About erectile dysfunction

4 CONTRAINDICATIONS 4.1 NitratesConsistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1, 12.2)], VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsVIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet.

Other targets: Therapeutic roles

5 WARNINGS AND PRECAUTIONS 5.1 CardiovascularThere is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease.

• Viagra is a popular medication used to treat erectile dysfunction.
• It contains sildenafil citrate, which increases blood flow to the penis.
• Viagra tablets are typically taken 30-60 minutes before sex.
• The effects of Viagra can last for about 4-6 hours.
• Common side effects include headaches, flushing, and dizziness.
• Viagra should be used under medical supervision.

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [see Clinical Pharmacology (12.2)].

While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.There are no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution.Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg);Patients with cardiac failure or coronary artery disease causing unstable angina.5.2 Prolonged Erection and PriapismProlonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.VIAGRA should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of VIAGRA in patients with sickle cell or related anemias.5.3 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

An observational study evaluated whether recent use of PDE5 inhibitors, as a class, was associated with acute onset of NAION.

Other uses for this medicine

To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction TherapiesThe safety and efficacy of combinations of VIAGRA with other PDE5 Inhibitors, including REVATIO viagra tablet for sex or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.5.8 Effects on BleedingThere have been postmarketing reports of bleeding events in patients who have taken VIAGRA. In addition, the combination of heparin and VIAGRA had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.The safety of VIAGRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.5.9 Counseling Patients About Sexually Transmitted DiseasesThe use of VIAGRA offers no protection against sexually transmitted diseases. From this information, it is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)]. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).

Incidence not known

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [see Warnings and Precautions (5.1)]Prolonged Erection and Priapism [see Warnings and Precautions (5.2)]Effects on the Eye [see Warnings and Precautions (5.3)]Hearing Loss [see Warnings and Precautions (5.4)]Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)]Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)]Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)]Effects on Bleeding [see Warnings and Precautions (5.8)]Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)]The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.VIAGRA was administered to over 3700 patients (aged 19–87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year.In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for VIAGRA (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose.

Does sildenafil interact with other medicines (drug interactions)?

The results suggest an approximate 2 fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use.

• Viagra’s patent expired in many countries, leading to generics.
• Overdose symptoms include severe hypotension and visual changes.
• Do not double dose if the first dose does not work.
• Physical activity and mental arousal contribute to its effectiveness.
• Sexual health education can improve medication outcomes.
• Trust only licensed healthcare providers for prescription and advice.

From this information, it is not possible to determine whether viagra vardenafil 20mg these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including VIAGRA, for this uncommon condition.There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).5.4 Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.1, 6.2)].5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensivesAlpha-blockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers.

2.4 Dosage Adjustments Due to Drug Interactions

Key takeaway

Top What Is the Female Version of Viagra Called Related Articles

In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions (7.2) and Clinical Pharmacology (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).Consideration should be given to the following:Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.

Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [see Dosage and Administration (2.3)].In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.Anti-hypertensivesVIAGRA has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and VIAGRA, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [see Drug Interactions (7.3) and Clinical Pharmacology (12.2)].5.6 Adverse Reactions with the Concomitant Use of RitonavirThe concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction TherapiesThe safety and efficacy of combinations of VIAGRA with other PDE5 Inhibitors, including REVATIO viagra tablet for sex or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.5.8 Effects on BleedingThere have been postmarketing reports of bleeding events in patients who have taken VIAGRA. In addition, the combination of heparin and VIAGRA had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.The safety of VIAGRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.5.9 Counseling Patients About Sexually Transmitted DiseasesThe use of VIAGRA offers no protection against sexually transmitted diseases.

5.3 Effects on the Eye

4 CONTRAINDICATIONS 4.1 NitratesConsistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1, 12.2)], VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsVIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. 5 WARNINGS AND PRECAUTIONS 5.1 CardiovascularThere is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.There are no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution.Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg);Patients with cardiac failure or coronary artery disease causing unstable angina.5.2 Prolonged Erection and PriapismProlonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA.

Is there a “female Viagra”?

If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.VIAGRA should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of VIAGRA in patients with sickle cell or related anemias.5.3 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes. An observational study evaluated whether recent use of PDE5 inhibitors, as a class, was associated with acute onset of NAION. The results suggest an approximate 2 fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use. From this information, it is not possible to determine whether viagra vardenafil 20mg these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.

Other Interactions

Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including VIAGRA, for this uncommon condition.There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).5.4 Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.1, 6.2)].5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensivesAlpha-blockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions (7.2) and Clinical Pharmacology (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).Consideration should be given to the following:Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [see Dosage and Administration (2.3)].In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.Anti-hypertensivesVIAGRA has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and VIAGRA, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [see Drug Interactions (7.3) and Clinical Pharmacology (12.2)].5.6 Adverse Reactions with the Concomitant Use of RitonavirThe concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). From this information, it is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)].

How does Viagra work for ED?

There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases). 6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [see Warnings and Precautions (5.1)]Prolonged Erection and Priapism [see Warnings and Precautions (5.2)]Effects on the Eye [see Warnings and Precautions (5.3)]Hearing Loss [see Warnings and Precautions (5.4)]Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)]Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)]Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)]Effects on Bleeding [see Warnings and Precautions (5.8)]Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)]The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.VIAGRA was administered to over 3700 patients (aged 19–87 years) during pre-marketing clinical trials worldwide.

Is Viagra approved for women?

Viagra and other medications

Drug details

Over 550 patients were treated for longer than one year.In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for VIAGRA (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose.