Spedra Online UK

Spedra contains avanafil, a second-generation phosphodiesterase type 5 (PDE5) inhibitor developed specifically for erectile dysfunction (ED).

Avanafil has the highest selectivity for PDE5 over other PDE isoforms among the available PDE5 inhibitors, which may account for its favourable side-effect profile.

Its most notable clinical advantage is the rapid onset of action: avanafil reaches peak plasma concentration in approximately 30-45 minutes, and clinical studies have demonstrated efficacy as early as 15 minutes after dosing in some patients.

The duration of action is approximately 6-12 hours.

In pivotal phase III trials, avanafil significantly improved erectile function across all ED severity categories and aetiologies, including difficult-to-treat populations such as diabetic men and post-prostatectomy patients.

The BNF lists avanafil alongside sildenafil, tadalafil, and vardenafil as a PDE5 inhibitor option for ED.

Food has minimal effect on the speed or extent of absorption, providing additional practical convenience compared to sildenafil.

Take one tablet approximately 15-30 minutes before planned sexual activity. Swallow whole with water.

Spedra can be taken with or without food; high-fat meals do not significantly affect its pharmacokinetics. Do not take more than one dose in 24 hours.

Avoid excessive alcohol consumption (more than 3 units), as this can increase the risk of hypotension and impair erectile function. Sexual stimulation is required for avanafil to produce an erection.

If no effect is observed after several attempts at the starting dose, consult your prescriber to discuss dose adjustment or alternative options.

The recommended starting dose is 100 mg, taken approximately 15-30 minutes before sexual activity.

Based on individual response and tolerability, the dose may be reduced to 50 mg or increased to 200 mg. Maximum frequency: once daily. In patients taking moderate CYP3A4 inhibitors (e.g.

erythromycin, fluconazole, verapamil), the maximum dose is 100 mg, with a dosing interval of at least 48 hours.

Concomitant use with potent CYP3A4 inhibitors (ketoconazole, ritonavir) is contraindicated. In patients aged >65, no dose adjustment is needed based on age alone.

Mild hepatic impairment requires no adjustment; moderate impairment limits the maximum to 100 mg. Severe hepatic or renal impairment: not recommended.

Side effects per SmPC frequency categories from pivotal clinical trial data.

Common (≥1/100 to <1/10): Headache (approximately 10%), flushing (approximately 4%), nasal congestion (approximately 3%), back pain.

Uncommon (≥1/1,000 to <1/100): Dizziness, somnolence, sinus congestion, dyspepsia, nausea, palpitations, tachycardia, hot flush, visual disturbances, myalgia, fatigue.

Rare (≥1/10,000 to <1/1,000): Priapism (erection lasting >4 hours), non-arteritic anterior ischaemic optic neuropathy (NAION), sudden sensorineural hearing loss.

Avanafil's high PDE5 selectivity means visual disturbances (PDE6-mediated) are less frequent than with sildenafil. Cardiovascular adverse events in trials were comparable to placebo.

If priapism occurs, seek emergency medical attention immediately.

Spedra must not be combined with organic nitrates or nitric oxide donors in any form; severe, potentially fatal hypotension may result.

Allow at least 12 hours after the last avanafil dose before administering nitrates if required in an emergency (shorter washout than tadalafil due to avanafil's shorter half-life).

Caution with alpha-blockers: patients should be stabilised on alpha-blocker therapy before initiating avanafil, and the lowest avanafil dose should be used.

Cardiovascular assessment is recommended in patients with risk factors before prescribing PDE5 inhibitors. Not studied in patients with hereditary degenerative retinal disorders.

Caution in patients predisposed to priapism (sickle cell disease, multiple myeloma, leukaemia) or with anatomical penile deformity.

Spedra is contraindicated in patients with hypersensitivity to avanafil or any excipient, concurrent use of nitrates or nitric oxide donors, concurrent use of potent CYP3A4 inhibitors (ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, nelfinavir, saquinavir), recent stroke or MI, severe hypotension (<90/50 mmHg), unstable angina, severe hepatic impairment, severe renal impairment (eGFR <30), and conditions where sexual activity is inadvisable.