4 CONTRAINDICATIONS

The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12.Figure 9.

• Sildenafil tablets LP 100 mg is not an aphrodisiac; it enhances natural response.
• Sexual stimulation is necessary for the medication to work effectively.
• Discuss any underlying health conditions with your healthcare provider.

Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval)Figure 10 displays subgroup efficacy analyses in Study 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 10. Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by study subpopulation in Study 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.Of the 277 treated patients, 259 entered a long-term, uncontrolled extension study. At the end of 1 year, 94% of these patients were still alive. Additionally, walk distance and functional class status appeared to be stable in patients taking sildenafil citrate. Without a control group, these data must be interpreted cautiously.Study 2 (Sildenafil Citrate co-administered with epoprostenol)A randomized, double-blind, placebo controlled study (Study 2) 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). Table 4 displays the number of patients with clinical worsening events in Study 2.

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 11.Table 4.

4. Cialis

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. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval) Figure 10 displays subgroup efficacy analyses in Study 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 Study 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. Of the 277 treated patients, 259 entered a long-term, uncontrolled extension study. Without a control group, these data must be interpreted cautiously.

Cite this article

Study 2 (Sildenafil Citrate co-administered with epoprostenol) A randomized, double-blind, placebo controlled study (Study sildenafil citrate tables 2) 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. 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). 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). Kaplan-Meier plot of time to clinical worsening is presented in Figure 11.

Related treatment guides

Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2 Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil citrate compared to placebo. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, 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, over the counter drugs containing sildenafil USP equivalent to the nominally indicated amount of sildenafil.They are available as follows:Bottles of 10: NDC 63187-789-10Bottles of 20: NDC 63187-789-20Bottles of 30: NDC 63187-789-30Bottles of 50: NDC 63187-789-50Bottles of 60: NDC 63187-789-60Bottles of 90: NDC 63187-789-90Recommended Storage for Sildenafil Tablets: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Sildenafil tablets, 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 10: NDC 63187-789-10 Bottles of 20: NDC 63187-789-20 Bottles of 30: NDC 63187-789-30 Bottles of 50: NDC 63187-789-50 Bottles of 60: NDC 63187-789-60 Bottles of 90: NDC 63187-789-90 Recommended Storage for Sildenafil Tablets: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION See 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. Clinical Worsening Events in Study 2Figure 11.

Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2Improvements in WHO functional class for PAH were also demonstrated in sildenafil 5mg for sale subjects on sildenafil citrate compared to placebo. Studies of Adults with Pulmonary Arterial Hypertension Study 1 (Sildenafil Citrate monotherapy (20 mg, 40 mg and 80 mg three times a day)) A randomized, double-blind, placebo-controlled study of sildenafil citrate (Study 1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure of greater than or equal to 25 mmHg at rest with a pulmonary capillary wedge pressure less than 15 mmHg). 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. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval) Figure 10 displays subgroup efficacy analyses in Study 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 Study 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. Of the 277 treated patients, 259 entered a long-term, uncontrolled extension study. Without a control group, these data must be interpreted cautiously. Study 2 (Sildenafil Citrate co-administered with epoprostenol) A randomized, double-blind, placebo controlled study (Study sildenafil citrate tables 2) 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. 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). 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). Kaplan-Meier plot of time to clinical worsening is presented in Figure 11. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2 Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil citrate compared to placebo.

What is sildenafil?

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. 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.This product’s label may have been updated. For current full prescribing information, please visit by:Amneal Pharmaceuticals Co. (I) Pvt.

What are the serious side effects of sildenafil?

Ltd.Ahmedabad, INDIA 382220Distributed by:Amneal PharmaceuticalsGlasgow, KY 42141Repackaged by:Proficient Rx LPThousand Oaks, CA 91320Rev. See 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.

