SC 20 Pill: white, round, 7mm

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.

• Sildenafil tablets are specifically formulated to mitigate potential side effects.
• The tablet's white color is typical for certain dosages or brands.
• Patients with cardiovascular issues should consult a doctor before use.
• Sildenafil is sometimes used to treat certain cases of erectile dysfunction caused by depression medication.
• The effects of sildenafil can be enhanced by reducing alcohol intake.
• Contraceptive methods do not impact sildenafil's effectiveness.
• Sildenafil does not cause spontaneous erections without sexual stimulation.
• It is important to remain seated or relaxed after taking sildenafil.
• The pill’s manufacturing process includes strict quality control protocols.
• Beware of unregulated markets selling unverified sildenafil tablets.
• Follow dosing instructions carefully to prevent overdose or underdose.

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 NitratesConcomitant 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 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 [see Contraindications (4)]. Concomitant use of sildenafil citrate with strong CYP3A inhibitors is not recommended [see Clinical 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. 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 (see Data).The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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/m2 basis, 32- and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day.

• Sildenafil is classified as a prescription medication in most countries.
• Proper diagnosis of ED by a doctor is essential before using sildenafil.
• Sildenafil’s primary function is to facilitate normal erectile response.
• The drug's onset of action can vary among individuals.
• White sildenafil tablets are sometimes found in counterfeit markets.
• It’s advisable to start with the lowest effective dose.
• Some patients report a “refractory” period after taking sildenafil.
• Sildenafil should not be used with certain recreational drugs like poppers.
• The medication’s safety profile is well-understood when used correctly.
• Inform your healthcare provider if you experience prolonged erections.
• Keep an updated record of all medications while using sildenafil.

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/m2 basis).8.2 LactationRisk SummaryLimited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. There is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. 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 has 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, 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. Other reported clinical experience has not identified differences in responses between the elderly and 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)]. Limited 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 sildenafil 20 mg prescription is used during pregnancy. 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 (see Data).

• Some sildenafil tablets are coated to improve taste and ease swallowing.
• Sildenafil should not be used if allergic to citrate compounds.
• Cost savings on generic sildenafil make it accessible to more users.
• The medication requires no special diet, but avoid fatty foods close to ingestion.
• Sildenafil may cause a modest drop in blood pressure temporarily.
• Do not share prescribed sildenafil with others; it is tailored to individual health.
• Inform your doctor of all medications and health conditions before use.
• Sildenafil may have different effects based on age and health status.
• The medication has been available in various formulations for convenience.
• The effectiveness may vary, and some users might need dose adjustments.
• Always keep sildenafil tablets out of reach of children and pets.

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. Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.

How it works

No 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/m2 basis, 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/m2 basis). Limited 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. The safety and effectiveness of sildenafil citrate has 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.

12.3 Pharmacokinetics

Limited 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. The safety and effectiveness of sildenafil citrate has 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)].

Allergy warning

No dose adjustment for mild to moderate impairment is required. 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)]. 10 OVERDOSAGE In studies with healthy volunteers of single sildenafil citrates doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased.In cases of overdose, standard supportive measures should be adopted as required. In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased.

Sildenafil side effects

In cases of overdose, standard supportive measures should be adopted as required. Sildenafil is also marketed as VIAGRA® for erectile dysfunction.Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-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 are formulated as white to off-white, round shaped film-coated tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-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. 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)]. No dose adjustment for mild to moderate impairment is required.

5.6 Combination with other PDE-5 Inhibitors

Sildenafil tablets, USP are formulated as white to off-white, round shaped film-coated tablets for oral administration. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.Studies in vitro have shown that sildenafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (10-fold for PDE6, greater than 80-fold for PDE1, greater than 700-fold for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10, and PDE11). The approximately 4,000-fold selectivity for PDE-5 versus PDE3 is important because PDE3 is involved in control of cardiac contractility.

How does sildenafil work (mechanism of action)?

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)]. 10 OVERDOSAGE In studies with healthy volunteers of single sildenafil citrates doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased.In cases of overdose, standard supportive measures should be adopted as required. In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased. In cases of overdose, standard supportive measures should be adopted as required. Sildenafil is also marketed as VIAGRA® for erectile dysfunction.Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-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 are formulated as white to off-white, round shaped film-coated tablets for oral administration.

8.6 Renal Impairment

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/m2 basis).8.2 LactationRisk SummaryLimited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. There is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. 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 has 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, 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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Overall Rating

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)]. Limited 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 sildenafil 20 mg prescription is used during pregnancy. 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 (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Is there an equivalent medication to Viagra for women?

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. Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. No 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/m2 basis, 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/m2 basis). Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-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 are formulated as white to off-white, round shaped film-coated tablets for oral administration. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.Studies in vitro have shown that sildenafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (10-fold for PDE6, greater than 80-fold for PDE1, greater than 700-fold for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10, and PDE11). The approximately 4,000-fold selectivity for PDE-5 versus PDE3 is important because PDE3 is involved in control of cardiac contractility.

Sildenafil (Revatio) contraindications

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 Warnings and Precautions (5.4), Patient Counseling Information (17)]. 7 DRUG INTERACTIONS NitratesConcomitant 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.

Pulmonary hypertension

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 [see Contraindications (4)]. Concomitant use of sildenafil citrate with strong CYP3A inhibitors is not recommended [see Clinical 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.

Alcohol interaction warning

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 (see Data).The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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/m2 basis, 32- and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day.