INDICATIONS AND USAGE
Carcinogenesis Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 20-and 38-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg.
- The usual starting dose of sildenafil for ED is 50 mg, but 20 mg may be prescribed for some patients.
- Prescription requirements ensure safe usage and proper dosing based on health conditions.
- Always follow a doctor’s instructions when taking sildenafil 20 mg.
Sildenafil was not carcinogenic when administered to mice for 18 to 21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.4 times the MRHD on a mg/m2 basis in a 50 kg subject. Impairment of Fertility There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the human male AUC. In clinical studies, sildenafil tablets was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. Sildenafil tablets were evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover). Sildenafil tablets were administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. Sildenafil tablets demonstrated statistically significant improvement compared to placebo in all 21 studies. Efficacy Endpoints in Controlled Clinical Studies The effectiveness of sildenafil tablets were evaluated in most studies using several assessment instruments. The primary measure in the principal studies was a sexual function questionnaire (the International Index of Erectile Function -IIEF) administered during a 4-week treatment-free run-in period, at baseline, at follow-up visits, and at the end of double-blind, placebo-controlled, at-home treatment. Efficacy Results from Controlled Clinical Studies The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function. Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil tablets were better than that seen in patients treated with placebo. Effect of Sildenafil Tablets and Placebo on Maintenance of Erection by Baseline Score. Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of sildenafil tablets, respectively, reported an improvement in their erections, compared to 24% on placebo. Overall treatment p<0.0001 Figure 7. Percentage of Patients Reporting an Improvement in Erections .
4. Contraindications
They are available as follows: Bottles of 30 tablets NDC 31722-966-30 Bottles of 100 tablets NDC 31722-966-01 Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and '115' on the other side. They are available as follows: Bottles of 30 tablets NDC 31722-967-30 Bottles of 100 tablets NDC 31722-967-01 Recommended Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications(4.1)]. Guanylate Cyclase (GC) Stimulators Physicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)]. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.
Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)]. Cardiovascular Considerations Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Sudden Loss of Vision Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a ''crowded'' optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].
Take the meds in advance and be patient
Sudden Hearing Loss Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4)and Adverse Reactions (6.2)]. Priapism Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. Avoid Use with other PDE5 Inhibitors Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions(5.7)]. In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of sildenafil tablets on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50 to 100 mg of sildenafil tablets vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil tablets vs about 20% on placebo. At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections. Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of sildenafil tablets; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on over the counter drugs containing sildenafil the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil tablets compared to placebo. On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 25mg | 60 + 4 Pills | 71.99€ 68.56€ | |
| Viagra Generic | 100mg | 120 + 6 Pills | 149.50€ 142.38€ | |
| Viagra Generic | 150mg | 90 + 6 Pills | 147.18€ 140.17€ | |
| Kamagra Soft Tabs | 100mg | 20 Pills | 79.79€ 75.99€ | |
| Kamagra | 100mg | 360 + 6 Pills | 839.95€ 799.95€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Kamagra Soft Tabs | 100mg | 180 + 8 Pills | 425.45€ 405.19€ | |
| Kamagra Oral Jelly | 100mg | 90 + 8 Sachets | 303.56€ 289.10€ | |
| Kamagra Polo | 100mg | 180 + 8 Pills | 446.52€ 425.26€ | |
| Viagra Generic | 50mg | 90 + 6 Pills | 107.37€ 102.26€ | |
| Kamagra Polo | 100mg | 20 Pills | 83.56€ 79.58€ | |
| Viagra Generic | 150mg | 30 + 2 Pills | 72.32€ 68.88€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Viagra Generic | 25mg | 360 + 10 Pills | 213.68€ 203.50€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Kamagra Oral Jelly | 100mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
| Kamagra | 100mg | 84 + 6 Pills | 264.44€ 251.85€ |
Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.
Why is this medication prescribed?
Sexually Transmitted Disease The use of sildenafil tablets offers no protection against sexually transmitted diseases. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: Evaric Pharmaceuticals Inc. 155 COMMERCE DRIVE, HAUPPAUGE, New York (NY) 11788, United States (USA).
What Are the Available Sildenafil Dosages?
Sildenafil Tablets, USP (sil den' a fil) What is the most important information I should know about sildenafil tablets? The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil tablets. On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo. Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo.
What is Sildenafil for Erectile Dysfunction?
Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics.
Different sildenafil strengths
They are available as follows: Bottles of 30 tablets NDC 31722-965-30 Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated sildenafil price ireland tablets debossed with 'E' on one side and '114 'on the other side. They are available as follows: Bottles of 30 tablets NDC 31722-966-30 Bottles of 100 tablets NDC 31722-966-01 Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and '115' on the other side.
What happens if I miss a dose?
In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of sildenafil tablets on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50 to 100 mg of sildenafil tablets vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil tablets vs about 20% on placebo. At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections. Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of sildenafil tablets; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on over the counter drugs containing sildenafil the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil tablets compared to placebo.
8.6 Renal Impairment
On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil tablets. On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo. Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.
How Sildenafil Works to Treat ED
Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. They are available as follows: Bottles of 30 tablets NDC 31722-965-30 Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated sildenafil price ireland tablets debossed with 'E' on one side and '114 'on the other side. They are available as follows: Bottles of 30 tablets NDC 31722-967-30 Bottles of 100 tablets NDC 31722-967-01 Recommended Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications(4.1)]. Guanylate Cyclase (GC) Stimulators Physicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)]. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)]. Cardiovascular Considerations Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Sudden Loss of Vision Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a ''crowded'' optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3)and Adverse Reactions (6.2)]. Sudden Hearing Loss Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].
Before taking this medicine
Carcinogenesis Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 20-and 38-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg. Sildenafil was not carcinogenic when administered to mice for 18 to 21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.4 times the MRHD on a mg/m2 basis in a 50 kg subject. Impairment of Fertility There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the human male AUC. In clinical studies, sildenafil tablets was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. Sildenafil tablets were evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover).
Before taking sildenafil,
Sildenafil tablets were administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. Sildenafil tablets demonstrated statistically significant improvement compared to placebo in all 21 studies. Efficacy Endpoints in Controlled Clinical Studies The effectiveness of sildenafil tablets were evaluated in most studies using several assessment instruments. The primary measure in the principal studies was a sexual function questionnaire (the International Index of Erectile Function -IIEF) administered during a 4-week treatment-free run-in period, at baseline, at follow-up visits, and at the end of double-blind, placebo-controlled, at-home treatment. Efficacy Results from Controlled Clinical Studies The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function.
Why this range helps:
Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil tablets were better than that seen in patients treated with placebo. Effect of Sildenafil Tablets and Placebo on Maintenance of Erection by Baseline Score. Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of sildenafil tablets, respectively, reported an improvement in their erections, compared to 24% on placebo. Overall treatment p<0.0001 Figure 7. Percentage of Patients Reporting an Improvement in Erections . Priapism Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets.
- 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.
Avoid Use with other PDE5 Inhibitors Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions(5.7)]. Sexually Transmitted Disease The use of sildenafil tablets offers no protection against sexually transmitted diseases. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: Evaric Pharmaceuticals Inc. 155 COMMERCE DRIVE, HAUPPAUGE, New York (NY) 11788, United States (USA). Sildenafil Tablets, USP (sil den' a fil) What is the most important information I should know about sildenafil tablets?