Stendra™ (avanafil) tablet 50, 100 mg | US

 

Generic Stendra™

 

 

Description Of Stendra™

 

Common brands:	Stendra™
Active Ingredient:	Avanafil
Manufacturer:	Vivus Inc.
Release form:	Tablet
Dosage:	50 mg, 100 mg
Quantity:	12, 24, 36, 60, 88, 120
Age:	18 years and older

 

 

STENDRA™ (avanafil) is a cGMP-specific selective PDE5 inhibitor.

Avanafil is designated chemically as (s) -4 – [(3-chloro-4-methoxybenzyl) amino] – 2 – [2- (hydroxymethyl) – 1 – pyrrolidinyl] – n-(2 – pyrimidinylmethyl) – 5-pyrimidincarboxamide and has the structural formula below:

Avanafil is a white crystalline powder, molecular formula C 23 h 26 ClN 7 o 3 and molecular weight 483.95, it is slightly soluble in ethanol, practically insoluble in water, soluble in 0.1 mol / l hydrochloric acid. STENDRA™ for oral administration is available in pale yellow oval tablets containing 50 mg, 100 mg or 200 mg avanafil, depending on the dose. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: mannitol, fumaric acid, hydroxypropylcellulose, low carbon hydroxypropylcellulose, calcium carbonate, magnesium stearate and yellow iron oxide.

Dosage and application of STENDRA™

Avanafilindication-Erectile Dysfunction

The recommended starting dose is 100 mg. STENDRA™ should be taken orally as needed, approximately 15 minutes before sexual intercourse.

Depending on individual efficacy and tolerance, the dose may be increased to 200 mg 15 minutes before intercourse or reduced to 50 mg 30 minutes before intercourse. The lowest dose should be used to provide benefits.

The maximum recommended frequency is once a day. Sexual stimulation is required to respond to treatment.

STENDRA™ can be taken with or without food.

 

STANDRA™ DOSAGE FORMS

STENDRA™ (avanafil) is available in pale yellow oval tablets containing 50 mg, 100 mg or avanafil, depending on the dose.

 

STENDRA™ and alcohol

Patients should be aware that alcohol and PDE5 inhibitors, including STENDRA™ , act as mild vasodilators. When light vasodilators are taken in combination, the blood pressure lowering effects of each compound can be amplified. Therefore, physicians should inform patients that excessive alcohol consumption (for example, more than 3 units) in combination with STENDRA™ may increase the risk of orthostatic signs and symptoms, including increased pulse, decreased standing blood pressure, dizziness and headaches.

 

Advantages and disadvantages of Stendra™

More:

• It acts faster than other drugs of this class (it can be taken 15 minutes before sexual intercourse)
• No need to bring to work every day
• It can be taken with or without food
• Well tolerated

Except:

• It can not be used if you have recently taken nitrates such as Isordil, Imdur or nitroglycerin (Nitro-BID, Nitro-Dur, Nitrostat).
• Available only as a brand name drug, so it can be expensive
• It is not recommended for people who have suffered a heart attack or stroke in the past 6 months.

The main advantage of STENDRA™ over its prominent counterparts is the speed of impact. Despite the fact that the instructions for use recommend the lowest dose to take a tablet 30 minutes before sexual intercourse, clinical studies have shown that the full effect can be achieved already at 15 minutes, while the full effect, for example, Viagra begins no earlier than 30 minutes after taking the tablet.

 

Doctor’s tips for using STENDRA™

• Take STENDRA™ (avanafil) only when needed and no more than once a day.
• If your erection lasts more than 4 hours, immediately go to the emergency room or call your doctor, as this can damage your penis.
• STENDRA™ (avanafil) does not stop the spread of sexually transmitted diseases (STDs) such as herpes or HIV. Practice safe sex using a latex or polyurethane condom.
• Taking Stendra™ (avanafil) with alcohol may increase the risk of low blood pressure. If you plan to take STENDRA™ (avanafil), limit your alcohol intake to no more than 3 servings.

Physicians should discuss with patients the appropriate use of STENDRA™ and the expected benefits of it. It should be clarified that for the appearance of an erection after taking STENDRA™, sexual stimulation is necessary. Patients should be informed about the dose of STENDRA™. Inform patients that the recommended starting dose of STENDRA™ is 100 mg, which should be taken approximately 15 minutes before sexual intercourse begins. Depending on efficacy and tolerability, the dose may be increased to 200 mg 15 minutes before intercourse or reduced to 50 mg 30 minutes before intercourse. The lowest dose should be used to provide benefits. Patients should be encouraged to contact their attending physician to change the dosage.

Do not take STENDRA™ if you:

• taking medications called “nitrates”
• consuming street drugs called “poppers”, such as amyl nitrate and butyl nitrate
• If you are allergic to avanafil or any of the ingredients in STENDRA™. At the end of this brochure, you will find the full list of Stendra™ ingredients.

Before taking STENDRA™, tell your doctor if you:

• there are or have been heart problems such as a heart attack, irregular heartbeat, angina pectoris, or heart failure
• he had heart surgery in the last 6 months
• suffered a stroke
• have low blood pressure or high blood pressure that is not controlled
• having a deformed shape of the penis
• he had an erection that lasted more than 4 hours
• you have problems with blood cells, such as sickle cell disease, multiple myeloma, or leukemia
• retinitis pigmentosa, a rare genetic (hereditary) eye disease)
• he never had severe vision loss, including an eye problem called non-arterial anterior ischemic optic neuropathy (NAION)
• have bleeding problems
• have or have stomach ulcers
• having liver problems
• have kidney problems or kidney dialysis
• there are other medical conditions

What are the side effects of STENDRA™ ?

Any medication has risks and benefits. Even if the drug works, you may experience unwanted side effects.

Consult a doctor immediately if you experience any of the following:

• Duration of erection more than 4 hours
• Vision loss
• Hearing loss

The following side effects may disappear over time as your body gets used to the drug. Tell your doctor immediately if you continue to experience these symptoms or if they get worse over time.

Common side effects

• Headache (7%)
• Washing (4%)
• Stuffy nose (3%)
• Flu-like symptoms (3%)
• Back Pain (2%)

Other side effects

• Hypertension
• Morning sickness
• Abdominal Pain
• Constipation
• Rash

 

STENDRA™ mechanism of action

The physiological mechanism of penile erection involves the release of nitric oxide (NO) into the corpus cavernosum during sexual stimulation. It does not then activate the enzyme guanylate cyclase, which leads to an increase in cGMP levels, causing relaxation of the smooth muscles of the corpus cavernosum and allowing blood flow. stendra-eu.com Avanafil does not have a direct relaxing effect on the isolated human cavernous body, but enhances the action of NO by inhibiting PDE5, which is responsible for the degradation of cGMP in the cavernous body. Since sexual stimulation is necessary to trigger the local release of nitric oxide, inhibition of PDE5 has no effect in the absence of sexual stimulation.

In vitro studies have shown that avanafil is selective for PDE5. Its influence on PDE5 more powerful than other famous phosphodiesterase (more than 100 times for pde6; more than 1000 times for PDE4, PDE8 and PDE10; more than 5000 times for PDE2 and PDE7; more than 10,000 times for PDE1. , PDE3, PDE9 and PDE11). Avanafil is more than 100 times more effective against PDE5 than PDE6, which is found in the retina and is responsible for phototransduction. In addition to the smooth musculature of the human body, PDE5 also manifests itself in other tissues, including platelets, smooth muscles of vessels and internal organs, as well as skeletal muscles, brain, heart, liver, kidneys, lungs, pancreas, prostate, bladder, testicles and seminal vesicles.

 

Effect of STENDRA™ on erectile response

In a single-dose, placebo-controlled, blind study of 82 patients with organic and / or psychogenic erectile dysfunction, visual sexual stimulation resulted in an improvement in erection after administration of STENDRA™ compared to placebo, evaluated by an objective measure of hardness and duration. erections (RigiScan ® ). Efficacy was evaluated with RigiScan at discrete time intervals ranging from 20 to 40 minutes post-administration and 100 to 120 minutes post-administration.

Effect of STENDRA™ on blood pressure

Single oral doses of STENDRA™ (200 mg) administered to healthy male volunteers resulted in mean changes in systolic / diastolic blood pressure from baseline of -5.3 / -3.7 mm HG.1 hour after administration, compared with mean baseline changes in the placebo group. 2.7 / -0.4 mm HG the reduction in systolic / diastolic blood pressure 1 hour after taking STENDRA™ 200 mg compared to placebo was 8.0 / 3.3 mm HG.

How can I store STENDRA™ ?

Store STENDRA™ at 68-77 ° F (20-25 ° C). stendra-eu.com keep STENDRA™ away from light.