5 WARNINGS AND PRECAUTIONS
Patients who had failed to respond to bosentan were also excluded. Patients with left ventricular ejection fraction less than 45% or left ventricular shortening fraction less than 0.2 also were not studied.Patients were randomized to receive placebo (n = 70) or sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. They had either primary pulmonary hypertension (PPH) (63%), PAH associated with CTD (30%), or PAH following surgical repair of left-to-right congenital heart lesions (7%). The study population consisted of 25% men and 75% women with a mean age of 49 years (range: 18 to 81 years) and baseline 6-minute walk distance between 100 and 450 meters (mean 343).The primary efficacy endpoint was the change from baseline at Week 12 (at least 4 hours after the last dose) in the 6-minute walk distance. Placebo-corrected mean increases in walk distance of 45 to 50 meters were observed with all doses of sildenafil. These increases were significantly different from placebo, but the sildenafil dose groups were not different from each other (see Figure 3), indicating no additional clinical benefit from doses higher than 20 mg three times a day. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at Week 8 and Week 12.Figure 3. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in SUPER-1: Mean (95% Confidence Interval)Figure 4 displays subgroup efficacy analyses in SUPER-1 for the change from baseline in 6-Minute Walk Distance at Week 12 including baseline walk distance, disease etiology, functional class, gender, age, and hemodynamic parameters.Figure 4.
12.1 Mechanism of Action
Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than sildenafil-treated patients and that sildenafil-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074). Kaplan-Meier plot of time to clinical worsening is presented in Figure 5.Figure 5. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil compared to placebo. More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH.Study A1481243 (NCT00323297) - Sildenafil Added to Bosentan Therapy – Lack of Effect on Exercise CapacityA randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months. The PAH patients included those with primary PAH and PAH associated with CTD.
Sildenafil side effects
Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5 to 125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6-minute walk distance (6MWD). The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 sildenafil citrate 200mg price mg plus bosentan and bosentan alone.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil). SUPER-1 (NCT00644605) - Sildenafil monotherapy [20 mg, 40 mg, and 80 mg three times a day] Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-dose glass vial.Single-Dose Vials in a Carton of 1 NDC 55150-166-13Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Discard Unused Portion.The vial stopper is not made with natural rubber latex.Sterile, Nonpyrogenic Sildenafil injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-dose glass vial. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).Inform patients of contraindication of sildenafil with regular and/or intermittent use of organic nitrates.Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction.
Viagra Tablets
Advise patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. Such an event may be a sign of NAION.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil. These events may be accompanied by tinnitus and dizziness.This product's label may have been updated. For current full prescribing information, please visit eugiaus.comAll brands listed are the trademarks of their respective owners and are not trademarks of Eugia Pharma Specialities Limited.Distributed by:Eugia US LLC279 Princeton-Hightstown Rd.E. Windsor, NJ 08520Manufactured by:Eugia Pharma Specialities LimitedHyderabad - 500032India Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by Study Subpopulation in SUPER-1: Mean (95% Confidence Interval)Key: PAH = pulmonary arterial hypertension; CTD = connective tissue disease; PH = pulmonary hypertension; PAP = pulmonary arterial pressure; PVRI = pulmonary vascular resistance index; TID = three times daily.SUPER-2 (NCT00159887) Long-term Treatment of PAHIn a long-term follow-up of patients who were treated with sildenafil (n=277), K-M estimates of survival at 1, 2, and 3 years were 94%, 88% , and 79%, respectively. These uncontrolled observations do not allow comparison with a group not given sildenafil and cannot be used to determine the long term-effect of sildenafil on mortality.PACES-1 (NCT00159861) - sildenafil Co-administered with EpoprostenolA randomized, double-blind, placebo-controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients had to have a mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg and a pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg at rest via right heart catheterization within 21 days before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 349 meters).
- Sildenafil 12.5 mg is a lower dose used for mild erectile dysfunction.
- It helps relax blood vessels to increase blood flow.
- Often prescribed when starting treatment or for lighter symptoms.
Patients were randomized to placebo or sildenafil (in a fixed titration starting from 20 mg to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy.At baseline patients had PPH (80%) or PAH secondary to CTD (20%); WHO Functional Class I (1%), II (26%), III (67%), or IV (6%); and the mean age was 48 years, 80% were female, and 79% were Caucasian.There was a statistically significant greater increase from baseline in 6-minute walk distance at Week 16 (primary endpoint) for the sildenafil group compared with the placebo group.
