Sildenafil doses of 25-100 mg reduce the maximum supine systolic/diastolic blood pressure by an average of about 8.4/5.5 mm Hg within 1-2 hours after administration of the drug in healthy adults, returning to baseline values within 4-8 hours after a dose. Clinicians should consider whether patients with underlying cardiovascular disease could be affected adversely by the vasodilatory activity of selective PDE type 5 inhibitor therapy, especially in combination with sexual activity. Because there are no controlled clinical data establishing the safety and efficacy of sildenafil in the following subpopulations of patients with ED, the drug should be used with caution in those with a recent (within 6 months) myocardial infarction, stroke, or life-threatening arrhythmia; in those with resting hypotension (blood pressure less than 90/50 mm Hg) or hypertension (blood pressure exceeding 170/110 mm Hg); and in those with cardiac failure or coronary artery disease causing unstable angina. [1][31][101][127][144][154][155][159] The possibility of a hypotensive reaction in patients receiving a selective PDE type 5 inhibitor concomitantly with antihypertensive drug therapy should be considered. [28][31][67] The risk of an undesired hypotensive response is of particular concern in patients with congestive heart failure and a borderline low blood volume and low blood pressure status as well as in patients with left-ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis), those with severely impaired autonomic control of blood pressure, and in those who are receiving a complex, multidrug antihypertensive regimen. [1][67] Some experts state that monitoring of blood pressure during initiation of sildenafil therapy may be useful in identifying patients who may have an undesirable hypotensive response to the drug and is recommended for patients receiving a multidrug antihypertensive regimen and in those with congestive heart failure who have a borderline low blood volume because of concern about the potential consequences on blood pressure. [28][67][159] In patients with severe renal impairment, concomitant use of sildenafil and antihypertensive agents should be undertaken with caution. 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.

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[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.

4.2 Hypersensitivity Reactions

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 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.

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[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). [1] Limited data indicate that sildenafil and its active sildenafil citrate 150 mg red pill 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][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.

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[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).

Use Case	Patient Group	Effect Duration	Common Side Effects
Erectile Dysfunction	Men aged 40-70	4-6 hours	Headache, flushing, nasal congestion
Pulmonary Hypertension	Adults with PAH	4-6 hours	Dizziness, visual disturbances
Off-label Sexual Enhancement	Men over 40	Varies	Muscle aches, digestive upset
Sildenafil for High Altitude Sickness	Travelers	4-6 hours	Low blood pressure, dizziness

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.

Proper Use

8.7 Hepatic Impairment

[1][67] Some experts state that monitoring of blood pressure during initiation of sildenafil therapy may be useful in identifying patients who may have an undesirable hypotensive response to the drug and is recommended for patients receiving a multidrug antihypertensive regimen and in those with congestive heart failure who have a borderline low blood volume because of concern about the potential consequences on blood pressure. [28][67][159] In patients with severe renal impairment, concomitant use of sildenafil and antihypertensive agents should be undertaken with caution. 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.

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[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). 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 lovegra sildenafil "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.

Patient Group	Recommended Dosage	Administration Tips	Contraindications
Adult Men with ED	200 mg once daily	Take 30-60 min before activity	Nitrate medication use, severe liver impairment
Pulmonary Hypertension	20 mg three times daily	Take with water, on an empty stomach	Concurrent use of compatible medications
Elderly Patients	Start with lower doses	Adjust based on response	Liver or kidney impairment
Patients with Kidney Disease	Dose adjustment may be needed	Follow physician instructions	Severe renal impairment

[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.

2. Sildenafil Tablets Dosage and Administration

[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 lovegra sildenafil "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. [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.

6.1 Clinical Trials Experience

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. 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.

Organic Nitrates, Nitrites, and Nitric Oxide Donors

[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 agent, use caution. [1] Patients should be stable on an α-adrenergic blocking sildenafil oral jelly 100mg lovegra 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). 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.

Men should avoid taking sildenafil on an empty stomach if prone to nausea.
The drug may cause hiccups or flushing in some users.
Inform your doctor of any past eye conditions before starting sildenafil.
Do not use sildenafil within 24 hours of consuming large amounts of alcohol.
It is essential to follow prescribed dosing to prevent complications.
Understand that sildenafil does not protect against sexually transmitted diseases.

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 agent, use caution.

Side Effect	Frequency	Severity	Management Suggestions
Headache	Common	Mild	Analgesics, hydration
Visual disturbances	Less common	Mild-moderate	Discontinue use if persistent
Dizziness	Common	Mild	Sit or lie down, avoid driving
Priapism	Rare	Severe	Seek immediate medical attention
Hearing loss	Very rare	Severe	Discontinue medication, seek help

[1] Patients should be stable on an α-adrenergic blocking sildenafil oral jelly 100mg lovegra 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. 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 they should be counseled regarding protective measures to guard against such transmission.

Sildenafil 200 mg may cause dizziness; avoid driving until effects are known.
It is not a hormone and does not increase testosterone levels.
Some men may experience a rash or skin reactions.
Do not take sildenafil more than once in 24 hours.
Discontinue use and seek medical advice if adverse reactions occur.
Combining sildenafil with other vasodilators can be dangerous.

Sildenafil for ED (e.g., Viagra®) is not indicated for use in females.

Sildenafil 200 mg may cause visual disturbances like blurred vision.
Consult your doctor if side effects persist or worsen.
Avoid grapefruit or grapefruit juice while taking sildenafil.
This medication should only be used under medical supervision.
Sildenafil is also used to treat pulmonary arterial hypertension.
Do not share sildenafil 200 mg with others.

[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). [1] Limited data indicate that sildenafil and its active sildenafil citrate 150 mg red pill metabolite are present in human milk. [1] There is no information about the effects of sildenafil on the breastfed infant or on milk production.

5. Warnings and Precautions

[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. [1] The manufacturer states that safety and efficacy of 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.

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5.6 Adverse Reactions with the Concomitant Use of Ritonavir

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. [1] The manufacturer states that safety and efficacy of 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.