Spedra: What Are The Alternatives?

Myths about erectile dysfunction

  • Erectile dysfunction is a normal part of growing older.
  • Erectile dysfunction does not affect young men.
  • Trouble in getting an erection is because you are not attracted to your partner.
  • Pills are the only way to treat erectile dysfunction.
  • Erectile dysfunction may be treated without seeing a doctor by using herbal remedies and supplements.

 

Erectile dysfunction

The National Institute of Health defines erectile dysfunction as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Erectile dysfunction represents the most common sexual problem in men. It has a significant impact on the physical and psychological health of men worldwide and can also affect the quality of life of both the sufferers and their partners.

 

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What are the risk factors for erectile dysfunction?

The following risk factors may be associated with the occurrence of erectile dysfunction:

  • Advancing age;
  • Cardiovascular disease;
  • Cigarette smoking;
  • Diabetes mellitus
  • History of pelvic irradiation or surgery, including radical prostatectomy;
  • Hormonal disorders (e.g., hypogonadism, hypothyroidism, hyperprolactinemia);
  • Hypercholesterolemia;
  • Hypertension;
  • Illicit drug use (e.g., cocaine, methamphetamine);
  • Medications (e.g., antihistamines, benzodiazepines, selective serotonin reuptake inhibitors);
  • Neurologic conditions (e.g., Alzheimer disease, multiple sclerosis, Parkinson disease, paraplegia, quadriplegia, stroke);
  • Obesity;
  • Peyronie disease;
  • Psychological conditions (e.g., anxiety, depression, guilt, history of sexual abuse, marital or relationship problems, stress);
  • Sedentary lifestyle;
  • Venous leakage.

 

The medicines or other substances that may contribute to erectile dysfunction include:

  • Analgesics: opiates;
  • Anticholinergics: tricyclic antidepressants;
  • Anticonvulsants: phenytoin, phenobarbital
  • Antidepressants: lithium, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants;
  • Antihistamines: dimenhydrinate, diphenhydramine, hydroxyzine, meclizine, promethazine;
  • Antihypertensives: alpha blockers, beta blockers, calcium channel blockers, clonidine, methyldopa, reserpine;
  • Anti-Parkinson agents: bromocriptine, levodopa, trihexyphenidyl;
  • Cardiovascular agents: digoxin, disopyramide, gemfibrozil;
  • Cytotoxic agents: methotrexate;
  • Diuretics: spironolactone, thiazides;
  • Hormones 5-alpha reductase inhibitors, corticosteroids, oestrogens, luteinizing hormone-releasing hormone agonists, progesterone;
  • Illicit drugs, alcohol and nicotine: Amphetamines, barbiturates, cocaine, heroin, marijuana;
  • Immunomodulators; Interferon-alfa;
  • Tranquillizers: benzodiazepines, butyrophenones, phenothiazines.

 

Diagnostic evaluation of erectile dysfunction

The diagnostic evaluation of erectile dysfunction is based on:

  • Sexual, medical and psychological history of the patient;
  • Physical examination;
  • Laboratory testing;
  • Imaging testing.

 

What is Spedra?

Spedra is the brand name of avanafil, a medicine used to treat adult men with erectile dysfunction. Spedra is available as tablets (50, 100 and 200 mg) and can only be obtained with a prescription.

The efficacy and safety profile of Spedra have been assessed in three main clinical studies involving over 3400 men diagnosed with erectile dysfunction. The first study includes men with erectile dysfunction only, the second study looked mainly at men who have erectile dysfunction associated with diabetes, and the third study includes men who had erectile dysfunction after surgery on the prostate gland.

Each study lasted for 12 weeks. Different doses of Spedra were administered approximately 30 minutes before sexual activity were compared with placebo. The main efficacy outcomes in all three studies were the percentage of erections that lasted long enough for successful intercourse, the percentage of successful vaginal penetrations, and the change in an assessment score for erectile function.

In all three studies, Spedra was shown to be more effective than placebo. The results of the first study showed that Spedra taken approximately 30 minutes before sexual activity at a dose of 100 or 200 mg increased the percentage of successful attempts at intercourse from about 13% before treatment to about 57%, whereas placebo only increased it to 27%. The medicine also produced about 20% more successful vaginal penetrations than placebo.

