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Nonarteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely during postmarketing experience in temporal association with use of all PDE type 5 inhibitors for the treatment of ED. [1][190][191][192][196][197] Most, but not all, of these patients had underlying anatomic or vascular risk factors for the development of NAION, including but not limited to low cup-to-disc ratio (''crowded" optic disc), age (older than 50 years), diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia, and smoking. [1][191][192][196] Available data suggest that the annual incidence of NAION in the general population of men 50 years of age or older is 2.5-11.8 cases per 100,000. [1] Results of an observational study in patients with recent, episodic PDE type 5 inhibitor use (typical of ED treatment) suggest an approximately two-fold increase in the risk of NAION, with a risk estimate of 2.15 within 5 half-lives of such use. [1] A risk estimate of 2.27 was reported in a similar study. Causality assessment is difficult because of the small number of events, the large number of patients receiving PDE type 5 inhibitors, the occurrence of optic neuropathy in a similar population of individuals who have not been exposed to PDE type 5 inhibitors, and plausible alternative causes (e.g., vascular risk factors, anatomic defects).
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[1][31][127][131][139][146][147] Because of the risk of penile tissue damage and permanent loss of potency if priapism is not treated immediately, patients should be warned to seek immediate medical attention if an erection persists for longer than 4 hours. Sildenafil should be used with caution in patients with anatomic deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) and in patients who have conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia). Caution is advised when PDE type 5 inhibitors are co-administered with α-adrenergic blocking agents; blood pressure may be lowered significantly and in some patients, symptomatic hypotension (e.g., dizziness, lightheadedness, fainting) may occur. [1] Patients who demonstrate hemodynamic instability during therapy with an α-adrenergic blocking agent alone are at increased risk for symptomatic hypotension with concomitant use of a PDE type 5 inhibitor. In patients who exhibit hemodynamic instability while receiving an α-adrenergic blocking sildenafil pick up agent, use caution.
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[1] Patients should be stable on an α-adrenergic blocking agent prior to initiation of sildenafil, and sildenafil should be administered at the lowest possible dose. [1] In patients receiving an optimal dose of sildenafil, initiate the α-adrenergic blocking agent at the lowest dose. Concomitant administration of ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). [1] Data are limited; decreased blood pressure, syncope, and prolonged erection have been reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). [1] Use sildenafil with caution in patients receiving ritonavir; reduced sildenafil dosage is recommended to decrease the chance of adverse reactions to sildenafil.
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Bleeding events have been reported in patients taking sildenafil for ED. [1] In patients with bleeding disorders or active peptic ulcers, sildenafil should be used with caution since safety of the drug has not been established. [1][27][33][67][131] The possibility that sildenafil could potentiate the effects of certain other drugs exhibiting antiplatelet activity should be considered. Safety and efficacy have not been established for use of sildenafil in combination with other PDE type 5 inhibitors or other treatments for ED; such combinations may further lower blood pressure and are not recommended. Patients should be advised that use of sildenafil provides no protection against sexually transmitted diseases and buy sildenafil uk they should be counseled regarding protective measures to guard against such transmission. If sudden vision loss or decreased vision occurs in one or both eyes while a patient is receiving a PDE type 5 inhibitor, the patient should discontinue the drug and contact a clinician immediately. Clinicians should discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE type 5 inhibitors. [1] Sildenafil should be used with caution for the treatment of ED in these patients and only when the anticipated benefits outweigh the risks.
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Although at greater risk for NAION compared to the general population, evidence is insufficient to support screening for "crowded" optic disc in prospective users of PDE type 5 inhibitors for the treatment of ED. Sildenafil should be used with caution in patients with retinitis pigmentosa, a retinal disorder that may be accompanied by a genetic disorder of retinal phosphodiesterases in some patients, since data establishing the safety and efficacy of the drug in these patients currently are lacking. Sudden decrease or loss of hearing, with or without concomitant vestibular manifestations (e.g., tinnitus, dizziness), has been reported in temporal association with use of PDE type 5 inhibitors, including sildenafil.
| Medication | Average Cost (USD) | Dose Frequency | Generic Availability | Effect Duration |
|---|---|---|---|---|
| Sildenafil | 10 - 15 | As needed | Yes | 4-6 hours |
| Tadalafil | 15 - 20 | Daily or as needed | Yes | 24-36 hours |
| Vardenafil | 12 - 18 | As needed | Yes | 4-5 hours |
| Avanafil | 20 - 25 | As needed | Limited | 6 hours |
[1] It is unclear whether these otic effects are directly related to PDE type 5 inhibitors or attributed to other underlying risk factors for hearing loss, a combination of these factors, or to other factors.
| Country | Average Cost (USD) | Price Range (USD) | Brand Availability |
|---|---|---|---|
| USA | 12.50 | 10 - 15 | Widely available |
| Canada | 11.75 | 10 - 14 | Generic & Brand |
| UK | 9.80 | 8 - 12 | Generic mostly |
| Australia | 13.20 | 11 - 16 | Brand and generic |
| India | 2.50 | 2 - 3 | Mostly generics |
Patients should discontinue sildenafil and seek medical attention immediately if sudden hearing loss or decreased hearing occurs. Prolonged erection (exceeding 4 hours) and priapism (painful erection exceeding 6 hours) have been reported infrequently during postmarketing surveillance with sildenafil. [1][31][127][131][139][146][147] Because of the risk of penile tissue damage and permanent loss of potency if priapism is not treated immediately, patients should be warned to seek immediate medical attention if an erection persists for longer than 4 hours.
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Nonarteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely during postmarketing experience in temporal association with use of all PDE type 5 inhibitors for the treatment of ED. [1][190][191][192][196][197] Most, but not all, of these patients had underlying anatomic or vascular risk factors for the development of NAION, including but not limited to low cup-to-disc ratio (''crowded" optic disc), age (older than 50 years), diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia, and smoking. [1][191][192][196] Available data suggest that the annual incidence of NAION in the general population of men 50 years of age or older is 2.5-11.8 cases per 100,000. [1] Results of an observational study in patients with recent, episodic PDE type 5 inhibitor use (typical of ED treatment) suggest an approximately two-fold increase in the risk of NAION, with a risk estimate of 2.15 within 5 half-lives of such use. [1] A risk estimate of 2.27 was reported in a similar study.
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Causality assessment is difficult because of the small number of events, the large number of patients receiving PDE type 5 inhibitors, the occurrence of optic neuropathy in a similar population of individuals who have not been exposed to PDE type 5 inhibitors, and plausible alternative causes (e.g., vascular risk factors, anatomic defects). If sudden vision loss or decreased vision occurs in one or both eyes while a patient is receiving a PDE type 5 inhibitor, the patient should discontinue the drug and contact a clinician immediately. Clinicians should discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE type 5 inhibitors. [1] Sildenafil should be used with caution for the treatment of ED in these patients and only when the anticipated benefits outweigh the risks. Although at greater risk for NAION compared to the general population, evidence is insufficient to support screening for "crowded" optic disc in prospective users of PDE type 5 inhibitors for the treatment of ED.
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Sildenafil should be used with caution in patients with retinitis pigmentosa, a retinal disorder that may be accompanied by a genetic disorder of retinal phosphodiesterases in some patients, since data establishing the safety and efficacy of the drug in these patients currently are lacking. Sudden decrease or loss of hearing, with or without concomitant vestibular manifestations (e.g., tinnitus, dizziness), has been reported in temporal association with use of PDE type 5 inhibitors, including sildenafil. [1] It is unclear whether these otic effects are directly related to PDE type 5 inhibitors or attributed to other underlying risk factors for hearing loss, a combination of these factors, or to other factors. Patients should discontinue sildenafil and seek medical attention immediately if sudden hearing loss or decreased hearing occurs. Prolonged erection (exceeding 4 hours) and priapism (painful erection exceeding 6 hours) have been reported infrequently during postmarketing surveillance with sildenafil. Sildenafil should be used with caution in patients with anatomic deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) and in patients who have conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
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In patients with any degree of hepatic impairment (e.g. cirrhosis), consider reducing the initial dose of sildenafil to 25 mg.[1] In patients with mild (creatinine clearance 50-80 mL/minute) or moderate (creatinine clearance 30-49 mL/minute) renal impairment, the pharmacokinetics of a single 50-mg oral dose of sildenafil are not altered. [1][31][131] However, in patients with severe (creatinine clearance less than 30 mL/minute) renal impairment, sildenafil clearance is reduced, resulting in AUC and peak plasma concentrations of the parent drug that are approximately double those in age-matched healthy adults. [1][31][67][131] In addition, AUC and peak plasma concentrations of the N-demethylated metabolite are 200 and 79% greater, respectively, than those in individuals with normal renal function. In patients with severe renal impairment (creatinine clearance less than 30 mL/minute), consider reducing the initial dose of sildenafil to 25 mg.[1] The most common adverse effects (>=2%) of sildenafil used for the treatment of ED include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.
