May increase the dose up to 100 mg PO as needed approximately 1 hour before sexual activity.
- The medication is classified as a controlled substance in some jurisdictions.
- Over-reliance on sildenafil without addressing underlying causes is discouraged.
- Psychological counseling may benefit some patients with ED.
- Detailed medical history helps determine if sildenafil is safe.
- Education on possible side effects improves patient safety.
- The drug does not cause dependency.
- Proper use ensures maximum therapeutic benefit and safety.
Dose may be titrated as needed based on symptoms and tolerability to a maximum of 80 mg PO 3 times daily. Although dose-response improvement in exercise ability was not observed in short-term clinical trials in adults with pulmonary hypertension, the delay in clinical worsening with long-term use of sildenafil in a clinical trial supports dosing up to a maximum of 80 mg PO 3 times daily.
| Condition | Description | Recommended Dosage | Notes |
|---|---|---|---|
| Erectile Dysfunction (ED) | Difficulty achieving or maintaining an erection | 50 mg before activity | Can be adjusted based on response |
| Pulmonary Arterial Hypertension | High blood pressure in lungs | 20 mg three times daily | Prescribed under medical supervision |
| Off-label uses | Other potential uses | Varies | Use under healthcare provider guidance |
A maximum dose in pediatric patients has not been identified.
What Other Drugs Interact with Sildenafil?
The most common side effects of SILDENAFIL CITRATE TABLETS are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking SILDENAFIL CITRATE TABLETS. Most, but not all, of these men had heart problems before taking SILDENAFIL CITRATE TABLETS. It is not known if SILDENAFIL CITRATE TABLETS caused these problems. These are not all the possible side effects of SILDENAFIL CITRATE TABLETS. For more information, ask your healthcare provider or pharmacist.
Serious Adverse Effects
You may report side effects to FDA at 1-800-FDA-1088. How should I store SILDENAFIL CITRATE TABLETS? Store SILDENAFIL CITRATE TABLETS at room temperature between 68°F to 77°F (20°C to 25°C). Keep SILDENAFIL CITRATE TABLETS and all medicines out of the reach of children. General information about the safe and effective use of SILDENAFIL CITRATE TABLETS. Based on experience in adults, the dose may be titrated as needed to a maximum of 40 mg PO 3 times daily based on symptoms and tolerability. Avoid higher dosing due to a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy. 0.5 to 1 mg/kg/dose PO every 8 hours. Prior to the release of pediatric pulmonary hypertension guidelines, the generally accepted dose of sildenafil was 0.5 to 2 mg/kg/dose every 6 to 8 hours, with some regimens, particularly those described in earlier reports, administering doses every 4 hours; however, guidelines recommend more conservative dosing based on a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy, as seen in the STARTS-2 trial.
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Relevance of this data to the infant population is unclear. 0.22 to 0.5 mg/kg/dose PO as a single dose 1 hour prior to discontinuing iNO or 4 times daily. None of the 15 patients receiving a single sildenafil dose of 0.3 to 0.5 mg/kg/dose PO 1 hour prior to discontinuation of iNO experienced rebound pulmonary hypertension compared to 10 of 14 patients receiving placebo. In 7 patients receiving sildenafil 0.22 to 0.47 mg/kg/dose PO 4 times daily, mean iNO dose was significantly reduced compared to baseline within 24 hours of sildenafil initiation (12.2 vs.
1. How it works
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SILDENAFIL CITRATE TABLETS for a condition for which it was not prescribed. Do not give SILDENAFIL CITRATE TABLETS to other people, even if they have the same symptoms that you have. This Patient Information leaflet summarizes the most important information about SILDENAFIL CITRATE TABLETS. If you would like more information, talk with your healthcare provider.
Vitamin K Antagonists
You can ask your healthcare provider or pharmacist for information about SILDENAFIL CITRATE TABLETS that is written for health professionals. For more sildenafil citrates information, go to or call 1-800-438-1985 What are the ingredients in SILDENAFIL CITRATE TABLETS? This Patient Information has been approved by the U.S. Food and Drug Administration. This product's label may have been updated. 29.8 ppm, p = 0.024).
What to avoid
For current full prescribing information, please visit Cardura (doxazosin mesylate), and Minipress (prazosin HCl) are registered trademarks of Pfizer Inc. The other brands listed are trademarks of their respective owners and are not trademarks of Pfizer Inc. The makers of these brands are not affiliated with and do not endorse Pfizer Inc or its products. Phosphodiesterase Inhibitors for EDPhosphodiesterase Inhibitors for PAH May be administered without regard to meals. Shake well for at least 10 seconds prior to each administration.Measure dose with an oral dosing syringe or calibrated measuring device.Concentration of the suspension is 10 mg/mL.
Special Populations
Oral suspension (e.g., Liqrev)Storage: Store at room temperature of 20 to 25 degrees C (68 to 77 degrees F). Discard any unused portion after 90 days of opening the bottle.Powder for oral suspension (e.g., Revatio or generic equivalents)):Do not mix with any other medication or additional flavoring agent.Prior to reconstitution, tap the bottle to loosen the powder.Reconstitute with a total of 90 mL of water added in 2 portions. Initially, add 60 mL of water to the bottle and shake vigorously for at least 30 seconds. Add the remaining 30 mL of water and shake vigorously for at least 30 seconds.Remove the cap and press the adaptor for the oral syringe into the neck of the bottle; replace cap.Write an expiration date of 60 days from the date of reconstitution on the bottle label.Storage: Store below 30 degrees C (86 degrees F) or in refrigerator at 2 to 8 degrees C (36 to 46 degrees F). Discard any unused portion after 60 days. Guidelines recommend sildenafil use to prevent rebound pulmonary hypertension and facilitate iNO weaning in patients with evidence of increased pulmonary artery pressure upon iNO withdrawal; however, they do not provide specific dosing. Recommended maintenance dosing for pulmonary hypertension is 0.5 to 1 mg/kg/dose PO 3 times daily in persons younger than 1 year, 10 mg PO 3 times daily in persons weighing 20 kg or less, and 20 mg PO 3 times daily in persons weighing more than 20 kg.
Warnings & Precautions
Extemporaneous 2.5 mg/mL sildenafil oral suspension:NOTE: Extemporaneously prepared sildenafil oral suspension is not approved by the FDA; an FDA-approved powder for oral suspension is now commercially available.With a mortar and pestle, grind thirty 25-mg sildenafil citrate tablets to a fine powder.In a separate container, mix 1 of the following: 1) 150 mL of Ora-Sweet with 150 mL of Ora-Plus; or 2) 150 mL of Simple Syrup, NF with 150 mL of methylcellulose 1%.Add a small amount of the mixture to the fine powder and mix into a uniform paste. Add geometric amounts of the vehicle to the almost desired volume while mixing. Transfer to a graduated cylinder and adjust to volume while mixing.Place in amber plastic bottles. Shake well before each use.Storage: This suspension is stable for 91 days when stored at 4 and 25 degrees C. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
How can I get Viagra to work?
Sildenafil women sildenafil injection is available as a ready to use solution; further dilution is not required.Administer as an IV bolus injection. May decrease the dose to 25 mg or increase the dose to 100 mg PO as needed approximately 1 hour before sexual activity. The dose may be taken from 30 minutes to 4 hours before sexual activity. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. 25 mg PO as needed approximately 1 hour before anticipated sexual activity. A double-blind, placebo-controlled, crossover study evaluated sildenafil for symptomatic secondary Raynaud's phenomenon resistant to vasodilatory therapy. Patients (n = 18, 15 were female) were randomly assigned to receive placebo or sildenafil 50 mg PO twice daily for 4 weeks; a washout period of 1 week was used before crossover. The results showed that sildenafil significantly improved microcirculation and symptoms associated with Raynaud's. In patients with chronic digital ulcerations, sildenafil treatment resulted in healing of trophic lesions which reappeared or progressed when sildenafil was stopped. Ulcerations did not heal while receiving placebo. Sildenafil therapy may be an alternative therapy in patients with Raynaud's resistant to sildenafil 100mg blue pill vasodilatory therapy. 50 mg PO every 8 hours starting the day before ascent and continuing for 5 days after reaching the target altitude or until descent is initiated as an alternative to nifedipine. Prophylactic medications should only be considered for individuals with a prior history of high altitude pulmonary edema.
- Sildenafil is available in most countries through prescription only.
- It is used worldwide, with varying approval statuses.
- FDA and EMA have rigorous testing standards for sildenafil.
- Using the drug responsibly can lead to successful treatment outcomes.
- Combining sildenafil with other medications requires medical supervision.
- Be aware of the potential for drug interactions with heart or blood pressure meds.
- Always consult a healthcare professional for personalized advice.
Delay use in extremely premature infants until retinal vascularization is established. The pharmacokinetics of sildenafil are highly variable in neonates; careful dose titration and monitoring is recommended. Prior to the release of pediatric pulmonary hypertension guidelines, the generally accepted dose of sildenafil was 0.5 to 2 mg/kg/dose every 6 to 8 hours, with doses ranging up to 3 mg/kg/dose every 6 hours ; however, guidelines recommend more conservative dosing based on a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy, as seen in the STARTS-2 trial. Relevance of this data to the neonatal population is unclear.
- Sildenafil is not recommended for children or minors.
- Elderly patients may need lower doses due to sensitivity.
- Use with caution if you have a history of stroke or unstable angina.
- Combining sildenafil with other ED drugs increases side effects risks.
- Be aware of counterfeit or substandard sildenafil products.
- Always purchase medication from reputable pharmacies.
- Consult a healthcare professional prior to initiating therapy.
0.4 mg/kg IV loading dose over 3 hours followed by a continuous infusion of 0.067 mg/kg/hour (1.6 mg/kg/day); this dose has been proposed based on the results of an open-label, dose-escalation study in 36 term neonates.
| Contraindication | Explanation | Severity Level | Notes |
|---|---|---|---|
| Nitrates use | Can cause severe hypotension | Critical | Avoid concomitant use |
| Heart conditions | Risk of cardiovascular events | Moderate | Consult healthcare provider |
| Hypotension | Low blood pressure | Moderate | Use with caution |
| Retinal Disorders | Potential for vision impairment | Mild | Seek medical advice |
Very limited data are available; intermittent IV infusions have been used when oral intake was not possible in 3 neonates. An initial dosage of 0.4 to 0.5 mg/kg/dose IV every 6 hours (infused over 3 hours) was given to 2 term neonates with pulmonary hypertension secondary to congenital diaphragmatic hernia. The dose was gradually titrated up to 2 mg/kg/dose IV based on clinical response. For doses less than 1.5 mg/kg/dose IV, the infusion time was gradually decreased to over 1 hour (weaned by 1 hour every 36 to 48 hours). The third neonate (gestational age 25 weeks, postnatal age 18.6 weeks) was receiving oral sildenafil 1.67 mg/kg/dose PO every 6 hours and was converted to sildenafil 1.25 mg/kg/dose IV every 6 hours when she became "nothing-by-mouth" (NPO) status.
| Property | Description | Value | Units |
|---|---|---|---|
| Molecular Weight | The mass of one mole of sildenafil citrate | 474.58 | g/mol |
| Chemical Formula | Molecular composition | C22H30N6O4S | |
| Solubility | Water solubility | Slightly soluble | at 25°C |
| pH of Solution | Typical pH when dissolved in water | 3.8 - 4.2 | |
| Melting Point | The temperature at which it melts | 196 - 198 | °C |