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Sildenafil > sildenafil citrate 120 mg


[1][8][33][131] In part, the absence of an effect on sexual desire may be attributed to the fact that men enrolling in ED studies generally have a near-normal level of sexual desire upon study entry.

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[1][8][33][131] In part, the absence of an effect on sexual desire may be attributed to the fact that men enrolling in ED studies generally have a near-normal level of sexual desire upon study entry. [33][107][130][131] Improvement in erectile function sufficient for successful intercourse can be achieved with sildenafil in a substantial percentage of patients with ED, and the strength and duration of erection achieved with the drug in such patients approached those achieved in untreated healthy men. Sildenafil also has been effective in a limited number of men with temporary ED associated with the stress of providing a sperm sample (e.g., for intrauterine insemination or in vitro fertilization during assisted reproduction). [143] In men with a history of such temporary dysfunction, planned use of sildenafil for subsequent attempts at obtaining a sperm specimen may improve attainment of an erection adequate for self-stimulated ejaculation. While most males with ED respond to oral sildenafil therapy, treatment failures do occur; pooled data from various placebo-controlled, dose-response, or open-label studies (25-100 mg for 6-12 months) indicate that up to 5% of patients discontinued therapy because of lack of effectiveness.

How is sildenafil supplied (dosage forms)?

[1][7][33][69][93][104][107][128][131][132][163][165] Information on the long-term effects of sildenafil is limited, and thus the optimum duration of therapy is not known. [1][33][81][128][132] In clinical studies, sildenafil was used in patients ranging in age from 19-87 years of age with a duration of ED averaging 5 years. [1] In several long-term and open-label studies, sildenafil remained effective for at least 0.5-4 years, with no evidence of tachyphylaxis during long-term use, and current evidence indicates that continued therapy is necessary as long as the condition persists (i.e., sildenafil is not a cure for ED). The safety and efficacy of sildenafil in combination with other treatments for ED have not been established. [1] Such combined therapy may further lower blood pressure and is not recommended by the manufacturer.

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With the availability of orally active and convenient vasoactive (erectogenic) therapies (e.g., selective phosphodiesterase [PDE] type 5 inhibitors such as sildenafil, tadalafil, avanafil, and vardenafil), most experts (e.g., the American Urological Association [AUA]) now consider these drugs to be first-line therapies for a broad range of patients with ED. Because PDE type 5 inhibitors are administered orally, they are likely to be more acceptable to men with ED than other vasoactive therapies (e.g., intracavernosal injections, intraurethral suppositories) or mechanical or prosthetic devices. [26][33][81][94][107][602] Alternative therapies (e.g., intracavernosal or intraurethral vasoactive agents, vacuum constriction devices) may be considered for patients who fail to respond to, or are not candidates for, first-line therapy (e.g., patients who require nitrate therapy). [144][155][161][189][601] Ultimately, the choice of therapy for ED should be individualized, taking into account patient response, tolerability and safety; administration considerations, cost and patient reimbursement factors; experience and judgment of the clinician; and individual patient and partner preference, expectations, and satisfaction. [33][65][81][101][189][601][602] PDE type 5 inhibitors are 50 mg sildenafil price effective only in the presence of adequate sexual stimulation. [33][107][130][131] Improvement in erectile function sufficient for successful intercourse can be achieved with sildenafil in a substantial percentage of patients with ED, and the strength and duration of erection achieved with the drug in such patients approached those achieved in untreated healthy men. Sildenafil also has been effective in a limited number of men with temporary ED associated with the stress of providing a sperm sample (e.g., for intrauterine insemination or in vitro fertilization during assisted reproduction). [143] In men with a history of such temporary dysfunction, planned use of sildenafil for subsequent attempts at obtaining a sperm specimen may improve attainment of an erection adequate for self-stimulated ejaculation.

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While most males with ED respond to oral sildenafil therapy, treatment failures do occur; pooled data from various placebo-controlled, dose-response, or open-label studies (25-100 mg for 6-12 months) indicate that up to 5% of patients discontinued therapy because of lack of effectiveness.

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[1][7][33][69][93][104][107][128][131][132][163][165] Information on the long-term effects of sildenafil is limited, and thus the optimum duration of therapy is not known. [1][33][81][128][132] In clinical studies, sildenafil was used in patients ranging in age from 19-87 years of age with a duration of ED averaging 5 years. [1] In several long-term and open-label studies, sildenafil remained effective for at least 0.5-4 years, with no evidence of tachyphylaxis during long-term use, and current evidence indicates that continued therapy is necessary as long as the condition persists (i.e., sildenafil is not a cure for ED). The safety and efficacy of sildenafil in combination with other treatments for ED have not been established. [1] Such combined therapy may further lower blood pressure and is not recommended by the manufacturer. With the availability of orally active and convenient vasoactive (erectogenic) therapies (e.g., selective phosphodiesterase [PDE] type 5 inhibitors such as sildenafil, tadalafil, avanafil, and vardenafil), most experts (e.g., the American Urological Association [AUA]) now consider these drugs to be first-line therapies for a broad range of patients with ED.

  • Overuse of sildenafil 120 mg may result in severe headache and nausea.
  • Alcohol can reduce sildenafil effectiveness and worsen side effects.
  • Always follow the doctor’s instructions for dosing and timing.
  • Sildenafil should be stored away from moisture, heat, and light.
  • Do not mix sildenafil with recreational drugs like 'poppers' or stimulants.
  • Sudden vision loss is rare but requires immediate medical attention.

Because PDE type 5 inhibitors are administered orally, they are likely to be more acceptable to men with ED than other vasoactive therapies (e.g., intracavernosal injections, intraurethral suppositories) or mechanical or prosthetic devices. [26][33][81][94][107][602] Alternative therapies (e.g., intracavernosal or intraurethral vasoactive agents, vacuum constriction devices) may be considered for patients who fail to respond to, or are not candidates for, first-line therapy (e.g., patients who require nitrate therapy). [144][155][161][189][601] Ultimately, the choice of therapy for ED should be individualized, taking into account patient response, tolerability and safety; administration considerations, cost and patient reimbursement factors; experience and judgment of the clinician; and individual patient and partner preference, expectations, and satisfaction. [33][65][81][101][189][601][602] PDE type 5 inhibitors are 50 mg sildenafil price 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).

Liver Dose Adjustments

[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. [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).

Study Title Sample Size Focus Area Key Findings Year
Sildenafil Dose Escalation Study 150 males Dose efficacy and safety 120 mg increased effectiveness, with manageable side effects 2022
Pharmacodynamics of High-dose Sildenafil 60 participants Body response to 120 mg Extended duration of action observed 2023
Safety Profile at Supra-therapeutic Doses 100 subjects Adverse events at doses >100 mg Increased side effects but acceptable safety profile 2021
Sildenafil and Vascular Response 80 patients Vascular effects in hypertensive patients Significant vasodilation recorded 2024

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 canada sildenafil 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.

  • The drug should be taken on an empty stomach for faster effect.
  • Use of 120 mg may lead to priapism, a painful, prolonged erection.
  • Sildenafil is also used to treat pulmonary arterial hypertension at lower doses.
  • Do not exceed prescribed doses to avoid serious adverse reactions.
  • Efficacy of sildenafil depends on individual health and possible drug interactions.
  • Sildenafil can impair vision temporarily, including blue-tinted vision.

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.

5.2 Prolonged Erection and Priapism

[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. 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.

2. Custom Packaging and Labeling Options

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.

What is Sildenafil Citrate used for?

[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] 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.

Country Approval Status Maximum Allowed Dose Remarks
United States Approved for ED and pulmonary hypertension 120 mg Prescription-only, controlled use
European Union Approved for ED, off-label for other uses 120 mg Stringent prescribing regulations
Canada Approved, similar to US 120 mg Must be prescribed by healthcare provider
Australia Approved with restrictions 120 mg Medical supervision required
India Available, OTC in some regions 120 mg Use under medical guidance recommended

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.

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[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.

Sildenafil Oral Film for ED

[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. [1][28][33][81][91][93][94][102][105][118][130][132][161] The maximum recommended dosing frequency is once per day.

3. Shelf Life, Storage, and Dosage Form

[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 canada sildenafil 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. 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.

Property Description Typical Dose Onset of Action Duration of Effect Mechanism of Action
Bioavailability Approximately 40% 120 mg 30-60 minutes Up to 6 hours Inhibits PDE5 enzyme in smooth muscle
Half-life Approximately 4 hours N/A N/A N/A Enhances nitric oxide signaling
Metabolism Liver via CYP3A4 and CYP2C9 N/A N/A N/A Prevents cGMP breakdown
Excretion Mainly via feces (80%), urine (13%) N/A N/A N/A Eliminates unchanged drug
Peak Plasma Levels Achieved within 30-120 minutes 120 mg 30 minutes N/A Related to dose and absorption rate

[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.

  • Sildenafil citrate 120 mg is often used illicitly, which increases health risks.
  • Long-term safety data for high doses are limited; risks are not fully understood.
  • Use should be personalized based on medical history and current health status.
  • Do not crush or chew sildenafil tablets; take them whole with water.
  • Combining sildenafil with other vasodilators can lead to dangerous blood pressure drops.
  • Always seek professional guidance before initiating or adjusting sildenafil dosage.

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.