Clinical Trials and Efficacy Data

Relevance of this data to the neonatal population is unclear.

• Sildenafil citrate was first approved by the FDA in 1998.
• Its brand name is Viagra, but generic versions are available.
• The drug is available in tablets of various strengths, typically 25-100 mg.
• It can be prescribed for both men and in specific cases, women.
• Proper dosage varies based on health status and response.
• Use caution in patients with heart problems or low blood pressure.
• It is not a hormone or a testosterone booster.

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);

What Are Warnings and Precautions for Sildenafil?

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. 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.

Clinical monitoring

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. 29.8 ppm, p = 0.024). 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. A double-blind, placebo-controlled, crossover study evaluated sildenafil for symptomatic secondary Raynaud's phenomenon resistant to vasodilatory therapy. this dose has been proposed based on the results of an open-label, dose-escalation study in 36 term neonates.

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Very limited data are available; intermittent IV infusions have been used when oral intake was not possible in 3 neonates.

Storage Condition	Details	Temperature Range	Light Exposure	Humidity
Preferred Storage	Cool, dry place	15-30°C	Keep in original container	Avoid humidity
Keep away from light	Protect from direct sunlight	N/A	Yes	N/A
Out of reach of children	Safety precaution	N/A	N/A	N/A

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.

Dosage And Administration

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. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Revatio Injection

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. You can ask your healthcare provider or pharmacist for information about SILDENAFIL CITRATE TABLETS that is written for health professionals. The dose was gradually titrated up to 2 mg/kg/dose IV based on clinical response.

What is Sildenafil Citrate?

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. 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.

Off-Label Use and Dosage (Pediatric)

Add geometric amounts of the vehicle to the women sildenafil 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. Sildenafil injection is available as a ready to use solution; further dilution is not required.Administer as an IV bolus injection. 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).

Brand Name	Manufacturer	Formulation Type	Typical Dosage	Notes
Viagra	Pfizer	Tablet	25, 50, 100 mg	Most well-known brand
Revatio	Pfizer	Tablet	20 mg	For pulmonary hypertension
Sildenafil Citrate	Various generic manufacturers	Tablet	25, 50, 100 mg	Generic versions available
Kamagra	Ajanta Pharma	Oral Gel	100 mg	Used off-label in some countries

The third neonate (gestational age 25 weeks, postnatal age 18.6 weeks) was receiving oral sildenafil 1.67 mg/kg/dose PO every

2. Upsides

For more 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. For current full prescribing information, please visit Cardura (doxazosin mesylate), and Minipress (prazosin HCl) are registered trademarks of Pfizer Inc.

What should I do if I miss a dose of sildenafil?

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. Oral suspension (e.g., Liqrev)Storage: Store at room temperature of 20 to 25 degrees C (68 to 77 degrees F). 6 hours and was converted to sildenafil 1.25 mg/kg/dose IV every 6 hours when she became "nothing-by-mouth" (NPO) status. All 3 neonates were also receiving inhaled nitric oxide at the time of sildenafil initiation.

Frequently asked questions

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. May increase the dose up to 100 mg PO as needed approximately 1 hour before sexual activity.

How it works

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. A maximum dose in pediatric patients has not been identified. 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. The duration of treatment ranged from 6 to 51 days, and respiratory support was able to be decreased over time in all patents.

• Some users report headaches and dizziness after taking sildenafil.
• A common side effect is facial flushing and nasal congestion.
• Rare side effects include sudden hearing loss or vision loss.
• Priapism requires urgent medical attention to prevent tissue damage.
• Sudden vision loss should be immediately evaluated by a doctor.
• Allergic reactions such as rash, hives, or swelling are possible.
• Discontinue use and seek medical help if serious side effects occur.

Hepatic dosing adjustments for adults with erectile dysfunction:Consider a starting dose of 25 mg in adults with any degree of hepatic impairment.Hepatic

Side Effects

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 sildenafil 100 mg tab 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 vasodilatory therapy.

Most Recent Events

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. 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. dosing adjustments for patients with pulmonary hypertension:No adjustment needed for adults with mild to moderate hepatic impairment (Child Pugh class A or B).

• 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.

The effect of severe hepatic impairment (Child Pugh class C) has not been studied.

• Sildenafil citrate is a medication used primarily for erectile dysfunction.
• It works by relaxing blood vessels to increase blood flow.
• Sildenafil is also prescribed for pulmonary arterial hypertension.
• Common side effects include headache, flushing, and nasal congestion.
• It should be taken 30-60 minutes before sexual activity.
• Alcohol and high-fat meals can reduce its effectiveness.
• Do not take with nitrate medications due to risk of severe hypotension.