insufficient, gradually increase the dose to 50~75mg at intervals of 1~2 weeks and administer orally once daily after a meal. The dose may be adjusted according to symptoms, but the maximum daily dose is 75mg.

Ingredients

Manufacturer
Genewon Science Co., Ltd.

Efficacy & effects

Improvement of urinary symptoms caused by benign prostatic hyperplasia

  • Urination disorders
View approved original text

Urination disorders caused by benign prostatic hyperplasia can mainly lead to symptoms such as difficulty urinating, frequent urination, and nocturia. This medication is used to improve these urination disorders caused by benign prostatic hyperplasia.

Dosage and Administration

Adult dosage

In adults, start with naftopidil 25mg once daily. If the effect is insufficient, gradually increase the dose to 50~75mg at intervals of 1~2 weeks and administer orally once daily after a meal. The dose may be adjusted according to symptoms, but the maximum daily dose is 75mg.

Precautions

This medication should not be used by patients who have previously had allergic reactions to any ingredient in this medication. Additionally, it contains lactose, so it should not be administered to patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption. Patients with impaired liver function should be cautious as blood levels of this medication may increase. Patients with severe heart or cerebrovascular issues, the elderly, those taking PDE5 inhibitors, and patients with orthostatic hypotension should also use this medication with caution. Excessive dosage may lead to significantly low blood pressure, so the dosage must be strictly adhered to. When starting this medication or suddenly increasing the dosage, dizziness or lightheadedness may occur, so care should be taken when performing dangerous activities like working at heights or driving. When taking antihypertensive medications together, blood pressure may drop too low, so discuss with healthcare providers about adjusting the dosage. This medication is a symptomatic treatment; therefore, if there is no effect, other treatment methods such as surgery should be considered. If serious adverse reactions such as liver dysfunction, jaundice, or syncope occur while taking this medication, it should be discontinued immediately, and healthcare providers should be consulted. Commonly reported mild side effects include dizziness, hypotension, gastrointestinal discomfort, and rarely skin rashes or hypersensitivity reactions. Keep this medication out of the reach of children, and take the tablet out of the packaging before consumption. Caution should be exercised as swallowing the tablet in its packaging may pose a risk of esophageal injury.

Side effects

  • Dizziness
  • unsteadiness
  • vertigo
  • hypotension
  • discomfort in the stomach
  • liver dysfunction
  • jaundice
  • syncope
  • loss of consciousness
  • hypersensitivity
Show 65 more
  • rash
  • itching
  • hives
  • erythema multiforme
  • headache
  • heavy head
  • lethargy
  • drowsiness
  • tinnitus
  • numbness
  • tremor
  • taste disturbance
  • feeling of cloudiness in the head
  • flushing
  • warmth
  • arrhythmia
  • tachycardia
  • diarrhea
  • constipation
  • dry mouth
  • nausea
  • vomiting
  • bloating
  • abdominal pain
  • elevated AST(GOT)
  • elevated ALT(GPT)
  • elevated LDH
  • elevated ALP
  • decreased platelet count
  • blurred vision
  • intraoperative miosis syndrome
  • chloasma
  • edema
  • urinary incontinence
  • chills
  • eyelid edema
  • shoulder stiffness
  • nasal congestion
  • erectile dysfunction
  • gynecomastia
  • chest pain
  • speech disorder
  • hemorrhoids
  • worsening of micturition disorder
  • hematuria
  • pyuria
  • cystitis
  • decreased urine flow
  • urinary tract infection
  • urethral pain
  • insomnia
  • back pain
  • weakness
  • fever
  • fatigue
  • ejaculation disorder
  • increased sweating
  • angina
  • skeletal pain
  • shingles
  • bladder carcinoma
  • cerebral infarction
  • bronchiectasis
  • worsening of polyuria
  • retrograde ejaculation

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

Storage

This medication should be stored in a tightly sealed container that can block light, and it is advisable to keep it at room temperature between 1 to 30 degrees Celsius. Storing it in this manner will help maintain the efficacy of the medication for a longer time.

Appearance and packaging

Appearance

White round 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.