SPIAGRA Sildenafil Citrate Film-Coated Tablet 100 mg
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DESCRIPTION
SPIAGRA contains sildenafil citrate, a phosphodiesterase type 5 (PDE5) inhibitor.
Each film-coated tablet provides 100 mg sildenafil (as citrate).
It works by:
• Enhancing the effect of nitric oxide (NO)
• Increasing cyclic guanosine monophosphate (cGMP) levels
• Causing relaxation of smooth muscles in the corpus cavernosum
• Improving blood flow to the penis during sexual stimulation
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USES
• Treatment of erectile dysfunction (ED) in adult men
• Helps achieve and maintain an erection sufficient for sexual activity
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DOSAGE AND ADMINISTRATION
• Adults (men ≥18 years):
o Recommended dose: 50 mg taken as needed, approximately 1 hour before sexual activity
o Dose 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
• May act faster when taken on an empty stomach
• Sexual stimulation is required for effectiveness
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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 (dose adjustment may be needed)
• Retinitis pigmentosa or other retinal disorders
Contraindications:
• Concomitant use with nitrates (e.g., nitroglycerin, isosorbide dinitrate)
• Use with guanylate cyclase stimulators (e.g., riociguat)
• Known hypersensitivity to sildenafil
General Precautions:
• May cause sudden drop in blood pressure, especially with alcohol or antihypertensives
• Use cautiously in patients with anatomical penile deformities or predisposition to priapism
• Not indicated 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
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SIDE EFFECTS
Common:
• Headache
• Flushing
• Dyspepsia
• Nasal congestion
• Dizziness
• Visual disturbances (e.g., bluish vision, blurred vision)
Less Common:
• Palpitations
• Nausea
• Skin rash
Serious (seek immediate medical attention):
• Priapism (erection lasting >4 hours)
• Sudden vision loss or hearing loss
• Severe hypotension
• Chest pain or cardiac events
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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