Generic Name and Formulations:
Vardenafil (as HCl) 10mg; orally disintegrating tabs; peppermint flavor; contains phenylalanine, sorbitol.
Bayer and GlaxoSmithKline
Indications for STAXYN:
Not interchangeable with vardenafil (Levitra) 10mg film-coated tabs. Take without liquid. Place one tab on tongue, approx. 1hr before sexual activity; max 1 tab/day. Concomitant α-blockers (patients should be stable on α-blocker therapy before starting): use lower doses of vardenafil film-coated tabs as initial therapy.
Concomitant nitrates, or nitric oxide donors. Concomitant guanylate cyclase (GC) stimulators (eg, riociguat).
Not for use in women. Confirm diagnosis before therapy. Congenital QT prolongation: avoid use. Cardiovascular disease (eg, MI, stroke or life-threatening arrhythmia within 6 months; systolic BP <90 or BP >170/110; unstable angina, LV outflow obstruction, severe cardiac failure), moderate or severe hepatic impairment, on renal dialysis, hereditary degenerative retinal disorders and retinitis pigmentosa: not recommended. Anatomical penile deformation. Predisposition to priapism. History of non-arteritic anterior ischemic optic neuropathy (NAION) or those with "crowded" optic disc. Advise patients to discontinue if sudden vision or hearing loss occurs. Patients for whom sexual activity is inadvisable or contraindicated. Bleeding disorders. Active peptic ulcer. Phenylketonuria. Fructose intolerance.
See Contraindications. Hypotension with nitrates, GC stimulators. Avoid Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics, others that cause QT prolongation. Additive hypotensive effects with concomitant α-blockers, other antihypertensives; caution. Concomitant moderate or potent CYP3A4 inhibitors (eg, erythromycin, grapefruit juice, clarithromycin, ketoconazole, itraconazole, indinavir, saquinavir, atazanavir, ritonavir), or other erectile dysfunction treatments: not recommended.
Phosphodiesterase type 5 inhibitor (cGMP-specific).
Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain, sudden vision or hearing loss, cardiovascular effects (eg, hypotension, tachycardia), QT prolongation; rare: priapism, prolonged erection.
Tabs (blister cards)—1 x 4
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