Spedra: Uses, Dosage & Side Effects
A fast-acting oral phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction in adult men, with onset of effect as early as 15 minutes after dosing
Spedra (avanafil) is an orally administered, highly selective phosphodiesterase type 5 (PDE5) inhibitor prescribed for the treatment of erectile dysfunction (ED) in adult men. Marketed by A. Menarini in Europe and as Stendra in the United States, avanafil is known for its rapid onset of action, with clinical effect often observed as soon as 15 minutes after dosing. Spedra works only in the presence of sexual stimulation by enhancing the nitric oxide–cyclic GMP pathway, which increases blood flow to the penis. Spedra is available as 50 mg, 100 mg, and 200 mg film-coated tablets and requires a valid prescription from a licensed healthcare professional.
Quick Facts: Spedra
Key Takeaways
- Spedra (avanafil) is an oral, highly selective PDE5 inhibitor indicated for the treatment of erectile dysfunction (ED) in adult men and is one of the fastest-acting medications in its class, with an onset as early as 15 minutes.
- It works only during sexual stimulation by inhibiting PDE5, increasing cGMP levels in the smooth muscle of the corpus cavernosum, and enhancing blood flow into the penis to produce and maintain an erection.
- Spedra must never be combined with nitrates (such as nitroglycerin), amyl nitrite (“poppers”), or guanylate cyclase stimulators such as riociguat, because the combination can cause life-threatening hypotension.
- The recommended starting dose is 100 mg taken approximately 15–30 minutes before sexual activity, and the maximum recommended frequency is once per day; the dose may be titrated up to 200 mg or down to 50 mg based on response and tolerability.
- The most common side effects – headache, flushing, and nasal congestion – are usually mild and transient; however, sudden vision or hearing loss and erections lasting longer than 4 hours require immediate medical evaluation.
What Is Spedra and What Is It Used For?
Spedra contains the active substance avanafil, a highly selective and reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). It is one of four oral PDE5 inhibitors currently approved for the treatment of erectile dysfunction – alongside sildenafil, tadalafil, and vardenafil – and is distinguished by its rapid onset of action and favourable selectivity profile. Spedra was first approved by the European Medicines Agency (EMA) in June 2013, and is marketed in the United States under the brand name Stendra, which received U.S. Food and Drug Administration (FDA) approval in April 2012.
Erectile dysfunction is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. ED is extraordinarily common: epidemiological studies suggest that the global prevalence may exceed 150 million men, with rates that increase significantly with age. The condition affects approximately 40% of men by age 40 and more than 70% of men by age 70, although many cases remain undiagnosed and untreated due to embarrassment, cultural factors, or lack of access to care. ED is not simply an inconvenience – it is strongly associated with reduced quality of life, relationship difficulties, depression, and anxiety, and can be an early warning sign of underlying cardiovascular disease, diabetes, or hormonal disturbances.
The pathophysiology of erection involves a complex interplay between psychological, neurological, vascular, and hormonal systems. During sexual stimulation, nerve endings and endothelial cells in the corpus cavernosum of the penis release nitric oxide (NO). Nitric oxide activates the enzyme guanylate cyclase, which converts guanosine triphosphate (GTP) into cyclic GMP (cGMP). cGMP in turn relaxes the smooth muscle of the corpus cavernosum, allowing arterial inflow of blood and compression of venous outflow, producing a rigid erection. The enzyme PDE5 normally breaks down cGMP, thereby terminating the erection. By inhibiting PDE5, avanafil prolongs the action of cGMP and facilitates and enhances the erectile response. Importantly, because avanafil acts on an existing pathway that requires nitric oxide release, it has no effect without sexual stimulation.
Spedra is indicated for the treatment of erectile dysfunction in adult men. It is effective across a wide range of etiologies, including:
- Organic ED due to vascular disease, endothelial dysfunction, atherosclerosis, hypertension, dyslipidemia, or cardiovascular risk factors (provided the patient has been medically cleared for sexual activity).
- Diabetic ED, including ED related to type 1 or type 2 diabetes mellitus, in which small-vessel disease and diabetic neuropathy impair the normal erectile response.
