Sildenafil 10 mg/ml Oral suspension

Pull the plunger out of the barrel and rinse both parts with water.

Dry all parts with a clean paper towel.

• 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.

Push the plunger back into the barrel.

Frequently asked questions

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. Recommended Storage for Sildenafil for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect from moisture.

Inclement Weather

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 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. 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.

2.3 Reconstitution of the Powder for Oral Suspension

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. Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. See the “Discard after” date written on the bottle label. Keep sildenafil for oral suspension and all medicines out of the reach of children. 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. Food and Drug Administration.

Uses of Sildenafil Oral Suspension:

Supplies you will need to take or give a dose of sildenafil for oral suspension (See Figure A): 1 bottle of sildenafil oral jelly 100mg lovegra 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. 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.

Alcohol interaction warning

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. Cialis vs Viagra - What's the difference between them? Do you know these 11 amazing facts about Viagra? Is generic Viagra available in the U.S.? 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. Obtain the required number of sildenafil citrate tablets or the required quantity of powder and place in a mortar. Pulverize the tablets, if used, to a fine powder.

Pregnancy & Lactation

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.

Sildenafil vs. tadalafil

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 oral suspension if the bottle adaptor is not in the bottle. 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. Add a small quantity of the Ora-Plus:Ora-Sweet mixture and mix to a smooth paste. Geometrically, add the remainder of the Ora-Plus:Ora-Sweet mixture to final volume and mix well. Use: Sildenafil citrate oral liquid has been used to treat pediatric pulmonary arterial hypertension in children in whom the risk-benefit profile of sildenafil is deemed acceptable. Packaging: Package in tight, light-resistant containers.1 Labeling: Keep out of reach of children. Stability: A beyond-use date of up to 91 days may be used for this preparation.1-4 Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).5 Discussion: A number of stability studies have been conducted on oral liquid formulations of sildenafil for pediatric use. From these, it appears that sildenafil is relatively stable in vehicles, with an acidic pH around 4 to 5.

5.4 Visual Loss

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

5.7 Priapism

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. 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. Sildenafil for oral suspension at 10 mg/mL (Revatio) is commercially available with a beyond-use date of 60 days after reconstitution.

Route of administration

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. e.

Other Medical Problems

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. 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)]. One study involved compounded sildenafil citrate in a citrate-buffered solution (0.1 M, pH 4) and either a syrup excipient (resulting in a suspension) or a sugar-free syrup excipient (resulting in a solution); both had pH values of approximately 4.2. Both the suspension and the solution were slightly pink and fruit-flavored.

8. Use In Specific Populations

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. Turn the cap in the direction of the arrow (clockwise) to close the bottle. Wash the oral dosing syringe after each use. The suspension demonstrated stability for 91 days at both 4°C and 25°C; however, the solution was stable only for 30 sildenafil tablets lp 100 mg days, possibly related to a nonredispersible sediment at the bottom of the container.3 A study by Nahata and colleagues that involved sildenafil citrate tablets (Revatio 20 mg) with a mixture of 1:1 Ora-Sweet and Ora-Plus at 2.5 mg/mL and pH 4.5-4.7 demonstrated stability of 91 days at both 4°C and 25°C.

• Sildenafil syrup is an off-label form of erectile dysfunction medication.
• It's designed for easier ingestion compared to tablets.
• Not approved by most regulatory agencies for syrup form.
• Dosing and safety information are less documented for syrup.
• Usually, sildenafil is available in tablet form, not syrup.

Also studied was a mixture of 1:7 (1% methyl cellulose:simple syrup) at pH 5.1 to 4.9 that also demonstrated stability of 91 days at both 4°C and 25°C.4 Sildenafil citrate (C22H30N6O4S.C6H8O7, MW 666.70) occurs as a white to off-white, crystalline powder that is soluble 3.5 mg/mL in water. It is formulated as tablets equivalent to 25 mg, 50 mg, and 100 mg of sildenafil for oral administration.