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Quantitative variables were presented in mean, standard deviation, minimum, and maximum. The Kruskal–Wallis test was used to compare quantitative variables between study groups. Socio-demographic characteristics are presented in Table 1. Groups A, B, and C showed a statistically significant improvement in the ArIIEF-5 scores after treatment with tadalafil 5 mg tablet and ODF tadalafil 5 mg compared to ODF placebo (p < 0.001) (Table 2, Fig. The efficacy of ODF tadalafil 5 mg and tadalafil 5 mg tablet was markedly higher compared to placebo (p < 0.001). Improvement in both formulations was reported in all patients compared to placebo across all groups. Compliance was significantly higher among patients on ODF tadalafil 5 mg compared to tadalafil 5 mg tablet in groups B and C, respectively (p < 0.001) (Table 2). Regarding adverse effects, muscle and back pains were significantly higher among patients receiving tadalafil 5 mg tablet compared to other formulations in group A (p = 0.040) (Table 2). While headache, gastrointestinal (GIT) upset, and muscle and back pains were significantly reported among patients receiving tadalafil 5 mg tablet compared to other formulations in group B (p < 0.001, < 0.001, and 0.012, respectively) (Table 2). Finally, GIT upset was significantly reported among patients receiving tadalafil 5 mg tablet compared to other formulations in group C (p < 0.001) (Table 2). The core findings of the current study were that participants across all groups showed a statistically significant improvement in the ArIIEF-5 scores after tadalafil 5 mg tablet and ODF tadalafil 5 mg compared to ODF placebo.
- The treatment is not intended for female use.
- Keep strips away from sources of heat and sunlight.
- Report any unusual symptoms to your healthcare provider immediately.
Furthermore, post hoc analysis showed that improvement after tadalafil 5 mg tablet and ODF tadalafil 5 mg was mainly significant compared to placebo, and both formulations were comparable in efficacy. Patients who received ODF tadalafil 5 mg were significantly more compliant to treatment compared to tadalafil 5 mg tablet.
- Side effects may include headaches, flushing, or dizziness.
- Seek medical advice if adverse reactions occur or persist.
- Do not exceed the recommended dosage to avoid health risks.
(2018) stated that safety and tolerability features of the ODF formulation were found to be comparable to those of the film-coated tablet formulation [18]. Furthermore, the same aforementioned study conducted by Park et al. (2018) [18] reported no serious adverse events in the study arms, either in oral tablet tadalafil or ODF tadalafil [18], which could also be seen as contradictory to our findings. (2017) [19] revealed that sildenafil ODF exhibited comparable levels of safety and efficacy to the conventional film-coated tablet [19]. However, the aforementioned study revealed that the ODF formulation elicited greater overall satisfaction among the patients [19], which could be seen as similar to our findings. In the same context, the prevalence of headache in ODF decreased, and the duration and intensity of flushing and nasal congestion were lower in a study conducted by De Toni et al. (2018) [20] that could be seen in agreement with the current findings. Although both formulations demonstrated comparable efficacy in the current study, yet, the ODF tadalafil 5 mg formulation demonstrated lesser side effects as well as better tolerability. Henceforth, the findings of the current study could be postulated that a rapid ODF pre-gastric absorption resulted in a faster onset of action with subsequent enhanced bioavailability and therapeutic outcomes as well as reduced dosing and adverse effects [21]. Furthermore, the safety profiles could be enhanced by lowering toxic metabolites that resulted from hepatic metabolism since the drug was mostly absorbed from buccal mucosa [14]. The main limitation of the current study was the relatively small sample size per group. Also, the inability to measure the serum levels of both formulations to evaluate the pharmacokinetic properties can be added as a limitation. Finally, exclusion of patients with serious medical comorbidities which might have interfered with the effectiveness of each drug formulation can be regarded as another limitation. However, it should be emphasized that we did not need to monitor any potential side effects from both formulations of tadalafil 5 mg administration especially cardiovascular complications since patients with severe ED and associated serious comorbidities were excluded from the study as mentioned in the previous limitation.
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Ther Clin Risk Manag 3(6):975–981 McMurray JG, Feldman RA, Auerbach SM, Deriesthal H, Wilson N; Multicenter Study Group (2007) Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction. Ther Clin Risk Manag 3(6):975–981 Park S-I, Heo S-H, Kim G et al (2018) Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet. Drug Des Dev Ther 12:935–942 Park S-I, Heo S-H, Kim G et al (2018) Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet. Drug Des Dev Ther 12:935–942 Cocci A, Capece M, Cito G et al (2017) Effectiveness and safety of oro-dispersible sildenafil in a new film formulation for the treatment of erectile dysfunction: comparison between sildenafil 100 mg film-coated tablet and 75 mg oro-dispersible film. Furthermore, it is worth mentioning that proper diagnosis and treatment of ED as well as its risk factors optimize control and management of any associated comorbidity with ED [22]. Eventually, large prospective studies should be conducted to assess the prevalence and severity of adverse events of tadalafil tablets compared to ODF and to assess the difference of tadalafil tablets among patients with organic ED due to medical comorbidities, metabolic and malabsorption syndromes. ODF tadalafil 5 mg is an effective, tolerable, and safe drug formulation that can be used regularly or on-demand exactly as tadalafil 5 mg tablets with lesser adverse events and higher compliance rates. The data that support the findings of this study are available from the corresponding author upon reasonable request. Shamloul R, Ghanem H (2013) Erectile dysfunction. Salama MN, Eid AA, Hatem A, Swidan AK (2020) Prevalence of erectile dysfunction in Egyptian males with metabolic syndrome. Zedan H, Hareadei AA, Abdel Sayed AA, Abdel Maguid EM (2010) Cigarette smoking, hypertension and diabetes mellitus as risk factors for erectile dysfunction in upper Egypt.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Soft Tabs | 20mg | 20 + 2 Pills | 66.98€ 63.79€ | |
| Cialis Generic | 5mg | 270 + 10 Pills | 205.81€ 196.01€ | |
| Cialis Generic | 2.5mg | 360 + 10 Pills | 260.03€ 247.65€ | |
| Cialis Generic | 20mg | 120 + 8 Pills | 188.15€ 179.19€ | |
| Cialis Generic | 2.5mg | 90 + 6 Pills | 112.43€ 107.08€ | |
| Cialis Generic | 5mg | 60 + 4 Pills | 86.02€ 81.92€ | |
| Cialis Generic | 10mg | 30 + 4 Pills | 63.32€ 60.30€ | |
| Cialis Super Active | 20mg | 60 + 8 Pills | 230.32€ 219.35€ | |
| Cialis Super Active | 20mg | 270 + 30 Pills | 661.49€ 629.99€ | |
| Cialis Generic | 40mg | 120 + 8 Pills | 206.98€ 197.12€ |
EMHJ-East Mediterr Health J 16(3):281–285 Zedan H, Hareadei AA, Abdel Sayed AA, Abdel Maguid EM (2010) Cigarette smoking, hypertension and diabetes mellitus as risk factors for erectile dysfunction generic cialis soft tabs online in upper Egypt. EMHJ-East Mediterr Health J 16(3):281–285 Saad HM, GamalEl Din SF, Elbokl OM, Adel A (2022) Predictive factors of erectile dysfunction in Egyptian individuals after contracting COVID-19: a prospective case–control study. Saad HM, GamalEl Din SF, Elbokl OM, Adel A (2022) Predictive factors of erectile dysfunction in Egyptian individuals after contracting COVID-19: a prospective case–control study. Kamal EE, Zedan HM, Ismail AA, Hussein K, Zakaria M, Badran AY (2021) Erectile dysfunction in Egyptian patients with chronic obstructive pulmonary disease. Egypt J Dermatol Venerol 41(1):38 Kamal EE, Zedan HM, Ismail AA, Hussein K, Zakaria M, Badran AY (2021) Erectile dysfunction in Egyptian patients with chronic obstructive pulmonary disease. Egypt J Dermatol Venerol 41(1):38 McMahon CG (2019) Current diagnosis and management of erectile dysfunction. Med J Aust 210(10):469–476 McMahon CG (2019) Current diagnosis and management of erectile dysfunction. Med J Aust 210(10):469–476 Brock GB, McMahon CG, Chen KK et al (2002) Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol 168(4 Pt 1):1332–1336 Brock GB, McMahon CG, Chen KK et al (2002) Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol 168(4 Pt 1):1332–1336 Coward RM, Carson CC (2008) Tadalafil in the treatment of erectile dysfunction. Ther Clin Risk Manag 4(6):1315–1330 Coward RM, Carson CC (2008) Tadalafil in the treatment of erectile dysfunction. Ther Clin Risk Manag 4(6):1315–1330 Hoffmann EM, Breitenbach A, Breitkreutz J (2011) Advances in orodispersible films for drug delivery.
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(2018) [18] reported no serious adverse events in the study arms, either in oral tablet tadalafil or ODF tadalafil [18], which could also be seen as contradictory to our findings. (2017) [19] revealed that sildenafil ODF exhibited comparable levels of safety and efficacy to the conventional film-coated tablet [19]. However, the aforementioned study revealed that the ODF formulation elicited greater overall satisfaction among the patients [19], which could be seen as similar to our findings. In the same context, the prevalence of headache in ODF decreased, and the duration and intensity of flushing and nasal congestion were lower in a study conducted by De Toni et al. (2018) [20] that could be seen in agreement with the current findings.
Design of PVP/VA S-630 based tadalafil solid dispersion to enhance the dissolution rate
Although both formulations demonstrated comparable efficacy in the current study, yet, the ODF tadalafil 5 mg formulation demonstrated lesser side effects as well as better tolerability. Henceforth, the findings of the current study could be postulated that a rapid ODF pre-gastric absorption resulted in a faster onset of action with subsequent enhanced bioavailability and therapeutic outcomes as well as reduced dosing and adverse effects [21]. Furthermore, the safety profiles could be enhanced by lowering toxic metabolites that resulted from hepatic metabolism since the drug was mostly absorbed from buccal mucosa [14]. The main limitation of the current study was the relatively small sample size per group. Also, the inability to measure the serum levels of both formulations to evaluate the pharmacokinetic properties can be added as a limitation.
Arch. Ital. Urol. Androl.
Finally, exclusion of patients with serious medical comorbidities which might have interfered with the effectiveness of each drug formulation can be regarded as another limitation. However, it should be emphasized that we did not need to monitor any potential side effects from both formulations of tadalafil 5 mg administration especially cardiovascular complications since patients with severe ED and associated serious comorbidities were excluded from the study as mentioned in the previous limitation. Furthermore, it is worth mentioning that proper diagnosis and treatment of ED as well as its risk factors optimize control and management of any associated comorbidity with ED [22]. Eventually, large prospective studies should be conducted to assess the prevalence and severity of adverse events of tadalafil tablets compared to ODF and to assess the difference of tadalafil tablets among patients with organic ED due to medical comorbidities, metabolic and malabsorption syndromes. ODF tadalafil 5 mg is an effective, tolerable, and safe drug formulation that can be used regularly or on-demand exactly as tadalafil 5 mg tablets with lesser adverse events and higher compliance rates. Expert Opin Drug Deliv 8(3):299–316 Hoffmann EM, Breitenbach A, Breitkreutz J (2011) Advances in orodispersible films for drug delivery.
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The data that support the findings of this study are available from the corresponding author upon reasonable request. Shamloul R, Ghanem H (2013) Erectile dysfunction. Salama MN, Eid AA, Hatem A, Swidan AK (2020) Prevalence of erectile dysfunction in Egyptian males with metabolic syndrome. Zedan H, Hareadei AA, Abdel Sayed AA, Abdel Maguid EM (2010) Cigarette smoking, hypertension and diabetes mellitus as risk factors for erectile dysfunction in upper Egypt. EMHJ-East Mediterr Health J 16(3):281–285 Zedan H, Hareadei AA, Abdel Sayed AA, Abdel Maguid EM (2010) Cigarette smoking, hypertension and diabetes mellitus as risk factors for erectile dysfunction generic cialis soft tabs online in upper Egypt.
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EMHJ-East Mediterr Health J 16(3):281–285 Saad HM, GamalEl Din SF, Elbokl OM, Adel A (2022) Predictive factors of erectile dysfunction in Egyptian individuals after contracting COVID-19: a prospective case–control study. Saad HM, GamalEl Din SF, Elbokl OM, Adel A (2022) Predictive factors of erectile dysfunction in Egyptian individuals after contracting COVID-19: a prospective case–control study. Kamal EE, Zedan HM, Ismail AA, Hussein K, Zakaria M, Badran AY (2021) Erectile dysfunction in Egyptian patients with chronic obstructive pulmonary disease. Egypt J Dermatol Venerol 41(1):38 Kamal EE, Zedan HM, Ismail AA, Hussein K, Zakaria M, Badran AY (2021) Erectile dysfunction in Egyptian patients with chronic obstructive pulmonary disease. Egypt J Dermatol Venerol 41(1):38 McMahon CG (2019) Current diagnosis and management of erectile dysfunction.
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Med J Aust 210(10):469–476 McMahon CG (2019) Current diagnosis and management of erectile dysfunction. Med J Aust 210(10):469–476 Brock GB, McMahon CG, Chen KK et al (2002) Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol 168(4 Pt 1):1332–1336 Brock GB, McMahon CG, Chen KK et al (2002) Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol 168(4 Pt 1):1332–1336 Coward RM, Carson CC (2008) Tadalafil in the treatment of erectile dysfunction. Ther Clin Risk Manag 4(6):1315–1330 Coward RM, Carson CC (2008) Tadalafil in the treatment of erectile dysfunction. Expert Opin Drug Deliv 8(3):299–316 Ketul P, Patel KR, Patel MR, Patel NM (2013) Fast dissolving films: a novel approach to oral drug delivery. Ketul P, Patel KR, Patel MR, Patel NM (2013) Fast dissolving films: a novel approach to oral drug delivery.
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Ther Clin Risk Manag 4(6):1315–1330 Hoffmann EM, Breitenbach A, Breitkreutz J (2011) Advances in orodispersible films for drug delivery. Expert Opin Drug Deliv 8(3):299–316 Hoffmann EM, Breitenbach A, Breitkreutz J (2011) Advances in orodispersible films for drug delivery. Expert Opin Drug Deliv 8(3):299–316 Ketul P, Patel KR, Patel MR, Patel NM (2013) Fast dissolving films: a novel approach to oral drug delivery. Ketul P, Patel KR, Patel MR, Patel NM (2013) Fast dissolving films: a novel approach to oral drug delivery. Dixit RP, Puthli SP (2009) Oral strip technology: overview and future potential.
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J Control Release 139(2):94–107 Dixit RP, Puthli SP (2009) Oral strip technology: overview and future potential. J Control Release 139(2):94–107 Amin PM, Gangurde AB, Alai PV (2015) Oral film technology: challenges and future scope for pharmaceutical industry. Int J Pharm Pharm Res 3(3):184–203 Amin PM, Gangurde AB, Alai PV (2015) Oral film technology: challenges and future scope for pharmaceutical industry. Int J Pharm Pharm Res 3(3):184–203 Bala R, Pawar P, Khanna S, Arora S (2013) Orally dissolving strips: a new approach to oral drug delivery system. Int J Pharma Investig 3:67–76 Bala R, Pawar P, Khanna S, Arora S (2013) Orally dissolving strips: a new approach to oral drug delivery system.
In vitro and in vivo characteristics of prochlorperazine oral disintegrating film
Int J Pharma Investig 3:67–76 World Medical Association (2013) World medical association declaration of helsinki: ethical principles for medical research involving human subjects. World Medical Association (2013) World medical association declaration of helsinki: ethical principles for medical research involving human subjects. Shamloul R, Ghanem H, Abou-zeid A (2004) Validity of the arabic version of the sexual health inventory for men among Egyptians. Int J Impot Res 16(5):452–455 Shamloul R, Ghanem H, Abou-zeid A (2004) Validity of the arabic version of the sexual health inventory for men among Egyptians. Int J Impot Res 16(5):452–455 McMurray JG, Feldman RA, Auerbach SM, Deriesthal H, Wilson N; Multicenter Study Group (2007) Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction. Dixit RP, Puthli SP (2009) Oral strip technology: overview and future potential. J Control Release 139(2):94–107 Dixit RP, Puthli SP (2009) Oral strip technology: overview and future potential. J Control Release 139(2):94–107 Amin PM, Gangurde AB, Alai PV (2015) Oral film technology: challenges and future scope for pharmaceutical industry. Int J Pharm Pharm Res 3(3):184–203 Amin PM, Gangurde AB, Alai PV (2015) Oral film technology: challenges and future scope for pharmaceutical industry. Int J Pharm Pharm Res 3(3):184–203 Bala R, Pawar P, Khanna S, Arora S (2013) Orally dissolving strips: a new approach to oral drug delivery system. Int J Pharma Investig 3:67–76 Bala R, Pawar P, Khanna S, Arora S (2013) Orally dissolving strips: a new approach to oral drug delivery system. Int J Pharma Investig 3:67–76 World Medical Association (2013) World medical association declaration of helsinki: ethical principles for medical research involving human subjects. World Medical Association (2013) World medical association declaration of helsinki: ethical principles for medical research involving human subjects. Shamloul R, Ghanem H, Abou-zeid A (2004) Validity of the arabic version of the sexual health inventory for men among Egyptians. Int J Impot Res 16(5):452–455 Shamloul R, Ghanem H, Abou-zeid A (2004) Validity of the arabic version of the sexual health inventory for men among Egyptians. Int J Impot Res 16(5):452–455 McMurray JG, Feldman RA, Auerbach SM, Deriesthal H, Wilson N; Multicenter Study Group (2007) Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction. Ther Clin Risk Manag 3(6):975–981 McMurray JG, Feldman RA, Auerbach SM, Deriesthal H, Wilson N; Multicenter Study Group (2007) Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction. Ther Clin Risk Manag 3(6):975–981 Park S-I, Heo S-H, Kim G et al (2018) Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet. Drug Des Dev Ther 12:935–942 Park S-I, Heo S-H, Kim G et al (2018) Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet.
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Quantitative variables were presented in mean, standard deviation, minimum, and maximum. The Kruskal–Wallis test was used to compare quantitative variables between study groups. Socio-demographic characteristics are presented in Table 1. Groups A, B, and C showed a statistically significant improvement in the ArIIEF-5 scores after treatment with tadalafil 5 mg tablet and ODF tadalafil 5 mg compared to ODF placebo (p < 0.001) (Table 2, Fig. The efficacy of ODF tadalafil 5 mg and tadalafil 5 mg tablet was markedly higher compared to placebo (p < 0.001).
What are the most common side effects of tadalafil?
Improvement in both formulations was reported in all patients compared to placebo across all groups. Compliance was significantly higher among patients on ODF tadalafil 5 mg compared to tadalafil 5 mg tablet in groups B and C, respectively (p < 0.001) (Table 2). Regarding adverse effects, muscle and back pains were significantly higher among patients receiving tadalafil 5 mg tablet compared to other formulations in group A (p = 0.040) (Table 2). While headache, gastrointestinal (GIT) upset, and muscle and back pains were significantly reported among patients receiving tadalafil 5 mg tablet compared to other formulations in group B (p < 0.001, < 0.001, and 0.012, respectively) (Table 2). Finally, GIT upset was significantly reported among patients receiving tadalafil 5 mg tablet compared to other formulations in group C (p < 0.001) (Table 2).
Are there any medical conditions that can interact with Tadalafil?
The core findings of the current study were that participants across all groups showed a statistically significant improvement in the ArIIEF-5 scores after tadalafil 5 mg tablet and ODF tadalafil 5 mg compared to ODF placebo. Furthermore, post hoc analysis showed that improvement after tadalafil 5 mg tablet and ODF tadalafil 5 mg was mainly significant compared to placebo, and both formulations were comparable in efficacy. Patients who received ODF tadalafil 5 mg were significantly more compliant to treatment compared to tadalafil 5 mg tablet. (2018) stated that safety and tolerability features of the ODF formulation were found to be comparable to those of the film-coated tablet formulation [18]. Furthermore, the same aforementioned study conducted by Park et al. Drug Des Dev Ther 12:935–942 Cocci A, Capece M, Cito G et al (2017) Effectiveness and safety of oro-dispersible sildenafil in a new film formulation for the treatment of erectile dysfunction: comparison between sildenafil 100 mg film-coated tablet and 75 mg oro-dispersible film.
| Dosage Option | Recommended For | Max Daily Dose | Special Instructions |
|---|---|---|---|
| 10 mg per strip | Most users, mild to moderate ED | 1 strip/day | Take as needed, 15 min before activity |
| 20 mg per strip | Severe ED, no contraindications | 1 strip/day | Consult healthcare provider |
| Use on empty stomach | Improves absorption | Yes | Avoid heavy meals close to intake |