Another clinical study involving 440 adults with erectile dysfunction was also carried out. In that study, Spedra was taken approximately 15 minutes before sexual activity. The percentage of successful attempts was about 28% with Spedra at a dose of 200 mg and about 25% with a dose of 100 mg, compared with 14% with placebo.

Following the clinical studies and after evaluating the safety profile of Spedra, the Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the befits of Spedra are greater than its risks and recommended it was approved for use in the European Union. On 21 June 2013, the European Commission granted a marketing authorisation valid throughout the European Union for Spedra.

 

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Spedra

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Spedra is one of the newest treatments on the market for erectile dysfunction and differentiates itself by being quicker acting than Viagra.

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Product Description

About Spedra

Spedra is one of a group of drugs similar to Viagra known as phosphodiesterase 5 inhibitors (PDE-5).  They work by relaxing the blood vessels in the penis which results in more blood flowing to the penis when you are sexually excited.

Spedra is one of the newest treatments on the market for erectile dysfunction and differentiates itself by being quicker acting than Viagra. Spedra can take as little as 15-30 minutes to take effect whereas Viagra can take up to one hour.

How do I take it?

You should take Spedra approximately 15-30 minutes before you are planning to have intercourse. Spedra will last in your system for around 6 hours so when sexually aroused you will be able to have intercourse during this window of time.  Tablets are swallowed whole with a glass of water.  You must be sexually excited for the drug to work- Spedra treats the physical element of erectile dysfunction and will not increase sexual desire.  

Dosage

Spedra comes in three different strength tablets; 50mg, 100mg and 200mg.

100mg tablets are the standard dose and we recommend you try these first. If you experience side effects, you can reduce your dose to 50mg or if you find you require a stronger effect, you can try 200mg.

We do not recommend that you split tablets in half as you cannot guarantee that the bioavailability of active ingredient will be the same in both halves of the tablet (e.g. you may split a 200mg tablet but receive 150mg of active ingredient in one half and 50mg in the other).  

If you have any questions about the dose or directions for use, please contact us in the pharmacy on 01625 460621 to speak to our pharmacist or doctor in confidence. You can also email [email protected]

 

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The pharmacokinetic profile of Spedra

Absorption

After oral administration, Spedra is rapidly absorbed, with maximum plasma concentration observed after 30 to 45 minutes. When Spedra is taken with a high-fat meal, the rate of absorption is delayed at approximately 75 minutes.

 

Distribution

Spedra is approximately 99% bound to plasma proteins. Protein binding is independent of total active substance concentrations, age, renal and hepatic function. Spedra was not found to accumulate in plasma when dosed 200 mg twice daily over 7 days.

 

Biotransformation

Spedra is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The plasma concentrations of the major circulating metabolites are approximately 23% and 29% that of the parent compound, respectively. The first metabolite shows a phosphodiesterase selectivity profile similar to that of avanafil, while the second metabolite was inactive against phosphodiesterase type 5.

 

Elimination

Spedra is extensively metabolised in humans. After oral administration, avanafil is excreted as metabolites predominantly in the faeces (approximately 63% of administered oral dose) and to a lesser extent in the urine (approximately 21% of the administered oral dose).

 

How does Spedra work in erectile dysfunction?

The active ingredient in Spedra, avanafil, belongs to a group of medicines called phosphodiesterasetype-5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cyclic guanosine monophosphate is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cyclic guanosine monophosphate, Spedra enhances its effect on erectile function. Sexual stimulation is still needed to produce an erection.

 

The safety profile of Spedra

Serious side effects

You should stop taking Spedra and contact your healthcare professional if you notice any of the following serious side effects:sepdra-avanafil-200mg-4-tablets_2

  • Priapism, an erection that will not go away; if you get an erection that lasts more than 4 hours, this must be treated as soon as possible, or lasting damage can happen to your penis.
  • Sudden decrease or loss of vision in one or both eyes;
  • Sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).

 

Common side effects (may affect up to 1 in 10 patients)

  • headache
  • flushing
  • nasal congestion

 

Uncommon side effects (may affect up to 1 in 100 patients)

  • feeling dizzy;
  • feeling sleepy or very tired;
  • sinus congestion;
  • back pain;
  • hot flush;
  • feeling out of breath;
  • heartbeat changes seen on ECG;
  • indigestion;
  • blurry vision;
  • raised liver enzymes.

