Stendra

— THERAPEUTIC CATEGORIES —
  • Erectile dysfunction
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Stendra Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Avanafil 50mg, 100mg, 200mg; tabs.

    Pharmacological Class

    Phosphodiesterase type 5 inhibitor (cGMP-specific).

    How Supplied

    Tabs—30

    Manufacturer

    Metuchen Pharmaceuticals, LLC

    Generic Availability

    NO

    Stendra Indications

    Indications

    Erectile dysfunction.

    Stendra Dosage and Administration

    Adult

    Take 1 dose as needed approx. 15 mins before sexual activity at frequency of up to once daily. Initially 100mg. May reduce dose to 50mg taken approx. 30 mins before activity or increase to 200mg taken approx. 15 mins before activity. Concomitant moderate CYP3A4 inhibitors: max 50mg once every 24hrs. Concomitant α-blockers (patients should be stable on α-blocker therapy before starting): initially 50mg.

    Children

    <18yrs: not established.

    Stendra Contraindications

    Contraindications

    Concomitant organic nitrates (if medically necessary, allow ≥12hrs to elapse after last avanafil dose before considering initiation). Concomitant guanylate cyclase (GC) stimulators (eg, riociguat, vericiguat).

    Stendra Boxed Warnings

    Not Applicable

    Stendra Warnings/Precautions

    Warnings/Precautions

    Not for use in women. Confirm diagnosis before therapy. Cardiovascular disease (eg, MI, stroke, life-threatening arrhythmia, or coronary revascularization within 6 months; BP<90/50 or >170/100; unstable angina, angina with intercourse, NYHA Class ≥2 CHF, LV outflow obstruction, impaired autonomic regulation of BP): 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. Hereditary degenerative retinal disorders (including retinitis pigmentosa): not recommended. Patients for whom sexual activity is inadvisable or contraindicated. Bleeding disorders. Active peptic ulcer. Severe hepatic or renal impairment, on dialysis: not recommended.

    Stendra Pharmacokinetics

    See Literature

    Stendra Interactions

    Interactions

    See Contraindications. Hypotension with nitrates, GC stimulators. Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin), CYP450 inducers, or other ED treatments: not recommended. Potentiated by moderate CYP3A4 inhibitors (eg, erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, verapamil), grapefruit juice. Additive hypotensive effects with concomitant α-blockers, antihypertensives (eg, amlodipine, enalapril). Increased orthostatic hypotension with substantial alcohol consumption (eg, >3 units); caution. May potentiate nitric oxide donors (eg, sodium nitroprusside), desipramine, omeprazole, rosiglitazone.

    Stendra Adverse Reactions

    Adverse Reactions

    Headache, flushing, nasal congestion, nasopharyngitis, back pain; sudden vision or hearing loss; rare: cardiovascular events, prolonged erection, priapism.

    Stendra Clinical Trials

    See Literature

    Stendra Note

    Not Applicable

    Stendra Patient Counseling

    See Literature

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