13 NONCLINICAL TOXICOLOGY

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. 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.

Uses of Sildenafil Oral Suspension:

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. 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.

8.7 Patients with Renal Impairment

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. 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.

What should I know about sildenafil before taking it?

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. 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.

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.

• Sildenafil syrup may be preferred for those with swallowing issues.
• It can be mixed with water or other liquids if approved by a doctor.
• The taste of the syrup might require flavoring agents.
• There's limited data on the stability of sildenafil syrup long-term.
• Use of sildenafil in women is not approved and not well-studied.

Replace the cap sildenafil tablets 125 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.

5. Warnings and Precautions

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. Any remaining oral suspension should be discarded 60 days after reconstitution.

Dosage Forms and Strengths

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. Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil for oral suspension.

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

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. Distributed by: Aurobindo Pharma USA, Inc. Dry all parts with a clean paper towel.

8 USE IN SPECIFIC POPULATIONS

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.

Missed Dose

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. 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.

Description of Services

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 tablet sildenafil 50 mg 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). 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). Do not freeze mixed sildenafil oral suspension. Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist.

• 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.

See the “Discard after” date written on the bottle label. Keep sildenafil for oral suspension and all medicines out of the reach of children.

13 NONCLINICAL TOXICOLOGY

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 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.

Incidence not known

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. Do not take or give sildenafil for lovegra sildenafil oral suspension if the bottle adaptor is not in the bottle. Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown RoadEast Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India This Instructions for Use has been approved by the U.S.

• Investigational drugs or supplements claim to mimic sildenafil effects.
• The safety of homemade sildenafil syrup is not guaranteed.
• Pharmacovigilance involves monitoring adverse effects.
• Patients should inform providers of all medications taken.
• Regulatory oversight ensures quality and efficacy of medications.

Food and Drug Administration.

• Sildenafil has been investigated for alternative uses like altitude sickness.
• The syrup form is rarely available in commercial pharmacies.
• Reactions to sildenafil can vary based on individual health.
• Do not share sildenafil syrup with others to avoid adverse effects.
• Always adhere to prescribed dosages to prevent health risks.

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Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Mix 50 mL of Ora-Plus with 50 mL of Ora-Sweet for use as the vehicle in this preparation.

Uses of Sildenafil For Oral Suspension

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 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. Obtain the required number of sildenafil citrate tablets or the required quantity of powder and place in a mortar.