48:48.24 Phosphodiesterase type 5 inhibitors
Generic Name
Sildenafil citrate injection is available in single-use vials containing 10 mg of sildenafil in 12.5 mL.3764 Each mL of solution contains the equivalent of 0.8 mg of sildenafil as the citrate salt and dextrose in water for injection.3764
Equivalency
Sildenafil citrate 1.124 mg is equivalent to 0.8 mg of sildenafil.3764
Trade Name(s)
Revatio
Sildenafil citrate injection is administered by intravenous bolus injection.3764
Sildenafil citrate injection is a clear, colorless solution.3764 Intact vials should be stored at controlled room temperature.3764 Vials are for single use only; unused portions should be discarded.3764
Syringes
Sildenafil citrate (Revatio) diluted in dextrose 5% to a concentration of 0.067 or 0.667 mg/mL was stored in 50-mL polypropylene syringes (Plastipak, Becton Dickinson) at 20 to 25°C and 37°C for 7 days.3765 The drug was found to be stable with less than 5% loss in 7 days at either storage temperature.3765
Filtration
Sildenafil citrate (Viatris) prepared at sildenafil concentrations of 60 and 600 mcg/mL in dextrose 5% was delivered as 4 mL of solution through 0.2- or 0.22-µm syringe filters composed of nylon (Phenomenex), polyethersulfone (Millex GP), or mixed cellulose esters (Millex GS), or a 0.2-µm polyethersulfone inline filter (Pall).4056 The concentration of sildenafil recovered in the filtrate was measured by HPLC and compared with that of unfiltered solution.4056 Although lower drug recovery was observed in the first mL of filtrate compared with subsequent milliliters, for the 600-mcg/mL solution, sildenafil recovery remained over 90% through all filters tested.4056 For the 60-mcg/mL solution, only the nylon syringe filter (Phenomenex) allowed for over 90% sildenafil recovery in the first mL of filtrate and subsequent milliliters.4056 For the polyethersulfone (Millex GP) and mixed cellulose ester (Millex GS) syringe filters and polyethersulfone inline filter (Pall), sildenafil recovery was below 80% in the first mL of filtrate but increased to over 90% for subsequent milliliters.4056
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