TGP Sildenafil Citrate Tablet 100 mg
________________________________________
DESCRIPTION
TGP Sildenafil Citrate contains sildenafil citrate, a phosphodiesterase type 5 (PDE5) inhibitor.
Each tablet provides 100 mg sildenafil (as citrate).
It acts by:
• Enhancing the nitric oxide (NO)–cGMP pathway
• Increasing cGMP levels in the corpus cavernosum
• Promoting smooth muscle relaxation
• Improving penile blood flow during sexual stimulation
________________________________________
USES
• Treatment of erectile dysfunction (ED) in adult men
• Helps achieve and maintain an erection sufficient for sexual activity
________________________________________
DOSAGE AND ADMINISTRATION
• Adults (men ≥18 years):
o Recommended starting dose: 50 mg, taken approximately 1 hour before sexual activity
o May be increased to 100 mg or decreased to 25 mg based on efficacy and tolerability
o Maximum dosing frequency: once daily
Administration:
• Take orally with or without food
• Faster onset may occur when taken on an empty stomach
• Requires sexual stimulation for effect
________________________________________
PRECAUTIONS
Use with caution or avoid in patients with:
• Cardiovascular disease (e.g., recent myocardial infarction, stroke)
• Severe hypotension or uncontrolled hypertension
• Severe hepatic impairment
• Renal impairment
• Retinal disorders (e.g., retinitis pigmentosa)
Contraindications:
• Concomitant use with nitrates (e.g., nitroglycerin, isosorbide dinitrate)
• Use with guanylate cyclase stimulators (e.g., riociguat)
• Known hypersensitivity to sildenafil
General Precautions:
• Risk of sudden decrease in blood pressure, especially with alcohol or antihypertensives
• Use cautiously in patients with penile deformities or predisposition to priapism
• Not intended for use in women or children
Drug Interactions:
• Increased sildenafil levels with:
o CYP3A4 inhibitors (e.g., ketoconazole, erythromycin)
• Reduced effectiveness with:
o CYP3A4 inducers (e.g., rifampicin)
• Additive hypotensive effects with:
o Alpha-blockers and antihypertensives
________________________________________
SIDE EFFECTS
Common:
• Headache
• Flushing
• Dyspepsia
• Nasal congestion
• Dizziness
• Visual disturbances (e.g., blurred or bluish vision)
Less Common:
• Nausea
• Palpitations
• Skin rash
Serious (seek immediate medical attention):
• Priapism (erection lasting more than 4 hours)
• Sudden vision loss or hearing loss
• Severe hypotension
• Chest pain or cardiac events
________________________________________
STORAGE
• Store at temperatures not exceeding 25–30°C
• Keep in a cool, dry place, protected from light and moisture
• Keep out of reach of children