 

Rare side effects (may affect up to 1 in 1000 patients)

  • influenza-like illness;
  • stuffy or runny nose;
  • hay fever;
  • congestion in the upper respiratory tract;
  • gout;
  • trouble sleeping;
  • premature ejaculation;
  • chest pain;
  • high blood pressure;
  • dry mouth;
  • stomach ache;
  • diarrhoea;
  • rash;
  • muscle pain;
  • muscle spasm;
  • frequent urination;
  • penile disorder;
  • spontaneous erection without sexual stimulation;
  • itching in the genital area;
  • swelling in the feet or ankles;
  • pink or red urine;
  • blood in the urine;
  • an abnormal blood test result for the prostate, test called „PSA‟;
  • an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of red blood cells;
  • an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function;
  • weight gain;
  • fever.

A lot of the side effects are similar between different E.D medications. If Spedra is not the right choice for you, we have also looked at the side-effects of Viagra (Sildenafil)

 

How should I take Spedra?

Spedra should be taken exactly as your doctor has told you. The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity. The dose could be increased at 200 mg if your doctor decided that 100 mg dose was too weak for you. Also, you could administer a lower dose of 50 mg tablet if the doctor decided that the 100 mg tablet is too strong for you.

Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil („moderate CYP3A4 inhibitors‟) the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.

It is important to know that Spedra will not work without sexual stimulation.

 

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Therapy for erectile dysfunction: Alternatives for Spedra

Lifestyle modification

The first-line therapy for erectile dysfunction is based on lifestyle changes and modifying pharmacotherapy that may contribute to erectile dysfunction. Sedentary lifestyle, a significant risk factor for cardiovascular disease, may also be a modifiable risk factor for erectile dysfunction. Obesity was also shown to increase the risk of erectile dysfunction. One study determined that one-third of men who were obese improved their erectile dysfunction with moderate weight loss and an increase in the amount and duration of regular exercise. Men who smoke present a double risk for erectile dysfunction compared with non-smokers.

In conclusion, patient education should be aimed at:

  • Increasing exercise;
  • Losing weight to achieve a body mass index (BMI) less than 30 kg per m2;
  • Stop smoking.

 

Pharmacotherapy

First-line therapy –

Phosphodiesterase type 5 inhibitors are considered the first-line therapy for erectile dysfunction, being the most effective oral drugs.

Four phosphodiesterase type 5 inhibitors are available on market: sildenafil (Viagra®, Pfizer), vardenafil (Levitra®, Bayer), tadalafil (Cialis®, Lilly-ICOS) and avanafil (Spedra®). The differences between these options are discussed here. These agents do not directly cause penile erections but instead affect the response to sexual stimulation. Sildenafil was the first in this series of phosphodiesterase type 5 inhibitors. The newest phosphodiesterase type 5 inhibitor is avanafil, which was approved and launched in the U.K in March 2014. Each of these drugs is highly efficacious in the management of erectile dysfunction although pharmacokinetic and side-effect profiles differ and results for each drug may vary for individual men. If you’re looking for peace of mind when it comes to buying medication online, we’ve written an article on purchasing it here, and the safety of Viagra here.

 

Second-line therapy –

Patients with erectile dysfunction who do not respond to the treatment with oral phosphodiesterase type 5 inhibitors may be treated with vasoactive drugs administered intracavernosal. The intracavernosal administration of vasoactive drugs was introduced more than 20 years ago, being the first medical treatment for erectile dysfunction.

The first and the only approved drug for intracavernosal treatment of erectile dysfunction is alprostadil. Studies have shown that alprostadil is most efficacious as monotherapy at a dose of 5-40 μg. After the administration of alprostadil, the erection appears after 5-15 minutes and lasts according to the dose injected.

The complications that may occur after intracavernosal administration of alprostadil include:

  • penile pain,
  • prolonged erection,
  • priapism,
  • fibrosis,
  • mild hypotension at high doses.

The drug is contraindicated to be administered to men with a history of hypersensitivity to alprostadil, men at risk of priapism, and men with bleeding disorders.

Another approach in the treatment of erectile dysfunction with intracavernosal drugs is the combination therapy. Using the combination therapy enables the patient to take advantage of the different modes of action of the drugs being used, as well as alleviating side-effects by using lower doses of each drug. The following drugs may be used:

  • Papaverine (20-80 mg): was the first oral drug used for intracavernosal injections and it is most commonly used in combination therapy due to its high incidence of side effects as monotherapy;
  • Phentolamine;
  • Vasoactive intestinal peptides;
  • Nitric oxide donors (linsidomine);
  • Potassium channel openers;
  • Moxisylyte;
  • Calcitonin gene-related peptide.

Because of the side effects that may occur after intracavernosal injections, alprostadil may also be administered intraurethral. A specific formulation of alprostadil (125-1000 μg) in a medicated pellet (MUSE™) has been approved as a treatment for erectile dysfunction. Intraurethral pharmacotherapy is a second-line therapy and provides an alternative to intracavernosal injections in patients who prefer a less-invasive, although less-efficacious treatment.

The most common adverse events of intraurethral alprostadil are:

  • Local pain;
  • Dizziness;
  • Hypotension.

Very rare adverse events include:

  • Penile fibrosis;
  • Priapism;
  • Urethral bleeding (related to the mode of administration);
  • Urinary tract infection (related to the mode of administration).

Another way of administering alprostadil is topical. Topical alprostadil is formulated as a cream that includes a permeation enhancer to facilitate absorption of alprostadil (200 and 300μg) through the urethral meatus. Side effects include:

  • Penile erythema;
  • Penile burning;
  • Local pain.

 

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Third-line therapy –

The surgical implantation of a penile prosthesis represents the third-line therapy in the management of erectile dysfunction. This therapy may be considered only in patients who do not respond to pharmacotherapy or who prefer a permanent solution to their problem.

The penile implants are classified into two categories:

  • Inflatable devices (2- and 3-piece);
  • Malleable devices.

The 3-piece inflatable devices are preferred by the most patients due to the more natural erection obtained. This type of devices provides the best rigidity and the best flaccidity because they will fill every part of the corporal bodies. However, the 2-piece inflatable prosthesis can be a viable option among patients who are deemed at high-risk of complications with reservoir placements. Malleable prostheses result in a firm penis, which may be manually placed in an erect or flaccid state.

The prosthesis may be implanted by two main surgical approaches:

  • Penoscrotal;
  • Infrapubic.

The penoscrotal approach provides an excellent exposure. It affords proximal crural exposure if necessary, avoids dorsal nerve injury and permits direct visualization of pump placement. However, with this approach, the reservoir is blindly placed into the retropubic space, which can be a problem in patients with a history of major pelvic surgery (mainly radical cystectomy).

The infrapubic approach has the advantage of reservoir placement under direct vision, but the implantation of the pump may be more challenging, and patients are at a slightly increased risk of penile dorsal nerve injury.

Regardless of the indication, prosthesis implantation has one of the highest satisfaction rates (92-100% in patients and 91-95% in partners) among the treatment options for ED based on appropriate consultation.

The main complications of penile prosthesis implantation are:

  • Mechanical failure;
  • Infection.

Penile implants are an attractive solution for patients who do not respond to more conservative therapies. There is sufficient evidence to recommend this approach in patients not responding to less-invasive treatments due to its high efficacy, safety and satisfaction rates.

 

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References

  1. https://www.webmd.com/erectile-dysfunction/myths-and-facts-about-erectile-dysfunction#2
  2. Heidelbaugh JJ. Management of erectile dysfunction. Am Fam Physician. 2010 Feb 1;81(3):305-12. Review.
  3. https://www.healthline.com/health/erectile-dysfunction-tests#tests
  4. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Summary_for_the_public/human/002581/WC500145208.pdf
  5. Burke RM, Evans JD. Avanafil for treatment of erectile dysfunction: review of its potential. Vasc Health Risk Manag. 2012;8:517-23. doi: 10.2147/VHRM.S26712. Epub 2012 Aug 29. Review.
  6. Spedra. Summary of product characteristics
  7. Spedra. Patient information leaflet
  8. Al-Shaiji TF, Brock GB. Phosphodiesterase type 5 inhibitors for the management of erectile dysfunction: preference and adherence to treatment. Curr Pharm Des. 2009;15(30):3486-95.
  9. Corbin J. Mechanisms of action of PDE5 inhibition in erectile dysfunction. International Journal of Impotence Research. 2004;16(S1): S4-S7. Mechanism.
  10. K. Hatzimouratidis (Chair), F. Giuliano, I. Moncada, A. Muneer, A. Salonia (Vice-chair), P. Verze EAU Guidelines on Erectile Dysfunction, Premature Ejaculation, Penile Curvature and Priapism.

 

Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected].