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Abstract

Objective

This randomized, open-label study evaluated the efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men with benign prostatic hyperplasia.

Design

The study was a 2-period, double-blind, randomised, parallel-group, randomized, placebo-controlled trial. A total of 4,719 men, aged 40-60 years with erectile dysfunction had been randomly assigned to sildenafil (n = 9) or placebo (n = 7). The study was conducted in accordance with the International Conference on Harmonisation Guidelines (ICH) and the Declaration of Helsinki. Subjects were followed up during 3 years.

Results

A total of 9 patients (4.2%) were randomized to sildenafil and placebo. All patients showed an improvement of erectile function within 3 months of randomisation. Sildenafil significantly reduced the duration of erectile dysfunction and erectile function domain of the International Index of Erectile Function (IIEF) from baseline to 1 month and then to 4 months of randomisation. There was a decrease in IIEF total score and IIEF frequency from baseline to 1 month, while sildenafil significantly improved the IIEF total score and IIEF frequency from baseline to 1 month.

Conclusions

The findings of this study indicate that sildenafil significantly improves the duration of erectile dysfunction in men with benign prostatic hyperplasia. The results of this study indicate that sildenafil is effective and safe for the treatment of erectile dysfunction in men with benign prostatic hyperplasia.

Citation:Cirac I, Díaz-Gómez P, González-González A, Rodríguez-Gómez M (2019) Sildenafil Citrate for the Treatment of Erectile Dysfunction in Men with Benign Prostatic Hyperplasia: Results of the Randomized, Open-Labeled, Placebo-Controlled, Double-Blinded, Study. PLoS ONE 11(6): e0105125. https://doi.org/10.1371/journal.pone.0105125

Editor:Dávid Lángya, National University of fire, Agadirá, Brazil

Received:March 8, 2019;Accepted:April 7, 2019;Published:May 7, 2019

Copyright:© 2019 Cirac I, González-Gómez et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding:This work was supported by the National Science Foundation (grant no. 31003-73-8), the National Key Technology Ripienti per i l’Unitària, and by the National Agency for Research on Health (grant no. 2024-01-0123). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests:The authors have declared that no competing interests exist.

Introduction

Erectile dysfunction, the inability to achieve and maintain an erection, is common in men. It is defined as the inability to achieve and maintain an erection sufficient for sexual intercourse [, ]. In general, men with prostatic hyperplasia (PH) are at greater risk for the disease []. Although the pathogenesis of these diseases is not fully understood, the pathophysiology of men with prostatic hyperplasia is thought to be related to the accumulation of androgens, as well as a decrease in the level of androgens and testosterone in the blood [, ]. The increased levels of androgens, which are responsible for the development of benign prostatic hyperplasia, are associated with a greater risk for the development of prostatic cancer [].

VIAGRA (and/or ERECTION) MEDICATIONS

VIAGRA is a prescription medicine which is indicated in men to treat the erection dysfunction. It is also prescribed as an adjunct to other therapies, in the treatment of pulmonary arterial hypertension.

BrandVIAGRA
Active IngredientSildenafil
IndicationSildenafil Citrate (Sildenafil)
SizeVIAGRA 100MG
Prescription/Prescription-CanceledNo
CommentsIn the event that you experience any of the symptoms below, the physician may direct you to consult a physician before the use of any of the medicines. The doctor may prescribe another drug of the same or a different strength.
VIAGRA is a phosphodiesterase type 5 (PDE5) inhibitor. VIAGRA is used to help relax the muscles in the penis, to help improve blood flow, and to treat erectile dysfunction in men. VIAGRA works by increasing blood flow to the penis to help a man get an erection.

Uses

The erection dysfunction medicine is used for the treatment of the pulmonary arterial hypertension. The erection dysfunction is the inability to get or maintain an erection sufficient for sexual intercourse. VIAGRA treats the pulmonary arterial hypertension and is used in the treatment of the erectile dysfunction. VIAGRA is a prescription medicine for the treatment of the erection dysfunction.

Dosage

The dose of VIAGRA is one 100 mg tablet (VIAGRA Tablets) or one 150 mg tablet (VIAGRA Tablets) each hour. The dosage of VIAGRA is one tablet (VIAGRA Tablets) per day. The dosage of VIAGRA is one tablet per day, or one 100 mg tablet (VIAGRA Tablets) and one 150 mg tablet (VIAGRA Tablets) per day, each hour.

Therapeutic Category

VIAGRA is in the following therapeutic classes:

  • Tadalafil: For the treatment of the erection dysfunction
  • Vilidos: For the treatment of the erection dysfunction
  • Alfuzosin: For the treatment of the erection dysfunction

Warnings and Precautions

VIAGRA should be used under the guidance of a physician and should not be given to children, adolescents, and women.

Do not use VIAGRA if you are using any other PDE5 inhibitors. Taking more than the recommended dosage could cause your condition to be intensified.

It is important that this medicine be used only to treat the erection dysfunction in men.

Do not share this medicine with others. They may react in you differently than you do with this medicine.

Possible Side Effects

The most common side effects are headache, back pain, muscle pain, and nausea. Seek medical attention if any of these symptoms worsen.

In the event that you have any of the following side effects, contact the doctor immediately.

  • vision disturbance
  • indigestion
  • heart palpitations
  • headache
  • rash
  • vomiting
  • persistent headaches

More information about side effects is in the.

  • Tell your doctor if you have ever had an allergic reaction to VIAGRA or any other component of this medicine.
  • Tell your doctor if you have ever had an erection that lasted more than 4 hours in any position or could lasts more than 10 minutes.

Interactions

A. Top Drug-Drug Interactions:

1.Nitrates (e.g., nitroglycerin, isosorbide dinitrate): Cialis and nitrates both lower blood pressure. Taking them together can cause a significant and potentially life-threatening drop in blood pressure (hypotension), leading to dizziness, fainting, or even heart attack or stroke. It is contraindicated to use Cialis with nitrates or recreational "poppers" (amyl nitrites).

2.Alpha-blockers (e.g., prazosin, terazosin, tamsulosin): Both Cialis and alpha-blockers relax blood vessels, which can lead to excessive blood pressure reduction when used together. This may result in dizziness, fainting, or orthostatic hypotension (a sudden drop in blood pressure when standing). If needed, your doctor may adjust the dosage or recommend spacing the medications.

3.Other antihypertensive drugs (e.g., atenolol, propranolol, enalapril, lisinopril): Cialis can enhance the blood-pressure-lowering effects of these medications. While this interaction is usually less severe than with nitrates or alpha-blockers, it can still cause dizziness or fainting in sensitive individuals. Close monitoring of blood pressure is recommended.

Other Drug-Drug interactions:

  • Ketoconazole, itraconazole (used to manage fungal infection)
  • Protease inhibitors (used to manage HIV infection) Ex. ritonavir, lopinavir
  • Phenobarbital, phenytoin, carbamazepine (medicines used for fits)
  • Rifampicin, erythromycin, clarithromycin (medicines used for bacterial infections)
  • Other medicines used to improve blood flow to the penis (Ex. sildenafil)

B. Drug-Food Interactions:

Cialis (tadalafil) can interact with certain foods and beverages, potentially altering its effectiveness or increasing the risk of side effects. Here are the key drug-food interactions to be aware of:

  1. Grapefruit and Grapefruit Juice: Grapefruit can increase the levels of tadalafil in your blood by interfering with its metabolism. This may amplify side effects, such as headaches, dizziness, or low blood pressure. Avoid consuming grapefruit or grapefruit juice while taking Cialis.
  2. Alcohol: Drinking alcohol with Cialis can enhance the blood pressure-lowering effects of the medication, leading to symptoms like dizziness, lightheadedness, or fainting. Limiting alcohol intake is recommended while using Cialis.
  3. High-Fat Meals: While Cialis can be taken with or without food, consuming it with a high-fat meal may delay its onset of action. Opt for lighter meals if rapid effectiveness is needed.
  4. Caffeine: Though not a direct interaction, combining Cialis with high caffeine intake might worsen side effects like headaches or increase heart rate in sensitive individuals.
Key drug-food interactions:< ul>
  • Cialis (tadalafil) can enhance the blood pressure-lowering effects of certain medications. Here are the key drug-food interactions:
  • Alcoholism andlargelyThis interaction can degrade the stability of prescription medicine, weaken the drug's efficacy and increase side effects.
  • Fluctuating on small increase in alcohol consumption, AlozygcationThis may degrade the efficacy and effectiveness of the drug. Limit alcohol intake is recommended while using Cialis.
  • Contam savings: Key needs to be taken in the morning.
  • Key Clinically Important (Core) interactions: Key drug-food interactions: Key drug-food interactions: Key drug-food interactions: Key drug-food interactions:
  • C.

    Sildenafil citrate: Understanding Its Uses, Benefits and Side Effects

    Sildenafil, commonly known by its brand name Viagra, is a medication that belongs to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. It functions by relaxing the muscles around the blood vessels, allowing increased blood flow, which is necessary for the treatment of conditions such as erectile dysfunction (ED).

    Sildenafil belongs to a class of drugs called phosphodiesterase type 5 inhibitors, which work by inhibiting the enzyme PDE5. This enzyme is responsible for breaking down cyclic GMP, a substance in the body responsible for relaxing blood vessels, allowing the blood vessels to widen.

    How Sildenafil Works

    Sildenafil functions by inhibiting the enzyme PDE5, which is responsible for breaking down cyclic GMP, a substance in the body responsible for relaxing blood vessels. This relaxation occurs due to increased blood flow to the penis during sexual stimulation.

    By blocking PDE5, Sildenafil helps to increase the blood flow to the penis, enabling men to get an erection. This process is crucial in managing erectile dysfunction (ED).

    Sildenafil Dosage and Administration

    Sildenafil is available in a tablet form, typically taken as a single dose or in higher doses for maximum effectiveness. It is crucial to follow the prescribed dosage and avoid exceeding it, as this can lead to adverse effects.

    Possible Side Effects

    Like any medication, Sildenafil can cause side effects. Common side effects may include headache, flushing, indigestion, nasal congestion, upset stomach, indigestion, dizziness, or mild visual disturbances such as blurred vision or seeing halos around lights.

    However, more serious side effects such as sudden vision loss, hearing loss, or prolonged erections may occur. It is important to discuss any concerns or potential risks with your doctor.

    Sildenafil Precautions

    Before taking Sildenafil, it is essential to inform your doctor about any existing medical conditions or allergies you have, as well as any current medications you are taking.

    Additionally, Sildenafil is not recommended for people with a history of heart problems, liver or kidney disorders, or those taking nitrates for chest pain.

    It is crucial to discuss any concerns or side effects with your doctor before starting Sildenafil. They can provide guidance on proper dosing and monitoring.

    Sildenafil Precautions for Long-term Use

    Sildenafil is generally not recommended for long-term use, as it may cause side effects such as flushing, indigestion, or headache. It is also important to inform your doctor of any other medications you are taking, as they may interact with.

    Long-term use of Sildenafil is not recommended for people with a history of heart disease, liver or kidney disorders, or those taking nitrates for chest pain.

    Inform your doctor about all medications you are currently taking, including prescription and over-the-counter medications and supplements, as well as herbal products and dietary supplements.

    Long-term Use of Sildenafil

    However, it is advisable to avoid prolonged use due to the risk of potential side effects.

    Long-term use of Sildenafil is not recommended for people with a history of heart problems, liver or kidney disorders, or those taking nitrates for chest pain.

    Long-term use of Sildenafil is not recommended for long-term use, as it may cause side effects such as flushing, indigestion, or headache.

    Potential Side Effects

    While Sildenafil is generally safe and well-tolerated, it may cause side effects such as headaches, indigestion, and nasal congestion. These side effects are generally mild and temporary.