13 NONCLINICAL TOXICOLOGY

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.

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

The overall frequency of discontinuation in sildenafil citrate-treated patients was 3% (20 mg and 40 mg three times a day) and 8% (80 mg three times a day). The overall frequency of discontinuation for placebo was 3%.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 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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. 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) ].

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However, 50 mg sildenafil price due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.8.5 Geriatric UseClinical studies of sildenafil citrate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3)] .8.6 Patients with Hepatic ImpairmentNo dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology ( 12.3)] .8.7 Patients with Renal ImpairmentNo dose adjustment is required (including severe impairment CLcr <30 mL/min) [see Clinical Pharmacology ( 12.3)] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.1 Pregnancy

The safety and effectiveness of Sildenafil citrate have not been established in pediatric patients younger than 1 year of age. Clinical studies of sildenafil citrate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3)] . Severe impairment has not been studied [see Clinical Pharmacology ( 12.3)] . No dose adjustment is required (including severe impairment CLcr <30 mL/min) [see Clinical Pharmacology ( 12.3)] . 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 Warnings and Precautions ( 5.4), Patient Counseling Information ( 17) ]. 7 DRUG INTERACTIONS Concomitant use of sildenafil citrate with nitrates in any form is contraindicated [see Contraindications ( 4)] .Strong CYP3A InhibitorsConcomitant use of sildenafil citrate with strong CYP3A inhibitors is not recommended [ see Clinical 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 tablets to 20 mg three times a day when discontinuing sildenafil tables treatment with moderate-to-strong CYP3A inducers [ see Clinical Pharmacology ( 12.3) and Clinical Studies ( 14) ].

• Possible interactions include medications for HIV, antibiotics, and blood pressure.
• Overdose symptoms include severe headaches and chest pain.
• Seek immediate medical attention if adverse reactions occur.

Concomitant use of sildenafil citrate with nitrates in any form is contraindicated [see Contraindications ( 4)] . There are risks to the mother and fetus from untreated pulmonary arterial hypertension ( see Clinical Considerations). Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32-and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively (s ee Data).The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

5. Evaluation tests for ODF

Sildenafil is also marketed as VIAGRA ®for erectile dysfunction.Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo [4,3- d] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.Sildenafil Tablets USP: Sildenafil citrate is formulated as white, film-coated round tablets for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide and triacetin. Sildenafil tablets, USP, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo [4,3- d] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.

Are you currently using Sildenafil (Viagra, Revatio)?

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.Clinical ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskPregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.DataAnimal DataNo evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m 2basis, 32-and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day.

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In a rat pre-and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m 2basis).8.2 LactationRisk SummaryLimited published data from a case report describe the presence of sildenafil and its active metabolite in human milk.

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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. The overall frequency of discontinuation in sildenafil citrate-treated patients was 3% (20 mg and 40 mg three times a day) and 8% (80 mg three times a day). The overall frequency of discontinuation for placebo was 3%.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 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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) ].

Recreational use

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. 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) ]. 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 Warnings and Precautions ( 5.4), Patient Counseling Information ( 17) ]. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil citrate to an infant during lactation.8.4 Pediatric UseThe safety and effectiveness of Sildenafil citrate have not been established in pediatric patients younger than 1 year of age.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets.

However, 50 mg sildenafil price due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.8.5 Geriatric UseClinical studies of sildenafil citrate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3)] .8.6 Patients with Hepatic ImpairmentNo dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology ( 12.3)] .8.7 Patients with Renal ImpairmentNo dose adjustment is required (including severe impairment CLcr <30 mL/min) [see Clinical Pharmacology ( 12.3)] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

• Sildenafil film tablets are often used for pulmonary arterial hypertension off-label.
• They work by relaxing blood vessels to improve blood flow.
• Medical guidance is essential for off-label or long-term use.

The safety and effectiveness of Sildenafil citrate have not been established in pediatric patients younger than 1 year of age. Clinical studies of sildenafil citrate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3)] . Severe impairment has not been studied [see Clinical Pharmacology ( 12.3)] .

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7 DRUG INTERACTIONS Concomitant use of sildenafil citrate with nitrates in any form is contraindicated [see Contraindications ( 4)] .Strong CYP3A InhibitorsConcomitant use of sildenafil citrate with strong CYP3A inhibitors is not recommended [ see Clinical 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 tablets to 20 mg three times a day when discontinuing sildenafil tables 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 [see Contraindications ( 4)] . There are risks to the mother and fetus from untreated pulmonary arterial hypertension ( see Clinical Considerations).

Drugs you should not use with sildenafil

Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32-and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively (s ee Data).The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.Clinical ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskPregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.DataAnimal DataNo evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m 2basis, 32-and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. In a rat pre-and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m 2basis).8.2 LactationRisk SummaryLimited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil citrate to an infant during lactation.8.4 Pediatric UseThe safety and effectiveness of Sildenafil citrate have not been established in pediatric patients younger than 1 year of age.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. No dose adjustment is required (including severe impairment CLcr <30 mL/min) [see Clinical Pharmacology ( 12.3)] . Sildenafil is also marketed as VIAGRA ®for erectile dysfunction.Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo [4,3- d] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.Sildenafil Tablets USP: Sildenafil citrate is formulated as white, film-coated round tablets for oral administration.

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In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide and triacetin. Sildenafil tablets, USP, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo [4,3- d] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.

• Sildenafil film tablets typically start working within 30-60 minutes.
• The recommended dose varies, often 50mg before sexual activity.
• Do not take more than one tablet per 24 hours.