Sildenafil 20mg Tablets

[33][65][81][101][189][601][602] PDE type 5 inhibitors are effective only in the presence of adequate sexual stimulation. [1][189][602] Prior to proceeding to alternative therapies in patients reporting failure of selective PDE type 5 inhibitor therapy, an evaluation to determine whether there was an adequate trial should be undertaken. [34][104][602] Treatment failure may also be attributed to incorrect use of PDE type 5 inhibitor therapy (e.g., lack of sexual stimulation, medication taken with a large meal). [189] The possibility that another selective PDE type 5 inhibitor therapy may be effective should be considered in patients who fail an adequate trial with one drug. [189][601][602] Although differences in the pharmacokinetics of these drugs (onset and duration) may exist, data currently are insufficient to support the superiority of one selective PDE type 5 inhibitor over another. Administer sildenafil tablets orally without regard to meals; however, administration with a high-fat meal may delay the onset of action. [1] [117][131] Administer the drug approximately 1 hour before anticipated sexual activity.

2.1 Sildenafil Tablets

[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. [1][28][33][81][91][93][94][102][105][118][130][132][161][602][603] Sexual stimulation is required for response to therapy. Sildenafil tablets should be stored at 20-25°C (excursions permitted to 15-30°C). For the treatment of erectile dysfunction (ED), the recommended initial dosage of sildenafil is 50 mg orally as needed approximately 1 hour before anticipated sexual activity. [1][28][33][81][91][93][94][102][105][118][130][132][161] The maximum recommended dosing frequency is once per day. [1] The dose may be taken anywhere from 4 hours to 30 minutes before sexual activity. [1] Peak plasma concentrations are achieved within 30-120 minutes (median 60 minutes) when taken on an empty stomach; the erectile response is diminished at 4 hours compared with 2 hours after administration.

Based on effectiveness and tolerance, the dose subsequently may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg (maximum frequency once per day). [1][28][33][91][93][94][105][161] Evidence from dose-ranging studies indicates that erectile response is greater at 50- or 100-mg doses than at 25 mg.[1][28][33][130][131] Dosage of sildenafil, including both the dose and frequency of use, must be individualized carefully according to the patient's tolerance and erectile response. Concomitant use with protease inhibitors (e.g., ritonavir): An initial sildenafil dose of 25 mg is recommended in patients receiving protease inhibitors. [1][200] When used concomitantly, do not exceed a maximum single sildenafil dose of 25 mg in a 48 hour period and monitor for adverse effects. In patients with hepatic impairment (e.g., cirrhosis), consider reducing the initial dose of sildenafil to 25 mg.[1] In patients with severe renal impairment (creatinine clearance <30 mL/minute), consider reducing the initial dose of sildenafil to 25 mg.[1] In patients >= 65 years of age, consider reducing the initial dose of sildenafil to 25 mg.[1] Concomitant use of organic nitrates (e.g., nitroglycerin) in any form (e.g., orally, sublingually, transmucosally, parenterally), either regularly or intermittently. [1] Therapy for erectile dysfunction (ED), including sildenafil, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. [1] The evaluation of ED should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

5.7 Priapism

Concomitant use with protease inhibitors (e.g., ritonavir): An initial sildenafil dose of 25 mg is recommended in patients receiving protease inhibitors. [1][200] When used concomitantly, do not exceed a maximum single sildenafil dose of 25 mg in a 48 hour period and monitor for adverse effects. In patients with hepatic impairment (e.g., cirrhosis), consider reducing the initial dose of sildenafil to 25 mg.[1] In patients with severe renal impairment (creatinine clearance <30 mL/minute), consider reducing the initial dose of sildenafil to 25 mg.[1] In patients >= 65 years of age, consider reducing the initial dose of sildenafil to 25 mg.[1] Concomitant use of organic nitrates (e.g., nitroglycerin) in any form (e.g., orally, sublingually, transmucosally, parenterally), either regularly or intermittently. [1] Therapy for erectile dysfunction (ED), including sildenafil, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. [1] The evaluation of ED should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

8.7 Hepatic Impairment

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 150mg sildenafil for sale 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.

12.2 Pharmacodynamics

[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. 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 150mg sildenafil for sale 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.

16. How is Sildenafil Tablets supplied

[33][65][81][101][189][601][602] PDE type 5 inhibitors are effective only in the presence of adequate sexual stimulation. [1][189][602] Prior to proceeding to alternative therapies in patients reporting failure of selective PDE type 5 inhibitor therapy, an evaluation to determine whether there was an adequate trial should be undertaken. [34][104][602] Treatment failure may also be attributed to incorrect use of PDE type 5 inhibitor therapy (e.g., lack of sexual stimulation, medication taken with a large meal). [189] The possibility that another selective PDE type 5 inhibitor therapy may be effective should be considered in patients who fail an adequate trial with one drug. [189][601][602] Although differences in the pharmacokinetics of these drugs (onset and duration) may exist, data currently are insufficient to support the superiority of one selective PDE type 5 inhibitor over another.

Organic Nitrates, Nitrites, and Nitric Oxide Donors

Administer sildenafil tablets orally without regard to meals; however, administration with a high-fat meal may delay the onset of action. [1] [117][131] Administer the drug approximately 1 hour before anticipated sexual activity. [1][28][33][81][91][93][94][102][105][118][130][132][161][602][603] Sexual stimulation is required for response to therapy. Sildenafil tablets should be stored at 20-25°C (excursions permitted to 15-30°C). For the treatment of erectile dysfunction (ED), the recommended initial dosage of sildenafil is 50 mg orally as needed approximately 1 hour before anticipated sexual activity.

Make sure you’re turned on

[1][28][33][81][91][93][94][102][105][118][130][132][161] The maximum recommended dosing frequency is once per day. [1] The dose may be taken anywhere from 4 hours to 30 minutes before sexual activity. [1] Peak plasma concentrations are achieved within 30-120 minutes (median 60 minutes) when taken on an empty stomach; the erectile response is diminished at 4 hours compared with 2 hours after administration. Based on effectiveness and tolerance, the dose subsequently may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg (maximum frequency once per day). [1][28][33][91][93][94][105][161] Evidence from dose-ranging studies indicates that erectile response is greater at 50- or 100-mg doses than at 25 mg.[1][28][33][130][131] Dosage of sildenafil, including both the dose and frequency of use, must be individualized carefully according to the patient's tolerance and erectile response. [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. [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.

• Alcohol can interact with sildenafil, reducing its effectiveness and increasing side effects.
• Avoid alcohol consumption when planning to use sildenafil.
• Always inform your doctor about alcohol use prior to prescription.

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.

• Sildenafil 20 mg is contraindicated with nitrate medications due to risk of severe hypotension.
• Patients with heart problems should consult their doctor before use.
• It’s important to disclose all medications to your healthcare provider.

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.

How should I take sildenafil?

[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.

What Are the Available Sildenafil Dosages?

[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. 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.

Serious Side Effects

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. 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. [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.