Potential Side Effects of Sildenafil 60mg
Table 6: Hazard Ratios for Overall Survival, Assessed in the Proportional Hazards Model – Intent To Treat Population Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80- mg TID dose groups, respectively.
Other uses for this medicine
Of the total 229 patients who received sildenafil, there were 55, 74, and 100 patients in the low, medium, and high dose groups, respectively. Across the short-term and long-term studies, the overall duration of treatment from start of double-blind for individual patients ranged from 3 to 3,129 days. 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 VO2 was assessed 1 year after the start of the placebo-controlled study. Of sildenafil-treated patients developmentally able to perform the CPET 59/114 patients (52%) had not shown any deterioration in PVO2 from start of sildenafil.
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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 and ADVERSE REACTIONS]. 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 REVATIO TID, based on body weight, compared to those taking a lower dose of REVATIO 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. Patients were randomly assigned 1:1:1 to one of three treatment groups (5, 20, and 80 mg TID). Sildenafil 80 mg was also superior to 5 mg for time to first event of clinical worsening with HR (99.7% CI) = 0.44 (0.22, 0.89). Table 7: Hazard Ratios for Time to First Event of Clinical Worsening – Intent To Treat Population At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m.
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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.
Different sildenafil strengths
Mean increases in VO2peak percentage 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%). Figure 6: 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). Dose related improvements were observed with PVRI and mPAP.
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Statistically significant PVRI reductions compared to placebo were seen with the sildenafil medium and high dose groups (18% [95% CI: -32% to -2%] and 27% [95% CI: -39% to -14%], respectively) but not the low dose group (2% (95% CI: -20%, 20%). The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of -3.5 mmHg (95% CI: -8.9, 1.9) and -7.3 mmHg (95% CI: -12.4, -2.1), respectively; while the low dose group showed little difference from placebo (difference of 1.6 mmHg [95% CI: -4.5, 7.6]). Improvements were observed with cardiac index with all three sildenafil groups over placebo, 10%, 4%, and 15% for the low, medium, and high dose groups, respectively [see CLINICAL PHARMACOLOGY]. Of the 234 pediatric patients treated in the short-term, placebo-controlled study, 220 patients entered the long-term extension study. Patients who had been in the placebo group in the shortterm study were randomly reassigned to sildenafil treatment; patients weighing ≥ 20 kg entered the medium or high dose groups (1:2), while sildenafil citrate tablets 150 mg patients weighing > 20 kg entered the low, medium, or high dose groups (1:1:1). 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].
| Region | Approximate Cost per Tablet | Notes |
|---|---|---|
| USA | $10 - $15 | Generic options available |
| Europe | €8 - €12 | Varies by pharmacy |
| Australia | AUD 15 - 20 | Usually prescription-based |
| India | $1 - $3 | Generic widely available |
REVATIO® (re-VAH-tee-oh) (sildenafil) oral suspension What is the most important information I should know about REVATIO?
Why is this medication prescribed?
Most patients were PAH treatment naïve (83%). For most patients the etiology of PAH was idiopathic (72%). The most common WHO Functional Class was Class III (58% of patients). 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.
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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. At the time of a planned interim analysis (50% deaths) it was identified that the primary efficacy objective of this protocol was met and therefore the study was stopped. Based on the primary efficacy endpoint (mortality), the non-inferiority of sildenafil 80 mg TID arm versus 5 mg TID arm was met using a 2-sided significance level of 0.003 for the interim analysis. Primary comparison of the 80 mg TID group to the 5 mg TID group yielded the HR (99.7% CI) = 0.51 (0.22, 1.21); i.e., non-inferiority was established. Never take REVATIO sildenafil 20 mg prescription with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called “poppers” (amyl nitrate, butyl nitrate or nitrite) Riociguat, a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
- The drug belongs to the phosphodiesterase inhibitor class.
- It can cause nasal congestion and dyspepsia.
- It is not intended for recreational use.
- Effectiveness may vary among individuals.
Ask your healthcare provider or pharmacist if you are not sure if you or your child are taking a nitrate or a guanylate cyclase stimulator medicine. See “What are the possible side effects of REVATIO?” for more information about side effects. REVATIO is a prescription medicine used to treat pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. adults to improve your ability to exercise and help slow down the worsening of your physical condition.
- Sildenafil 60mg does not protect against sexually transmitted infections.
- Use condoms as a protective measure.
- Discuss any pre-existing conditions with your doctor.
- Its safety in women has not been established.
children 1 to 17 years old to improve their ability to exercise, and in children too young to do certain exercise and lung testing. It is not known if REVATIO is safe and effective in children younger than 1 year of age. Do not take REVATIO if you or your child: take riociguat, a guanylate cyclase stimulator medicine. are allergic to sildenafil or any of the ingredients in REVATIO. See the end of this leaflet for a complete list of ingredients in REVATIO.
| Study | Percentage of Effective Responses | Notes |
|---|---|---|
| Clinical trial A | 70% | Improved erections in majority of users |
| Real-world study B | 65% | Varies with individual health status |
| Meta-analysis C | 75% | Combined data from multiple studies |
Before taking REVATIO, tell your healthcare provider about all of your medical conditions, including if you or your child: have bleeding problems or a stomach (peptic) ulcer.
- Sildenafil 60mg is one of several doses available.
- Your doctor may adjust the dose based on response.
- Use only the dose prescribed to you.
- Do not self-adjust the medication without medical advice.
It is not known if REVATIO is safe in people with bleeding problems or who have a stomach ulcer. have an eye problem called retinitis pigmentosa have ever had sudden loss of vision in one or both eyes, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing have a deformed penis shape or Peyronie’s disease have any blood cell problems such as sickle cell anemia are pregnant or plan to become pregnant.
- Common side effects include flushing and nasal congestion.
- Seek emergency help if experiencing prolonged erection.
- Do not use if you are taking nitrates.
- Alcohol consumption can decrease effectiveness.
It is not known if REVATIO will harm your unborn baby.
Usual Adult Dose for Erectile Dysfunction
Patients were naïve for specific PAH therapy and the use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists were not permitted in the study, and neither were arginine supplementation, nitrates, alpha-blockers and potent CYP450 3A4 inhibitors. The primary objective of the study was to assess the effect of REVATIO on percent change from baseline in PVO2, normalized to body weight, from baseline to week 16 as measured by the Cardiopulmonary Exercise Test (CPET) (patients who were developmentally able to perform the test, n = 115). Secondary endpoints included hemodynamic monitoring, symptom assessment, WHO Functional Class, change in background treatment, and quality of life measurements (n = 234). Patients were allocated to one of three sildenafil treatment groups (low, medium, or high) or placebo. Actual doses administered were dependent on body weight (see Table 5).
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Table 5: Treatment Allocation by Dose and Body Weight in Pediatric Study The proportion of patients receiving supportive medicinal products at baseline (anticoagulants, digoxin, calcium channel blockers, diuretics and/or oxygen) was similar in the combined sildenafil treatment group (48%) and the placebo treatment group (42%). The primary endpoint was a percentage change in VO2peak from baseline to week 16 assessed by CPET. Mean baseline peak volume of oxygen consumed (VO2) values were similar across the sildenafil treatment groups (17 to 18 mL/kg/min), and slightly higher for the placebo treatment group (20 mL/kg/min). A total of 45% of patients were evaluable for CPET, which comprised those children ≥ 7 years old and developmentally able to perform the test. Children < 7 years were evaluable only for the secondary endpoints.
