Sildenafil Citrate
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use
The efficacy of sildenafil tablets in the treatment of pulmonary arterial hypertension (PAH) has not been adequately evaluated in patients taking bosentan.
History
There is currently no drug history available for this drug.
Other Information
Sildenafil tablets, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as sildenafil citrate tablets, 25 mg, 50 mg and 100 mg for erectile dysfunction.
Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.
Sildenafil Tablets: Sildenafil citrate is formulated as white, film-coated round tablets with 20 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide and triacetin.
Sources
Sildenafil Citrate Manufacturers
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Torrent Pharmaceuticals Limited
![Sildenafil Citrate Tablet [Torrent Pharmaceuticals Limited]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sildenafil Citrate | Torrent Pharmaceuticals Limited
2.1 Sildenafil TabletsThe recommended dose of sildenafil tablets is 20 mg three times a day (TID). Administer sildenafil tablet doses 4-6 hours apart.
In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg TID is not recommended.
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American Health Packaging
Sildenafil Citrate | American Health Packaging
2.1 Sildenafil TabletsThe recommended dose of sildenafil tablets is 20 mg three times a day (t.i.d.). Administer sildenafil tablet doses 4 to 6 hours apart.
In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg t.i.d. is not recommended.
![Sildenafil Citrate Tablet, Film Coated [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=39a5247d-f173-499d-9e4d-d17cf3dff63e&name=19f9c778-3b40-4e48-ab6e-b4290514a382-08.jpg)
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