Do not freeze mixed sildenafil

Introduction to Sildenafil For Oral Suspension

It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors. Inform patients taking sildenafil for oral suspension not to take VIAGRA or other PDE5 inhibitors. In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil-treated adults with PAH (WHO Group I) [see Clinical Studies (14)], the adverse reactions that were reported by at least 10% of sildenafil-treated patients in any dosing group,and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)]. In a rat pre-and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m2 basis).

Warnings for other groups

The safety and efficacy of Sildenafil have been established in pediatric patients younger than 1 year of age. Clinical studies of sildenafil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. 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 or almost white, slightly hygroscopic, crystalline powder and a molecular weight of 666.7. Sildenafil for Oral Suspension: Sildenafil for oral suspension sildenafil citrate 120 mg is supplied as white to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to1.12 g sildenafil) in an amber glass bottle intended for reconstitution. After chronic dosing of 80 mg three times a day to patients with PAH, no clinically relevant effects on electrocardiogram (ECG). oral suspension Throw away (discard) any

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Food and Drug Administration The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. Sildenafil (Sil-DEN-a-fil) for oral suspension Read this Instructions for Use before you start taking sildenafil oral suspension and each time you get a refill. Do nottake or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. Do nottake or give sildenafil oral suspension if the bottle adaptor is not in the bottle. Supplies you will need to take or give a dose of sildenafil oral suspension (See Figure A): 1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor 1 oral dosing syringe (provided in the carton) Step 1.Shake the bottle of sildenafil oral suspension for 10 seconds before each use. days after mixed by the pharmacist.

How is this medicine (Sildenafil Oral Suspension) best taken?

See the "Discard after" date written on the bottle label. General information about the safe and effective use of sildenafil for oral suspension Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. For more information, go to or call 1-800-399-2561. Inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide and xanthan gum Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. This Patient Information has been approved by the U.S.