Limitations Of Spedra

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The International Society for Sexual Medicine defines erectile dysfunction as the inability to achieve or maintain an erection suitable for satisfactory sex. When a man is sexually aroused, nerves and chemicals work together to relax smooth muscle tissue and widen arteries so that the penis can fill with blood. Veins constrict to keep the blood inside the penis, forming the erection. Once the man ejaculates, the blood is released back into the body.

Both emotional factors and also physical factors can contribute to the onset of erectile dysfunction. The most common causes of erectile dysfunction are poor blood flow to the penis, nerve damage, hormonal issues, medication side effects, Peyronie’s disease and psychological and stress.
Also, your lifestyle can interfere with this erectile function. Smoking, obesity, drug and alcohol abuse, an unhealthy diet and poor exercise habits are bad for your health and can contribute to other health conditions associated with erectile dysfunction.
Vascular erectile dysfunction and cardiovascular disease share common risk factors including obesity, hypertension, metabolic syndrome, diabetes mellitus, and smoking. Erectile dysfunction and cardiovascular disease also have common underlying pathological mechanisms, including endothelial dysfunction, inflammation, and atherosclerosis.

The incidence of erectile dysfunction

The incidence of erectile dysfunction increases with age. Men aged 18-59 years have an incidence of erectile dysfunction of 10%. Other data looking at similar groups divided the age groups into 10-year sections and found that, by setting individuals aged 18-29 years as a reference group, individuals aged 50-59 years have a 3.5 times higher incidence of erectile dysfunction. Another survey found that males older than 70 years have a 61% incidence of erectile dysfunction.

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What is Spedra?

Spedra is the trade name for an oral medication containing Avanafil. Avanafil belongs to a class of drugs known as PDE-5 (Phosphodiesterase type 5) inhibitors.
Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra works only if you are sexually stimulated.
Spedra was released by the Italian pharmaceutical specialist Menarini in 2014. This means that it will not be open to generic manufacturing by other companies until 2029 at the earliest.
The legal category for Spedra (Avanafil) is POM. This means that this medication is a prescription only medicine and it can only be supplied or sold according to the instructions in a prescription issued by a duly qualified and registered doctor or non-medical prescriber.
Other drugs in this class are Viagra, Cialis and Levitra.

 

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Mechanism of action

Spedra is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5. When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by Spedra produces increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Spedra has no effect in the absence of sexual stimulation.

How quickly does it work?

Spedra is intended to work faster than any other on-demand erectile dysfunction tablet. Whereas most other brands may take anywhere from 30-60 minutes to work, those using Spedra may see results in as little as 15 minutes.

How to take Spedra?

The recommended dose of Spedra is a 100 mg tablet, once a day.
You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was 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 an erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.
Dose adjustments are not required in patients aged 65 years and older. However, the available data on patients aged ≥70 years old is limited. Similarly, dose adjustments are not required in patients with diabetes mellitus or mild-to-moderate renal impairment.
You should take Spedra about 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated.
Spedra can be taken with or without food; if taken with food, it may take longer to work.

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Is Spedra simple to use?

Yes. Spedra is an oral treatment which is taken on demand. You simply take a pill roughly 30 minutes before you plan to have sex.
It doesn’t need to be taken at specific times on any given day, or with meals, so it’s not really possible to „forget” to take it.
Compared to other medication forms such as injections or urethral devices, Spedra tablets are a discreet and convenient way of administering treatment for erectile dysfunction.

 

Are there any limitations of Spedra?

Many men suffering from erectile dysfunction find treatment with Spedra to be of a huge benefit to them. Spedra is effectively controlling erectile dysfunction.
Recommendation for Spedra must be done by a healthcare professional. There are some limitations to its use like certain medical conditions which mean Spedra is not a suitable treatment for everybody. A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes before pharmacological treatment is considered.

  • You are allergic to avanafil or any other ingredients of Spedra;
  • You have heart problems;
  • You suffer from priapism, that is a persistent erection lasting 4 hours or more. This can happen in men with conditions like sickle cell disease, multiple
  • myeloma or leukaemia;
  • You have a physical condition that affects the shape of your penis (such as angulation, Peyronie’s disease or cavernosal fibrosis);
  • You have any bleeding disorder or active peptic ulceration;
  • You have a severe hepatic impairment (Child-Pugh C);
  • You have a severe renal impairment (creatinine clearance < 30 mL/min);
  • You 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;
  • You have hereditary degenerative retinal disorders;
  • You are using potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin).

It is important to speak to your doctor before taking Spedra. Your doctor will be able to evaluate your whole medical history, symptoms and current medication to give you the most appropriate and safe advice regarding the best course of action in treating erectile dysfunction.

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How effective is Spedra?

The percentages of successful intercourse attempts after taking each dose were as follows:6

The 50 mg dose had a 47% success rate;
The 100 mg dose had a 58% success rate;
The 200 mg dose had a 59% success rate.

Furthermore, in a „time to onset” study, 24.7 and 28.1 percent of those using the 100 mg and 200 mg doses respectively achieved an erection sufficient for intercourse at 15 minutes following administration.
Comparison of avanafil and sildenafil revealed the quicker onset of action for avanafil. Time to peak response for avanafil and sildenafil was 10 and 30 minutes, respectively. The study also demonstrated the comparable efficacy of these two PDE5 inhibitors. At maximal drug concentrations, avanafil and sildenafil potentiated penile tumescence by 325% and 304% (intravenous), and 415% and 358% (intra-duodenal). Both medicines produced dose-dependent changes in intracavernosal pressure following pelvic nerve stimulation

Which are the benefits of Spedra?

It is well known the speed at which Spedra works. Whereas most other tablet treatments taken on demand may take between 30-60 minutes to produce noticeable results in erectile dysfunction patients, Spedra is often reported to get to work within 15-30 minutes. However, this is not the only advantage of using Spedra.

It has been demonstrated the efficacy of Spedra in many trials and all its doses had an over 50% success rate;
Its price is in most of the cases lower than Viagra’s or Cialis;
Is a branded medication which means that is only one version of the treatment and it is in some respects easier to ensure you’re getting a genuine item.

 

How do I know if I need Spedra?

Having erection problems does not immediately mean you need to be taking a male sexual enhancement drug such as Spedra. Erectile dysfunction or impotence can be caused by a variety of reasons. Examine the reasons for your problems before taking Spedra.

  • Remember that Spedra is a cure for erectile dysfunction, which is a symptom. Don’t buy the medication before taking to your doctor first.
  • Determine if you have the desire to have sex with your partner. If the problem is psychological, Spedra may not work. Stress, anxiety and low self-esteem may be psychological factors that cause impotence. If your problem is not physical, a therapist can help you and your partner have a satisfactory sex life.
  • Consider the times you can have sexual intercourse when you desire it. The inability to maintain an erection for sex at least 25% of the time may indicate erectile dysfunction.
  • Visit your doctor for a thorough physical examination. Your doctor can rule out any underlying problems that could be causing erection difficulties.

 

What if Spedra does not work for me?

If you find that Spedra hasn’t worked for you on the first occasion, this does not mean that it won’t work for you at all. If it does not work after eight separate attempts, you could consider going up a strength to see if a higher Spedra dose might work for you or choose an alternative oral erectile dysfunction treatment.

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What happens if I miss a dose of Spedra?

Since Spedra is used as needed, you are not likely to be on a dosing schedule.
When you miss a dose, you should take it as soon as possible but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health problem and you miss a dose of Spedra, you should inform your doctor and ask his suggestion.

 

What are the side effects of Spedra?

Like all medicines, Spedra can cause side effects. Stop taking it and see a doctor straight away if you notice any of the following serious side effects:

  • An erection that will not go away (“priapism”). 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 (including not being able to get erections);
  • Blurred vision;
  • 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).

 

Does Spedra interact with other medicines?

Tell your doctor or pharmacist if you are taking any of the following medicines:3

  • Alpha-blockers – for prostate problems or for lowering your high blood pressure;
  • Medicines for an irregular heartbeat („arrhythmia”) such as quinidine, procainamide, amiodarone or sotalol;
  • Antibiotics for infections such as erythromycin;
  • Phenobarbital or primidone – for epilepsy;
  • Carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain;
  • Other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4 inhibitors’) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil;
  • Riociguat.

Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil. If any of the above apply to you, talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

 

Is Spedra affected by food or drink?

Medications can take longer to work if they are taken with or shortly following a large meal. Alcohol consumption can exacerbate erectile dysfunction, so drinking alcohol while taking Spedra will change the effect of this medicine. Drinking alcohol can also lower blood pressure, which means that someone taking Spedra may have an increased susceptibility experience hypotension if they do both at the same time.
Grapefruit juice may also increase a user’s sensitivity to the medicine. The manufacturers of Spedra advise that men taking it should avoid drinking grapefruit juice a minimum of 24 hours before.

 

What Spedra does not do?

  • Does not cure erectile dysfunction;
  • Does not increase your sexual desire;
  • Does not protect you or your partner from sexually transmitted diseases, including HIV;
  • Does not serve as a male form of birth control;
  • Does not help women, children and adolescents under 18 years of age.

 

Getting the most from your treatment

  • You and your partner will still act just as you would if you were not taking a medicine for erectile dysfunction. Relaxation and sexual stimulation are required in order to obtain the best from Spedra’s effects.
  • Do not drink large amounts of alcohol before you plan to take Spedra. Drinking too much alcohol can reduce your ability to get an erection and this may prevent you from getting the maximum benefit from this treatment. The combination of Spedra and alcohol will also increase the risk of experiencing unpleasant side-effects such as dizziness and hypotension;
  • It is recommended that you do not drink grapefruit juice during the 24 hours before you take Spedra. This is because there is a chemical in grapefruit juice which can increase the amount of avanafil in your bloodstream and this makes side-effects more likely;
  • Keep your regular appointments with your doctor, so your progress can be monitored. If you feel this treatment is too strong for you, discuss this with your doctor as your dose may need to be reduced. Alternatively, if you do not get an erection after taking Spedra, or if it does not last long enough for you to have sex, you should discuss this with your doctor; do not take more tablets than you have been told to;
  • You should not take Spedra if you are using any other products or taking any other medicines to treat erectile dysfunction.

 

Conclusion

Spedra is an excellent choice for treating erectile dysfunction as it increases the latency time during sexual intercourse. Also, Spedra is efficient in maintaining one or several erections, if you use it as recommended.

 

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References

  1. https://www.issm.info/sexual-health-qa/what-is-erectile-dysfunction1/;
  2. Ryan M Burke, Jeffery D Evans. Avanafil for treatment of erectile dysfunction: review of its potential. Vasc Health Risk Manag. 2012; 8: 517–523. PMCID: PMC3433322. PMID: 22973106. DOI: 10.2147/VHRM.S26712;
  3. https://www.ema.europa.eu/documents/product-information/spedra-epar-product-information_en.pdf;
  4. George T. Kedia, Stefan Ückert, Farhang Assadi-Pour, Markus A. Kuczyk, Knut Albrecht. Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties. Ther Adv Urol. 2013 Feb; 5(1): 35–41. PMCID: PMC3547533. PMID: 23372609. DOI: 10.1177/1756287212466282;
  5. Giovanni Corona, Mario Maggi, Emmanuele A. Avanafil: The second-generation treatment of erectile dysfunction. https://emj.europeanmedical-group.com/wp-content/uploads/sites/2/2018/01/Avanafil-The-Second-Generation-Treatment-of-Erectile-Dysfunction.pdf;
  6. https://www.treated.com/erectile-dysfunction/spedra/advantages-of-spedra;
  7. https://patient.info/medicine/avanafil-for-erectile-dysfunction-spedra.

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