Sildenafil 50mg Tablets “DK”
Manufacturer: Daiko Pharmaceutical Co.
Active Ingredient: Sildenafil Citrate (50mg)
Category: Oral Prescription Drug
Indications
▶️ Treatment of Erectile Dysfunction (ED)
Pharmacology
Sildenafil, originally developed for cardiovascular research, is a selective PDE5 inhibitor that enhances nitric oxide-mediated vasodilation in the penile corpus cavernosum, facilitating erections upon sexual stimulation.
Critical Safety Information
❗️ Black Box Warnings
- ⛔ Contraindicated with nitrates (risk of fatal hypotension)
- ⛔ Avoid concurrent use with guanylate cyclase stimulators
- ⚠️ Potential QT prolongation in predisposed patients
📋 Absolute Contraindications
• Hypersensitivity to sildenafil
• Retinitis pigmentosa
• Severe hepatic impairment (Child-Pugh C)
• Uncontrolled hypertension (>170/100mmHg)
• Recent MI/stroke (<6 months)
• Concomitant use of Class III antiarrhythmics (e.g. amiodarone)
⚠️ Adverse Reactions (Incidence >1%)
System Organ Class | Key Reactions |
---|---|
Cardiovascular | Facial flushing (12%), palpitations (4%), hypertension (2%) |
Neurological | Headache (16%), dizziness (7%), migraine (3%) |
Gastrointestinal | Dyspepsia (7%), nausea (4%), xerostomia (3%) |
Ocular | Cyanopsia (3%), blurred vision (2%), retinal hemorrhage (rare) |
Urogenital | Priapism (<1%)* |
Systemic | CK elevation (5%), influenza-like symptoms (3%) |
* PRIAPISM ALERT: >4-hour erection requires emergency intervention
🧪 Laboratory Abnormalities
- ↑ ALT/AST (5.8%)
- ↑ γ-GTP (4.2%)
- ↓ Hemoglobin (3.1%)
💊 Dosage & Administration
- Standard Dose: 25-50mg orally 1 hour before sexual activity
- Maximum frequency: Once daily
- Administration: With 240ml water on empty stomach
- Special Populations:
- Elderly (>65yo): Start with 25mg
- Hepatic/Renal impairment (CrCl<30ml/min): 25mg initial dose
🧾 Product Specifications
- Packaging: 10 tablets/blister
- Storage: Below 25°C in original container