3 DOSAGE FORMS AND STRENGTHS
The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.
- Sildenafil can cause visual disturbances like blurred vision.
- Alcohol consumption may increase side effects when using sildenafil.
- The syrup should be stored at room temperature away from light.
- Patients should avoid heavy meals before taking sildenafil.
- Regular monitoring is recommended for long-term use.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
6.2 Postmarketing Experience
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). 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).
How Sildenafil works
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. 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%). 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). Inform patients of contraindication of sildenafil for oral suspension with regular and/or intermittent use of organic nitrates.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 150mg | 90 + 6 Pills | 147.18€ 140.17€ | |
| Viagra Generic | 200mg | 120 + 8 Pills | 204.80€ 195.05€ | |
| Viagra Generic | 50mg | 60 + 4 Pills | 83.93€ 79.93€ | |
| Kamagra Polo | 100mg | 20 Pills | 83.56€ 79.58€ | |
| Kamagra | 100mg | 84 + 6 Pills | 264.44€ 251.85€ | |
| Kamagra Polo | 100mg | 180 + 8 Pills | 446.52€ 425.26€ | |
| Viagra Generic | 25mg | 180 + 6 Pills | 154.93€ 147.55€ | |
| Viagra Generic | 25mg | 90 + 6 Pills | 105.03€ 100.03€ | |
| Kamagra Polo | 100mg | 60 + 4 Pills | 189.39€ 180.37€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Kamagra | 100mg | 180 + 6 Pills | 436.79€ 415.99€ | |
| Kamagra Oral Jelly | 100mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
| Kamagra Oral Jelly | 100mg | 220 + 18 Sachets | 662.24€ 630.70€ | |
| Viagra Generic | 200mg | 90 + 6 Pills | 170.79€ 162.66€ | |
| Viagra Generic | 100mg | 10 Pills | 28.91€ 27.53€ | |
| Kamagra Oral Jelly | 100mg | 10 Sachets | 54.55€ 51.95€ |
Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction.
DRUG INTERACTIONS
Hazard Ratios for Time to First Event of Clinical Worsening – Intent To Treat Population Note: Sildenafil 5 mg is not an approved dosage. Abbreviations: 6MWD = 6-minute walk distance; CI = confidence interval; PAH = pulmonary arterial hypertension. Clinical worsening events were defined as reduction from baseline in the 6MWD test by at least 15% and worsening functional class from baseline, both confirmed by a second test/evaluation within 2 weeks. Count of cases of disease progression as the first event of clinical worsening. c.
8.7 Patients with Renal Impairment
Count of non-elective hospital stays for worsening PAH as the first event of clinical worsening. d. Count of deaths as the first event of clinical worsening. e. Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH. Advise patients taking sildenafil for oral suspension not to take VIAGRA or other PDE-5 inhibitors.
| Region | Estimated Market Size (2023) | Growth Rate | Key Players | Typical Uses Scope |
|---|---|---|---|---|
| North America | $150 million | 5% annually | Pfizer, Cipla, Teva | ED, pulmonary hypertension |
| Europe | $100 million | 4.5% annually | Bayer, Sun Pharma | Pulmonary hypertension, off-label uses |
| Asia-Pacific | $200 million | 7% annually | Cipla, Aurobindo, Zydus | Broader use, pediatric cases |
| Rest of World | $50 million | 3.5% annually | Various local manufacturers | Growing awareness and approval |
Advise patients to seek immediate medical attention for a sudden loss of
8. Use In Specific Populations
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 sildenafil gel 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.
Altitude sickness
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. Hazard Ratios for Overall Survival, Assessed in the Proportional Hazards Model – Intent To Treat Population On treatment deaths: Any death within 7 days of last dose was regarded as “On treatment”, thus might include deaths occurred after discontinuation from study treatment. Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH. Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80- mg TID dose groups, respectively. 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). vision in one or both eyes while taking sildenafil for oral suspension.
What are some things I need to know or do while I take Sildenafil Oral Suspension?
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)]. Sildenafil for Oral Suspension, 10 mg/mL is supplied in amber pet bottles.
8.4 Pediatric Use
Each bottle contains white to off-white granular powder containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. Recommended Storage for Sildenafil for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. Recommended Storage for Reconstituted Oral Suspension: Store below 30°C (86°F) or in refrigerator at 2° to 8°C (36° to 46°F). Such an event may be a sign of NAION.
Medicine brands for Sildenafil
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. 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 (12.2)].
8.6 Patients with Hepatic Impairment
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. 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 patients weighing > 20 kg entered the low, medium, or high dose groups (1:1:1). 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). Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil for oral suspension.
2.1 Sildenafil for Oral Suspension
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. Similarly, 191 of 229 patients (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year 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 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 TID, based on body weight, compared to those taking a lower dose of sildenafil 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.
Mechanism of Action
Patients were randomly assigned 1:1:1 to one of three treatment groups (5, 20, and 80 mg TID). 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. These events may be accompanied by tinnitus and dizziness.
- Sildenafil works by relaxing blood vessels to improve blood flow.
- Used primarily to treat erectile dysfunction and pulmonary hypertension.
- Syrup formulations may be used in children or those with swallowing difficulties.
- Proper storage of sildenafil syrup is essential to maintain efficacy.
- It is important to follow a healthcare provider’s instructions when using.
The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.
- The shelf life of sildenafil syrup depends on formulation and storage.
- Expiry dates should always be checked before use.
- Improper storage can lead to degradation of active ingredients.
- The liquid form allows for precise dose adjustments.
- Careful titration is essential to avoid overdose risks.
