Medication info

SAMSUNG NAPHTOPIDIL Tablet 75mg

Prescription medicationTabletOralExpired
Ingredient · strength
Naftopidil›75mg / 1 tablet
Manufacturer / importer
Samsung Pharmaceutical Co., Ltd.
Appearance
Round tablets that are yellowish-white to light yellow
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201805343 · Approved 2018.12.28

This product's status changed to Expired on 2023.12.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of voiding dysfunction due to benign prostatic hyperplasia
Who takes it
Adults
Adult dose
In adults, start treatment with naftopidil at 25mg once daily. If the effect is insufficient, increase the dose stepwise 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; however, the maximum daily dose is 75mg.

Ingredients

Manufacturer
Samsung Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of voiding dysfunction due to benign prostatic hyperplasia

  • Urinary disturbances due to benign prostatic hyperplasia
View approved original text

This medication is used to improve urinary disturbances caused by benign prostatic hyperplasia, such as weak urinary stream or the sensation of residual urine.

How to take

Adult dose

In adults, start treatment with naftopidil at 25mg once daily. If the effect is insufficient, increase the dose stepwise 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; however, the maximum daily dose is 75mg.

Precautions

This medication should not be used in patients with a history of allergic reactions to any of its components. Because this medication contains lactose, it should not be administered to patients with genetic disorders that prevent lactose digestion. Caution should be exercised in patients with impaired liver function, as the blood concentration of this medication may increase. Patients with severe heart or cerebrovascular problems have limited experience with this medication, so caution is advised. Elderly patients may have reduced liver function, leading to a higher risk of increased blood concentration as the drug is eliminated more slowly from the body. Caution is warranted when taken with antihypertensives or certain vasodilators, as blood pressure may drop too low. Patients with orthostatic hypotension may experience worsening symptoms when taking this medication, so care is required. During the course of taking this medication, side effects such as dizziness, lightheadedness, low blood pressure, and gastrointestinal discomfort may occur, and symptoms should be closely monitored. If any serious adverse reactions, such as severe liver dysfunction or loss of consciousness, occur, the medication should be discontinued immediately and medical advice sought. Overdose of this medication can lead to excessively low blood pressure, so the dosage must be adhered to precisely. During the initial dosing or when the dosage is suddenly increased, symptoms such as dizziness or lightheadedness may occur, so it is advisable to avoid working at heights or driving. If taking antihypertensives, changes in blood pressure should be closely monitored, and dosage adjustments may be necessary as needed. Keep out of reach of children and be sure to instruct them to take the medication out of the packaging for consumption to avoid injury to the esophagus if swallowed while still in the package. Elderly persons should be carefully monitored and administered with caution due to the possibility of decreased liver function. If any uncomfortable symptoms occur during the course of taking this medication, immediately report them to a healthcare provider for appropriate action.

Side effects

  • Dizziness
  • staggering
  • lightheadedness
  • hypotension
  • abdominal discomfort
  • liver dysfunction
  • jaundice
  • syncope
  • loss of consciousness
  • hypersensitivity
Show 65 more
  • rash
  • itching
  • hives
  • erythema multiforme
  • headache
  • heavy head
  • fatigue
  • drowsiness
  • tinnitus
  • numbness
  • tremor
  • taste disturbance
  • mental fog
  • dysesthesia
  • flushing
  • arrhythmia
  • tachycardia
  • diarrhea
  • constipation
  • dry mouth
  • nausea
  • vomiting
  • bloating
  • abdominal pain
  • elevated AST
  • elevated ALT
  • elevated LDH
  • elevated ALP
  • decreased platelet count
  • blurred vision
  • intraoperative iris hypotension syndrome
  • color vision deficiency
  • edema
  • urinary incontinence
  • chills
  • eyelid edema
  • shoulder stiffness
  • nasal congestion
  • erectile dysfunction
  • gynecomastia
  • chest pain
  • speech disorder
  • hemorrhoids
  • exacerbated urinary disorder
  • hematuria
  • pyuria
  • cystitis
  • decreased urine flow
  • urinary tract infection
  • urethral pain
  • worsened frequency of urination
  • insomnia
  • back pain
  • weakness
  • fever
  • fatigue
  • ejaculation disorder
  • increased sweating
  • angina
  • skeletal pain
  • shingles
  • bladder carcinoma
  • cerebral infarction
  • bronchiectasis
  • retrograde ejaculation

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

Storage

This medication is sensitive to light, so it must be stored in a container that does not allow light to enter. Additionally, it should be kept at room temperature between 1 degree and 30 degrees Celsius for safe storage. This will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Round tablets that are yellowish-white to light yellow

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.