Oral Sildenafil in the Treatment of Erectile Dysfunction
When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post-marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).
Mechanism of action
When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post-marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”). Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate. There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended.
#2 Serotonin
Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil citrate. Inform patients taking sildenafil citrate not to take VIAGRA or other PDE-5 inhibitors. If priapism (painful erection greater 150mg sildenafil for sale than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate.
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There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended. Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil citrate. Inform patients taking sildenafil citrate not to take VIAGRA or other PDE-5 inhibitors. If priapism (painful erection greater 150mg sildenafil for sale than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.
What Is Sex Time?
In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Hypotension [see Warnings and Precautions (5.1)]Vision Loss [see Warnings and Precautions (5.4)]Hearing Loss [see Warnings and Precautions (5.5)]Priapism [see Warnings and Precautions (5.7)]Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8)]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 practice.In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil citrate-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil citrate -treated patients in any dosing group, and were more frequent in sildenafil citrate -treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature. The overall frequency of discontinuation in sildenafil citrate -treated patients was 3% (20 mg and 40 mg three times a day).
5.2 Worsening Pulmonary Vascular Occlusive Disease
It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors.Nervous SystemSeizure, seizure recurrenceOphthalmologicNAION [see Warnings and Precautions (5.4), Patient Counseling Information (17)] . The following serious adverse events are discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1)] Vision Loss [see Warnings and Precautions (5.4)] Hearing Loss [see Warnings and Precautions (5.5)] Priapism [see Warnings and Precautions (5.7)] Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8)] 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 practice. In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil citrate-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil citrate -treated patients in any dosing group, and were more frequent in sildenafil citrate -treated patients than in placebo-treated patients are shown in Table 1. The overall frequency of discontinuation for placebo was 3%. Table 1: Most Common Adverse Reactions in Patients Treated with Sildenafil Citrate 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil Citrate -Treated Patients than Placebo-Treated Patients) In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil citrate (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil citrate + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)] .
Revatio Injection
The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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. In post-marketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors. NAION [see sildenafil citrate chewable tablets Warnings and Precautions (5.4), Patient Counseling Information (17)] . The overall frequency of discontinuation for placebo was 3%.Table 1: Most Common Adverse Reactions in Patients Treated with Sildenafil Citrate 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil Citrate -Treated Patients than Placebo-Treated Patients)In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil citrate (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil citrate + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.6.2 Post-marketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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.Cardiovascular EventsIn post-marketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and sildenafil oral jelly 100mg lovegra intracerebral hemorrhages have been reported in temporal association with the use of the drug. Most, but not all, of these patients had preexisting cardiovascular risk factors.
| Condition | Details | Importance |
|---|---|---|
| Temperature | Store below 30°C (86°F) | Maintain stability |
| Light | Keep in a dark, dry place | Prevent degradation |
| Humidity | Avoid moisture, keep dry | Prevent product deterioration |
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 use concurrent with sexual activity.
8.2 Lactation
In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Hypotension [see Warnings and Precautions (5.1)]Vision Loss [see Warnings and Precautions (5.4)]Hearing Loss [see Warnings and Precautions (5.5)]Priapism [see Warnings and Precautions (5.7)]Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8)]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 practice.In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil citrate-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil citrate -treated patients in any dosing group, and were more frequent in sildenafil citrate -treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature. The overall frequency of discontinuation in sildenafil citrate -treated patients was 3% (20 mg and 40 mg three times a day). The overall frequency of discontinuation for placebo was 3%.Table 1: Most Common Adverse Reactions in Patients Treated with Sildenafil Citrate 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil Citrate -Treated Patients than Placebo-Treated Patients)In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil citrate (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil citrate + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets.
Azole Antifungals
However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.6.2 Post-marketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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.Cardiovascular EventsIn post-marketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and sildenafil oral jelly 100mg lovegra intracerebral hemorrhages have been reported in temporal association with the use of the drug. 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 use concurrent with 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, or to a combination of these or other factors.Nervous SystemSeizure, seizure recurrenceOphthalmologicNAION [see Warnings and Precautions (5.4), Patient Counseling Information (17)] .
- Sildenafil tablets may interact with medications like alpha-blockers and certain antibiotics.
- Overdose symptoms include severe hypotension, headache, and visual disturbances.
- Always keep sildenafil tablets out of reach of children and pets.
The following serious adverse events are discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1)] Vision Loss [see Warnings and Precautions (5.4)] Hearing Loss [see Warnings and Precautions (5.5)] Priapism [see Warnings and Precautions (5.7)] Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8)] 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 practice. In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil citrate-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil citrate -treated patients in any dosing group, and were more frequent in sildenafil citrate -treated patients than in placebo-treated patients are shown in Table 1.
- Sildenafil tablets typically start working within 30 to 60 minutes after ingestion.
- The effects of sildenafil tablets can last up to 4-6 hours.
- Taking sildenafil with high-fat meals may delay its effectiveness.
The overall frequency of discontinuation for placebo was 3%. Table 1: Most Common Adverse Reactions in Patients Treated with Sildenafil Citrate 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil Citrate -Treated Patients than Placebo-Treated Patients) In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil citrate (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil citrate + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)] . The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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. In post-marketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors. NAION [see sildenafil citrate chewable tablets Warnings and Precautions (5.4), Patient Counseling Information (17)] .
- Sildenafil tablets are mainly used in adult men with erectile dysfunction.
- Regular use of sildenafil tablets requires medical supervision for safety.
- Do not use sildenafil tablets if you are allergic to any of the ingredients.
7 DRUG INTERACTIONS NitratesConcomitant use of sildenafil citrate with nitrates in any form is contraindicated [seeContraindications (4)].Strong CYP3A InhibitorsConcomitant use of sildenafil citrate with strong CYP3A inhibitors is not recommended [seeClinical Pharmacology (12.3)].Moderate-to-Strong CYP3A InducersConcomitant use of sildenafil citrate with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
7 DRUG INTERACTIONS NitratesConcomitant use of sildenafil citrate with nitrates in any form is contraindicated [seeContraindications (4)].Strong CYP3A InhibitorsConcomitant use of sildenafil citrate with strong CYP3A inhibitors is not recommended [seeClinical Pharmacology (12.3)].Moderate-to-Strong CYP3A InducersConcomitant use of sildenafil citrate with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. Dose up-titration of sildenafil citrate may be needed when initiating treatment with moderate-to-strong CYP3A inducers. Reduce the dose of sildenafil to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see Clinical Pharmacology (12.3) and Clinical Studies (14)] . Concomitant use of sildenafil citrate with nitrates in any form is contraindicated [seeContraindications (4)]. Concomitant use of sildenafil citrate with strong CYP3A inhibitors is not recommended [seeClinical Pharmacology (12.3)].
Sildenafil Oral Film for ED
Concomitant use of sildenafil citrate with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryLimited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. Dose up-titration of sildenafil citrate may be needed when initiating treatment with moderate-to-strong CYP3A inducers.
6.2 Postmarketing Experience
#7 Vardenafil(Levitra)
Reduce the dose of sildenafil to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see Clinical Pharmacology (12.3) and Clinical Studies (14)] . Concomitant use of sildenafil citrate with nitrates in any form is contraindicated [seeContraindications (4)]. Concomitant use of sildenafil citrate with strong CYP3A inhibitors is not recommended [seeClinical Pharmacology (12.3)]. Concomitant use of sildenafil citrate with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryLimited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy.
- Sildenafil is a PDE5 inhibitor specifically designed to treat erectile dysfunction.
- Use sildenafil tablets only as prescribed; do not share your medication.
- Contact your doctor if you notice an allergic reaction, such as swelling or rash.
