Is Spedra Effective?

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Erectile dysfunction

A diagnosis of erectile dysfunction is made when a man has a consistent or recurrent inability to either obtain or maintain an erection allowing for completion of sexual activity.
Usually, the diagnosis of erectile dysfunction should be made after at least 3 months of symptoms. However, if some type of trauma occurred prior to the patient developing symptoms, the patient may be diagnosed with erectile dysfunction in a shorter time frame. Patients can be diagnosed according to self-reported symptoms or by physiologic testing. If necessary, partner reporting may be used to initiate the process of screening a patient for erectile dysfunction.

 

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What is Spedra and what it is used for?

Spedra contains the active substance Avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence). Spedra is available in different doses: 50 mg, 100 mg or 200 mg of avanafil. Spedra comes as pale-yellow oval tablets, debossed with „50”, „100” or „200” on one side.
It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex, just as you would if you were not taking a medicine to help you.
Spedra will not help you if you do not have erectile dysfunction.
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.

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How to take Spedra?

The recommended dose is a 100 mg tablet, as needed. You should not take Spedra more than 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.
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.

 

How does Spedra work?

Spedra does not cause a man to be sexually aroused, it is only effective if you are sexually aroused.
To understand how it works you need to understand the mechanics of how a man gets an erection. When you get sexually stimulated, the nervous system in the erectile tissue of your penis releases nitric oxide (NO). The nitric oxide stimulates an enzyme that produces something called a messenger cyclic guanosine monophosphate (cGMP).
The cGMP relaxes the smooth muscle cells. One result of this is that the arteries in your penis dilate and the blood can flow into your penis more easily. Another result is that the erectile tissue itself fills with blood. Both of these processes result in an erection.
Spedra works by inhibiting a specific phosphodiesterase type 5 enzyme which is found in various body tissues, but primarily in the corpus cavernosum penis, as well as the retina. This maintains the level of cGMP in the smooth muscle cells. If you are not turned on, your brain will not stimulate the release of any nitric oxide and you will not produce any cGMP.

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Is Spedra effective?

Clinical studies have shown that when compared to placebo, Spedra and the other drugs in the same class, result in significant improvement in erectile function.
The claimed advantage of Spedra is that it has a very fast onset of action compared with other PDE5 inhibitors. It is absorbed quickly, reaching a maximum concentration within about 30–45 minutes. About two-thirds of the participants in trials were able to engage in sexual activity within 15 minutes.
Throughout all trials of Spedra, statistically significant improvements in all primary efficacy outcomes were observed for all three doses (50 mg, 100 mg and 200 mg) of avanafil compared with placebo. These were maintained with long-term treatment.
Although established to be a safe and effective drug, Spedra isn’t appropriate for everyone and may not work in all cases.

How quick is Spedra?

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

 

Is Spedra simple to use?

Yes. Spedra is a tablet treatment which is taken on demand. The user simply takes a pill roughly 30 minutes before they 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.
Spedra is also taken on a one-tablet basis, so the user does not have to remember how many tablets to take, or worry about reducing or increasing their dose in increments.
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.

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Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

  • 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).

Common (may affect up to 1 in 10 people):

  • Headache;
  • Flushing;
  • Nasal congestion.

Uncommon (may affect up to 1 in 100 people):

  • Feeling dizzy;
  • Feeling sleepy or very tired;
  • Sinus congestion;
  • Back pain;
  • Hot flush;
  • Feeling out of breath when you exert yourself;
  • Heartbeat changes seen on a heart tracing (ECG);
  • Increased heart beat;
  • Feeling your heartbeat in your chest (palpitations);
  • Indigestion, feeling or being sick to your stomach;
  • Blurry vision;
  • Raised liver enzymes.

Rare (may affect up to 1 in 1,000 people):

  • Influenza;
  • Influenza-like illness;
  • Stuffy or runny nose;
  • Hay fever;
  • Congestion in the nose, sinuses or upper part of the airway bringing air into the lungs;
  • Gout;
  • Trouble sleeping (insomnia);
  • Premature ejaculation;
  • Feeling strange;
  • Feeling unable to keep still;
  • Chest pain;
  • Serious chest pain;
  • Fast heart beat;
  • High blood pressure;
  • Dry mouth;
  • Stomach ache or heartburn;
  • Pain or discomfort in the lower abdomen;
  • Diarrhoea;
  • Rash;
  • Pain in the lower back or side of lower chest;
  • Muscle aches or pains;
  • Muscle spasms;
  • Frequent urination;
  • Penile disorder;
  • Spontaneous erection without sexual stimulation;
  • Itching in the genital area;
  • Feeling weak or tired all the time;
  • Swelling in the feet or ankles;
  • Increased blood pressure;
  • Pink or red urine, blood in the urine;
  • Abnormal extra sound from the heart;
  • An abnormal blood test result for a 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;
  • Nosebleed.

 

How to decrease the risk of Spedra side effects?AdobeStock_56098380

Avoid alcohol. Drinking more than one or two units of alcohol may alter the speed of onset and effectiveness of Spedra. Similarly, this might increase your risk of developing side effects;
Avoid recreational drugs. Recreational drugs contain nitrates which can cause side effects when taken alongside Spedra. Other recreational drugs can cause serious reactions;
Take a lower dose. Taking a lower dose will decrease the likelihood of developing side effects. This may reduce the effects of Spedra. It is always best to consult your doctor first if you plan on changing your prescribed dose, or taking other medicines alongside Spedra;
Avoid taking with food. Spedra is most effective when taken on an empty stomach. Taking it with food will slow down its effectiveness, but could reduce the possibility of side effects;
Check prescription medicines interactions with Spedra. Due to Spedra’s effect on the cardiovascular system, some prescription medicines will not interact well with Spedra. Doing so may increase the risk of side effects, possibly leading to fatal results.

 

Does it interact with other medicines?

Spedra interacts with many drugs. The following list is not complete but it is important to inform the doctor of all prescription and non-prescription medication taken, especially:

  • Nitrate medications (e.g. glyceryl trinitrate (GTN), nitroglycerin, isosorbide mononitrate or dinitrate);
  • Nitroprusside;
  • Cimetidine;
  • Erythromycin;
  • Azole antifungals (e.g., itraconazole, ketoconazole);
  • Mibefradil;
  • Rifampicin;
  • Alpha blockers, prescribed for a prostate disease or high blood pressure;
  • Ritonavir, Amyl, Butyl or Isopropyl nitrates;
  • Before taking any erectile dysfunction medication it is important to read the drug information sheet that comes with the packaging.

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Do not take Spedra:

  • If you are allergic to avanafil or any of the other ingredients of this medicine;
  • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure;
  • If you are taking any medication for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir;
  • If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin 56;
  • If you have a serious cardiac problem;
  • If you have had a stroke or heart attack in the last 6 months;
  • If you have low blood pressure or high blood pressure not controlled by medicines;
  • If you have chest pain (angina) or you get chest pain during sexual intercourse;
  • If you have a serious liver or kidney problem;
  • If you have loss of vision in one eye due to not enough blood getting to your eye;
  • If certain serious eye problems run in your family (such as retinitis pigmentosa);
  • If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors have been
  • shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

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Overdose

If you do take an overdose for any reason then please contact a medical professional. Adverse reactions are similar to those seen at lower doses but incidence rates and severities were increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as avanafil is highly bound to plasma proteins and it is not eliminated in the urine.

 

Pharmacokinetics

Absorption. Avanafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 0.5 to 0.75 hours of oral dosing in the fasted state. When avanafil is taken with a high-fat meal, the rate of absorption is reduced with a mean delay in Tmax of 1.25 hours and a mean reduction in Cmax of 39% (200 mg).

Distribution. Avanafil is approximately 99% bound to plasma proteins. Protein binding is independent of total active substance concentrations, age, renal and hepatic function. Avanafil was not found to accumulate in plasma when dosed 200 mg twice daily over 7 days. Based upon measurements of avanafil in semen of healthy volunteers 45-90 minutes after dosing, less than 0.0002% of the administered dose may appear in the semen of patients.

Biotransformation. Avanafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The plasma concentrations of the major circulating metabolites, M4 and M16, are approximately 23% and 29% that of the parent compound, respectively. The M4 metabolite shows a phosphodiesterase selectivity profile similar to that of avanafil and an in vitro inhibitory potency for PDE5 18% of that of avanafil. Therefore, M4 accounts for approximately 4% of total pharmacologic activity. The M16 metabolite was inactive against PDE5.

Elimination. Avanafil 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).

 

Who should not take Spedra?

  • Spedra (Avanafil) is indicated for the treatment of erectile dysfunction in adult men.
  • Spedra should not be taken by children and adolescents under 18 years of age.
  • Spedra is not indicated for use in women.
  • There are no data from the use of avanafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development.2

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Drinking alcohol when taking Spedra

Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol may also decrease your ability to get an erection.
Also, grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.
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. Spedra will not cause an erection unless you are sexually aroused;
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 the tablets. The combination of Spedra and alcohol will also increase your risk of side-effects such as dizziness;
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 the tablets are 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.

 

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References:

  1. Montorsi F, Adaikan G, Becher E, Giuliano F, Khoury S, Lue TF, Sharlip I, Althof SE, Andersson KE. Summary of the recommendations on sexual dysfunctions in men. J Sex Med. 2010 Nov;7(11):3572-88. PMID: 21040491. DOI: 10.1111/j.1743-6109.2010.02062.x;
  2. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002581/WC500145206.pdf;
  3. Ryan M Burke and 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;
  4. https://www.treated.com/erectile-dysfunction/spedra/advantages-of-spedra;
  5. https://patient.info/medicine/avanafil-for-erectile-dysfunction-spedra.

 

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