FULL PRESCRIBING INFORMATION: CONTENTS*
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.
| Tip | Explanation | Goal |
|---|---|---|
| Follow dosage instructions | Take exactly as prescribed | Prevent side effects or interactions |
| Be aware of side effects | Recognize common side effects and when to seek help | Ensure safety |
| Avoid alcohol and heavy meals | May decrease effectiveness or increase side effects | Maximize efficacy |
| Report health issues | Communicate with doctor about any adverse reactions or concerns | Maintain safety and treatment efficacy |
Do not take or give sildenafil for oral suspension if the bottle adaptor is not in the bottle.
- Sildenafil use should be disclosed to your healthcare provider.
- Not suitable for men with severe cardiovascular conditions.
- Ask about possible drug interactions before starting.
- Adjustments may be needed for older adults.
- Timing of medication is important for maximum effect.
- Monitoring for side effects helps prevent complications.
- Stop using sildenafil if health issues arise.
- Always follow professional medical advice.
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. Supplies you will sildenafil pink pill 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. Open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). Fully push down (depress) the plunger of the oral dosing syringe.
Adverse effects
Patients (38% male and 62% female) had body weight ≥ 8 kg and had idiopathic pulmonary arterial hypertension (33%), or PAH associated with congenital heart disease (systemic-to-pulmonary shunt 37%, surgical repair 30%). In this trial, 27% of patients were < 7 years old. The primary objective of the study was to assess the effect of sildenafil 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). 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.
Altitude sickness
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. 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).
How sildenafil is used
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. 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. 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”, sildenafil 45 mg chewable tablets thus might include deaths occurred after discontinuation from study treatment. Then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface. 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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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.
503A vs 503B
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.
Risk Summary
Any remaining oral sildenafil 12 5 mg 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. 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.
What Is the Maximum Safe Sildenafil Dosage?
Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil for oral suspension. The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. 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. 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.
Drug Label Information
Instructions for Use Sildenafil (sil den' a fil) Read this Instructions 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. 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. Slowly push the plunger of the oral dosing syringe all the way down to give the entire dose. 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.
6.2 Post-marketing Experience
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. Abbreviations: 6MWD = 6-minute walk distance; CI = confidence interval; PAH = pulmonary arterial hypertension.
Viagra form
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. Count of non-elective hospital stays for worsening PAH as the first event of clinical worsening. d.
Marketing and sales
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. 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). Replace the cap on the bottle, leaving the bottle adaptor in place. Turn the cap in the direction of the arrow (clockwise) to close the bottle. Wash the oral dosing syringe after each use. Pull the plunger out of the barrel and rinse both parts with water. Dry all parts with a clean paper towel. Push the plunger back into the barrel. Store the oral dosing syringe with the sildenafil for oral suspension bottle. How should I store sildenafil oral suspension? Store mixed (reconstituted) sildenafil oral suspension below 30°C (86°F) or in a refrigerator between 2° to 8°C (36° to 46°F).
- Sildenafil is sometimes used off-label for other health issues.
- Its interaction with blood thinners should be monitored.
- Men with retinitis pigmentosa should avoid sildenafil.
- Always inform healthcare providers about all treatments.
- Use sildenafil in conjunction with a healthy lifestyle.
- Avoid unnecessary medication to prevent side effects.
- Be aware of potential drug interactions with sildenafil.
- Proper storage maintains medication efficacy over time.
Do not freeze mixed sildenafil oral suspension. Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist.
- For best results, take sildenafil on an empty stomach.
- Eating fatty foods may delay its onset.
- The medication should be taken approximately 30 minutes before activity.
- Do not double dose to compensate for missed doses.
- Keep regular medical appointments during treatment.
- Report any worsening of symptoms to your doctor.
- Never use sildenafil if experiencing chest pain without medical guidance.
- Always follow the prescribed health regimen.
See the “Discard after” date written on the bottle label.
| Storage Condition | Details | Recommended Temperature |
|---|---|---|
| Temperature | Store in a cool, dry place | 20-25°C |
| Container | Keep in original packaging to prevent moisture | Airtight container |
| Light Exposure | Protect from direct sunlight | Yes |
| Expiry Date | Check before use | Typically 2-3 years |