VIAGRA 100mg. Tablets.
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Description
Sildenafil 100mg.
DESCRIPTION
Oral phosphodiesterase-5 (PDE5) inhibitor
Used for erectile dysfunction (ED or impotence) and for pulmonary arterial hypertension
Contraindicated for use in patients on nitrate therapy due to the risk of cardiovascular adverse events
COMMON BRAND NAMES
Revatio, Viagra
HOW SUPPLIED
Revatio Oral Pwd F/Recon: 1mL, 10mg
Revatio/Sildenafil/Sildenafil Citrate Intravenous Inj Sol: 0.8mg, 1mL
Revatio/Sildenafil/Sildenafil Citrate/Viagra Oral Tab: 20mg, 25mg, 50mg, 100mg
DOSAGE & INDICATIONS
In a pilot study, sildenafil (25 mg PO once daily at night) combined with alfuzosin (10 mg PO once daily after the same meal) proved to be more effective than monotherapy with either agent for improving both voiding and sexual function in men with ED and LUTS suggestive of benign prostatic hyperplasia (BPH). Marked improvements in International Prostate Symptom Scores (IPSS) were noted with the combination compared to each agent alone. As expected, alfuzosin monotherapy significantly improved urinary frequency, nocturia, maximum urinary flow rate (Qmax), and postvoid residual urine (PVRU) volume whereas sildenafil showed minimal or no significant impact. Monotherapy with sildenafil showed significant improvements in erectile function whereas alfuzosin showed only a trend for improvement. The combination of sildenafil and alfuzosin, however, showed the most improvement in LUTS and erectile function compared to monotherapy with each agent. Interestingly, another study reported that sildenafil monotherapy improved LUTS but had no effect on Qmax.
50 mg PO, approximately 1 hour prior to sexual activity, up to once daily. The dose may be taken from 0.5 to 4 hours before sexual activity. Increase up to 100 mg or decrease to 25 mg based on clinical response. Maximum dosing frequency is once daily. PDE5 inhibitors are first line agents for ED according to guidelines. Although associated with high rates of success, approximately 35% of ED patients fail to respond to PDE5 inhibitor therapy. A course of an alternate PDE5 inhibitor may be considered if a patient does not respond to a PDE5 inhibitor trial; a treatment failure may be deemed after at least 4 unsuccessful trials. Patients refractory to PDE5 inhibitors should be counseled on appropriate use, potentially modifiable factors (e.g., hormonal abnormalities, food or drug interactions, lack of adequate sexual stimulation, heavy alcohol use, and the patient’s relationship with his partner), and the risks and benefits of other therapies. Second-line treatment options include intracavernous injection and intra-urethral therapy. Follow-up visits for ED patients, regardless of therapy, are necessary to determine whether therapy continues to be effective and whether cardiovascular health has significantly changed.
25 mg PO, approximately 1 hour prior to sexual activity, up to once daily.
25 mg PO, approximately 1 hour prior to sexual activity, up to once daily. In patients receiving sildenafil with ritonavir, the maximum dosing frequency is every 48 hours.
NOTE: Studies establishing effectiveness were short-term (12 to 16 weeks) and included predominately patients with NYHA Functional Class II-III symptoms and idiopathic etiology (71%) or pulmonary hypertension associated with connective tissue disease (25%).
5 mg or 20 mg PO 3 times per day. It is recommended that doses be taken approximately 4 to 6 hours apart. Doses greater than 20 mg PO 3 times per day are not recommended by the manufacturer. In clinical trials, sildenafil improved exercise capacity, WHO functional class, and hemodynamics; no greater efficacy was achieved with the use of higher doses. In addition to improved exercise capacity and hemodynamic parameters, sildenafil (initiated at 20 mg 3 times daily, titrated to 40 to 80 mg 3 times daily) plus long-term epoprostenol therapy also resulted in delayed time to clinical worsening during clinical studies. Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity.
Sildenafil injection is intended for the continued treatment of patients with PAH who are currently prescribed oral sildenafil and are temporarily unable to tolerate oral medication.
2.5 mg or 10 mg IV bolus 3 times per day. The dose does not need to be adjusted for body weight.
20 mg PO 3 times daily. Monitor patients carefully. Avoid higher dosing due to a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy. A randomized, double-blind, placebo-controlled, dose-escalation study in 234 patients 1 to 17 years evaluated the effect of low (10 mg PO 3 times daily), medium (10 to 40 mg PO 3 times daily based on weight), and high (20 to 80 mg PO 3 times daily based on weight) doses of sildenafil on peak oxygen consumption (primary endpoint), functional class, and hemodynamics. After 16 weeks, the low dose did not result in improvement in these outcomes, and interim data from an extension study showed increased mortality risk after 3 years or more of treatment with high doses. The study protocol was altered at the point of the interim analysis of the extension study to the following weight-based dosage: 10 mg PO 3 times per day in patients weighing 8 to 20 kg, 10 to 20 mg PO 3 times per day in patients weighing 21 to 45 kg, and 20 mg PO 3 times per day in patients weighing more than 45 kg.
10 mg PO 3 times daily. Monitor patients carefully. Avoid higher dosing due to a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy. A randomized, double-blind, placebo-controlled, dose-escalation study in 234 patients 1 to 17 years evaluated the effect of low (10 mg PO 3 times daily), medium (10 to 40 mg PO 3 times daily based on weight), and high (20 to 80 mg PO 3 times daily based on weight) doses of sildenafil on peak oxygen consumption (primary endpoint), functional class, and hemodynamics. After 16 weeks, the low dose did not result in improvement in these outcomes, and interim data from an extension study showed increased mortality risk after 3 years or more of treatment with high doses. The study protocol was altered at the point of the interim analysis of the extension study to the following weight-based dosage: 10 mg PO 3 times per day in patients weighing 8 to 20 kg, 10 to 20 mg PO 3 times per day in patients weighing 21 to 45 kg, and 20 mg PO 3 times per day in patients weighing more than 45 kg.
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.
Doses of 50 mg PO twice daily and 25 mg PO every 8 hours have been used in clinical studies. One study used a step-up protocol using 50 mg PO twice daily for 4 weeks then 100 mg PO twice daily for 4 more weeks, however, no further benefit was seen at the higher dose. Sildenafil decreased pulmonary artery pressures and improved exercise capacity and symptoms in patients with moderate to severe pulmonary hypertension (PH). Additional studies reported sildenafil to be effective in treating pulmonary hypertension in patients with hemoglobinopathies and in those who were refractory to epoprostenol. The effect of sildenafil treatment on mortality in patients with PH has not been studied.
The effects of inhaled nitric oxide (NO), a single oral sildenafil dose, and the combination of oral sildenafil and inhaled NO were compared consecutively in 13 patients with severe pulmonary hypertension. Patients first received inhaled NO (10, 20, 40, and 80 ppm, each for 10 minutes); complete hemodynamics were taken at the most effective dose (80 ppm) in most patients. Nitric oxide was then stopped and, after 10 minutes, a single dose of sildenafil 75 mg PO was given. Monitoring occurred for 50 minutes with continuos ECG and arterial and pulmonary artery pressures; complete hemodynamics were recorded at 50 minutes (peak hemodynamic effects of sildenafil occur at about 50 minutes). One hour after sildenafil, inhaled NO was readministered. The results showed sildenafil was superior to NO in decreasing the mean pulmonary artery pressure and was equally effective and selective in reducing pulmonary vascular resistance. Sildenafil also caused a significant increase in the cardiac index whereas NO had no effect. Further, sildenafil decreased pulmonary artery wedge pressure (PAWP), while NO increased PAWP. The combination had additive vasodilatory effects in pulmonary circulation but not the systemic circulation. Additional studies are required to determine the maximal duration of effect, the pharmacokinetics, and the safety of sildenafil in patients with pulmonary hypertension.
The safety and efficacy of the combination of sildenafil and iloprost was evaluated in 30 patients with severe pulmonary hypertension (n = 16), chronic thromboembolic pulmonary hypertension (n = 13), or pulmonary hypertension due to aplasia of the left pulmonary artery (n = 1). Following administration of nitric oxide and aerosolized iloprost and a 2-hour observation period, patients were randomized to receive either 12.5 mg sildenafil, 50 mg sildenafil, 12.5 mg sildenafil plus inhaled iloprost, or 50 mg sildenafil plus inhaled iloprost. The study results indicated that the regimen containing 50 mg PO of sildenafil plus inhaled iloprost was the most effective at reducing pulmonary vascular resistance. This regimen also was synergistic, meaning the effect on pulmonary resistance was greater than either 50 mg sildenafil alone or iloprost alone. The 12.5 mg sildenafil dose regimen was the least potent of the regimens. Overall, the combination of sildenafil and inhaled iloprost appears to be an effective regimen with vasodilatory effects lasting over 3 hours and with no serious adverse events.
0.22 to 0.5 mg/kg/dose PO administered as a one time dose 1 hour prior to discontinuing iNO or given 4 times daily has been studied. None of the 15 patients receiving a one time 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. 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 patients younger than 1 year, 10 mg PO 3 times daily in patients weighing 20 kg or less, and 20 mg PO 3 times daily in patients weighing more than 20 kg.
In open-label studies of women with sexual dysfunction due to antidepressant therapy, improvements were reported following 50 mg PO given 60 to 90 minutes before sexual activity. If a partial response was noted with the initial dose, some patients were instructed to increase the dose to 100 mg PO.
A prospective, parallel-group, double-blind study involving 90 men evaluated the efficacy of sildenafil in improving sexual dysfunction associated with antidepressant therapy (i.e., selective and non-selective serotonin reuptake inhibitors). During the 6-week study, patients were randomly assigned to receive sildenafil at a flexible dose starting at 50 mg and adjusted to 100 mg before sexual activity or placebo; 89 patients completed the study. Sildenafil significantly improved erectile function, arousal, ejaculation, orgasm, and overall sexual satisfaction compared to patients receiving placebo.
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 vasodilatory therapy.
50 mg PO every 8 hours is recommended in clinical practice guidelines. Slow ascent is the primary recommended method for prevention of high altitude pulmonary edema (HAPE). Pharmacologic prophylaxis should only be considered for individuals with a prior history of HAPE, and nifedipine is preferred. Start prophylaxis the day prior to ascent. Continue prophylaxis for 5 days after reaching target altitude or until descent is initiated.
0.5 to 1 mg/kg/dose PO every 8 hours. 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.
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. Delay use in extremely premature infants until retinal vascularization is established.
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. All 3 neonates were also receiving inhaled nitric oxide at the time of sildenafil initiation. The duration of treatment ranged from 6 to 51 days, and respiratory support was able to be decreased over time in all patents.
†Indicates off-label use
MAXIMUM DOSAGE
100 mg/day PO for erectile dysfunction; 60 mg/day PO or 30 mg/day IV for pulmonary arterial hypertension. Doses up to 240 mg/day PO were utilized during clinical trials for pulmonary arterial hypertension; however, no greater efficacy was observed and the manufacturer recommends not to exceed 60 mg/day.
100 mg/day PO for erectile dysfunction; 60 mg/day PO or 30 mg/day IV for pulmonary arterial hypertension. Doses up to 240 mg/day PO were utilized during clinical trials for pulmonary arterial hypertension; however, no greater efficacy was observed and the manufacturer recommends not to exceed 60 mg/day.
Safety and efficacy have not been established. Guidelines recommend 20 mg PO 3 times daily.
Weight more than 20 kg: Safety and efficacy have not been established. Guidelines recommend 20 mg PO 3 times daily.
Weight 20 kg or less: Safety and efficacy have not been established. Guidelines recommend 10 mg PO 3 times daily.
Safety and efficacy have not been established. Guidelines recommend 1 mg/kg/dose PO every 8 hours.
Safety and efficacy have not been established. Guidelines recommend 1 mg/kg/dose PO every 8 hours and 0.4 mg/kg IV as a loading dose followed by a continuous infusion of 0.067 mg/kg/hour.
DOSING CONSIDERATIONS
Hepatic dosing adjustments for adult patients with erectile dysfunction:
The manufacturer recommends considering a starting dose of 25 mg in adult patients with any degree of hepatic impairment
Hepatic dosing adjustments for patients with pulmonary hypertension:
The manufacturer states there is no adjustment needed for adult patients with mild to moderate hepatic impairment. Severe impairment has not been studied. Specific guidelines for dosage adjustments in pediatric patients with renal impairment are not available.
Renal dosing adjustments for adult patients with erectile dysfunction:
CrCl greater than or equal to 30 mL/min: manufacturer recommends no dosage adjustment
CrCl less than 30 mL/min: manufacturer recommends reducing starting dose to 25 mg PO
Renal dosing adjustments for patients with pulmonary hypertension:
The manufacturer states there is no adjustment needed for adult patients with renal impairment. Specific guidelines for dosage adjustments in pediatric patients with renal impairment are not available.
Intermittent hemodialysis
Follow dosage adjustment for patients with CrCl less than 30 mL/min. Further dosage adjustment for hemodialysis is not needed since sildenafil is highly bound to plasma proteins and is unlikely to be significantly removed by hemodialysis.
ADMINISTRATION
May be administered without regard to meals.
Shake well for at least 10 seconds prior to each administration.
Measure dose with the provided oral dosing syringe.
Final concentration after reconstitution is 10 mg/mL.
Reconstitution:
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 constitution 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). Do not freeze. 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. 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.
Sildenafil injection is available as a ready to use solution; further dilution is not required.
Administer as an IV bolus injection.
STORAGE
Revatio:
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Viagra:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
Sildenafil is contraindicated in patients with a known hypersensitivity to any component of the tablet or injection. The safety and efficacy of combinations of sildenafil with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
The use of sildenafil is not recommended in patients with pulmonary veno-occlusive disease (PVOD). Administration of sildenafil in this population may significantly worsen cardiovascular status. In addition, if signs of pulmonary edema occur during sildenafil administration, the possibility of associated PVOD should be considered.
Sildenafil is contraindicated in patients who are currently on nitrate/nitrite therapy (see Drug Interactions). Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of organic nitrates and nitrites. Patients receiving nitrates in any form are not to receive sildenafil. This includes any patient who receives intermittent nitrate therapies. It is unknown if it is safe for patients to receive nitrates once sildenafil has been administered.
The following factors are associated with up to an eight time increase in plasma concentrations of sildenafil compared with healthy subjects: geriatric patients (40% increase in sildenafil AUC), hepatic disease (e.g., cirrhosis, 80% increase), severe renal impairment (i.e., CrCl < 30 ml/min, 100% increase), concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin (182% increase), itraconazole, ketoconazole, saquinavir (210% increase)). Because higher plasma concentrations may increase the incidence of adverse reactions, the sildenafil starting dose should be 25 mg in these patients. Additionally, ritonavir greatly increased the systemic concentrations of sildenafil in a study of healthy, non-HIV infected volunteers (11-fold increase in AUC). Based on these pharmacokinetic data, it is recommended not to exceed a maximum single dose of 25 mg sildenafil in a 48 hour period.
There is a degree of cardiac risk associated with sexual activity; therefore, prescribers should evaluate the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction. Over 75 deaths due to cardiovascular events have been reported in association with sildenafil use. In a study conducted at the Mayo Clinic, sildenafil was shown to have limited cardiovascular effects during exercise in men with known or probable coronary artery disease. The study reported that sildenafil had no effect on exercise capacity or the hemodynamic response to exercise. Systolic blood pressure was reduced an average of 7 mmHg compared to baseline. Another study showed that sildenafil inhibited beta-adrenergic-stimulated systolic function. Using dobutamine in healthy volunteers, investigators reported that sildenafil suppressed the cardiac response to dobutamine but had minimal effect under resting conditions. It was also reported that the effects of sildenafil were independent of cardiac afterload or preload changes. Health care professionals should consider whether the individual would be adversely affected by vasodilatory events. In particular, caution should be used if sildenafil is prescribed in the following patient groups: patients who have suffered a myocardial infarction, stroke, or life-threatening cardiac arrhythmias in the last 6 months; patients with resting hypotension (BP < 90/50) or resting hypertension (BP > 170/100); patients with fluid depletion; patients with cardiac disease, heart failure or coronary artery disease which causes unstable angina. The American College of Cardiology recommends that sildenafil be used with caution in the following: patients with active coronary ischemia who are not taking nitrates (e.g., positive exercise test for ischemia); patients with congestive heart failure and borderline low blood pressure and borderline low volume status; patients on a complicated, multidrug, antihypertensive program; and patients taking drugs that can prolong the half-life of sildenafil (see Drug Interactions). However, one study reported that sildenafil was effective and well tolerated in patients on multidrug antihypertensive regimens and was not associated with additional safety risks in these patients. Patients with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be particularly sensitive to the actions of sildenafil and other vasodilators. Doses of sildenafil above 25 mg should not be given within 4 hours of an alpha-blocker (e.g., doxazosin, see Drug Interactions).
Prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been associated with PDE5 inhibitor administration. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Sildenafil and other agents for the treatment of erectile dysfunction should be used with caution in patients with penile structural abnormality (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as such as sickle cell anemia, leukemia, multiple myeloma, polycythemia, or a history of priapism). However, in one retrospective study, treatment with sildenafil did not cause any worsening deformity or progression of Peyronie’s disease.
Patients should be reminded that sildenafil, when used for erectile dysfunction, offers no protection against sexually transmitted disease. Counseling of patients about protective measures, including the prevention of transmission of human immunodeficiency virus (HIV) infection, should be considered.
Sildenafil has no effect on bleeding time when taken alone or with aspirin. In vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). There is no safety information on the administration of sildenafil to patients with a coagulopathy or active peptic ulcer disease. Therefore, sildenafil should be administered with caution to these patients.
Use sildenafil cautiously in patients with preexisting visual disturbance. Post-marketing reports of sudden vision loss have occurred with phosphodiesterase inhibitors. Vision loss is attributed to a condition known as non-arteritic anterior ischemic optic neuropathy (NAION), where blood flow is blocked to the optic nerve. Patients with a history of NAION are at increased risk for recurrence. Only use a PDE5 inhibitor in these individuals if the anticipated benefit outweighs the risk. Patients with low cup to disc ratio (‘crowded disc’) are also at increased risk; however, this condition is uncommon, and there is insufficient evidence to support screening of prospective users of a PDE5 inhibitor. There is no safety information on the administration of sildenafil to patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa. A minority of patients with the inherited condition retinitis pigmentosa have genetic disorders of retinal phosphodiesterases. Therefore, sildenafil should be used with caution in these patients.
Limited data do not report a clear association with the use of sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. No evidence of teratogenicity or embryofetal toxicity was observed in animal reproduction studies using sildenafil at doses 32- and 65-times the recommended human dose. There are risks to the mother and fetus from untreated pulmonary arterial hypertension.
Limited clinical data preclude a clear determination of the risk of sildenafil to an infant during breast-feeding. Data from a case report describe the presence of sildenafil and its active metabolite in human milk. There is insufficient information on the effects of sildenafil on the breast-fed infant and no information on the effects of sildenafil on milk production.
Delay sildenafil use in extremely premature neonates until retinal vascularization is established. Phosphodiesterase type 5 (PDE5) inhibitors cross the blood-retina barrier and can inhibit retina-specific phosphodiesterase type 6 (PDE6). Expression of PDE6 in rod and cone photoreceptors of retinal tissue, and the discovery of PDE5 on retinal and choroid vasculature have raised concerns about the potential adverse effects sildenafil may have on the developing eye of premature neonates. An increased risk in the development or severity of retinopathy of prematurity has not been observed in retrospective studies ; however, further study is warranted.
In 2012, the FDA recommended against the use of sildenafil for the treatment of pulmonary hypertension in neonates, infants, children, or adolescents based on the results of a long-term pediatric clinical trial showing an increased risk of death in pediatric patients receiving a high dose of sildenafil compared to those receiving a low dose (HR 3.9, p = 0.007). The FDA has since clarified its recommendation stating that there may be patients in which the benefits of sildenafil therapy outweigh the risks, such as when other treatment options are limited and when close monitoring is available, and advises health care providers to weigh the risk-benefit profile for individual patients when deciding whether to initiate sildenafil. Despite the FDA’s caution against use, The Pediatric Pulmonary Hypertension Network (PPHNet) recommends cautious initiation and titration of sildenafil, avoidance of high doses (more than 20 mg PO 3 times daily), and consultation and/or referral to providers experienced in the treatment of pulmonary hypertension in pediatric patients. PPHNet also recommends against the abrupt discontinuation of sildenafil in pediatric patients currently receiving it as this could lead to clinical worsening or death. The FDA warning is based on chronic use of sildenafil as monotherapy and, therefore, does not apply to short-term use in critically ill patients.
Sildenafil should be used cautiously in patients with gastroesophageal reflux disease (GERD) or hiatal hernia associated with reflux esophagitis. Sildenafil can decrease the tone of the lower esophageal sphincter and inhibit esophageal motility.
Safety and efficacy of sildenafil has not been established in the treatment of pulmonary hypertension secondary to sickle cell disease. Vaso-occlusive crisis (sickle-cell crisis) requiring hospitalization has been reported more frequently in patients with pulmonary hypertension secondary to sickle cell disease who received sildenafil than by those who received placebo. Also, when using for erectile dysfunction, use sildenafil with caution in patients with sickle cell disease because the risk of priapism may be increased.
Additional information
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