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[12][28][30][31][57][65][66][70][78][83][94][144][145][160][161][189][601][602][603] A review of the patient's current drug regimens should be conducted to detect possible drug-induced ED (e.g., certain antihypertensive, antidepressant, antipsychotic, or antiarrhythmic agents); it may be possible to substitute alternative drug(s) that lessen the risk of such dysfunction. [12][28][70][81][118][144][161][602][603] In instances where substitution therapy is not feasible, concomitant vasoactive therapy with a PDE 5 type inhibitor may promote patient compliance by counteracting ED as an adverse effect.

How should this medicine be used?

[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.

What should I do if I accidentally use too much sildenafil?

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. [12][28][70][81][118][144][161][602][603] Efficacy of sildenafil is variable in patients with ED, in part depending on the underlying etiology, severity, and dose employed, but the drug generally appears to be effective in restoring sexual function to an acceptable level in the majority of treated men. [1][7][8][9][10][25][33][34][65][76][81][101][104][105][126][127][131][142][143][144] The erectile response generally increases with increasing sildenafil dose and plasma drug concentration, with response becoming greater at 50- and 100-mg doses than at 25 mg.[1][8][9][33][126][130][131][155] Analyses of subgroups of patients with ED indicate that efficacy of sildenafil is not affected by race or age, duration of ED, or duration of select underlying disease states (e.g., diabetes mellitus), and the drug has been effective in a broad range of patients with ED, including those with a history of coronary artery disease (e.g., coronary artery bypass graft [CABG]), hypertension, other cardiac disease (including ischemic heart disease), peripheral vascular disease, type 1 or 2 diabetes mellitus, depression, radical prostatectomy, prostate brachytherapy, transurethral resection of the prostate (TURP), spina bifida, spinal cord injury, and in patients taking antidepressants, antipsychotics, diuretics, and antihypertensive agents.

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[1][25][30][33][34][93][101][102][104][105][107][108][112][118][126][127][128][129][130][131][132][133][134][140][144] Pooled data from numerous fixed-dose and flexible-dose studies in men with ED secondary to a broad spectrum of organic and psychogenic causes showed increases in mean rates of successful intercourse (total successes divided by total attempts) to about 66-69% in those receiving sildenafil compared with about 20-22% for placebo. Erectile response to sildenafil is better in patients whose erectile function is less impaired at treatment initiation (e.g., those with some spontaneous successful intercourse, with partial erections, with erections during sleep, or with psychogenic causes). [1][33][105][145] In one flexible-dose study (dosage titration and maintenance up to 100 mg), mean scores for number of successful penetrations returned to normal in a subgroup of patients with psychogenic causes of ED; however, mean scores for maintenance of erections during intercourse in these men were lower than in untreated healthy men. [33][34] In a study in men with ED secondary to radical prostatectomy receiving fixed-dose sildenafil (100 mg), response to therapy was greatest in those who had undergone bilateral-nerve-sparing surgery than in those who had undergone unilateral or non-nerve-sparing procedures.

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[76][127] In sildenafil oral jelly 100 mg several randomized, double-blind, placebo-controlled studies in patients receiving sildenafil (flexible doses up to 100 mg or fixed doses ranging from 10-100 mg for 12 weeks) for the treatment of ED attributed to complications of diabetes mellitus, complications of spinal cord injury, or psychogenic causes, 48, 59, or 70% of all attempts at intercourse were successful, respectively, compared with 12, 13, or 29% of all attempts in those receiving placebo. [1][7][8][9][10][25][33][93] In these studies, sildenafil improved several aspects of sexual function including frequency, firmness, and maintenance of erection; frequency of orgasm; satisfaction and enjoyment of intercourse; and overall relationship satisfaction. [1][8][9][33][94][107][130][131][142] Pooled data from fixed- and flexible-dose studies indicate that sildenafil (50 or 100 mg) has no effect on sexual desire (i.e., rates of attempted intercourse, which averaged about 2 per week), but the rate of success increased to an average of 1.3 events per patient per week from 0.4 events per week with placebo. [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.

Drugs Affecting Gastric Acidity

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. [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. [104][127] Pooled data from various clinical trials indicate that sildenafil improved the erections of 43% of patients with ED secondary to radical prostatectomy compared with 15% of those receiving placebo. [1][104] A pooled analysis of 10 placebo-controlled studies of men with severe ED (organic etiology in 60%, psychogenic in 15%, and mixed in 25% of patients) treated with sildenafil (50-100 mg in fixed- or flexible-dose studies) indicated that 48% of the patients usually had erections sufficient for intercourse (score of 4, with 0 being unsuccessful and 5 being almost always successful) after treatment with sildenafil, compared with 8% of those receiving placebo. [76][127] In sildenafil oral jelly 100 mg several randomized, double-blind, placebo-controlled studies in patients receiving sildenafil (flexible doses up to 100 mg or fixed doses ranging from 10-100 mg for 12 weeks) for the treatment of ED attributed to complications of diabetes mellitus, complications of spinal cord injury, or psychogenic causes, 48, 59, or 70% of all attempts at intercourse were successful, respectively, compared with 12, 13, or 29% of all attempts in those receiving placebo. [1][7][8][9][10][25][33][93] In these studies, sildenafil improved several aspects of sexual function including frequency, firmness, and maintenance of erection; frequency of orgasm; satisfaction and enjoyment of intercourse; and overall relationship satisfaction. [1][8][9][33][94][107][130][131][142] Pooled data from fixed- and flexible-dose studies indicate that sildenafil (50 or 100 mg) has no effect on sexual desire (i.e., rates of attempted intercourse, which averaged about 2 per week), but the rate of success increased to an average of 1.3 events per patient per week from 0.4 events per week with placebo. [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.

Condition	Details	Recommended Practice
Temperature	Below 30°C	Store in a cool, dry place
Humidity	Less than 70%	Keep away from moisture
Light	Protect from direct sunlight	Store in original packaging
Out of Reach	Keep away from children	Ensure secure storage

[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).

Country	Status	Notes
USA	Approved by FDA	Prescription-only medication
UK	Prescription required	Manufactured under regulatory standards
Canada	Approved for ED and PAH	Prescription-based

[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. [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.

• Sildenafil citrate tablets are used to treat erectile dysfunction.
• The typical dosage of sildenafil citrate is 150 mg.
• These tablets work by increasing blood flow to the penis.
• Consult a doctor before taking 150 mg sildenafil tablets.

[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.

Advice To Patients

[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. 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.

How It Works

[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 effective only in sildenafil tables 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). 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.

Non-medical use

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).

Adverse effects

[12][28][30][31][57][65][66][70][78][83][94][144][145][160][161][189][601][602][603] A review of the patient's current drug regimens should be conducted to detect possible drug-induced ED (e.g., certain antihypertensive, antidepressant, antipsychotic, or antiarrhythmic agents); it may be possible to substitute alternative drug(s) that lessen the risk of such dysfunction. [12][28][70][81][118][144][161][602][603] In instances where substitution therapy is not feasible, concomitant vasoactive therapy with a PDE 5 type inhibitor may promote patient compliance by counteracting ED as an adverse effect. [12][28][70][81][118][144][161][602][603] Efficacy of sildenafil is variable in patients with ED, in part depending on the underlying etiology, severity, and dose employed, but the drug generally appears to be effective in restoring sexual function to an acceptable level in the majority of treated men. [1][7][8][9][10][25][33][34][65][76][81][101][104][105][126][127][131][142][143][144] The erectile response generally increases with increasing sildenafil dose and plasma drug concentration, with response becoming greater at 50- and 100-mg doses than at 25 mg.[1][8][9][33][126][130][131][155] Analyses of subgroups of patients with ED indicate that efficacy of sildenafil is not affected by race or age, duration of ED, or duration of select underlying disease states (e.g., diabetes mellitus), and the drug has been effective in a broad range of patients with ED, including those with a history of coronary artery disease (e.g., coronary artery bypass graft [CABG]), hypertension, other cardiac disease (including ischemic heart disease), peripheral vascular disease, type 1 or 2 diabetes mellitus, depression, radical prostatectomy, prostate brachytherapy, transurethral resection of the prostate (TURP), spina bifida, spinal cord injury, and in patients taking antidepressants, antipsychotics, diuretics, and antihypertensive agents. [1][25][30][33][34][93][101][102][104][105][107][108][112][118][126][127][128][129][130][131][132][133][134][140][144] Pooled data from numerous fixed-dose and flexible-dose studies in men with ED secondary to a broad spectrum of organic and psychogenic causes showed increases in mean rates of successful intercourse (total successes divided by total attempts) to about 66-69% in those receiving sildenafil compared with about 20-22% for placebo.

If you take more than the recommended amount of Viagra

Erectile response to sildenafil is better in patients whose erectile function is less impaired at treatment initiation (e.g., those with some spontaneous successful intercourse, with partial erections, with erections during sleep, or with psychogenic causes). [1][33][105][145] In one flexible-dose study (dosage titration and maintenance up to 100 mg), mean scores for number of successful penetrations returned to normal in a subgroup of patients with psychogenic causes of ED; however, mean scores for maintenance of erections during intercourse in these men were lower than in untreated healthy men. [33][34] In a study in men with ED secondary to radical prostatectomy receiving fixed-dose sildenafil (100 mg), response to therapy was greatest in those who had undergone bilateral-nerve-sparing surgery than in those who had undergone unilateral or non-nerve-sparing procedures. [104][127] Pooled data from various clinical trials indicate that sildenafil improved the erections of 43% of patients with ED secondary to radical prostatectomy compared with 15% of those receiving placebo. [1][104] A pooled analysis of 10 placebo-controlled studies of men with severe ED (organic etiology in 60%, psychogenic in 15%, and mixed in 25% of patients) treated with sildenafil (50-100 mg in fixed- or flexible-dose studies) indicated that 48% of the patients usually had erections sufficient for intercourse (score of 4, with 0 being unsuccessful and 5 being almost always successful) after treatment with sildenafil, compared with 8% of those receiving placebo. [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.

• Alcohol can increase the risk of side effects from sildenafil.
• Taking sildenafil does not protect against sexually transmitted infections.
• Patients should inform their doctor of all medications they take.
• Sildenafil may cause a drop in blood pressure in some cases.

[33][65][81][101][189][601][602] PDE type 5 inhibitors are effective only in sildenafil tables the presence of adequate sexual stimulation.

• Sildenafil 150 mg is considered a high dose for most users.
• Overdose can cause severe hypotension or cardiovascular issues.
• Use caution when taking other medications affecting blood pressure.
• Sildenafil should be taken only as prescribed by a healthcare provider.

[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. [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.

Tip	Explanation	Additional Advice
Take on an empty stomach	Food, especially high-fat meals, can delay absorption	For faster effect, take 30 mins prior
Avoid alcohol	Alcohol can impair erectile response and increase side effects	Use responsibly
Follow prescribed dose	Do not exceed 150 mg per dose	Consult doctor for any side effects

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

Technical Product Specification Table

Apcalis SX Jelly

[1] The dose may be taken anywhere from 4 hours to 30 minutes before sexual activity.