- Post-prostatectomy ED, following radical prostatectomy for prostate cancer – although response rates in this setting are more variable and depend on whether neurovascular bundles were spared during surgery.
- Psychogenic ED, in which the physical erectile mechanism is intact but psychological factors such as anxiety, depression, or relationship issues are the primary contributors.
- Mixed organic and psychogenic ED, which represents the largest subset of men presenting with ED in clinical practice.
Avanafil has been extensively studied in randomised, double-blind, placebo-controlled clinical trials involving several thousand men. These studies have consistently demonstrated significant improvements in the erectile function domain of the International Index of Erectile Function (IIEF), as well as improvements in the Sexual Encounter Profile (SEP) questions 2 and 3, which address successful penetration and successful intercourse respectively. The efficacy has been demonstrated in the general ED population as well as in specific subpopulations with diabetes and post-radical prostatectomy ED.
A key practical feature of avanafil is its rapid onset of action. In clinical studies, statistically significant improvements in erectile function were demonstrated as early as 15 minutes after dosing at the 200 mg strength in the fasted state. This is generally faster than other oral PDE5 inhibitors and can be particularly valuable for men who prefer more spontaneous sexual activity. The duration of action of avanafil is approximately 6 hours, which is shorter than tadalafil (up to 36 hours) but similar to sildenafil and vardenafil.
Spedra does not cure erectile dysfunction, nor does it increase sexual desire. It is an “on-demand” medication that facilitates the physical erectile response during sexual stimulation. Spedra is not approved for use in women, children, or adolescents, and it does not provide protection against sexually transmitted infections including HIV. Patients with ED should also have an evaluation of underlying causes, because ED can be the first manifestation of atherosclerotic cardiovascular disease.
Avanafil shows high selectivity for PDE5 over other phosphodiesterase isoforms. In biochemical assays, it is more than 100-fold more selective for PDE5 compared to PDE6 (which is expressed in the retina and mediates colour and light perception), which may translate to a lower incidence of visual side effects than seen with some older PDE5 inhibitors. Its selectivity over PDE11 (expressed in the heart, skeletal muscle, and testes) is also very high. This selectivity profile is a pharmacological rationale for the distinct tolerability pattern observed in clinical studies.
What Should You Know Before Taking Spedra?
Contraindications
There are several absolute contraindications that make the use of Spedra unsafe. These must be identified and assessed before the first dose is prescribed.
- Hypersensitivity: Do not take Spedra if you are allergic to avanafil or any of the other ingredients in the tablet (listed in Section 7).
- Concurrent use of nitrates or nitric oxide donors: Spedra must not be used with any form of organic nitrates (such as nitroglycerin for chest pain, isosorbide mononitrate, or isosorbide dinitrate) or nitric oxide donors (such as amyl nitrite, commonly known as “poppers”). The combination can produce a severe and potentially fatal fall in blood pressure.
- Severe cardiovascular disease: Patients for whom sexual activity is inadvisable due to underlying cardiovascular status should not take Spedra. This includes men who have experienced a myocardial infarction, stroke, or life-threatening arrhythmia within the preceding 6 months; those with unstable angina or angina that occurs during sexual intercourse; those with heart failure classified as New York Heart Association (NYHA) class 2 or greater in the preceding 6 months; those with severe uncontrolled hypertension (blood pressure above 170/100 mmHg) or hypotension (blood pressure below 90/50 mmHg).
- Severe hepatic impairment: Spedra should not be used in patients with severe liver impairment (Child-Pugh Class C), as its metabolism may be significantly reduced and plasma concentrations increased.
- Severe renal impairment: Spedra is not recommended for patients with severe renal impairment (creatinine clearance below 30 mL/min), as clinical data in this population are limited.
- Loss of vision due to NAION: Spedra must not be taken by patients who have previously experienced loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this was associated with previous PDE5 inhibitor use.
- Concurrent use of potent CYP3A4 inhibitors: Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, nefazodone, saquinavir, and telithromycin substantially increase avanafil plasma levels. Co-administration is either contraindicated or requires dose reduction and careful monitoring (see Drug Interactions).
- Guanylate cyclase stimulators: Spedra must not be used with riociguat (used for pulmonary hypertension), as the combination may cause symptomatic hypotension.
Warnings and Precautions
Seek urgent medical attention if you experience sudden decrease or loss of vision in one or both eyes (which could indicate NAION) or sudden decrease or loss of hearing (which could indicate sudden sensorineural hearing loss). Discontinue Spedra immediately and consult a healthcare provider. Although these events are rare, they have been reported in association with all PDE5 inhibitors, and the causal relationship has not been fully established.
Before prescribing Spedra, your doctor should take a thorough medical history and perform a physical examination to establish the diagnosis of erectile dysfunction, identify potential underlying causes, and assess cardiovascular risk. You should inform your doctor about all of the following:
- Cardiovascular disease: Because sexual activity itself is associated with cardiac risk, men with known cardiovascular disease should be evaluated before being prescribed a PDE5 inhibitor. PDE5 inhibitors cause mild, transient systemic vasodilation that may lower blood pressure by a few mmHg. Use with caution in patients with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic cardiomyopathy) or severely impaired autonomic blood pressure control.
- Anatomical deformation of the penis: Men with anatomical penile deformities (angulation, cavernosal fibrosis, or Peyronie’s disease) should use Spedra with caution.
- Predisposition to priapism: Conditions that predispose to priapism (an erection lasting more than 4 hours) – such as sickle-cell disease, multiple myeloma, leukemia, or anatomical deformation of the penis – require caution. Priapism, if not treated promptly, can lead to permanent loss of erectile function. Seek emergency care for any erection lasting longer than 4 hours.
- Bleeding disorders or active peptic ulcer disease: Safety data in patients with bleeding disorders or active peptic ulcer disease are limited, so Spedra should be used with caution in these settings.
- Retinitis pigmentosa: A minority of patients with the hereditary eye condition retinitis pigmentosa have genetic disorders of retinal phosphodiesterases. The safety of avanafil in this population is not established, and it is not recommended.
- Hearing disorders: Cases of sudden hearing loss have been reported temporally associated with PDE5 inhibitor use. If this occurs, stop taking Spedra and seek medical review.
- Alpha-blocker use: Men taking alpha-blockers (used for benign prostatic hyperplasia or hypertension) may experience symptomatic hypotension with concomitant PDE5 inhibitors. See Drug Interactions for specific guidance.
- Alcohol: Both alcohol and PDE5 inhibitors have mild vasodilatory properties. Drinking substantial amounts of alcohol while taking Spedra may increase the likelihood of symptomatic hypotension such as dizziness, headache, or fainting.
- Non-licensed treatments: Do not combine Spedra with non-licensed ED treatments or other PDE5 inhibitors. The safety and efficacy of such combinations have not been established.
Pregnancy and Breastfeeding
Spedra is not indicated for use by women and has not been studied in pregnancy or lactation. It should not be used in women or in children under 18 years of age. Men with partners who are pregnant should discuss any safety considerations with their healthcare provider, although transfer of clinically relevant amounts of avanafil through semen is not expected.
Driving and Operating Machinery
Spedra has a minor influence on the ability to drive and operate machines. Dizziness, somnolence, and blurred vision have been reported in a small proportion of users. You should be aware of how you respond to Spedra before driving or operating heavy machinery. Avoid driving if you experience dizziness or visual symptoms.
Important Information About Ingredients
Spedra tablets contain lactose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The tablets also contain a small amount of sodium (less than 1 mmol, or 23 mg, per tablet), which is essentially “sodium-free” and is clinically insignificant for most patients.
How Does Spedra Interact with Other Drugs?
Drug interactions with Spedra fall into two main categories. The first is pharmacodynamic interactions – interactions based on the combined effect of two drugs on the cardiovascular system or smooth muscle. The second is pharmacokinetic interactions – interactions based on how drugs affect the metabolism and blood concentration of avanafil. Avanafil is primarily metabolised by the cytochrome P450 3A4 (CYP3A4) enzyme, with a minor contribution from CYP2C9, so drugs that inhibit or induce CYP3A4 can significantly alter avanafil exposure.
