Table 4 displays the number of patients with clinical worsening events 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 citrate-treated patients and that sildenafil citrate-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074).
Study A1481243 (NCT00323297) - Sildenafil Citrate Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A 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 results indicate that there is no significant difference in sildenafil citrate tablets for female mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 20 mg are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil.They are available as follows:Bottles of 90: NDC 65162-351-09Bottles of 1000: NDC 65162-351-11Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Sildenafil Tablets USP, 20 mg are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil. Bottles of 90: NDC 65162-351-09 Bottles of 1000: NDC 65162-351-11 Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).Inform patients of contraindication of sildenafil citrate with regular and/or intermittent use of organic nitrates.Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients sildenafil uk price taking sildenafil citrate 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 citrate. 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 citrate. These events may be accompanied by tinnitus and dizziness.All trademarks listed are the property of their respective owner.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd.Ahmedabad 382220, INDIADistributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev.
Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of contraindication of sildenafil citrate 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 citrate 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 citrate. Kaplan-Meier plot of time to clinical worsening is presented in Figure 5.Table 4: Clinical Worsening Events in PACES-1Figure 5.
| Form | Available Strengths | Description | Notes |
|---|---|---|---|
| Tablets | 25 mg, 50 mg, 100 mg | Standard oral tablets | Most common dosage |
| Sublingual Tabs | 25 mg | Dissolve under tongue | Rapid absorption |
| Liquid Suspension | 10 mg/5 mL | For easy dosing, especially in children | Requires precise measurement |
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 citrate compared to placebo. More than twice as many sildenafil citrate-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 Citrate 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 mg to 125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6-minute walk distance (6MWD).
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The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone.Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. SUPER-1 (NCT00644605) - Sildenafil citrate monotherapy [20 mg, 40 mg, and 80 mg three times a day] A randomized, double-blind, placebo-controlled study of sildenafil citrate (SUPER-1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥ 25 mmHg at rest with a pulmonary capillary wedge pressure < 15 mmHg). 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 citrate 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. The study population consisted of 25% men and 75% women with a mean sildenafil otc 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.
The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at Week 8 and Week 12. 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.
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 PAH In 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 Citrate Co-administered with Epoprostenol A randomized, double-blind, placebo-controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients were randomized to placebo or sildenafil citrate (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 citrate group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil citrate 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 citrate 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 citrate (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).
Kaplan-Meier plot of time to clinical worsening is presented in Figure 5. Table 4: Clinical Worsening Events in PACES-1 Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1 Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil citrate compared to placebo.
| Side Effect | Incidence Rate | Severity | Commonality | Notes |
|---|---|---|---|---|
| Headache | High | Mild to moderate | Common | Usually resolves quickly |
| Flushing | Moderate | Mild | Common | Reddening of face and neck |
| Dizziness | Moderate | Mild to moderate | Common | Especially when standing up quickly |
| Vision Changes | Low | Mild to moderate | Less common | Blurred vision or light sensitivity |
More than twice as many sildenafil citrate-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 Citrate Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A 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 results indicate that there is no significant difference in sildenafil citrate tablets for female mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 20 mg are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil.They are available as follows:Bottles of 90: NDC 65162-351-09Bottles of 1000: NDC 65162-351-11Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Sildenafil Tablets USP, 20 mg are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil.
Bottles of 90: NDC 65162-351-09 Bottles of 1000: NDC 65162-351-11 Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).Inform patients of contraindication of sildenafil citrate with regular and/or intermittent use of organic nitrates.Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction.
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 citrate. These events may be accompanied by tinnitus and dizziness. All trademarks listed are the property of their respective owner. Note: Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies.
Multi-ingredient medications may also be listed when applicable. Dupixent is used to treat multiple inflammatory conditions, including moderate-to-severe eczema .. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Sildenafil, sold under the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension.
Advise patients sildenafil uk price taking sildenafil citrate 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 citrate. 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 citrate. These events may be accompanied by tinnitus and dizziness.All trademarks listed are the property of their respective owner.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd.Ahmedabad 382220, INDIADistributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of contraindication of sildenafil citrate 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 citrate 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 citrate.
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. 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 PAH In 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 Citrate Co-administered with Epoprostenol A randomized, double-blind, placebo-controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol.
Patients were randomized to placebo or sildenafil citrate (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 citrate group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil citrate 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 citrate 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 citrate (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). Kaplan-Meier plot of time to clinical worsening is presented in Figure 5. Table 4: Clinical Worsening Events in PACES-1 Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1 Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil citrate compared to placebo. More than twice as many sildenafil citrate-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. 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 citrate. These events may be accompanied by tinnitus and dizziness.
Table 4 displays the number of patients with clinical worsening events 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 citrate-treated patients and that sildenafil citrate-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.Table 4: Clinical Worsening Events in PACES-1Figure 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 citrate compared to placebo. More than twice as many sildenafil citrate-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 Citrate 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 mg 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 mg plus bosentan and bosentan alone.Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. SUPER-1 (NCT00644605) - Sildenafil citrate monotherapy [20 mg, 40 mg, and 80 mg three times a day] A randomized, double-blind, placebo-controlled study of sildenafil citrate (SUPER-1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥ 25 mmHg at rest with a pulmonary capillary wedge pressure < 15 mmHg).
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 citrate 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. The study population consisted of 25% men and 75% women with a mean sildenafil otc 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. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at Week 8 and Week 12. All trademarks listed are the property of their respective owner. Note: Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. Multi-ingredient medications may also be listed when applicable. Dupixent is used to treat multiple inflammatory conditions, including moderate-to-severe eczema .. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Sildenafil, sold under the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension.
| Storage Condition | Details | Notes |
|---|---|---|
| Temperature | Keep below 30°C (86°F) | Avoid excessive heat |
| Light | Keep away from direct sunlight | Protect from UV rays |
| Humidity | Store in dry place | Prevent moisture from degrading the tablet |
| Out of reach | Keep out of children's reach | Safety precaution |