The Truth About Erectile Dysfunction Sprays: Do They Really Work?

Do not take or give sildenafil for oral suspension if the bottle adaptor is not in the bottle.

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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. 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. Each bottle contains white to off-white granular powder containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil).

5.2 Worsening Pulmonary Vascular Occlusive Disease

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). The shelf-life of the reconstituted oral suspension is 60 days.

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Any remaining oral suspension should be discarded 60 days after reconstitution. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). 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. If the bottle adaptor is not in the bottle, contact your pharmacist.

Sildenafil for oral suspension should not be mixed with any other medicine or flavoring.

How long does one bottle of spray last?

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. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil for oral suspension. These events may be accompanied by tinnitus and dizziness. The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

How is sildenafil supplied (dosage forms)?

Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown RoadEast Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 02/2026 This Patient Information has been approved by the U.S. Food and Drug Administration. Instructions for Use Sildenafil (sil den' a fil) Read this Instructions pfizer sildenafil 100 for Use before you start taking sildenafil oral suspension or giving sildenafil oral suspension to your child and each time you get a refill. This information does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment. Supplies you will need to take or give a dose of sildenafil for oral suspension (See Figure A): 1 bottle of sildenafil for oral suspension with pre-inserted bottle adaptor 1 oral dosing syringe (provided in the carton) Shake the bottle of sildenafil oral suspension for 10 seconds before each use.

• Sildenafil spray is considered a fast-acting erectile aid.
• It can provide a discreet option for intimacy enhancement.
• The spray typically contains a small dose of sildenafil.
• Users should measure the spray dose carefully.
• Side effects are similar to other sildenafil forms.
• The spray may improve confidence in men with ED.
• Potential interactions include alcohol and certain medications.
• It’s important to avoid overuse or high doses.
• A healthcare professional should approve its use.
• Sildenafil spray can be part of a broader erectile health plan.
• Always read the packaging and leaflet before use.

Open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise).

• Sildenafil spray is a topical form used for erectile dysfunction treatment.
• It offers quick absorption due to its spray formulation.
• Typically, sildenafil spray acts faster than oral tablets.
• The spray is applied under the tongue for rapid effect.
• Dosage varies depending on individual health and response.
• It is important to follow prescribed instructions for safety.
• Sildenafil spray may cause side effects like headache or flushing.
• It should not be used with nitrates or certain medications.
• Long-term safety data on sildenafil spray is limited.
• It is prescribed by a healthcare professional.
• Always store sildenafil spray in a cool, dry place.

Fully push down (depress) the plunger of the oral dosing syringe. Then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface.

Does the spray have a taste?

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. Your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you. Do not take or give sildenafil for oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. Always use the oral dosing syringe that comes with sildenafil for oral suspension. If your carton does not come with an oral dosing syringe, contact your pharmacist. Turn the bottle upside down while holding the oral dosing syringe in place. Slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the mL marking on the syringe for your or your child’s prescribed dose. If your or your child's dose of sildenafil for oral suspension is more than 2 mL (20 mg), you will need to divide the dose.

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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. Patients were randomly assigned 1:1:1 to one of three treatment groups (5, 20, and 80 mg TID).

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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.

8.5 Geriatric Use

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. Follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. If you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil for oral suspension flows back into the bottle and repeat Step 4.

Turn the bottle back upright with the oral dosing syringe still in place.

Place the bottle on a flat surface. Remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (See Figure F) Do not press on the plunger of the oral dosing syringe at this time. Put the tip of the oral dosing syringe into your or your child's mouth and point it towards the inside of the cheek. Slowly push the plunger of the oral dosing syringe all the way down to give the entire dose.

• Sildenafil spray offers a non-invasive alternative to injections.
• It promotes blood flow to the penile area.
• The onset of action is usually faster than tablets.
• It is an option for men who dislike swallowing pills.
• The spray may reduce gastrointestinal discomfort.
• Consistent use without medical advice is discouraged.
• Dose titration might be necessary for effectiveness.
• It may be used in combination with other ED treatments.
• Possible side effects include nasal congestion or dizziness.
• Proper storage extends the shelf life of the spray.
• Contact a healthcare provider if adverse effects occur.

Do not squirt the medicine out quickly. If you are giving sildenafil for oral suspension to a child, make sure they are in an upright position before giving the medicine. Replace the cap on the bottle, leaving the bottle adaptor in place.

• Sildenafil spray is a modern alternative for ED therapy.
• It reduces the waiting time before sexual activity.
• The spray is generally well-tolerated with proper use.
• It might be prescribed for specific health conditions.
• The method of administration differs from oral tablets.
• Use of the spray should be coordinated with a doctor.
• It can be used alongside other treatments under supervision.
• The spray dose can be adjusted for optimal response.
• Patients should report any unusual symptoms promptly.
• Sildenafil spray offers privacy compared to other methods.
• Read all warnings and precautions on product packaging.

Turn the cap in the direction of the arrow (clockwise) to close the bottle.

6. Adverse Reactions/Side Effects

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). Hazard Ratios for Time to First Event of Clinical Worsening – Intent To Treat Population Note: Sildenafil 5 mg is not an approved dosage.

Are you currently using Sildenafil (Viagra, Revatio)?

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 200mg sildenafil citrate the first event of clinical worsening. c. Count of non-elective hospital stays for worsening PAH as the first event of clinical worsening.

6.1 Clinical Trials Experience

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. At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m.