Clinical Specifications

Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil citrate. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil citrate. This product’s label may have been updated. For current full prescribing information, please visit PATIENT INFORMATION Sildenafil (sil-DEN-a-fil) TabletsRead this Patient Information before you start taking sildenafil tablets and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, 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, over the counter drugs containing sildenafil USP equivalent to the nominally indicated amount of sildenafil.They are available as follows:Bottles of 10: NDC 63187-789-10Bottles of 20: NDC 63187-789-20Bottles of 30: NDC 63187-789-30Bottles of 50: NDC 63187-789-50Bottles of 60: NDC 63187-789-60Bottles of 90: NDC 63187-789-90Recommended Storage for Sildenafil Tablets: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Sildenafil tablets, 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 10: NDC 63187-789-10 Bottles of 20: NDC 63187-789-20 Bottles of 30: NDC 63187-789-30 Bottles of 50: NDC 63187-789-50 Bottles of 60: NDC 63187-789-60 Bottles of 90: NDC 63187-789-90 Recommended Storage for Sildenafil Tablets: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION See 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.

5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia

The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12.Figure 9. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval)Figure 10 displays subgroup efficacy analyses in Study 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 10. Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by study subpopulation in Study 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.Of the 277 treated patients, 259 entered a long-term, uncontrolled extension study. At the end of 1 year, 94% of these patients were still alive. Additionally, walk distance and functional class status appeared to be stable in patients taking sildenafil citrate.

Common Side Effects

Without a control group, these data must be interpreted cautiously.Study 2 (Sildenafil Citrate co-administered with epoprostenol)A randomized, double-blind, placebo controlled study (Study 2) 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). Table 4 displays the number of patients with clinical worsening events in Study 2.

What are the most common side effects of sildenafil?

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 11.Table 4. Clinical Worsening Events in Study 2Figure 11. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2Improvements in WHO functional class for PAH were also demonstrated in sildenafil 5mg for sale subjects on sildenafil citrate compared to placebo. Studies of Adults with Pulmonary Arterial Hypertension Study 1 (Sildenafil Citrate monotherapy (20 mg, 40 mg and 80 mg three times a day)) A randomized, double-blind, placebo-controlled study of sildenafil citrate (Study 1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure of greater than or equal to 25 mmHg at rest with a pulmonary capillary wedge pressure less than 15 mmHg). 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.This product’s label may have been updated. For current full prescribing information, please visit by:Amneal Pharmaceuticals Co. (I) Pvt.

• Sildenafil tablets LP 100 mg is approved by the FDA for ED treatment.
• The medication can improve erectile response in men with ED.
• Follow prescribed dosage instructions carefully for safety.

Ltd.Ahmedabad, INDIA 382220Distributed by:Amneal PharmaceuticalsGlasgow, KY 42141Repackaged by:Proficient Rx LPThousand Oaks, CA 91320Rev. See 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.

1. Viagra

If you have any questions about sildenafil tablets, ask your doctor or pharmacist.What is the most important information I should know about sildenafil tablets?Never take sildenafil tablets with any nitrate medicines. Your blood pressure could drop quickly to an unsafe level. Nitrate medicines include:•Medicines that treat chest pain (angina)•Nitroglycerin in any form including tablets, patches, sprays, and ointments•Isosorbide mononitrate or dinitrate•Street drugs called “poppers” (amyl nitrate or nitrite)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate medicine.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH).

What should I do if I miss a dose of sildenafil?

Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil citrate. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil citrate.

7.1 Nitrates

This product’s label may have been updated. For current full prescribing information, please visit PATIENT INFORMATION Sildenafil (sil-DEN-a-fil) TabletsRead this Patient Information before you start taking sildenafil tablets and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about sildenafil tablets, ask your doctor or pharmacist.What is the most important information I should know about sildenafil tablets?Never take sildenafil tablets with any nitrate medicines. Your blood pressure could drop quickly to an unsafe level. Nitrate medicines include:•Medicines that treat chest pain (angina)•Nitroglycerin in any form including tablets, patches, sprays, and ointments•Isosorbide mononitrate or dinitrate•Street drugs called “poppers” (amyl nitrate or nitrite)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate medicine.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH).