The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 7.
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Advise the patient to read the FDA-approved patient labeling ( Patient Information) 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)]. 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. Therefore, when SILDENAFIL TABLETS is 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)]. Physicians should discuss with patients sildenafil oral jelly 100 mg the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.
How is sildenafil supplied (dosage forms)?
Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)]. 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)]. 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)]. 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.
Use In Specific Populations
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)]. 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 the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar. The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period. In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. 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 50–100 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. During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that SILDENAFIL TABLETS improved their erections. Men with untreated ED had relatively low baseline scores for all aspects sildenafil citrate tablets for female of sexual function measured (again using a 5-point scale) in the IIEF. 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. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on SILDENAFIL TABLETS, 48% of intercourse attempts were successful versus 12% on placebo.
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One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. Diary data indicated that on SILDENAFIL TABLETS, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.
- Store sildenafil film tablets in a cool, dry place away from children.
- Expiry date is stamped on the package; do not use expired medication.
- Proper storage helps maintain drug efficacy and safety.
Across all trials, SILDENAFIL TABLETS improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.
What are Wind-Eze Soft Gel Capsules?
The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 7. In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar. The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period. In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients.
Does sildenafil interact with foods or drinks?
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 50–100 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. During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that SILDENAFIL TABLETS improved their erections. Men with untreated ED had relatively low baseline scores for all aspects sildenafil citrate tablets for female of sexual function measured (again using a 5-point scale) in the IIEF. 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.
Missed Dose
One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on SILDENAFIL TABLETS, 48% of intercourse attempts were successful versus 12% on placebo. One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. 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.
1. Introduction
Recreational use
Clinical monitoring
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. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information)NitratesPhysicians 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) StimulatorsPhysicians 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 PressurePhysicians 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 sildenafil 100mg hexal and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when SILDENAFIL TABLETS is 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 ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians 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. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors.
| Parameter | Value |
|---|---|
| Absorption Rate | Rapid, peak in 30-120 min |
| Bioavailability | Approx. 40% |
| Half-life | About 4 hours |
| Metabolism | Liver (cytochrome P450 enzymes) |
Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. 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 LossPhysicians 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)].PriapismPhysicians 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. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take SILDENAFIL TABLETS with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. 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 DiseaseThe use of SILDENAFIL TABLETS offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].
- Sildenafil film tablets are oral medications used to treat erectile dysfunction.
- These tablets are smooth, coated, and designed for quick swallowing.
- They contain sildenafil citrate as the active ingredient.
Advise the patient to read the FDA-approved patient labeling ( Patient Information) 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)]. 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. Therefore, when SILDENAFIL TABLETS is 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)].
| Step | Description |
|---|---|
| Granulation | Mixing active and excipients, forming granules |
| Compression | Compressing into tablets |
| Coating | Applying film coating |
| Quality Control | Testing for potency, disintegration, purity |
Physicians should discuss with patients sildenafil oral jelly 100 mg the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)]. 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.
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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. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information)NitratesPhysicians 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) StimulatorsPhysicians 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 PressurePhysicians 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 sildenafil 100mg hexal and an alpha-blocker may lead to symptomatic hypotension in some patients.
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Therefore, when SILDENAFIL TABLETS is 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 ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians 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. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. 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 LossPhysicians 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.
Regional issues
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)].PriapismPhysicians 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. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take SILDENAFIL TABLETS with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. 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 DiseaseThe use of SILDENAFIL TABLETS offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)]. 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)]. 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)]. 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. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)]. 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)].