6 ADVERSE REACTIONS

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) ]. Caution 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.

Proper Use

The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.When sildenafil tablets was taken as recommended (on an as-needed basis) in flexible-dose, placebo- controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil tablets at least once weekly, and the following adverse reactions were reported:The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets is uncertain. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.Cardiovascular and cerebrovascularSerious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil tablets.

What’s the best sildenafil dosage for beginners?

Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil tablets without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil tablets and sexual activity. It is not possible to determine whether these events are related directly to sildenafil tablets, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1) and Patient Counseling Information (17)].Hemic sildenafil premature ejaculation and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil tablets for ED is not known.Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.Respiratory: epistaxisSpecial senses:Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil tablets. 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. Sildenafil tablets 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 sildenafil tablets, 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)]. 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)].

The safety and efficacy canada sildenafil of combinations of sildenafil tablets with other PDE5 Inhibitors, including REVATIO 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.

• Sildenafil 25 mg has a rapid onset compared to higher doses.
• It is considered effective for most men with mild to moderate ED.
• Alcohol intake can reduce the effectiveness of the medication.
• The medication is generally safe when used as directed by a healthcare provider.

There have been postmarketing reports of bleeding events in patients who have taken sildenafil tablets.

• Avoid driving or operating machinery until you see how sildenafil affects you.
• Tell your doctor about all medications you are taking before starting sildenafil.
• It's important not to take more than one pill in a 24-hour period.
• Check for any contraindications with your healthcare provider beforehand.

In addition, the combination of heparin and sildenafil tablets had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration.

6.2 Postmarketing Experience

In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil tablets, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4) and Patient Counseling Information (17)].Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil tablets. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3) and Patient Counseling Information (17)].Urogenital: prolonged erection, priapism [see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria. 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.

Revatio Tablets

The use of sildenafil tablets offers no protection against sexually transmitted diseases. 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.Sildenafil tablets was administered to over 3700 patients (aged 19–87 sildenafil 12 5 mg 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 sildenafil tablets (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies.

When to See a Doctor

Other Medical Problems

At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.When sildenafil tablets was taken as recommended (on an as-needed basis) in flexible-dose, placebo- controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil tablets at least once weekly, and the following adverse reactions were reported:The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets is uncertain. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil tablets.

What should I know about storage and disposal of this medication?

In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil tablets, 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)]. 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)]. The safety and efficacy canada sildenafil of combinations of sildenafil tablets with other PDE5 Inhibitors, including REVATIO 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. There have been postmarketing reports of bleeding events in patients who have taken sildenafil tablets.

Comparing Sildenafil vs. Tadalafil Dosage

In addition, the combination of heparin and sildenafil tablets had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of sildenafil tablets offers no protection against sexually transmitted diseases. 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.Sildenafil tablets was administered to over 3700 patients (aged 19–87 sildenafil 12 5 mg 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 sildenafil tablets (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.Cardiovascular and cerebrovascularSerious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil tablets.

7.1 Nitrates

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) ]. Caution 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.

When and How to Take Sildenafil for Best Results

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. Sildenafil tablets has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications. Most, but not all, of these patients had preexisting cardiovascular risk factors.

How it works

What Are the Available Sildenafil Dosages?

Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil tablets without sexual activity.

Others were reported to have occurred hours to days after the use of sildenafil tablets and sexual activity.

It is not possible to determine whether these events are related directly to sildenafil tablets, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1) and Patient Counseling Information (17)].Hemic sildenafil premature ejaculation and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil tablets for ED is not known.Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.Respiratory: epistaxisSpecial senses:Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil tablets. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil tablets, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4) and Patient Counseling Information (17)].Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil tablets. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3) and Patient Counseling Information (17)].Urogenital: prolonged erection, priapism [see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria. 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.