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The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil group compared with 4 meters for the placebo group giving an adjusted treatment difference of 26 meters (95% CI: 10.8, 41.2) (p = 0.0009).Patients on sildenafil achieved a statistically significant reduction in mPAP compared to those on placebo. A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favor of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003).Time to clinical worsening of PAH was defined as the time from randomization to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy). Table 4 displays the number of patients with clinical worsening events 50 mg sildenafil price in PACES-1. Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than sildenafil-treated patients and that sildenafil-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074).
Reviews for Sildenafil
Kaplan-Meier plot of time to clinical worsening is presented in Figure 5.Figure 5. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil compared to placebo. More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH.Study A1481243 (NCT00323297) - Sildenafil Added to Bosentan Therapy – Lack of Effect on Exercise CapacityA randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months. The PAH patients included those with primary PAH and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5 to 125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6-minute walk distance (6MWD). The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 sildenafil citrate 200mg price mg plus bosentan and bosentan alone.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil).
6.1 Clinical Trials Experience
SUPER-1 (NCT00644605) - Sildenafil monotherapy [20 mg, 40 mg, and 80 mg three times a day] Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-dose glass vial.Single-Dose Vials in a Carton of 1 NDC 55150-166-13Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Discard Unused Portion.The vial stopper is not made with natural rubber latex.Sterile, Nonpyrogenic Sildenafil injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-dose glass vial.
| Country | Legal Status | Can be OTC? | Prescription Required? |
|---|---|---|---|
| United States | Prescription only | No | Yes |
| European Union | Prescription required | No | Yes |
| India | Available OTC in some locations | Yes | No |
| Australia | Prescription required | No | Yes |
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).Inform patients of contraindication of sildenafil with regular and/or intermittent use of organic nitrates.Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. Such an event may be a sign of NAION.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil.
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Patients who had failed to respond to bosentan were also excluded. Patients with left ventricular ejection fraction less than 45% or left ventricular shortening fraction less than 0.2 also were not studied.Patients were randomized to receive placebo (n = 70) or sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. They had either primary pulmonary hypertension (PPH) (63%), PAH associated with CTD (30%), or PAH following surgical repair of left-to-right congenital heart lesions (7%). The study population consisted of 25% men and 75% women with a mean age of 49 years (range: 18 to 81 years) and baseline 6-minute walk distance between 100 and 450 meters (mean 343).The primary efficacy endpoint was the change from baseline at Week 12 (at least 4 hours after the last dose) in the 6-minute walk distance. Placebo-corrected mean increases in walk distance of 45 to 50 meters were observed with all doses of sildenafil.
Can I take sildenafil every day?
These increases were significantly different from placebo, but the sildenafil dose groups were not different from each other (see Figure 3), indicating no additional clinical benefit from doses higher than 20 mg three times a day. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at Week 8 and Week 12.Figure 3. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in SUPER-1: Mean (95% Confidence Interval)Figure 4 displays subgroup efficacy analyses in SUPER-1 for the change from baseline in 6-Minute Walk Distance at Week 12 including baseline walk distance, disease etiology, functional class, gender, age, and hemodynamic parameters.Figure 4. Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by Study Subpopulation in SUPER-1: Mean (95% Confidence Interval)Key: PAH = pulmonary arterial hypertension; CTD = connective tissue disease; PH = pulmonary hypertension; PAP = pulmonary arterial pressure; PVRI = pulmonary vascular resistance index; TID = three times daily.SUPER-2 (NCT00159887) Long-term Treatment of PAHIn a long-term follow-up of patients who were treated with sildenafil (n=277), K-M estimates of survival at 1, 2, and 3 years were 94%, 88% , and 79%, respectively. These uncontrolled observations do not allow comparison with a group not given sildenafil and cannot be used to determine the long term-effect of sildenafil on mortality.PACES-1 (NCT00159861) - sildenafil Co-administered with EpoprostenolA randomized, double-blind, placebo-controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol.
Altitude Sickness (Off-Label Use)
Patients had to have a mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg and a pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg at rest via right heart catheterization within 21 days before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 349 meters). Patients were randomized to placebo or sildenafil (in a fixed titration starting from 20 mg to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy.At baseline patients had PPH (80%) or PAH secondary to CTD (20%); WHO Functional Class I (1%), II (26%), III (67%), or IV (6%); and the mean age was 48 years, 80% were female, and 79% were Caucasian.There was a statistically significant greater increase from baseline in 6-minute walk distance at Week 16 (primary endpoint) for the sildenafil group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil group compared with 4 meters for the placebo group giving an adjusted treatment difference of 26 meters (95% CI: 10.8, 41.2) (p = 0.0009).Patients on sildenafil achieved a statistically significant reduction in mPAP compared to those on placebo. A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favor of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003).Time to clinical worsening of PAH was defined as the time from randomization to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy). Table 4 displays the number of patients with clinical worsening events 50 mg sildenafil price in PACES-1. These events may be accompanied by tinnitus and dizziness.This product's label may have been updated.
