Spedra Contraindications



Menarini-Von Heyden


Agencia Lei Va Hong


A. Menarini
Full Prescribing Info
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite) (see Interactions).
The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension (see Interactions).
Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra.
The use of avanafil is contraindicated in: Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; Patients with resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg); Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater.
Patients with severe hepatic impairment (Child-Pugh C).
Patients with severe renal impairment (creatinine clearance < 30 mL/min).
Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see Precautions).
Patients with known hereditary degenerative retinal disorders.
Patients who are using potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (see Dosage & Administration, Precautions and Interactions).
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