Common Adverse Effects
Sildenafil is metabolized principally via hepatic cytochrome P-450 (CYP) microsomal isoenzymes 3A4 (major route) and 2C9 (minor route). [1][91][131] Inhibitors and inducers of these isoenzymes may reduce or increase sildenafil clearance, respectively. In vitro studies indicate that sildenafil is a weak inhibitor of the CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4. [1][26][67][250] Sildenafil is not expected to affect the pharmacokinetics of substrates of these CYP enzymes at clinically relevant concentrations. Caution is advised when PDE type 5 inhibitors are co-administered with α-adrenergic blocking agents; blood pressure may be lowered significantly and in some patients, symptomatic hypotension (e.g., dizziness, lightheadedness, fainting) may occur. [1] Patients who demonstrate hemodynamic instability during therapy with an α-adrenergic blocking agent alone are at increased risk for symptomatic hypotension with concomitant use of a PDE type 5 inhibitor. In patients who exhibit hemodynamic instability while receiving an α-adrenergic blocking sildenafil pick up agent, use caution. [1] Patients should be stable on an α-adrenergic blocking agent prior to initiation of sildenafil, and sildenafil should be administered at the lowest possible dose. [1] In patients receiving an optimal dose of sildenafil, initiate the α-adrenergic blocking agent at the lowest dose.
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Concomitant administration of ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). [1] Data are limited; decreased blood pressure, syncope, and prolonged erection have been reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). [1] Use sildenafil with caution in patients receiving ritonavir; reduced sildenafil dosage is recommended to decrease the chance of adverse reactions to sildenafil. Bleeding events have been reported in patients taking sildenafil for ED. [1] In patients with bleeding disorders or active peptic ulcers, sildenafil should be used with caution since safety of the drug has not been established. [1][27][33][67][131] The possibility that sildenafil could potentiate the effects of certain other drugs exhibiting antiplatelet activity should be considered. Safety and efficacy have not been established for use of sildenafil in combination with other PDE type 5 inhibitors or other treatments for ED; such combinations may further lower blood pressure and are not recommended. Patients should be advised that use of sildenafil provides no protection against sexually transmitted diseases and buy sildenafil uk they should be counseled regarding protective measures to guard against such transmission. Sildenafil for ED (e.g., Viagra®) is not indicated for use in females. [1] There are no data with use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in rats and rabbits receiving up to 200 mg/kg daily of sildenafil during organogenesis. [1] These doses in rats and rabbits represent about 16 and 32 times, respectively, the maximum recommended human dose (MRHD) for the treatment of ED on a mg/m2 basis in a 50-kg patient.
| Medication | Cost (USD) per 100 mg | Generic Availability | Notes |
|---|---|---|---|
| Sildenafil | 10 - 15 | Yes | Most affordable option |
| Tadalafil | 15 - 20 | Yes | Longer effect but slightly more expensive |
| Vardenafil | 12 - 18 | Yes | Similar price to sildenafil |
| Avanafil | 20 - 25 | Limited | More costly but faster acting |
[1] No adverse effects were observed Iin a prenatal and postnatal development study in rats receiving 30 mg/kg daily for 36 days (equivalent to 2-times the MRHD on a mg/m2 basis in a 50-kg subject).
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Sildenafil for ED (e.g., Viagra®) is not indicated for use in females. [1] There are no data with use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in rats and rabbits receiving up to 200 mg/kg daily of sildenafil during organogenesis. [1] These doses in rats and rabbits represent about 16 and 32 times, respectively, the maximum recommended human dose (MRHD) for the treatment of ED on a mg/m2 basis in a 50-kg patient. [1] No adverse effects were observed Iin a prenatal and postnatal development study in rats receiving 30 mg/kg daily for 36 days (equivalent to 2-times the MRHD on a mg/m2 basis in a 50-kg subject).