- Common side effects include headaches, flushing, and nasal congestion.
- Rarely can cause vision changes, such as blurred vision or color tinge.
- Serious side effects require immediate medical attention.
For current full prescribing information, please visit eugiaus.comAll brands listed are the trademarks of their respective owners and are not trademarks of Eugia Pharma Specialities Limited.Distributed by:Eugia US LLC279 Princeton-Hightstown Rd.E. Windsor, NJ 08520Manufactured by:Eugia Pharma Specialities LimitedHyderabad - 500032India Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
- Sildenafil 12.5 mg may be prescribed for pulmonary hypertension as well.
- Dose adjustments may be necessary based on age or medical history.
- Regular medical checkups help monitor treatment effects.
Inform patients of contraindication of sildenafil with regular and/or intermittent use of organic nitrates. Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.
| Age Group | Percentage of Users | Common Health Conditions | Notes |
|---|---|---|---|
| 30-40 | 20% | Erectile Dysfunction | Young adults, occasional use |
| 41-50 | 35% | Erectile Dysfunction | Most common age group |
| 51-60 | 25% | Cardiovascular issues | Monitoring recommended |
| 60+ | 20% | Multiple health issues | Dose adjustments may be needed |
Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. Such an event may be a sign of NAION. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil.
How should I take sildenafil?
Inform patients of contraindication of sildenafil with regular and/or intermittent use of organic nitrates. Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors. Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. Such an event may be a sign of NAION.
Interactions that increase your risk for side effects
Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil. These events may be accompanied by tinnitus and dizziness. This product's label may have been updated. For current full prescribing information, please visit eugiaus.com All brands listed are the trademarks of their respective owners and are not sildenafil 100mg blue pill trademarks of Eugia Pharma Specialities Limited. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg per 12.5 mL - Container Label PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg per 12.5 mL - Container-Carton (1 Vial) Published online by Cambridge University Press: 19 October 2021 A summary is not available for this content so a preview has been provided.
Drug Interactions
Please use the Get access link above for information on how to access this content. 729 - 732Publisher: Cambridge University PressPrint publication year: 2020 PDE5 inhibitors – pharmacology and clinical applications 20 years after sildenafil discovery. Br J Pharmacol 2018;175(13):2554–65.CrossRefGoogle ScholarPubMed Expert Opin Pharmacother 2003;4(3):397–405.CrossRefGoogle ScholarPubMed Accessibility compliance for the HTML of this chapter is currently unknown and may be updated in the future. To save this book to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. These events may be accompanied by tinnitus and dizziness.
| Aspect | Details | Notes |
|---|---|---|
| Temperature | 20°C to 25°C | Keep away from heat and moisture |
| Light | Keep in a dark place | Protect from direct sunlight |
| Humidity | Avoid high humidity | Store in a dry place |
| Container Type | Original container with tight seal | Prevent moisture ingress |
This product's label may have been updated. For current full prescribing information, please visit eugiaus.com All brands listed are the trademarks of their respective owners and are not sildenafil 100mg blue pill trademarks of Eugia Pharma Specialities Limited. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg per 12.5 mL - Container Label PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg per 12.5 mL - Container-Carton (1 Vial) Published online by Cambridge University Press: 19 October 2021 A summary is not available for this content so a preview has been provided.
- Sildenafil 12.5 mg should be taken 30-60 minutes before sexual activity.
- It is usually effective for up to 4-6 hours.
- Does not cause an automatic erection; stimulation is needed.
Please use the Get access link above for information on how to access this content. 729 - 732Publisher: Cambridge University PressPrint publication year: 2020 PDE5 inhibitors – pharmacology and clinical applications 20 years after sildenafil discovery. Br J Pharmacol 2018;175(13):2554–65.CrossRefGoogle ScholarPubMed Expert Opin Pharmacother 2003;4(3):397–405.CrossRefGoogle ScholarPubMed Accessibility compliance for the HTML of this chapter is currently unknown and may be updated in the future. To save this book to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account.
Before Using
Revatio Tablets
Erectile Dysfunction
Then enter the ‘name’ part of your Kindle email address below.