Hezkue / Sildenafil Spray

Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil for oral suspension.

• Sildenafil spray is approved in some regions for ED.
• It may provide a more convenient dosing method.
• Users should avoid driving until effects are known.
• The spray’s rapid absorption may enhance spontaneity.
• It is important to monitor blood pressure when using.
• Sildenafil spray should not be used with grapefruit juice.
• It’s essential to disclose all health conditions to the doctor.
• The spray formulation might reduce medication costs.
• It can be part of a healthy lifestyle for better results.
• Consistent application improves and prolongs effectiveness.
• Always consult healthcare providers before starting.

These events may be accompanied by tinnitus and dizziness.

Who Should Avoid Using Hezkue Spray?

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. 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)].

What to do if you get Hezkue spray side effects

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. 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 brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

• Sildenafil spray is a convenient solution for ED.
• It bypasses the digestive system for faster action.
• Proper storage enhances product longevity.
• It is important to adhere to prescribed doses.
• Be aware of possible side effects like flushing or nasal congestion.
• The spray may not be suitable for everyone.
• Men with certain medical conditions should seek advice.
• Self-medication without consultation is risky.
• The spray’s onset time varies with individual factors.
• Using the spray responsibly minimizes risks.
• Always read accompanying instructions thoroughly.

Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown RoadEast Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500

Country/Region	Approval Status	Notes
United States	Not FDA approved for spray form	Available through clinical trials
European Union	Under investigation	Not yet commercialized
Australia	Restricted to research purposes	Not available commercially
Asia (e.g., India)	Limited approval for sildenafil formulations	Regulatory pathway ongoing

032, India Revised: 02/2026 This Patient Information has been approved by the U.S.

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Food and Drug Administration.

Storage Condition	Temperature Range	Protection Required	Shelf Life
Room Temperature	20-25°C	Keep away from heat and moisture	2 years
Refrigeration Recommended	2-8°C	Avoid freezing	N/A
Exposure to sunlight	No direct sunlight	Store in a dark place	N/A

Instructions for Use Sildenafil (sil den' a fil) Read this Instructions for Use before you start taking

Quick Summary

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 sildenafil gel 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.

8.2 Lactation

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. 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. sildenafil oral suspension or giving sildenafil oral suspension to your child and each time you get a refill.

Substance/Class	Effect on Sildenafil Spray	Recommendation
Nitrates	Potent hypotensive effect	Avoid concomitant use
Alpha-blockers	Increased risk of low blood pressure	Use with caution, under supervision
Alcohol	Enhances side effects	Limit or avoid consumption
Other PDE5 inhibitors	Increased risk of adverse effects	Do not combine

This information does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment.

How Does Spray for Erectile Dysfunction Work?

e. Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH. 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.

Is Silfin Oral Spray safe for people with diabetes?

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. 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. Ask your healthcare provider or pharmacist to show you how to measure and take or give your child’s prescribed dose of sildenafil for oral suspension.

Dosage and How to Use Hezkue Spray Correctly

Inform patients of contraindication of sildenafil for oral suspension 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 for oral suspension 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 for oral suspension. Such an event may be a sign of NAION. Your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you.

5. Warnings and Precautions

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). 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.

Can I take Silfin Oral Spray as often as I want?

Count of cases of disease progression as the first event of clinical worsening. c. 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. Do not take or give sildenafil for oral suspension and contact your pharmacist if the medicine in the bottle is still a powder.

How to use Silfin Liquid

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). The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution. Advise the 150mg sildenafil for sale patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Always use the oral dosing syringe that comes with sildenafil for oral suspension.

6. Adverse Reactions/Side Effects

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. 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%).

6.2 Postmarketing Experience

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)]. 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. If your carton does not come with an oral dosing syringe, contact your pharmacist.

• Sildenafil spray utilizes absorption through oral mucosa.
• It provides a discreet alternative for erectile issues.
• Use the spray about 10-20 minutes before intimacy.
• It generally has fewer gastrointestinal side effects.
• The spray must be kept out of reach of children.
• Users should avoid alcohol to prevent adverse reactions.
• Compatibility with other medications should be checked.
• The spray may be part of a comprehensive ED treatment plan.
• Discontinue use and consult a doctor if adverse reactions occur.
• The spray’s effectiveness can improve confidence in men.
• Training on proper application enhances safety and effectiveness.