3 DOSAGE FORMS & STRENGTHS
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 -treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil -treated patients in any dosing group, and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1.
| Condition | Patient Age Group | Dosage Recommendations | Notes |
|---|---|---|---|
| Erectile Dysfunction | Adults (18-65) | 20 mg, 1 hour before | 用于改善勃起功能 |
| Pulmonary Hypertension | Adults | 10–20 mg, 3 times daily | 用于降低肺动脉压力 |
| Off-label Performance Enhancement | Adults | Under medical supervision | 未经批准，需医生指导 |
| Children with Pulmonary Hypertension (Rare) | 1–17 years | 10 mg as prescribed | 特殊病例，严格监控 |
The overall frequency of discontinuation in sildenafil -treated patients was 3% (20 mg three times a day).
Why is this medication prescribed?
What are the serious side effects of sildenafil?
Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil -Treated Patients than Placebo-Treated Patients)In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (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 + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)].In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg TID groups [see Clinical Studies (14)].Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. 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)].
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In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil -treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil -treated patients in any dosing group, and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil -Treated Patients than Placebo-Treated Patients) In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (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 + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)]. In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg TID groups [see Clinical Studies (14)]. 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. Limited clinical data during lactation preclude a clear lovegra sildenafil determination of the risk of sildenafil to an infant during lactation.8.4 Pediatric UseAdditional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product.
Before Using
Disease-Associated Maternal and/or Embryo/Fetal Risk Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. 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 is a white or almost white, slightly hygroscopic crystalline powder with a solubility of 10 mg/ 100ml in water and a molecular weight of 666.7.Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution.
What special dietary instructions should I follow?
What should I do if I miss a dose of sildenafil?
Warnings and Precautions
Following reconstitution with 93 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. 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] buy sildenafil uk sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white or almost white, slightly hygroscopic crystalline powder with a solubility of 10 mg/ 100ml in water and a molecular weight of 666.7.
- The shelf life of sildenafil syrup depends on formulation and storage.
- Expiry dates should always be checked before use.
- Improper storage can lead to degradation of active ingredients.
- The liquid form allows for precise dose adjustments.
- Careful titration is essential to avoid overdose risks.
Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution.
- Sildenafil syrup can cause side effects like headaches, flushing, or dizziness.
- Combining sildenafil syrup with nitrates can be dangerous.
- The syrup's consistency may vary; formulation stability is key.
- Misuse or overdose can lead to serious cardiovascular issues.
- Always consult a doctor before using sildenafil syrup.
The inhibition of PDE5 in these tissues by sildenafil may be the basis for the enhanced platelet anti-aggregatory activity of nitric oxide observed in vitro, and the mild peripheral arterial-venous dilatation in vivo.12.2 PharmacodynamicsEffects of Sildenafil on Hemodynamic MeasuresAdultsPatients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) compared to those on placebo in a study with no background vasodilators [see SUPER-1 in Clinical Studies (14)]. Changes from Baseline in Hemodynamic Parameters at Week 12 [mean (95% CI)] for the Sildenafil 20 mg Three Times a Day and Placebo GroupmPAP = mean pulmonary arterial pressure; PVR= pulmonary vascular resistance;SVR = systemic vascular resistance; RAP = right atrial pressure; CO = cardiac output;HR = heart rate. * The number of patients per treatment group varied slightly for each parameter due to missing assessments.Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.Effects of Sildenafil on Blood PressureSingle oral doses of sildenafil 100 mg administered to healthy volunteers produced decreases in supine blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8/5 mmHg).
| Ingredient | Quantity per 100ml | Function | 备注 |
|---|---|---|---|
| Sildenafil citrate | 20 mg | Active pharmaceutical ingredient | 主要成分，用于治疗勃起功能障碍 |
| Xanthan gum | 0.5 g | Thickening agent | 用于增加粘稠度 |
| Flavored syrup base | 50 ml | Flavor enhancement | 改善口感 |
| Preservatives | As required | Prevent microbial growth | 确保产品稳定性 |
| Purified water | 49.45 ml | Solvent | 溶剂基础 |
The decrease in blood pressure was most notable approximately 1–2 hours after dosing and was not different from placebo at 8 hours.
Before taking this medicine
An evaluation of visual function at doses up to 200 mg revealed no effects of sildenafil on visual acuity, intraocular sildenafil citrate 120 mg pressure, or pupillometry.12.3 PharmacokineticsAbsorption and DistributionSildenafil is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (25 to 63%).
- Contraindications include hypersensitivity to sildenafil.
- Patients with heart conditions should consult a cardiologist before use.
- Sildenafil’s safety profile is well-studied in adults.
- The syrup should not be used with children without medical advice.
- Proper disposal of unused syrup is important to avoid misuse.
Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with PAH compared to healthy volunteers.Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product.
Expert advice for Sildenafil
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 -treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil -treated patients in any dosing group, and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. The overall frequency of discontinuation in sildenafil -treated patients was 3% (20 mg three times a day). Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil -Treated Patients than Placebo-Treated Patients)In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (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 + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)].In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg TID groups [see Clinical Studies (14)].Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. 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)].
Pulmonary hypertension
In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil -treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil -treated patients in any dosing group, and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil -Treated Patients than Placebo-Treated Patients) In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (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 + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)]. In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg TID groups [see Clinical Studies (14)]. 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. Limited clinical data during lactation preclude a clear lovegra sildenafil determination of the risk of sildenafil to an infant during lactation.8.4 Pediatric UseAdditional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product.
Sildenafil side effects
Disease-Associated Maternal and/or Embryo/Fetal Risk Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. 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 is a white or almost white, slightly hygroscopic crystalline powder with a solubility of 10 mg/ 100ml in water and a molecular weight of 666.7.Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Following reconstitution with 93 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. 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] buy sildenafil uk sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white or almost white, slightly hygroscopic crystalline powder with a solubility of 10 mg/ 100ml in water and a molecular weight of 666.7. Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.Geriatric PatientsHealthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18 to 45 years). In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 200 % and 79 %, respectively, in patients with severe renal impairment compared to patients with normal renal function.Hepatic ImpairmentIn volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B), sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment. Sildenafil is not expected to affect the pharmacokinetics of compounds which are substrates of these CYP enzymes at clinically relevant concentrations.In vivo studiesThe effects of other drugs on sildenafil pharmacokinetics and the effects of sildenafil on the exposure to other drugs are shown in Figure 1 and Figure 2, respectively.Figure 1.
- Sildenafil syrup is sometimes used in pediatric cases, off-label.
- Off-label use in children requires careful dosage adjustment.
- Lack of standardization makes typical dosing guidelines difficult.
- Pharmacokinetics in syrup form are less well-studied.
- Always seek professional medical advice before use.
This concentration range covers the same increased sildenafil exposure observed in specifically-designed drug interaction studies with CYP3A inhibitors (except for potent inhibitors such as ketoconazole, itraconazole, and ritonavir).CYP3A4 Inducers Including BosentanConcomitant administration of strong CYP3A inducers is expected to cause substantial decreases in plasma levels of sildenafil.
Mechanism of action
The inhibition of PDE5 in these tissues by sildenafil may be the basis for the enhanced platelet anti-aggregatory activity of nitric oxide observed in vitro, and the mild peripheral arterial-venous dilatation in vivo.12.2 PharmacodynamicsEffects of Sildenafil on Hemodynamic MeasuresAdultsPatients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) compared to those on placebo in a study with no background vasodilators [see SUPER-1 in Clinical Studies (14)]. Changes from Baseline in Hemodynamic Parameters at Week 12 [mean (95% CI)] for the Sildenafil 20 mg Three Times a Day and Placebo GroupmPAP = mean pulmonary arterial pressure; PVR= pulmonary vascular resistance;SVR = systemic vascular resistance; RAP = right atrial pressure; CO = cardiac output;HR = heart rate. * The number of patients per treatment group varied slightly for each parameter due to missing assessments.Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.Effects of Sildenafil on Blood PressureSingle oral doses of sildenafil 100 mg administered to healthy volunteers produced decreases in supine blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8/5 mmHg). The decrease in blood pressure was most notable approximately 1–2 hours after dosing and was not different from placebo at 8 hours.
How sildenafil is used
An evaluation of visual function at doses up to 200 mg revealed no effects of sildenafil on visual acuity, intraocular sildenafil citrate 120 mg pressure, or pupillometry.12.3 PharmacokineticsAbsorption and DistributionSildenafil is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (25 to 63%). Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with PAH compared to healthy volunteers.Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.Geriatric PatientsHealthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18 to 45 years). In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 200 % and 79 %, respectively, in patients with severe renal impairment compared to patients with normal renal function.Hepatic ImpairmentIn volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B), sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment. Sildenafil is not expected to affect the pharmacokinetics of compounds which are substrates of these CYP enzymes at clinically relevant concentrations.In vivo studiesThe effects of other drugs on sildenafil pharmacokinetics and the effects of sildenafil on the exposure to other drugs are shown in Figure 1 and Figure 2, respectively.Figure 1.
5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease
This concentration range covers the same increased sildenafil exposure observed in specifically-designed drug interaction studies with CYP3A inhibitors (except for potent inhibitors such as ketoconazole, itraconazole, and ritonavir).CYP3A4 Inducers Including BosentanConcomitant administration of strong CYP3A inducers is expected to cause substantial decreases in plasma levels of sildenafil.