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[1] Limited data indicate that sildenafil and its active metabolite are present in human milk. [1] There is no information about the effects of sildenafil on the breastfed infant or on milk production. Reproduction studies revealed no evidence of impaired fertility at sildenafil dosages up to 60 mg/kg daily (for 36 days in female rats and 102 days in male rats), a dosage representing more than 25 times the human male AUC. [1] No effect on sperm motility or morphology was noted after a single 100-mg oral sildenafil dose in healthy human adults. Sildenafil for ED (e.g., Viagra®) is not indicated for use in pediatric patients.
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[1] The manufacturer states that safety and efficacy of sildenafil oral solution sildenafil in children have not been established. The AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45 and 57% higher, respectively, in healthy volunteers >=65 years of age compared to healthy volunteers 18-45 years of age. [1] Clinical studies included patients >=65 years of age (18%) and >=75 years of age (2%); no overall differences in safety and efficacy were observed between older (>=65 years of age) and younger (<65 years of age) patients[1] Because higher plasma levels may increase the incidence of adverse reactions, consider reducing the initial sildenafil dosage to 25 mg in older patients. In patients with hepatic cirrhosis (Child-Pugh class A or B), sildenafil clearance is reduced, resulting in increased AUC (by 85%) and peak plasma concentrations (by 47%) compared with values observed in age-matched healthy adults. [1][31][131] The effect of severe hepatic impairment on the pharmacokinetics of sildenafil has not been evaluated to date. [1] Limited data indicate that sildenafil and its active metabolite are present in human milk. [1] There is no information about the effects of sildenafil on the breastfed infant or on milk production. Reproduction studies revealed no evidence of impaired fertility at sildenafil dosages up to 60 mg/kg daily (for 36 days in female rats and 102 days in male rats), a dosage representing more than 25 times the human male AUC. [1] No effect on sperm motility or morphology was noted after a single 100-mg oral sildenafil dose in healthy human adults. Sildenafil for ED (e.g., Viagra®) is not indicated for use in pediatric patients.
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[1] The manufacturer states that safety and efficacy of sildenafil oral solution sildenafil in children have not been established. The AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45 and 57% higher, respectively, in healthy volunteers >=65 years of age compared to healthy volunteers 18-45 years of age. [1] Clinical studies included patients >=65 years of age (18%) and >=75 years of age (2%); no overall differences in safety and efficacy were observed between older (>=65 years of age) and younger (<65 years of age) patients[1] Because higher plasma levels may increase the incidence of adverse reactions, consider reducing the initial sildenafil dosage to 25 mg in older patients. In patients with hepatic cirrhosis (Child-Pugh class A or B), sildenafil clearance is reduced, resulting in increased AUC (by 85%) and peak plasma concentrations (by 47%) compared with values observed in age-matched healthy adults. [1][31][131] The effect of severe hepatic impairment on the pharmacokinetics of sildenafil has not been evaluated to date. In patients with any degree of hepatic impairment (e.g. cirrhosis), consider reducing the initial dose of sildenafil to 25 mg.[1] In patients with mild (creatinine clearance 50-80 mL/minute) or moderate (creatinine clearance 30-49 mL/minute) renal impairment, the pharmacokinetics of a single 50-mg oral dose of sildenafil are not altered.
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[1][31][131] However, in patients with severe (creatinine clearance less than 30 mL/minute) renal impairment, sildenafil clearance is reduced, resulting in AUC and peak plasma concentrations of the parent drug that are approximately double those in age-matched healthy adults. [1][31][67][131] In addition, AUC and peak plasma concentrations of the N-demethylated metabolite are 200 and 79% greater, respectively, than those in individuals with normal renal function. In patients with severe renal impairment (creatinine clearance less than 30 mL/minute), consider reducing the initial dose of sildenafil to 25 mg.[1] The most common adverse effects (>=2%) of sildenafil used for the treatment of ED include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Sildenafil is metabolized principally via hepatic cytochrome P-450 (CYP) microsomal isoenzymes 3A4 (major route) and 2C9 (minor route). [1][91][131] Inhibitors and inducers of these isoenzymes may reduce or increase sildenafil clearance, respectively. In vitro studies indicate that sildenafil is a weak inhibitor of the CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4. [1][26][67][250] Sildenafil is not expected to affect the pharmacokinetics of substrates of these CYP enzymes at clinically relevant concentrations.