3 DOSAGE FORMS & STRENGTHS
Talk to your pharmacist or care team if you have questions.
Society and culture
See the detailed Instructions for Use that comes with sildenafil for oral suspension for information on how to take or give sildenafil oral suspension.Sildenafil oral suspension will be mixed for you by your pharmacist. If you take too much sildenafil for oral suspension, call your healthcare provider or go to 20mg sildenafil the nearest hospital emergencyroom right away. Sildenafil for oral suspension may cause serious side effects, including: See "What is the most important information I should know about sildenafil for oral suspension?" Decreased blood pressure.Sildenafil for oral suspension may cause low blood pressure that last for a short time. Decreased eyesight or permanent loss of vision in one or both eyescan be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). The most common side effects of sildenafil for oral suspension in adults include: getting red or hot in the face (flushing) These are not all the possible side effects of sildenafil for oral suspension.
8.2 Lactation
You may report side effects to FDA at 1 -800-FDA-1088. See the "Discard after" date written on the bottle label. General information about the safe and effective use of sildenafil for oral suspension Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. For more information, go to or call 1-800-399-2561. Inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide and xanthan gum Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets.
Dosage for pulmonary arterial hypertension (PAH)
This Patient Information has been approved by the U.S. Food and Drug Administration The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. 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. Do nottake or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. Do nottake or give sildenafil oral suspension if the bottle adaptor is not in the bottle. Talk to your care team about the use of this medication in children.
| Condition | Details | Remarks |
|---|---|---|
| Temperature | Store between 15°C to 30°C | Protect from excessive heat |
| Light Exposure | Keep in a dark place or in opaque container | Protect from light |
| Humidity | Avoid high humidity environments | Prevent product degradation |
| Shelf Life | Typically 2 years from manufacturing date | Check expiry date before use |
While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.
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Overdosage: If you think you have taken too much of this
| Precaution/Contraindication | Details | Advice |
|---|---|---|
| Nitrate use | Contraindicated with sildenafil | Risk of severe hypotension |
| Cardiovascular disease risk | Use with caution | Consult cardiologist before use |
| Liver or kidney impairment | Dose adjustment needed | Monitor liver/kidney function tests |
| Allergies to sildenafil or excipients | Check ingredients before administration | Discontinue if allergic reactions occur |
medicine contact a poison control center or emergency room at once.
What are some side effects that I need to call my doctor about right away?
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. Do not freeze mixed sildenafil oral suspension Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. This product's label may have been updated. For current full prescribing information, please visit SILDENAFIL - sildenafil citrate for suspension ANI Pharmaceuticals, Inc. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information The recommended dosage of sildenafil for oral suspension is 20 mg three times a day.
Prior authorization
Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. SILDENAFIL (sil DEN a fil) treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing your blood vessels and lowering the blood pressure in your lungs, which makes it easier for your heart to pump blood to the rest of your body. NOTE: This medicine is only for you.
- Sildenafil syrup can cause side effects like headaches, flushing, or dizziness.
- Combining sildenafil syrup with nitrates can be dangerous.
- The syrup's consistency may vary; formulation stability is key.
- Misuse or overdose can lead to serious cardiovascular issues.
- Always consult a doctor before using sildenafil syrup.
Do not share this medicine with others.
- Manufacturing of sildenafil syrup requires specialized equipment.
- The syrup form must undergo stability testing before release.
- Some formulations may include sweeteners to improve taste.
- Off-label compounding can carry legal and safety risks.
- Clinicians should carefully consider risks before prescribing syrup.
If you miss a dose, take it as soon as you can.
2.1 Recommended Dosage in Adults
You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. If it is almost time for your next dose, take only that dose.
11. Sildenafil Oral Suspension Description
In a rat pre-and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m2 basis). The safety and efficacy of Sildenafil have been established in pediatric patients younger than 1 year of age. Clinical studies of sildenafil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white or almost white, slightly hygroscopic, crystalline powder and a molecular weight of 666.7. Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to1.12 g sildenafil) in an amber glass bottle intended for reconstitution.
Professional resources
After chronic dosing of 80 mg three times a day to patients with PAH, no clinically relevant effects on electrocardiogram (ECG). SUPER-1 (NCT00644605) - Sildenafil monotherapy [20 mg, 40 mg, and 80 mg three times a day] A randomized, double-blind, placebo-controlled study of Sildenafil (SUPER-1)was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥ 25 mmHg at rest with a pulmonary capillary wedge pressure <15 mmHg). Patients were randomized to receive placebo (n=70) or Sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. The improvement in walk distance was apparent after 4 Week of treatment and was maintained at week 8 and week 12. PACES-1 (NCT00159861) - Sildenafil Co-administered with Epoprostenol A randomized, double-blind, placebo controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol.
How is sildenafil supplied (dosage forms)?
Table 4 displays the number of patients with clinical worsening events in (PACES-1). Kaplan- Meier plot of time to clinical worsening is presented in Figure 5. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5 to 125 mg twice a day).The primary efficacy endpoint was the change from baseline at Week 12 in 6-minute walk distance (6MWD). Each bottle contains white to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Store below 30°C (86°F) or in refrigerator at 2° to 8°C (36° to 46°F). Do not take double or extra doses.
Further information
It can also help you breathe easier and be more active. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. They need to know if you have any of these conditions: History of blood diseases, such as sickle cell anemia or leukemia Stomach ulcers, other stomach or intestine problems An unusual or allergic reaction to sildenafil, other medications, foods, dyes, or preservatives Take it as directed on the prescription label at the same time every day. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Do not mix this medication with other medications or flavoring. Do not take this medication with any of the
- 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.
following: Nitrates, such as amyl nitrite, isosorbide dinitrate, isosorbide
- Contraindications include hypersensitivity to sildenafil.
- Patients with heart conditions should consult a cardiologist before use.
- Sildenafil’s safety profile is well-studied in adults.
- The syrup should not be used with children without medical advice.
- Proper disposal of unused syrup is important to avoid misuse.
mononitrate, nitroglycerin This medication may also interact with the
| Country | Approval Status | Regulatory Body | Remarks |
|---|---|---|---|
| United States | Approved for pulmonary hypertension, off-label for ED | FDA | Prescription medication |
| European Union | Approved with similar indications | EMA | Prescription required |
| India | Approved for ED and pulmonary hypertension | CDSCO | Over the counter in some regions |
| Canada | Approved, prescription-only | Health Canada | Strict prescribing guidelines |
following: Other medications may affect the way this medication works.
5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease
The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. Sildenafil (Sil-DEN-a-fil) for Oral Suspension What is the most important information I should know about sildenafil for oral suspension? Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called "poppers" (amyl nitrate, butyl nitrate or nitrite) Riociguat ,a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
Dosage Forms and Strengths
Ask your healthcare provider or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. See "What are the possible side effects of Sildenafil for oral suspension?" Before taking sildenafil for oral suspension, tell your healthcare provider about all of your medical conditions, including if you: have bleeding problems or a stomach (peptic) ulcer. have an eye problem called retinitis pigmentosa have ever had sudden loss of vision in one or both eyes, including an eye problem called non-arteritic anterior have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing have a deformed penis shape or Peyronie's disease have any blood cell problems such as sickle cell anemia are pregnant or plan to become pregnant. Sildenafil for oral suspension passes into your breast milk. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
5.2 Worsening Pulmonary Vascular Occlusive Disease
Sildenafil for oral suspension and certain other medicines may affect each other and can cause side effects Especially tell your healthcare provider if you take: See "What is the most important information I should know aboutsildenafil for oral suspension?" Do nottake VIAGRA or other PDE-5 inhibitors during treatment with sildenafil for oral suspension. Keep a list of your or your child's medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider may change your dose of sildenafil for oral suspension as needed. Sildenafil may be prescribed to you as sildenafil oral suspension. Take your prescribed dose of sildenafil for oral suspension 3 times a day.