staxyn vardenafil hydrochloride tablet orally disintegrating

1 INDICATIONS AND USAGE STAXYN ® is indicated for the treatment of erectile dysfunction. • STAXYN is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 )

glaxosmithkline llc

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] nausea` `[4] fatigue` `[5] off label use` `[6] diarrhoea` `[7] headache` `[8] pain` `[9] pneumonia` `[10] dizziness`

5 years ago

ROUND WHITE BLANK

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied STAXYN (vardenafil HCl) are white, round orally disintegrating tablets with no debossing. STAXYN orally disintegrating tablets are packaged into foil blisterpacks and supplied as a 4 tablet unit. Package Strength NDC Code 1 blister card containing 4 tablets 10 mg 0173-0822-04 In addition to the active ingredient, vardenafil, each tablet contains aspartame, peppermint flavor, magnesium stearate, and Pharmaburst™ B2 (crospovidone, mannitol, silica colloidal hydrated, and sorbitol). 16.2 Recommended Storage Store STAXYN at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. STAXYN is dispensed in blisterpacks. The patient should be advised to examine the blisterpack before use and not use if blisters are torn, broken, or missing.

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