Sildenafil Tablets: Package Insert / Prescribing Info

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2.1 Dosage Information
12.2 Pharmacodynamics
Proper Use

The safety and efficacy of combinations of sildenafil 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 . In addition, the combination of heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.

Men should avoid taking sildenafil on an empty stomach if prone to nausea.
The drug may cause hiccups or flushing in some users.
Inform your doctor of any past eye conditions before starting sildenafil.
Do not use sildenafil within 24 hours of consuming large amounts of alcohol.
It is essential to follow prescribed dosing to prevent complications.
Understand that sildenafil does not protect against sexually transmitted diseases.

The use of sildenafil 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 was administered to over 3700 patients (aged 19-87 years) during pre-marketing clinical trials worldwide.

Sildenafil 200 mg may cause dizziness; avoid driving until effects are known.
It is not a hormone and does not increase testosterone levels.
Some men may experience a rash or skin reactions.
Do not take sildenafil more than once in 24 hours.
Discontinue use and seek medical advice if adverse reactions occur.
Combining sildenafil with other vasodilators can be dangerous.

Over 550 patients were treated for longer than one year.In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil (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. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies† Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.When sildenafil 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 at least once weekly, and the following adverse reactions were reported:Table 2. Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Flexible-Dose Phase II/III Studies† Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision.The following events occurred in <2% of patients in controlled clinical trials; a causal sildenafil oral jelly 100 mg relationship to sildenafil is uncertain.

Sildenafil 200 mg is not recommended for women or children.
Overuse can lead to serious cardiovascular problems.
The medication should be part of a comprehensive treatment plan.
Use caution if combining sildenafil with other ED medications.
Inform your healthcare provider of all health conditions before use.
Ensure correct timing to maximize the drug's effectiveness.

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 .

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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 without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil and sexual activity. It is not possible to determine whether these events are related directly to sildenafil, 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 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 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. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.

8.2 Lactation

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, 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. 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) andPatient 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 sildenafil 50g 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. Because 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.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies † Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. When sildenafil 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 at least once weekly, and the following adverse reactions were reported: Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Flexible-Dose Phase II/III Studies Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. The following adverse reactions have been identified during post approval use of sildenafil . 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. 7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. 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. 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 without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil and sexual activity. It is not possible to determine whether these events are related directly to sildenafil, 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 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 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. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.

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Interacting Drug/Class	Effect on Sildenafil	Clinical Significance	Recommendations
Nitrates	Potentiates vasodilation	Risk of severe hypotension	Avoid concomitant use
CYP3A4 inhibitors (e.g., Ritonavir)	Increase sildenafil plasma levels	Risk of increased side effects	Reduce dose or avoid
Alpha-blockers	Additive blood pressure lowering	Hypotension	Use with caution, monitor BP
CYP3A4 inducers (e.g., Rifampin)	Decrease sildenafil effectiveness	May reduce efficacy	Adjust dose accordingly

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) andPatient Counseling Information (17)], and hematuria.

2.1 Dosage Information

Viagra form

Missed Dose

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 sildenafil 50g 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.

12.2 Pharmacodynamics

5.3 Effects on the Eye

Because 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. Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies † Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. When sildenafil 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 at least once weekly, and the following adverse reactions were reported: Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Flexible-Dose Phase II/III Studies Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. The following adverse reactions have been identified during post approval use of sildenafil . 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.

Proper Use

What are the most common side effects of sildenafil?

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 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 sildenafil (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. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies† Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.When sildenafil 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 at least once weekly, and the following adverse reactions were reported:Table 2. Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Flexible-Dose Phase II/III Studies† Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision.

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In these studies, only one patient discontinued due to abnormal vision.The following events occurred in <2% of patients in controlled clinical trials; a causal sildenafil oral jelly 100 mg relationship to sildenafil 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 . 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. Most, but not all, of these patients had preexisting cardiovascular risk factors. 7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated.