Medication info
Zydena Tablet 100 mg (Udenafil)

Zydena Tablet 100 mg (Udenafil)

Prescription medicationTabletOral
Ingredient · strength
Udenafil›100mg / 1 tablet
Manufacturer / importer
Dong-A ST Co., Ltd.
Appearance
This medication is an oval film-coated tablet of light orange color.
Packaging
For domestic use - 8 tablets/PTP, for export - 1 tablet/PTP, for export - 2 tablets/PTP, for export - 4 tablets/PTP
Approval status
Active

MFDS item code 200500258 · Approved 2005.11.29

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults
Adult dose
Adult men: Take 100mg as a single dose approximately 30 minutes to 12 hours before anticipated sexual activity. The maximum recommended frequency of administration is once daily. An increase to 200mg should be considered cautiously only after thoroughly evaluating adverse reactions and other effects at 100mg. This drug may be taken with or without food. Elderly patients (65 years and older): No dose adjustment is required in elderly male patients. Patients with renal impairment: No dose adjustment is required in male patients with mild renal impairment. Patients with hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A).

Ingredients

Manufacturer
Dong-A ST Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used to treat erectile dysfunction, specifically male sexual dysfunction.

How to take

Adult dose

Adult men: Take 100mg as a single dose approximately 30 minutes to 12 hours before anticipated sexual activity. The maximum recommended frequency of administration is once daily. An increase to 200mg should be considered cautiously only after thoroughly evaluating adverse reactions and other effects at 100mg. This drug may be taken with or without food. Elderly patients (65 years and older): No dose adjustment is required in elderly male patients. Patients with renal impairment: No dose adjustment is required in male patients with mild renal impairment. Patients with hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A).

Precautions

This medication is used as a treatment for erectile dysfunction and can exert strain on the heart during sexual activity, so a thorough cardiovascular evaluation by a physician is necessary before starting treatment. It is generally not used in patients with heart or vascular problems. Particularly, patients with significant left ventricular outflow obstruction or severely impaired blood pressure control may be more sensitive to the vascular dilatory effects of this medication and should exercise caution. If an erection lasts longer than 4 hours, immediate medical assistance should be sought as untreated priapism can lead to penile tissue damage or impotence. Patients taking nitrate compounds or nitric oxide donors concurrently with this medication may experience dangerously low blood pressure, therefore, it is essential to inform the physician and avoid combination. Patients with allergies to this medication or its excipients, serious cardiovascular diseases, a history of stroke or myocardial infarction within the last 6 months, uncontrolled hypertension or hypotension, hereditary retinal disorders, severe liver or kidney dysfunction, those taking specific antiviral agents, children under 18 years of age, and patients with lactose intolerance should not use this medication. Patients with anatomical penile deformation, hematologic diseases, or diminished liver or kidney function should use this medication cautiously, as well as those taking certain antifungals, antibiotics, or alpha-blockers. Common side effects of this medication include facial flushing, headaches, eye redness, dyspepsia, and less commonly dizziness, blurred vision, skin rashes, and nausea. This medication impacts the heart and blood vessels, so cardiovascular status must be evaluated before sexual activity, and it should be used restrictively only in patients who clinically require treatment for erectile dysfunction. Caution should be exercised as dizziness or blurred vision may occur when driving or operating machinery. It should not be used by pregnant or breastfeeding women, and dosage adjustments are not necessary for the elderly.

Side effects

  • Facial flushing
  • headache
  • conjunctival injection
  • nasal congestion
  • dyspepsia
  • chest pain
  • abdominal pain
  • fatigue
  • feeling of warmth
  • chest discomfort
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  • dizziness
  • neck stiffness
  • paresthesia
  • blurred vision
  • eye pain
  • color vision deficiency
  • eye edema
  • facial swelling
  • urticaria
  • itching
  • nausea
  • dental pain
  • constipation
  • gastritis
  • discomfort in the epigastric region
  • urinary incontinence
  • thirst
  • shortness of breath
  • nasal dryness
  • periarticular inflammation
  • feeling of heaviness in the head
  • feeling cold or lethargic
  • palpitations
  • orthostatic dizziness
  • hypersomnia
  • ear fullness
  • ocular discomfort
  • rash
  • erythematous rash
  • vomiting
  • diarrhea
  • shortness of breath during exercise
  • cough
  • epistaxis
  • increased libido
  • hypotension
  • hypertension
  • erythema
  • abnormal pigmentation
  • low back pain
  • muscle weakness
  • facial paralysis
  • retrograde ejaculation
  • perineal pain in males
  • urinary tract infection
  • pharyngitis
  • increased creatine phosphokinase
  • increased gamma-glutamyl transferase
  • visual disturbances
  • gastroesophageal reflux
  • palpitations

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is recommended to maintain a room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

This medication is an oval film-coated tablet of light orange color.

Package unit

For domestic use - 8 tablets/PTP, for export - 1 tablet/PTP, for export - 2 tablets/PTP, for export - 4 tablets/PTP

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.