Mean increases in VO 2peakpercentage change from baseline at Week 16, were observed with all 3 sildenafil doses (range of 6% to 13%, Figure 6), with little change with placebo (0.5%). Percentage Change from Baseline in VO2Peak: Mean (95% Confidence Intervals) The estimated difference between the combined sildenafil doses and placebo was 8% (95% CI: 0.2 to 16). The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p=0.056). The estimated difference between the sildenafil medium dose group and placebo was 11±5% (95% CI: 2 to 21). STARTS-2 ( NCT00159874) - Long-Term Survival with Oral Sildenafil Monotherapy in Treatment-Naïve Pediatric Pulmonary Arterial Hypertension Of the 234 pediatric patients treated in the short-term, placebo-controlled study, 220 patients entered the long-term extension study. By sildenafil treatment group, median duration of sildenafil treatment was 1,696 days (excluding the 5 patients who received placebo in double-blind and were not treated in the long-term extension study). Peak VO 2was assessed 1 year after the start of the placebo-controlled study.
Similarly, 191 of 229 patients (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment. Kaplan-Meier estimates of survival at 3 years in patients >20 kg in weight at baseline were 94%, 93%, and 85% in the low, medium, and high dose groups, respectively; for patients ≤20 kg in weight at baseline, the survival estimates were 94% and 93% for patients in the medium and high dose groups, respectively [ see Use in Specific Populations ( 8.4) and Adverse Reactions ( 6.1) ]. Study A1481324 ( NCT02060487) - Study to Assess the Effects of Sildenafil citrate on Mortality in Adults with PAH A study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH was conducted following the observation of a higher risk of mortality in pediatric patients taking a high dose of Sildenafil citrate TID, based on body weight, compared to those taking a lower dose of Sildenafil citrate in the long-term extension of the pediatric clinical trial.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 100mg | 360 + 10 Pills | 330.21€ 314.49€ | |
| Viagra Generic | 200mg | 180 + 10 Pills | 277.56€ 264.34€ | |
| Kamagra Soft Tabs | 100mg | 272 + 12 Pills | 593.42€ 565.16€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Viagra Generic | 100mg | 10 Pills | 28.91€ 27.53€ | |
| Viagra Generic | 50mg | 10 Pills | 26.87€ 25.59€ | |
| Viagra Generic | 200mg | 30 + 2 Pills | 83.07€ 79.11€ | |
| Kamagra Polo | 100mg | 20 Pills | 83.56€ 79.58€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ | |
| Viagra Generic | 150mg | 60 + 4 Pills | 111.25€ 105.95€ | |
| Viagra Generic | 50mg | 180 + 8 Pills | 158.82€ 151.26€ | |
| Viagra Generic | 25mg | 270 + 8 Pills | 184.26€ 175.49€ | |
| Kamagra Polo | 100mg | 84 + 4 Pills | 244.49€ 232.85€ |
The study was a randomized, double-blind, parallel-group study in 385 adults with PAH. Treatment groups were well balanced with respect to baseline demographics of strata history of PAH treatment and etiology of PAH, as well as the WHO Functional Class categories. The primary objective of the study was to compare sildenafil 80 mg TID versus 5 mg TID for mortality, with success defined by ruling out twice the mortality at 80 mg. The key secondary efficacy endpoint was time to first event of clinical worsening, defined as a composite endpoint of all-cause mortality, hospitalization for worsening PAH or disease progression.
| Dose (mg) | Typical Usage Frequency | Onset of Action | Duration of Effect |
|---|---|---|---|
| 25 | As needed, 1 time/day | 30-60 minutes | Up to 4 hours |
| 50 | As needed, 1-2 times/day | 30-60 minutes | Up to 6 hours |
| 100 | As needed, 1 time/day | 30-60 minutes | Up to 4-6 hours |
An additional secondary endpoint was 6MWD at Months 6 and 12. Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80mg TID dose groups, respectively At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m. At Month 6, the median change from baseline was highest for sildenafil 80 mg TID with 28 m compared to 18 m and 19 m for sildenafil 5 mg TID and sildenafil 20 mg TID groups, respectively. The same was seen at Month 12, the median change from baseline for sildenafil 80 mg TID group was 33 m compared to 17 m for sildenafil 5 mg TID and 31 m in sildenafil 20 mg TID groups. Overall, the safety data for sildenafil 20 mg TID and for the higher sildenafil 80 mg TID dose were consistent with the established safety profile of sildenafil in previous adult PAH studies [ see Adverse Reactions ( 6.1) ]. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side.Bottles of 30 with child-resistant closure NDC 76420-613-30 (repackaged from NDC 13668-185-xx)Bottles of 60 with child-resistant closure NDC 76420-613-60 (repackaged from NDC 13668-185-xx)Bottles of 90 with child-resistant closure NDC 76420-613-90 (relabeled/repackaged from NDC 13668-185-90/NDC 13668-185-xx)Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
• Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. Trademarks are the property of their respective owners. First of all, thank you for choosing Numan. If your prescription request for Sildenafil 50mg or 100mg has been accepted, or if you considering whether this treatment may be suitable for you, we'd like to help you learn how to use it to its best effect, and give you some important information before you start taking it. Sildenafil works by helping to relax and open up the blood vessels in your penis, allowing for increased blood flow.
This means that when you are sexually aroused, you can achieve a harder and longer-lasting erection. If you’re interested in understanding the science behind erections and how sildenafil works in more detail, check out Numan’s Erection Handbook, which has everything you need to know about erections and more. You have had an allergic reaction to sildenafil or any similar medications in the past You have had an allergic reaction to sildenafil or any similar medications in the past You are taking medications which contain nitrates (usually for chest pain) You are taking medications which contain nitrates (usually for chest pain) You have recently had a heart attack or a stroke You have recently had a heart attack or a stroke You have a serious heart or liver condition You have a serious heart or liver condition You have a history of non-arthritic anterior ischaemic optic neuropathy (NAION) You have a history of non-arthritic anterior ischaemic optic neuropathy (NAION) You have an inherited condition affecting your retinas, such as retinitis pigmentos You have an inherited condition affecting your retinas, such as retinitis pigmentos have a deformity of your penis, such as Peyronie’s disease have a deformity of your penis, such as Peyronie’s disease have a bleeding disorder, such as haemophilia have a bleeding disorder, such as haemophilia have a heart condition, including left ventricular outflow obstruction have a heart condition, including left ventricular outflow obstruction have sickle cell anaemia, leukaemia or multiple myeloma have sickle cell anaemia, leukaemia or multiple myeloma Sildenafil should only be used by men over the age of 18 who have erectile dysfunction. It should not be used with other treatments for erectile dysfunction. If you aren’t sure whether you have any of the conditions listed above, please consult your doctor.
Taking sildenafil doesn’t result in an instantaneous erection - a little bit of planning is required. Sildenafil starts working an hour after you take it, and the effects last for four to five hours. This means that there’s a window of about three hours when you can plan to have sex - and you’ll need to be sexually aroused for sildenafil to take effect. Your resultant erection should feel harder and last longer than before. Eating a large meal at the same time as taking sildenafil can delay the effects by about an hour. Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 with child-resistant closure NDC 76420-613-30 (repackaged from NDC 13668-185-xx) Bottles of 60 with child-resistant closure NDC 76420-613-60 (repackaged from NDC 13668-185-xx) Bottles of 90 with child-resistant closure NDC 76420-613-90 (relabeled/repackaged from NDC 13668-185-90/NDC 13668-185-xx) Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 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 tablets 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 tablets 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 tablets. 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 tablets. These events may be accompanied by tinnitus and dizziness.Trademarks are the property of their respective owners.Relabeled and Repackaged by:Enovachem PHARMACEUTICALSTorrance, CA 90501 Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform patients of contraindication of sildenafil tablets 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 premature ejaculation sildenafil tablets 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 tablets. • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. Trademarks are the property of their respective owners. First of all, thank you for choosing Numan.
If your prescription request for Sildenafil 50mg or 100mg has been accepted, or if you considering whether this treatment may be suitable for you, we'd like to help you learn how to use it to its best effect, and give you some important information before you start taking it. Sildenafil works by helping to relax and open up the blood vessels in your penis, allowing for increased blood flow.
This means that when you are sexually aroused, you can achieve a harder and longer-lasting erection. If you’re interested in understanding the science behind erections and how sildenafil works in more detail, check out Numan’s Erection Handbook, which has everything you need to know about erections and more. You have had an allergic reaction to sildenafil or any similar medications in the past You have had an allergic reaction to sildenafil or any similar medications in the past You are taking medications which contain nitrates (usually for chest pain) You are taking medications which contain nitrates (usually for chest pain) You have recently had a heart attack or a stroke You have recently had a heart attack or a stroke You have a serious heart or liver condition You have a serious heart or liver condition You have a history of non-arthritic anterior ischaemic optic neuropathy (NAION) You have a history of non-arthritic anterior ischaemic optic neuropathy (NAION) You have an inherited condition affecting your retinas, such as retinitis pigmentos You have an inherited condition affecting your retinas, such as retinitis pigmentos have a deformity of your penis, such as Peyronie’s disease have a deformity of your penis, such as Peyronie’s disease have a bleeding disorder, such as haemophilia have a bleeding disorder, such as haemophilia have a heart condition, including left ventricular outflow obstruction have a heart condition, including left ventricular outflow obstruction have sickle cell anaemia, leukaemia or multiple myeloma have sickle cell anaemia, leukaemia or multiple myeloma Sildenafil should only be used by men over the age of 18 who have erectile dysfunction.
It should not be used with other treatments for erectile dysfunction. If you aren’t sure whether you have any of the conditions listed above, please consult your doctor.
The recommended starting dose for sildenafil is 50mg/100mg taken once per day, as needed. If you feel the effect of sildenafil is too strong or too weak, feel free to contact us and we can advise you on adjusting your dosage. You should not take more than one dose of sildenafil within 24 hours. It’s worth noting that sildenafil doesn’t alter libido or sexual desire. It also doesn’t have an effect on your testosterone levels.
If you experience any of the following serious (but uncommon) side effects, you should stop taking sildenafil and seek urgent medical attention: an allergic reaction - symptoms include swelling of the lips, throat and eyelids, sudden difficulty in breathing or wheezing, dizziness, collapse an allergic reaction - symptoms include swelling of the lips, throat and eyelids, sudden difficulty in breathing or wheezing, dizziness, collapse chest pains - you should not use nitrate-containing medication to treat this chest pains - you should not use nitrate-containing medication to treat this a prolonged erection lasting more than four hours, which may be painful.
Taking sildenafil doesn’t result in an instantaneous erection - a little bit of planning is required.
Sildenafil starts working an hour after you take it, and the effects last for four to five hours. This means that there’s a window of about three hours when you can plan to have sex - and you’ll need to be sexually aroused for sildenafil to take effect. Your resultant erection should feel harder and last longer than before. Eating a large meal at the same time as taking sildenafil can delay the effects by about an hour. The recommended starting dose for sildenafil is 50mg/100mg taken once per day, as needed.
Mean increases in VO 2peakpercentage change from baseline at Week 16, were observed with all 3 sildenafil doses (range of 6% to 13%, Figure 6), with little change with placebo (0.5%). Percentage Change from Baseline in VO2Peak: Mean (95% Confidence Intervals) The estimated difference between the combined sildenafil doses and placebo was 8% (95% CI: 0.2 to 16). The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p=0.056). The estimated difference between the sildenafil medium dose group and placebo was 11±5% (95% CI: 2 to 21). STARTS-2 ( NCT00159874) - Long-Term Survival with Oral Sildenafil Monotherapy in Treatment-Naïve Pediatric Pulmonary Arterial Hypertension Of the 234 pediatric patients treated in the short-term, placebo-controlled study, 220 patients entered the long-term extension study.
By sildenafil treatment group, median duration of sildenafil treatment was 1,696 days (excluding the 5 patients who received placebo in double-blind and were not treated in the long-term extension study). Peak VO 2was assessed 1 year after the start of the placebo-controlled study. Similarly, 191 of 229 patients (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment. Kaplan-Meier estimates of survival at 3 years in patients >20 kg in weight at baseline were 94%, 93%, and 85% in the low, medium, and high dose groups, respectively; for patients ≤20 kg in weight at baseline, the survival estimates were 94% and 93% for patients in the medium and high dose groups, respectively [ see Use in Specific Populations ( 8.4) and Adverse Reactions ( 6.1) ]. Study A1481324 ( NCT02060487) - Study to Assess the Effects of Sildenafil citrate on Mortality in Adults with PAH A study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH was conducted following the observation of a higher risk of mortality in pediatric patients taking a high dose of Sildenafil citrate TID, based on body weight, compared to those taking a lower dose of Sildenafil citrate in the long-term extension of the pediatric clinical trial.
The study was a randomized, double-blind, parallel-group study in 385 adults with PAH. Treatment groups were well balanced with respect to baseline demographics of strata history of PAH treatment and etiology of PAH, as well as the WHO Functional Class categories. The primary objective of the study was to compare sildenafil 80 mg TID versus 5 mg TID for mortality, with success defined by ruling out twice the mortality at 80 mg. The key secondary efficacy endpoint was time to first event of clinical worsening, defined as a composite endpoint of all-cause mortality, hospitalization for worsening PAH or disease progression. An additional secondary endpoint was 6MWD at Months 6 and 12. If you feel the effect of sildenafil is too strong or too weak, feel free to contact us and we can advise you on adjusting your dosage. You should not take more than one dose of sildenafil within 24 hours. It’s worth noting that sildenafil doesn’t alter libido or sexual desire. It also doesn’t have an effect on your testosterone levels.
Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80mg TID dose groups, respectively At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m. At Month 6, the median change from baseline was highest for sildenafil 80 mg TID with 28 m compared to 18 m and 19 m for sildenafil 5 mg TID and sildenafil 20 mg TID groups, respectively. The same was seen at Month 12, the median change from baseline for sildenafil 80 mg TID group was 33 m compared to 17 m for sildenafil 5 mg TID and 31 m in sildenafil 20 mg TID groups. Overall, the safety data for sildenafil 20 mg TID and for the higher sildenafil 80 mg TID dose were consistent with the established safety profile of sildenafil in previous adult PAH studies [ see Adverse Reactions ( 6.1) ]. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side.Bottles of 30 with child-resistant closure NDC 76420-613-30 (repackaged from NDC 13668-185-xx)Bottles of 60 with child-resistant closure NDC 76420-613-60 (repackaged from NDC 13668-185-xx)Bottles of 90 with child-resistant closure NDC 76420-613-90 (relabeled/repackaged from NDC 13668-185-90/NDC 13668-185-xx)Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 with child-resistant closure NDC 76420-613-30 (repackaged from NDC 13668-185-xx) Bottles of 60 with child-resistant closure NDC 76420-613-60 (repackaged from NDC 13668-185-xx) Bottles of 90 with child-resistant closure NDC 76420-613-90 (relabeled/repackaged from NDC 13668-185-90/NDC 13668-185-xx) Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 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 tablets 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 tablets 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 tablets. 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 tablets.
These events may be accompanied by tinnitus and dizziness.Trademarks are the property of their respective owners.Relabeled and Repackaged by:Enovachem PHARMACEUTICALSTorrance, CA 90501 Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform patients of contraindication of sildenafil tablets 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 premature ejaculation sildenafil tablets 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 tablets. If you experience any of the following serious (but uncommon) side effects, you should stop taking sildenafil and seek urgent medical attention: an allergic reaction - symptoms include swelling of the lips, throat and eyelids, sudden difficulty in breathing or wheezing, dizziness, collapse an allergic reaction - symptoms include swelling of the lips, throat and eyelids, sudden difficulty in breathing or wheezing, dizziness, collapse chest pains - you should not use nitrate-containing medication to treat this chest pains - you should not use nitrate-containing medication to treat this a prolonged erection lasting more than four hours, which may be painful.