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Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥50.An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions ()].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including tadalafil tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population; however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil tablets, for this uncommon condition.Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.5.5 Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including tadalafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
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Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing tadalafil tablets, it is important to note the following: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention. Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets.
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Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors. The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for tadalafil tablets, and therefore until further information is available, tadalafil tablets are not recommended for the following groups of patients: myocardial infarction within the last 90 days unstable angina or angina occurring during sexual intercourse New York Heart Association Class 2 or greater heart failure in the last 6 months uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including tadalafil tablets. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (, )].5.6 Alpha-blockers and AntihypertensivesPhysicians should discuss with patients the potential for tadalafil tablets to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications [see Drug Interactions () and Clinical Pharmacology ()].Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including tadalafil tablets, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Tadalista Super Active | 20mg | 270 + 30 Pills | 661.49€ 629.99€ | |
| Cialis Generic | 20mg | 60 + 6 Pills | 117.76€ 112.15€ | |
| Cialis Generic | 40mg | 30 + 4 Pills | 74.97€ 71.40€ | |
| Cialis Generic | 20mg | 10 Pills | 31.49€ 29.99€ | |
| Cialis Generic | 60mg | 90 + 6 Pills | 196.67€ 187.30€ | |
| Cialis Generic | 60mg | 60 + 4 Pills | 145.06€ 138.15€ | |
| Cialis Generic | 2.5mg | 30 + 4 Pills | 51.95€ 49.48€ | |
| Cialis Generic | 5mg | 90 + 6 Pills | 115.91€ 110.39€ | |
| Cialis Generic | 10mg | 270 + 10 Pills | 308.71€ 294.01€ | |
| Cialis Generic | 60mg | 30 + 2 Pills | 85.33€ 81.27€ | |
| Cialis Generic | 40mg | 90 + 6 Pills | 171.35€ 163.19€ | |
| Cialis Generic | 10mg | 90 + 6 Pills | 146.17€ 139.21€ | |
| Cialis Generic | 10mg | 60 + 6 Pills | 105.81€ 100.77€ | |
| Tadalista Super Active | 20mg | 10 Pills | 55.64€ 52.99€ |
When vasodilators are used in combination, an additive effect on blood pressure may be anticipated.
6.2 Postmarketing Experience
When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions () and Clinical Pharmacology ()], which may lead to symptomatic hypotension (e.g., fainting). Consideration should be given to the following:ED•Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.•In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended dose.•In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.•Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs.•[see Dosage and Administration () and Drug Interactions ()].BPH•The efficacy of the coadministration of an alpha-blocker and tadalafil tablets for the treatment of BPH has not been adequately studied, and due to the potential vasodilatory effects of combined use resulting in blood pressure lowering, the combination of tadalafil tablets and alpha-blockers is not recommended for the treatment of BPH.
Statistical analysis
[see Dosage and Administration (), Drug Interactions (), and Clinical Pharmacology (. )].•Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting tadalafil tablets for once daily use for the treatment of BPH.5.7 Renal ImpairmentTadalafil Tablets for Use as NeededTadalafil tablets should be limited to 5 mg not more than once in every 72 hours in patients with creatinine clearance less than 30 mL/min or end-stage renal disease on hemodialysis. The starting dose of tadalafil tablets in patients with creatinine clearance 30 – 50 mL/min should be 5 mg not more than once per day, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. [see Use in Specific Populations ()].Tadalafil Tablets for Once Daily UseEDDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablets for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min [see Use in Specific Populations ()].BPH and ED/BPHDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablets for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min. In patients with creatinine clearance 30 – 50 mL/min, start dosing at 2.5 mg once daily, and increase the dose to tadalafil for premature ejaculation 5 mg once daily based upon individual response [see Dosage and Administration (2.6), Use in Specific Populations (), and Clinical Pharmacology ()].5.8 Hepatic ImpairmentTadalafil Tablets for Use as NeededIn patients with mild or moderate hepatic impairment, the dose of tadalafil tablets should not exceed 10 mg. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions () and Clinical Pharmacology ()], which may lead to symptomatic hypotension (e.g., fainting). Consideration should be given to the following:ED•Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.
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Because of insufficient information in patients with severe hepatic impairment, use of tadalafil tablets in this group is not recommended [see Use in Specific Populations ()].Tadalafil Tablets for Once Daily UseTadalafil tablets for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment. Because of insufficient information in patients with severe hepatic impairment, use of tadalafil tablets in this group is not recommended [see Use in Specific Populations ()].5.9 AlcoholPatients should be made aware that both alcohol and tadalafil tablets, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Clinical Pharmacology ()].5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)Tadalafil tablets are metabolized predominantly by CYP3A4 in the liver. The dose of tadalafil tablets for use as needed should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole [see Drug Interactions ()].
Impact of patient characteristics and comorbidities on erectile function and treatment satisfaction during treatment with tadalafil OaD
In patients taking potent inhibitors of CYP3A4 and tadalafil tablets for once daily use, the maximum recommended dose is 2.5 mg [see Dosage and Administration ()].5.11 Combination with Other PDE5 Inhibitors or Erectile Dysfunction TherapiesThe safety and efficacy of combinations of tadalafil tablets and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take tadalafil tablets with other PDE5 inhibitors, including ADCIRCA®.5.12 Effects on BleedingStudies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time, relative to aspirin alone. Tadalafil tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration. Although tadalafil tablets have not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.5.13 Counseling Patients About Sexually Transmitted DiseasesThe use of tadalafil tablets offers no protection against sexually transmitted diseases. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.•In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended dose.•In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.•Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs.•[see Dosage and Administration () and Drug Interactions ()].BPH•The efficacy of the coadministration of an alpha-blocker and tadalafil tablets for the treatment of BPH has not been adequately studied, and due to the potential vasodilatory effects of combined use resulting in blood pressure lowering, the combination of tadalafil tablets and alpha-blockers is not recommended for the treatment of BPH. [see Dosage and Administration (), Drug Interactions (), and Clinical Pharmacology (.
- Tadalafil 5mg has a duration of action up to 36 hours.
- It can improve spontaneous sexual activity.
- Dosage adjustments may be necessary for certain health conditions.
)].•Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting tadalafil tablets for once daily use for the treatment of BPH.5.7 Renal ImpairmentTadalafil Tablets for Use as NeededTadalafil tablets should be limited to 5 mg not more than once in every 72 hours in patients with creatinine clearance less than 30 mL/min or end-stage renal disease on hemodialysis. The starting dose of tadalafil tablets in patients with creatinine clearance 30 – 50 mL/min should be 5 mg not more than once per day, and the maximum dose should be limited to 10 mg not more than once in every 48 hours.
- In rare cases, tadalafil can cause vision changes.
- Allergic reactions may include rash, swelling, or difficulty breathing.
- Seek medical advice if side effects are severe or persistent.
[see Use in Specific Populations ()].Tadalafil Tablets for Once Daily UseEDDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablets for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min [see Use in Specific Populations ()].BPH and ED/BPHDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablets for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min. In patients with creatinine clearance 30 – 50 mL/min, start dosing at 2.5 mg once daily, and increase the dose to tadalafil for premature ejaculation 5 mg once daily based upon individual response [see Dosage and Administration (2.6), Use in Specific Populations (), and Clinical Pharmacology ()].5.8 Hepatic ImpairmentTadalafil Tablets for Use as NeededIn patients with mild or moderate hepatic impairment, the dose of tadalafil tablets should not exceed 10 mg. Because of insufficient information in patients with severe hepatic impairment, use of tadalafil tablets in this group is not recommended [see Use in Specific Populations ()].Tadalafil Tablets for Once Daily UseTadalafil tablets for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment.
- Overdose signs include painful erections lasting over 4 hours.
- Seek immediate medical attention if overdose is suspected.
- Follow dosage directions strictly to avoid complications.
Because of insufficient information in patients with severe hepatic impairment, use of tadalafil tablets in this group is not recommended [see Use in Specific Populations ()].5.9 AlcoholPatients should be made aware that both alcohol and tadalafil tablets, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased.
- Tadalafil 5mg may interact with other medications.
- Follow prescribed instructions for safe use.
- Misuse can lead to serious health risks or side effects.
Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Clinical Pharmacology ()].5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)Tadalafil tablets are metabolized predominantly by CYP3A4 in the liver. The dose of tadalafil tablets for use as needed should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole [see Drug Interactions ()]. In patients taking potent inhibitors of CYP3A4 and tadalafil tablets for once daily use, the maximum recommended dose is 2.5 mg [see Dosage and Administration ()].5.11 Combination with Other PDE5 Inhibitors or Erectile Dysfunction TherapiesThe safety and efficacy of combinations of tadalafil tablets and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take tadalafil tablets with other PDE5 inhibitors, including ADCIRCA®.5.12 Effects on BleedingStudies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time, relative to aspirin alone. Tadalafil tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration. Although tadalafil tablets have not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.5.13 Counseling Patients About Sexually Transmitted DiseasesThe use of tadalafil tablets offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing tadalafil tablets, it is important to note the following: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.
| Property | Description | Value/Notes |
|---|---|---|
| Active Ingredient | Tadalafil | 5 mg |
| Drug Class | Phosphodiesterase type 5 inhibitor | - |
| Half-life | 17.5 hours | Approximate |
| Bioavailability | ~80% | Oral administration |
| Absorption Time | 2 hours | Peak plasma concentration |
| Metabolism | Liver (via CYP3A4 enzyme) | - |
| Excretion | Feces (~61%), Urine (~36%) | - |
Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.
17.3 Cardiovascular Considerations
Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥50.An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions ()].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence.
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Therefore, PDE5 inhibitors, including tadalafil tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population; however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil tablets, for this uncommon condition.Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.5.5 Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including tadalafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including tadalafil tablets. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (, )].5.6 Alpha-blockers and AntihypertensivesPhysicians should discuss with patients the potential for tadalafil tablets to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications [see Drug Interactions () and Clinical Pharmacology ()].Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including tadalafil tablets, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for tadalafil tablets, and therefore until further information is available, tadalafil tablets are not recommended for the following groups of patients: myocardial infarction within the last 90 days unstable angina or angina occurring during sexual intercourse New York Heart Association Class 2 or greater heart failure in the last 6 months uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure.