This is a new medication to treat erectile dysfunction. Its active substance is avanafil, a phosphodiesterase type 5 inhibitor (PDE5 inhibitor), which increases blood flow to the penis. Spedra is an excellent solution for treating men with erectile dysfunction. One of the main advantages of this new drug is that it is faster than most ED-related medications. The results will be displayed in just 20-30 minutes after taking the tablet.
What is it used for?
Spedra is used to treat male impotence. Male impotence can cause several problems in your relationship if not properly addressed. Spedra is perfect for this as it will help you get a firm and longer erection. Spedra causes the blood vessels in the penis to enlarge, thus increasing blood flow to the cavernous body. You'll get a healthy erection in a moment.
How is Spedra used?
You can take Spedra 30 minutes before any sexual activity. Although you can take it with or without food, this medicine is most effective when taken on an empty stomach. Keep in mind that for Spedra to take effect, sexual stimulation is always necessary.
Spedra comes in 50 mg, 100 mg and 200 mg tablets. Normally for an adult is a tablet 30 minutes before any sexual activity. Please do not take Spedra more than once a day. If you are not sure about your dose, please speak with your doctor who will give you all the information you need. Also, read the package leaflet for more information about dosing and administration.
Spedra Clinical Results: This clinical research shows that Spedra had a positive effect on more than half of men. An erection occurred in 24.7% of users of 100 mg 15 minutes after intake and in 28.1% of users of 200 mg. This erection proved to be good enough to have sex.
Avanafil: new FDA-approved medicine for erectile dysfunction
How does Spedra - Avanafil work?
The active substance in Spedra, avanafil, belongs to a group of medicines called "phosphodiesterase type 5 (PDE5) inhibitors". It works by blocking the enzyme phosphodiesterase, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). CGMP occurs in the penis during normal sexual stimulation, where it causes the relaxation of the muscles of the cavernous bodies (the spongy tissue present in the penis), which favors blood flow in the cavernous bodies and, therefore, an erection. By blocking cGMP degradation, Spedra improves its effect on erectile function. However, sexual stimulation is still needed to produce an erection.
What benefit has Spedra - Avanafil shown during the studies?
Spedra has been studied in three main studies involving 3,400 patients with erectile dysfunction. The first study included patients recruited from the general population; however, since some conditions associated with erectile dysfunction could affect the response to treatment, the second study mainly involved patients with erectile dysfunction and diabetes and subjects in the third study with erectile dysfunction secondary to prostate surgery. In these studies, which lasted 12 weeks, different doses of Spedra taken approximately 30 minutes before a placebo sexual relationship (a simulated tablet) were compared. The main parameters of effectiveness in the three studies were the percentage of erections of sufficient duration to allow a complete sexual relationship. The percentage of vaginal penetrations and score variations for the evaluation of erectile function. In all studies, Spedra was more effective than placebo. In the first study, Spedra, taken approximately 30 minutes before intercourse at a dose of 100 or 200 mg, increased the percentage of complete sex from approximately 13% prior to treatment to approximately 57%, while placebo only led to an increase by 27%. Compared to placebo, the drug also allowed approximately 60% more vaginal penetrations. The improvement in the evaluation score was approximately 5-7 higher than with placebo. An additional study was conducted with 440 adults with erectile dysfunction, in which Spedra was hired about 15 minutes before a sexual relationship.
What are the risks associated with Spedra - Avanafil?
The most common side effects of Spedra (which can affect up to 1 in 10 people) are headache, skin redness and nasal congestion; Back pain has also been reported to affect one in 100 people. For the full list of side effects reported with Spedra, see the package leaflet. Before prescribing Spedra, doctors should consider the potential risks of sexual activity in cardiac patients. The drug should not be used in people with severe heart or circulatory problems, including patients who have had a heart attack, stroke or severe arrhythmia in the last six months (heart rhythm irregularity) and subjects who have unstable angina (type of severe chest pain), angina during sex, heart failure or hyper or hypotension.
Spedra should not be taken in combination with certain other medicines, including nitrates (a type of medicine used to treat angina), or with medicines that greatly reduce the demolition of Spedra in the body. For the full list of limitations, see the package leaflet.
Why has Spedra - Avanafil been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Spedra was more effective than placebo at allowing sexual intercourse to be completed. However, the fact that the drug has not been directly compared to other medicines in its class makes it difficult to assess its potential role in the treatment of erectile dysfunction. In terms of safety, the side effects are similar to those observed with other drugs of the same class. The Committee therefore decided that Spedra's benefits are greater than its risks and recommended that it be authorised for use in the EU.
¿Qué medidas se están tomando para garantizar el uso seguro y efectivo de Spedra - Avanafil?
Se ha desarrollado un plan de gestión de riesgos para garantizar que Spedra se utilice de la manera más segura posible. Con base en este plan, se ha agregado información de seguridad al resumen de las características del producto y al prospecto de Spedra, incluidas las precauciones apropiadas que deben seguir los profesionales de la salud y los pacientes.
El medicamento se usa en hombres para eliminar la impotencia (disfunción eréctil). Es un inhibidor de la enzima fosfodiesterasa tipo 5 (PDE - 5). El medicamento provoca la relajación (relajación) de los músculos lisos y el flujo sanguíneo en el tejido del pene, lo que contribuye a una erección.
El medicamento está indicado para hombres adultos para eliminar la disfunción eréctil de diversa gravedad, que es causada por razones fisiológicas y psicológicas.
No se utiliza en niños y mujeres. Tampoco se usa para insuficiencia hepática y / o renal grave, hipersensibilidad a este producto farmacéutico.
Se prohíbe el uso simultáneo de Spedra y nitratos (en cualquier forma), así como inhibidores potentes de la enzima CYP3A4 (incluidos itraconazol, telitromicina, ketoconazol, claritromicina, atazanavir, ritonavir). Spedra no se usa simultáneamente con otros productos farmacéuticos del grupo inhibidor PDE-5.
Use with caution under the following conditions:
predisposition to priapism (prolonged erection, often painful, not associated with sexual arousal);
Anatomical deformation of the penis (e.g. with Peyronie's disease);
a stroke or myocardial infarction that has occurred in the last six months;
cardiovascular diseases in which sexual activity is contraindicated;
Uncontrolled changes in blood pressure caused by hypotension or hypertension.
It also requires caution when using this medicine simultaneously with antihypertensive medicinal products, moderate CYP3A4 inhibitors (including fluconazole, erythromycin, diltiazem, verapamil).
Pregnancy and lactation
It is not used during these periods as the drug Spedra is not intended for use in women.
Dosage and administration
Spedra tablets are taken as needed within fifteen minutes to half an hour before the alleged sexual activity. This tool is obtained independently of food.
The recommended starting dose is 100 mg. The dose of the drug can be adjusted according to the individual characteristics of a man's body. Therefore, the dose can be reduced to 50 mg or increased to 200 mg. The duration of the medicine is four to six hours.
It is recommended to take a pharmaceutical preparation once within 24 hours. The maximum single dose is 200 mg.
It should be noted that an erection after taking the medicine occurs only with sexual stimulation.
When this tool is used in doses that exceed those recommended, side effects characteristic of it may develop, but of greater severity.
In case of overdose, it is necessary to discontinue the use of Spedra and consult a doctor. In case of overdose, symptomatic treatment is usually performed.
Side effects of taking this drug include side effects such as headache, hot flashes, runny nose, back pain, nasal congestion and sore throat. It can also cause drowsiness, nausea, blurred vision, tachycardia (increased heart rate), dizziness, muscle tension, feeling palpitations, vomiting, fatigue and abdominal pain.
If any unusual reaction occurs, you should stop taking the medicine and consult your doctor.