Adegra 25 mg tablet: Each coated tablet contains Sildenafil 25 mg as Citrate INN.
Adegra 50 mg tablet: Each coated tablet contains Sildenafil 50 mg as Citrate INN.
Adegra 100 mg tablet: Each coated tablet contains Sildenafil 100 mg as Citrate INN.
Adegra ® is a preparation of Sildenafil Citrate which is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) and used as an oral therapy for erectile dysfunction. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase which results in increased levels of cyclic guanosine monophosphate (cGMP) producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by Sildenafil causes increased levels of cGMP inthe corpus cavernosum resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.
Route: Oral
Adults (>18 years):
Initially 50 mg approximately 1 hour before sexual activity. Titrate between 25–100 mg as needed (maximum 1 dose in 24 hours; maximum single dose: 100 mg). Swallow whole with water.
Pediatric:
Not indicated for individuals under 18 years.
Geriatric (≥65 years):
Reduced clearance; consider starting dose of 25 mg.
Organic nitrates (nitroglycerin, isosorbide) cause severe, potentially fatal hypotension (contraindicated); alpha-blockers cause symptomatic orthostatic hypotension; strong CYP3A4 inhibitors (ketoconazole, ritonavir, erythromycin) increase sildenafil exposure; CYP3A4 inducers (rifampin) decrease sildenafil efficacy.
Sildenafil is contra-indicated in patients receiving nitrates, in patients in whom vasodilation or sexual activity are inadvisable or in patients with a previous history of non-arteritic anterior ischaemic optic neuropathy. In the absence of information, manufacturers contra-indicate these drugs in hypotension (should be avoided if systolic blood pressure below is 90 mmHg), recent stroke, unstable angina, and myocardial infarction. Sildenafil Citrate is contraindicated in patients with known hypersensitivity to any component of the tablet.
Common: Dyspepsia, nausea, vomiting, headache, migraine, flushing, dizziness, myalgia, back pain, visual disturbances, nasal congestion. Less Common: Painful red eyes, palpitation, tachycardia, hypotension, hypertension, epistaxis. Rare: Syncope, rash, facial edema, Stevens-Johnson syndrome, priapism, arrhythmia, unstable angina, myocardial infarction, seizures, sudden hearing loss, retinal vascular occlusion.
Overdose
No Data
Category B. Not indicated for use in females. No evidence of teratogenicity in animal studies. Lactation: Not indicated for use in nursing women.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep away from the reach of children.