Major Interactions
| Interacting Drug / Class | Effect | Clinical Significance |
|---|---|---|
| Organic nitrates (nitroglycerin, isosorbide mono/dinitrate) | Severe, potentially fatal hypotension due to enhanced vasodilation | Absolute contraindication – never combine |
| Nitric oxide donors (amyl nitrite, “poppers”) | Severe hypotension, syncope, myocardial infarction | Absolute contraindication |
| Riociguat (guanylate cyclase stimulator) | Symptomatic hypotension | Contraindicated |
| Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, telithromycin, nefazodone) | Major increase in avanafil plasma levels (≥13-fold with ritonavir) | Contraindicated (EU SmPC) or use not recommended |
| Moderate CYP3A4 inhibitors (erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, verapamil) | Moderate increase in avanafil levels (~3-fold increase in AUC with erythromycin) | Limit maximum dose to 100 mg and not more than once every 48 hours |
| Alpha-blockers (doxazosin, tamsulosin, alfuzosin) | Additive hypotensive effect, risk of symptomatic hypotension | Ensure patient is stable on alpha-blocker; start Spedra at lowest dose (50 mg) |
Minor Interactions
| Interacting Drug / Class | Effect | Clinical Significance |
|---|---|---|
| Antihypertensive agents (ACE inhibitors, ARBs, beta-blockers, diuretics, calcium channel blockers) | Minor additive decrease in blood pressure | Generally well tolerated; caution if blood pressure is borderline |
| Grapefruit juice | Modest inhibition of intestinal CYP3A4, possible increase in avanafil levels | Avoid large quantities within 24 hours of dosing |
| Alcohol | Both are mild vasodilators; combination may potentiate hypotensive effects | Avoid excessive alcohol intake (more than 3 units) |
| CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St. John’s wort) | Decreased avanafil levels, potentially reduced efficacy | Avoid combination; efficacy may be diminished |
| Other PDE5 inhibitors (sildenafil, tadalafil, vardenafil) | Additive PDE5 inhibition with increased risk of side effects | Do not combine; only one PDE5 inhibitor should be used at a time |
| CYP2C9 substrates (warfarin) | No clinically significant pharmacokinetic interaction observed | No dose adjustment required |
It is essential to inform all of your healthcare providers – including your general practitioner, urologist, cardiologist, and pharmacist – about your use of Spedra, even if you use it only occasionally. This is particularly important in emergency situations: if you present with chest pain, medical personnel need to know whether you have taken a PDE5 inhibitor within the previous 48 hours, because this will change which treatments are safe to administer.
What Is the Correct Dosage of Spedra?
Spedra is an on-demand medication, meaning it is taken as needed before sexual activity rather than on a fixed daily schedule. Individualisation of the dose is key to achieving the best balance between efficacy and tolerability. Your doctor will determine the appropriate starting dose and may titrate the dose up or down based on your response after several attempts.
Adults
Standard Adult Dose
Starting dose: 100 mg taken orally approximately 15 to 30 minutes before sexual activity
Dose range: 50 mg, 100 mg, or 200 mg based on individual response and tolerability
Maximum dose: 200 mg
Maximum frequency: Once per day
Spedra can be taken with or without food, but taking it on an empty stomach may result in slightly faster onset of action. Sexual stimulation is required for Spedra to be effective – the medication does not initiate an erection by itself.
Elderly Patients (65 Years and Older)
No specific dose adjustment is routinely required for elderly patients based on age alone. However, elderly patients may be more likely to have concurrent medical conditions, use multiple medications, or have reduced organ function. It is therefore reasonable to start at the lowest dose (50 mg) and titrate up only if needed, particularly in those over 75 years of age. Overall, avanafil has been well tolerated in studies that included men up to the age of 87 years.
Kidney Impairment
Renal Impairment
Mild to moderate impairment (CrCl 30–80 mL/min): Start at 100 mg; dose adjustment not routinely required.
Severe impairment (CrCl < 30 mL/min) or dialysis: Not recommended due to limited clinical data.
Liver Impairment
Hepatic Impairment
Mild to moderate impairment (Child-Pugh A or B): Start at 50 mg; titrate cautiously based on tolerability up to a maximum of 100 mg.
Severe impairment (Child-Pugh C): Contraindicated – not recommended.
Diabetes Mellitus
No dose adjustment is required based on diabetes alone. However, diabetic ED is often more difficult to treat, and response rates in diabetic patients may be lower than in the general ED population. Some patients with diabetes may benefit from the 200 mg dose, once efficacy and tolerability of lower doses have been established.
Children and Adolescents
Spedra is not indicated for use in individuals under 18 years of age. The safety and efficacy of avanafil in children and adolescents have not been established, and there is no relevant clinical use in this population.
Women
Spedra is not indicated for women. It should not be used by women of any age, including pregnant or breastfeeding women.
Missed Dose
Because Spedra is taken on an as-needed basis rather than on a fixed daily schedule, the concept of a “missed dose” does not apply in the traditional sense. If you intended to take Spedra before sexual activity but forgot, you can take it later; however, you must wait at least 24 hours before taking another dose. Do not take a double dose to compensate for a missed one.
Overdose
In single-dose studies, avanafil at doses up to 800 mg (four times the recommended maximum) was generally tolerated, although adverse events were more frequent and intense at higher doses. In cases of overdose, standard supportive measures should be taken. If you suspect that you or someone else has taken too much Spedra, contact a healthcare provider or poison control immediately. Symptoms of overdose may include severe headache, flushing, dizziness, visual disturbances, back pain, muscle pain, and hypotension. Dialysis is unlikely to accelerate clearance because avanafil is highly protein-bound.
How to Take Spedra
Spedra is supplied as pale-yellow, oval-shaped film-coated tablets. The tablets should be swallowed whole with a glass of water. They can be taken with or without food. For maximum benefit, the tablet should be taken approximately 15 to 30 minutes before anticipated sexual activity. The timing is flexible: because of the medication’s rapid absorption and relatively long window of effect, Spedra can be taken anywhere from 15 minutes to several hours before sexual activity.
A heavy, high-fat meal can slow the absorption of avanafil and may delay its onset of action, although the overall efficacy is not clinically compromised. Consuming substantial amounts of alcohol (more than 3 units) can increase the risk of symptomatic hypotension such as dizziness, orthostatic hypotension, and fainting. Moderate alcohol intake is generally acceptable, but caution is advised.
What Are the Side Effects of Spedra?
Like all medicines, Spedra can cause side effects, although not everyone gets them. Overall, avanafil is well tolerated in the majority of patients, and most adverse events are mild to moderate and short-lived. The side effect profile is consistent with the known pharmacology of PDE5 inhibitors, with the most frequent events reflecting the mild vasodilatory action of the drug class.
Side Effect Frequency Distribution
Very Common
May affect more than 1 in 10 people
- Headache
- Flushing (redness and warmth of the face, neck, and upper chest)
Common
May affect up to 1 in 10 people
- Nasal congestion (stuffy nose)
- Sinus congestion
- Back pain
- Dizziness
- Indigestion (dyspepsia)
- Nausea
- Blurred vision
- Palpitations (awareness of heart beat)
- Increased heart rate (tachycardia)
- Feeling hot
- Hepatic enzyme elevation (transient)
Uncommon
May affect up to 1 in 100 people
- Influenza-like symptoms
- Allergic rhinitis
- Gout, hyperglycemia
- Insomnia, anxiety, premature ejaculation
- Somnolence (drowsiness)
- Exertional dyspnoea (breathlessness on exertion)
- Rhinitis, runny nose
- Dry mouth, gastritis, lower abdominal pain, vomiting, reflux
- Rash
- Muscle pain (myalgia), muscle spasms
- Frequent urination, haematuria (blood in urine)
- Penile pain, spontaneous erection without sexual stimulation
- Genital itching
- Fatigue, chest pain, peripheral edema, pyrexia (fever)
- Abnormal liver function tests, abnormal urine analysis
- Blood pressure elevation, blood in semen
- Angina pectoris, chest tightness, arrhythmias
- Hypertension
Rare
May affect up to 1 in 1,000 people
- Pruritus (itching) of the eye, eyelid swelling, ocular hyperaemia (red eyes)
- Tinnitus (ringing in the ears)
- Vertigo
- Myocardial infarction, unstable angina
- Nasal dryness, epistaxis (nosebleeds)
- Steven-Johnson syndrome (severe skin reaction)
- Peyronie’s disease aggravation
- Priapism (prolonged erection lasting more than 4 hours – medical emergency)
Very Rare / Not Known
May affect fewer than 1 in 10,000 people or frequency cannot be estimated
- Non-arteritic anterior ischaemic optic neuropathy (NAION) – sudden decrease or loss of vision
- Sudden sensorineural hearing loss
- Serious cardiovascular events – including stroke, sudden cardiac death, ventricular arrhythmia
- Severe hypotension (low blood pressure)
- Hypersensitivity reactions including angioedema and anaphylaxis
When to Seek Emergency Medical Attention
- An erection lasting longer than 4 hours (priapism) – this is a medical emergency that can cause permanent damage to the penis if not treated promptly.
- Sudden vision loss in one or both eyes – this may indicate NAION.
- Sudden hearing loss, often with tinnitus or dizziness.
- Chest pain during or after sexual activity – do not take nitroglycerin. Go to the nearest emergency department and tell them you have taken a PDE5 inhibitor.
- Severe allergic reaction – swelling of the face, lips, tongue, or throat; difficulty breathing; severe rash.
- Fainting or signs of very low blood pressure (severe light-headedness, pallor, cold sweat).
If you experience side effects that are troublesome or persistent – including any side effects not listed here – inform your doctor, pharmacist, or nurse. Reporting suspected adverse reactions is an important part of ongoing drug safety surveillance. You can report side effects to your national pharmacovigilance authority (for example, the EMA in Europe, the FDA MedWatch programme in the United States, or the MHRA Yellow Card Scheme in the United Kingdom). Reports from patients and healthcare professionals help regulators monitor the ongoing benefit-risk profile of Spedra.
How Should Spedra Be Stored?
Correct storage of Spedra helps ensure that the medication remains stable, effective, and safe throughout its shelf life. Poor storage conditions – particularly exposure to high temperatures and moisture – can degrade the active ingredient and alter the appearance or integrity of the tablet.
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze. Avoid storing in places that can get very hot, such as in a car during summer or on a windowsill in direct sunlight.
- Humidity: Keep the tablets in the original blister pack to protect from moisture. Do not transfer tablets to pill organisers or unlabeled containers, which may expose them to humid conditions.
- Light: Store the blister in the original outer carton to protect from light.
- Children: Keep this medicine out of the sight and reach of children. Although Spedra is not known to be particularly toxic to children, accidental ingestion of any prescription medication by a child should prompt immediate medical evaluation.
- Expiry date: Do not take Spedra after the expiry date stated on the blister and outer carton. The expiry date refers to the last day of the stated month. Expired medication may have reduced efficacy and is not recommended for use.
- Appearance: Do not use if you notice any visible damage to the tablet, including cracking, chipping, discolouration, or unusual odour. Healthy tablets are pale-yellow, oval-shaped film-coated tablets with the appropriate dose marking embossed on one side.
Do not throw away any medicines via wastewater or household waste. Unused or expired Spedra should be returned to your pharmacy or a designated pharmaceutical waste collection point. This helps protect the environment by preventing pharmaceutical residues from entering water supplies.
What Does Spedra Contain?
Active Substance
The active substance is avanafil. Each film-coated tablet contains either 50 mg, 100 mg, or 200 mg of avanafil, depending on the strength prescribed. Avanafil is a second-generation PDE5 inhibitor chemically distinct from sildenafil, tadalafil, and vardenafil, designed to offer high selectivity for PDE5 and rapid absorption.
Inactive Ingredients (Excipients)
The other ingredients in Spedra tablets are:
- Mannitol (bulking agent)
- Fumaric acid (pH modifier)
- Hydroxypropylcellulose (binder)
- Low-substituted hydroxypropylcellulose (disintegrant)
- Calcium carbonate (excipient)
- Magnesium stearate (lubricant)
- Ferric oxide yellow (colouring agent, E172)
- Talc (glidant)
- Titanium dioxide (coating agent, E171)
Appearance and Pack Sizes
Spedra tablets are pale-yellow, oval-shaped, film-coated tablets. The tablets are embossed with the dose marking on one side, corresponding to the strength (50, 100, or 200). Spedra is available in blister packs containing 2, 4, 8, or 12 tablets. Not all pack sizes may be marketed in every country.
Marketing Authorisation Holder and Manufacturer
Spedra is authorised in the European Union by A. Menarini Industrie Farmaceutiche Riunite S.r.l. In the United States, avanafil is marketed as Stendra and distributed by Metuchen Pharmaceuticals (previously VIVUS, Inc.), the originator of the molecule. The medication is manufactured under strict pharmaceutical good-manufacturing-practice (GMP) standards and regulated by the EMA, FDA, and other national competent authorities in countries where it is available.
Frequently Asked Questions About Spedra
Spedra (avanafil) is used to treat erectile dysfunction (ED) in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual activity. Spedra works by increasing blood flow to the penis during sexual stimulation and is effective for ED of both organic and psychogenic origin, including ED associated with diabetes, prostate surgery, and cardiovascular disease (in patients who are medically cleared for sexual activity).
Spedra is one of the fastest-acting PDE5 inhibitors available. It is typically taken 15 to 30 minutes before anticipated sexual activity, and some men notice an effect as early as 15 minutes after taking the tablet. Sexual stimulation is required for the medication to work – Spedra does not initiate an erection on its own. Taking it on an empty stomach may result in slightly faster onset, although it can be taken with or without food.
The clinical effect of Spedra typically lasts up to approximately 6 hours after a single dose, which is shorter than tadalafil (up to 36 hours) but comparable to sildenafil and vardenafil. Individual response varies based on dose, food intake, individual metabolism, and concurrent medications. Spedra should not be taken more than once in a 24-hour period, regardless of how long the previous effect lasted.
No. Spedra must absolutely not be taken with any form of organic nitrates (such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate) or nitric oxide donors (such as amyl nitrite, commonly known as “poppers”). The combination can cause a severe, potentially fatal drop in blood pressure. If you are prescribed nitrates for chest pain (angina), you must not take Spedra. This is an absolute contraindication. If you have taken Spedra and develop chest pain, inform medical personnel immediately so they can avoid giving you nitroglycerin.
The most common side effects of Spedra are headache, facial flushing (redness and warmth), and nasal congestion (stuffy nose). Less frequent side effects include back pain, dizziness, indigestion, nausea, blurred vision, and palpitations. Most side effects are mild to moderate, transient, and resolve without treatment. Serious but rare side effects include priapism (erection lasting more than 4 hours), sudden vision loss, and sudden hearing loss, all of which require immediate medical attention.
Spedra should only be used in men with cardiovascular disease who have been evaluated and medically cleared by a physician for sexual activity. Sexual intercourse itself poses a cardiac risk, and PDE5 inhibitors cause mild vasodilation and a small reduction in blood pressure. Spedra is contraindicated in men who have had a heart attack, stroke, or life-threatening arrhythmia within the past 6 months, those with severe heart failure (NYHA III-IV), unstable angina, severely uncontrolled hypertension, or severe hypotension. Always discuss your cardiovascular history with your doctor before starting Spedra.
All four medications are PDE5 inhibitors and share the same mechanism of action, but they differ in onset and duration. Spedra (avanafil) has the fastest onset (often within 15 minutes) and a duration of approximately 6 hours. Sildenafil (Viagra) usually works within 30–60 minutes and lasts 4–6 hours. Vardenafil (Levitra) has similar kinetics to sildenafil. Tadalafil (Cialis) has a slower onset but a much longer duration (up to 36 hours) and is also approved for daily low-dose use. Avanafil is sometimes preferred by men who value rapid onset or who experience visual side effects with other PDE5 inhibitors, as its selectivity over PDE6 is higher.
Spedra is licensed for on-demand use, not daily continuous use. The maximum dosing frequency is once per day. Unlike tadalafil, avanafil is not approved for low-dose daily therapy. If you require more regular erectile function support (for example, in the context of post-prostatectomy penile rehabilitation), your urologist may discuss alternative regimens or medications with you. Always follow your doctor’s prescription instructions.
References
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- U.S. Food and Drug Administration (FDA). Stendra (avanafil) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
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