10 OVERDOSAGE

Of these, 354 patients received SILDENAFIL ORAL FILM and 121 patients received placebo without regard to food and alcohol concomitant intake.

• Common side effects include headache, flushing, and nasal congestion.
• Serious side effects are rare but may include vision changes or priapism.
• Always consult with a healthcare provider before use.

The initial dose was 50 mg for subjects under 65 years and 25 mg for subjects 65 years or older with dose adjustment permitted up to 50 mg (for subjects 65 years or older), 75 mg or 100 mg or down to 25 mg based on efficacy and tolerability. By the end of the study, 94 (26.6%) and 115 (32.5%) patients in the SILDENAFIL ORAL FILM group were receiving 75 mg or 100 mg respectively. The efficacy of SILDENAFIL ORAL FILM, administered at flexible doses of 25 mg, 50 mg, 75 mg and 100 mg for the treatment of ED, was superior to placebo. Efficacy results are shown in Figure 6. Subgroup analyses by age, race, and ethnicity showed efficacy results consistent with the overall population. *Statistically significant differences vs. placebo; p-value <0.001 IIEF= International Index of Erectile Function, EF = Erectile Function, SEP Q2=Sexual Encounter Profile Question 2, SEP Q3 = Sexual Encounter Profile Question 3, N = Number of Subjects, SD = Standard Deviation, LS = Least Squares, CI = Confidence Interval. Sildenafil was assessed in many clinical studies for its effect on the ability of men with 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 was 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).

5. Warnings and Precautions

Sildenafil was 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 citrate demonstrated statistically significant improvement compared to placebo in all 21 studies. Sildenafil Efficacy Results from Controlled Clinical Studies The effect of sildenafil on one of the major end points, maintenance of erections after penetration, is shown in Figure 7, for the pooled results of 5 sildenafil fixed-dose, dose-response studies of greater than one-month duration, showing response according to baseline function. Results with all doses have been pooled, but scores showed greater improvement at the 50 and 100 mg doses than at the 25 mg dose. Figure 7 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil was better than that seen in patients treated with placebo.

Prior authorization

Figure7: Effect of Sildenafil and Placebo on Maintenance of Erection by Baseline Score The frequency of patients reporting improvement of erections in response to a global question in four of the sildenafil randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 8. Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of sildenafil, respectively, reported an improvement in their erections, compared to 24% on placebo. Figure8: Percentageof Patients Reportingan Improvement in Erections The patients in the sildenafil studies had varying degrees of ED. In many of the sildenafil 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 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 vs 0.4 on placebo; sildenafil oral jelly 100mg similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil citrate vs about 20% on placebo. Sildenafil was 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 citrate demonstrated statistically significant improvement compared to placebo in all 21 studies.

Product	Dosage	Quantity + Bonus	Price
Kamagra Polo	100mg	120 + 6 Pills	327.15€ 311.57€	Buy
Kamagra Polo	100mg	32 Pills	125.88€ 119.89€	Buy
Viagra Generic	50mg	60 + 4 Pills	83.93€ 79.93€	Buy
Viagra Generic	100mg	30 + 4 Pills	60.91€ 58.01€	Buy
Viagra Generic	50mg	20 Pills	40.52€ 38.59€	Buy
Viagra Generic	100mg	20 Pills	45.58€ 43.41€	Buy
Kamagra Soft Tabs	100mg	84 + 4 Pills	233.05€ 221.95€	Buy
Kamagra Polo	100mg	12 Pills	60.21€ 57.34€	Buy
Viagra Generic	150mg	60 + 4 Pills	111.25€ 105.95€	Buy
Viagra Generic	150mg	270 + 10 Pills	326.61€ 311.06€	Buy
Viagra Generic	150mg	360 + 10 Pills	423.48€ 403.31€	Buy

Sildenafil Efficacy Results from Controlled Clinical Studies The effect of sildenafil on one of the major end points, maintenance of erections after penetration, is shown in Figure 7, for the pooled results of 5 sildenafil fixed-dose, dose-response studies of greater than one-month duration, showing response according to baseline function. Results with all doses have been pooled, but scores showed greater improvement at the 50 and 100 mg doses than at the 25 mg dose.

ICO Registered Website

On a global improvement question, 83% of patients reported improved erections on sildenafil versus 12% on placebo. Diary data indicated that 20mg sildenafil 59% of attempts at sexual intercourse were successful on sildenafil compared to 13% on placebo. Across all trials, sildenafil 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 sildenafil studies (total n=179) and two sildenafil titration studies (total n=149) showed 84% of sildenafil patients reported improvement in erections compared with 26% of placebo. The changes from baseline in scoring on the two endpoint questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil .Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil and 29% for placebo.

8.4 Pediatric Use

Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups in sildenafil studies demonstrated efficacy regardless of baseline severity, etiology, race and age. Sildenafil 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 antihypertensives/diuretics. SILDENAFIL ORAL FILM is supplied as oral films in individually sealed foil pouches in four dosage strengths. Each carton contains 4 or 8 pouches. The product is an opaque light blue, thin, flexible oral film with film imprint code, and characteristic lemon and grapefruit flavor with the following dimensions: Recommended Storage:Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Figure 7 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil was better than that seen in patients treated with placebo. Figure7: Effect of Sildenafil and Placebo on Maintenance of Erection by Baseline Score The frequency of patients reporting improvement of erections in response to a global question in four of the sildenafil randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 8.

• These tablets provide a discreet alternative to traditional pills.
• They are designed to dissolve quickly in the mouth or be swallowed.
• Suitable for people who have difficulty swallowing capsules.

Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of sildenafil, respectively, reported an improvement in their erections, compared to 24% on placebo. Figure8: Percentageof Patients Reportingan Improvement in Erections The patients in the sildenafil studies had varying degrees of ED. In many of the sildenafil 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 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 vs 0.4 on placebo; sildenafil oral jelly 100mg similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil citrate vs about 20% on placebo. During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label sildenafil 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 improved their erections. Sildenafil 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 sildenafil study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268).

Mechanism of action

Concomitant administration of SILDENAFIL ORAL FILM and an alpha blocker may lead to symptomatic hypotension in some patients. Therefore, when SILDENAFIL ORAL FILM is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL ORAL FILM treatment and SILDENAFIL ORAL FILM should be initiated at the lowest dose [see Warnings and Precautions (5.5)]. Physicians should advise patients to stop use of all PDE5 inhibitors, including SILDENAFIL ORAL FILM 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, including sildenafil. 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 ORAL FILM, for this uncommon condition [see Warnings and Precautions (5.3),Adverse Reactions (6.2)]. 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; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil compared to placebo. On a global improvement question, 57% of sildenafil patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil, 48% of intercourse attempts were successful versus 12% on placebo. One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) sildenafil study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted.

Detection in biological fluids

Of these, 354 patients received SILDENAFIL ORAL FILM and 121 patients received placebo without regard to food and alcohol concomitant intake. The initial dose was 50 mg for subjects under 65 years and 25 mg for subjects 65 years or older with dose adjustment permitted up to 50 mg (for subjects 65 years or older), 75 mg or 100 mg or down to 25 mg based on efficacy and tolerability. By the end of the study, 94 (26.6%) and 115 (32.5%) patients in the SILDENAFIL ORAL FILM group were receiving 75 mg or 100 mg respectively. The efficacy of SILDENAFIL ORAL FILM, administered at flexible doses of 25 mg, 50 mg, 75 mg and 100 mg for the treatment of ED, was superior to placebo. Efficacy results are shown in Figure 6.

Vybrique Oral Film

Subgroup analyses by age, race, and ethnicity showed efficacy results consistent with the overall population. *Statistically significant differences vs. placebo; p-value <0.001 IIEF= International Index of Erectile Function, EF = Erectile Function, SEP Q2=Sexual Encounter Profile Question 2, SEP Q3 = Sexual Encounter Profile Question 3, N = Number of Subjects, SD = Standard Deviation, LS = Least Squares, CI = Confidence Interval. Sildenafil was assessed in many clinical studies for its effect on the ability of men with 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 was 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). The changes from baseline in scoring on the two endpoint questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil. On a global improvement question, 83% of patients reported improved erections on sildenafil versus 12% on placebo. Diary data indicated that 20mg sildenafil 59% of attempts at sexual intercourse were successful on sildenafil compared to 13% on placebo. Across all trials, sildenafil improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.

• Possible interactions include medications for HIV, antibiotics, and blood pressure.
• Overdose symptoms include severe headaches and chest pain.
• Seek immediate medical attention if adverse reactions occur.

Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose sildenafil studies (total n=179) and two sildenafil titration studies (total n=149) showed 84% of sildenafil patients reported improvement in erections compared with 26% of placebo. The changes from baseline in scoring on the two endpoint questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil .Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil and 29% for placebo. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups in sildenafil studies demonstrated efficacy regardless of baseline severity, etiology, race and age. Sildenafil 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 antihypertensives/diuretics.

Aspect	Data/Estimate
Market Size (2024)	Approx. USD 1.5 billion
Major Countries Exporting	USA, India, China
Growth Rate (CAGR 2024-2029)	About 6% annually
Leading Manufacturers	Pfizer, Teva, Sun Pharmaceutical

SILDENAFIL ORAL FILM is supplied as oral films in individually sealed foil pouches in four dosage strengths. Each carton contains 4 or 8 pouches. The product is an opaque light blue, thin, flexible oral film with film imprint code, and characteristic lemon and grapefruit flavor with the following dimensions: Recommended Storage:Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Advise the patient to read the FDA-approved patient labeling ( Patient Information) Advise patients to place SILDENAFIL ORAL FILM directly onto the tongue where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids.

Step	Description
Granulation	Mixing active and excipients, forming granules
Compression	Compressing into tablets
Coating	Applying film coating
Quality Control	Testing for potency, disintegration, purity

Advise patients not to cut or chew SILDENAFIL ORAL FILM [seeDosage and Administration (2.4) ]. Physicians should discuss with patients the contraindication of SILDENAFIL ORAL FILM with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications (4.1)].

4.2 Hypersensitivity Reactions

Advise the patient to read the FDA-approved patient labeling ( Patient Information) Advise patients to place SILDENAFIL ORAL FILM directly onto the tongue where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids. Advise patients not to cut or chew SILDENAFIL ORAL FILM [seeDosage and Administration (2.4) ]. Physicians should discuss with patients the contraindication of SILDENAFIL ORAL FILM 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 ORAL FILM 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 ORAL FILM to augment the blood pressure lowering effect of alpha-blockers and antihypertensive medications. Physicians should discuss with patients the contraindication of SILDENAFIL ORAL FILM 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 ORAL FILM to augment the blood pressure lowering effect of alpha-blockers and antihypertensive medications. Concomitant administration of SILDENAFIL ORAL FILM and an alpha blocker may lead to symptomatic hypotension in some patients.

Data availability statement

During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label sildenafil 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 improved their erections. Sildenafil 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 sildenafil study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). 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; all patients, however, were receiving 50 mg or 100 mg at the end of the study.

Pulmonary Arterial Hypertension

There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil compared to placebo. On a global improvement question, 57% of sildenafil patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil, 48% of intercourse attempts were successful versus 12% on placebo. One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) sildenafil study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. The changes from baseline in scoring on the two endpoint questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil. Therefore, when SILDENAFIL ORAL FILM is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL ORAL FILM treatment and SILDENAFIL ORAL FILM should be initiated at the lowest dose [see Warnings and Precautions (5.5)]. Physicians should advise patients to stop use of all PDE5 inhibitors, including SILDENAFIL ORAL FILM and seek medical attention in the event of a sudden loss of vision in one or both eyes.

What is Daktarin Gold 2% Cream?

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, including sildenafil. 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 ORAL FILM, for this uncommon condition [see Warnings and Precautions (5.3),Adverse Reactions (6.2)].