Sildenafil (Page 5 of 6)
16 HOW SUPPLIED/STORAGE AND HANDLING
Sildenafil powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the total volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.
Sildenafil for Oral Suspension, 10 mg/mL | ||
Package Configuration | Strength | NDC |
Powder for oral suspension — 125 mL Amber Glass Bottle | 10 mg/mL (when reconstituted) | 70954-168-10 |
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°C to 8°C (36°F to 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.
17 PATIENT COUNSELLING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
- Inform patients of contraindication of sildenafil 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 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. 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. These events may be accompanied by tinnitus and dizziness.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Novitium Pharma LLC.
Manufactured by:
Novitium Pharma LLC,
70 Lake Drive, East Windsor
New Jersey 08520
LB4137-03
Revised: 01/2024
PATIENT INFORMATION
Sildenafil (sil den’ a fil) for oral suspension |
What is the most important information I should know about sildenafil for oral suspension? Never take sildenafil for oral suspension with any nitrate or guanylate cyclase stimulator medicines.
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What is sildenafil for oral suspension? Sildenafil for oral suspension is a prescription medicine used to treat pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. Sildenafil for oral suspension may be used in:
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Do not take sildenafil for oral suspension if you:
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Before taking sildenafil for oral suspension, tell your healthcare provider about all of your medical conditions, including if you:
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How should I take sildenafil for oral suspension?
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What are the possible side effects of sildenafil for oral suspension? Sildenafil for oral suspension may cause serious side effects, including:
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How should I store sildenafil for oral suspension?
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General information about the safe and effective use of sildenafil for oral suspension. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use sildenafil for oral suspension for a condition for which it was not prescribed. Do not give sildenafil for oral suspension to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about sildenafil for oral suspension that is written for health professionals. |
What are the ingredients in sildenafil for oral suspension? Active ingredients: sildenafil citrateInactive ingredients:Sildenafil for oral suspension: sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide, sodium benzoate, colloidal silicon dioxide anhydrous and grape flavor.Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) for Oral Suspension. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Novitium Pharma LLC.Manufactured by:Novitium Pharma LLC, 70 Lake Drive, East WindsorNew Jersey 08520 |
This Patient Information has been approved by the U.S. Food and Drug Administration.
LB4137-03
Revised: 01/2024
Instructions for Use
Sildenafil (sil den’ a fil)
for oral suspension
Read this Instructions for Use before you start taking sildenafil oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Important information:
- Ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension.
- Your pharmacist will mix (reconstitute) sildenafil oral suspension before it is given to you. Do not take or give sildenafil 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 oral suspension. If your carton does not come with an oral dosing syringe, contact your pharmacist.
- Do not take or give sildenafil oral suspension if the bottle adaptor is not in the bottle. If the bottle adaptor is not in the bottle, contact your pharmacist.
- Sildenafil oral suspension should not be mixed with any other medicine or flavoring.
Supplies you will need to take or give a dose of sildenafil oral suspension (See Figure A):
- 1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor
- 1 oral dosing syringe (provided in the carton)
Step 1. Shake the bottle of sildenafil oral suspension for 10 seconds before each use. (See Figure B)
Step 2. Remove the cap. Open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). (See Figure C)
Step 3. 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. (See Figure D)
Step 4. 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 prescribed dose. (See Figure E)
If your dose of sildenafil oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil oral suspension.
If your dose of sildenafil 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 oral suspension flows back into the bottle and repeat Step 4.
Step 5. 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.
Step 6. Put the tip of the oral dosing syringe into your 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. (See Figure G)
If you are giving sildenafil oral suspension, make sure they are in an upright position before giving the medicine.
Step 7. 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. (See Figure H)
Step 8. Wash the oral dosing syringe after each use. Pull the plunger out of the barrel and rinse both parts with water. (See Figure I)
Step 9. Dry all parts with a clean paper towel. Push the plunger back into the barrel. Store the oral dosing syringe with the sildenafil oral suspension bottle.
How should I store sildenafil oral suspension?
- Store mixed (reconstituted) sildenafil oral suspension below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C).
- Do not freeze mixed sildenafil oral suspension.
- 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.
Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) for Oral Suspension. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Novitium Pharma LLC.
Manufactured by:
Novitium Pharma LLC,
70 Lake Drive, East Windsor
New Jersey 08520
This Instruction for Use has been approved by the U.S. Food and Drug Administration.
LB4137-03
Revised: 01/2024
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.