Adegra 50mg

Tablet
Sildenafil Citrate
ACI Pharmaceuticals

Other Strength:
- Adegra 100mg

Alternative:
- Enegra 50mg
- Silagra 50mg
- Vigorex 50mg
- Enigma 50mg
- Viamax 50mg
- X-Cite 50mg
- Veagra 50mg
- Starfil 50mg



Adegra
Description
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 cyclasewhich results in increased levels of cyclicguanosine 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 cavernosumbut 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 in the corpuscavernosumresulting 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.

Indication
Adegra®is indicated for thetreatment erectile dysfunctionin men.

Dosage and Administration
Adult over 18 years:Initially 50mg approximately 1 hour before sexual activity, subsequent doses adjusted according to response to 25–100mg as a single dose as needed; maximum 1 dose in 24 hours. Maximum single dose is 100mg. The tablet should be swallowed whole with a glass of water. Adegra®should not be taken more than once a day.Adegra®can be taken with or without foodbut, onset of effect may be delayed if taken with food. The ability to get an erection may be temporarily impaired by drinking alcohol. To get the maximum benefit from themedicine, it is advised not to drink excessive amounts of alcohol before taking Adegra®.

Pediatric use
Adegra® should not be given to individuals under the age of 18.

Geriatric Use
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil.Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered.

Use in Pregnancy and Lactation
Adegra® is not indicated for use by women.

Special considerations for patients with kidney or liver problems
Patients with kidney or liver problemsshould start with a lower dose (25mg).

Side effects
The side-effects of Sildenafil includedyspepsia, nausea, vomiting, headache (including migraine), flushing, dizziness, myalgia, back pain, visual disturbances (non-arteritic anterior ischaemic optic neuropathy has been reported. Drug should be stopped if sudden visual impairment occurs) and nasal congestion. Less common side-effects include painful red eyes, palpitation, tachycardia, hypo/hypertensionand epistaxis. Other side-effects reported rarely include syncope, hypersensitivity reactions (including rash, facial oedema, and Stevens-Johnson syndrome)and priapism. Serious cardiovascular events (including arrhythmia, unstable angina, and myocardial infarction), seizures, sudden hearing lossand retinal vascular occlusion have also been reported.

Contraindications
Sildenafil is contra-indicated in patients receiving nitrates, in patients in whom vasodilation or sexual activity are inadvisableor 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 avoidedif systolic blood pressure belowis90mmHg), recent stroke, unstable angina, and myocardial infarction. Sildenafil Citrate is contraindicated in patients with known hypersensitivity to any component of the tablet.

Drug interactions
Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce Sildenafil clearance andinducers of these isoenzymes may increase Sildenafil clearance.

Precautions
Sildenafil should be used with caution in cardiovascular disease (e.g.left ventricular outflow obstruction), anatomical deformation of the penis (e.g. angulation, cavernosal fibrosis, Peyronie’s disease)and in those with a predisposition to priapism (e.g. in sickle-cell disease, multiple myelomaor leukaemia). Concomitant treatment with a phosphodiesterase type-5 inhibitor and an alpha-blocker canincrease the risk of postural hypotension.Patient shouldbe stable on alpha-blocker therapy prior to initiatinga phosphodiesterase type-5 inhibitor (at a low dose).

Driving and using machinery
Sildenafilcan cause dizziness and affect vision. Cautions should be taken before driving or using machinery.

Pharmaceutical precautions
Store in a cool & dry place. Protectfrom light.Keep away from the reach of children.

Presentation
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

Package quantities
Adegra® 25 mg tablet: Carton of 4tablets in blister strips.
Adegra®50 mg tablet: Carton of 4tablets in blister strips.
Adegra®100 mg tablet: Carton of 4tablets in blister strips.

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