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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 (6.2)].Physicians should consider whether their patientswith underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.

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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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In patients with creatinine clearance 30 mL/min to 50 mL/min, start dosing at 2.5 mg once daily, and increase the dose to 5 mg once daily based upon individual response [see Dosage and Administration (2.6), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].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 (8.6)].Tadalafil Tablet for Once Daily UseTadalafil tablet 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 tablet in this group is not recommended [see Use in Specific Populations (8.6)].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 liquid viagra potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Clinical Pharmacology (12.2)].5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)Tadalafil tablets are metabolized predominantly by CYP3A4 in the liver.

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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 (7.2)]. In patients taking potent inhibitors of CYP3A4 and tadalafil tablet for once daily use, the maximum recommended dose is 2.5 mg [see Dosage and Administration (2.7)].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 50mg viagra tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration.

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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. 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 (6.1, 6.2)].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 (7.1) and Clinical Pharmacology (12.2)].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. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated.

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In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)], which may lead to symptomatic hypotension (e.g., fainting).

6.1 Clinical Trials Experience

Consideration should be given to the following:EDPatients 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, generic viagra professional sildenafil 100mg 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 (2.7) and Drug Interactions (7.1)].BPHThe 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 (2.7), Drug Interactions (7.1), and Clinical Pharmacology (12.2.

Country	Legal Status	Prescription Requirement	Remarks
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)].Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting tadalafil tablet 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 mL/min to 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 (8.7)].TadalafilTablet for Once Daily UseEDDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablet for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min [see Use in Specific Populations (8.7)].BPH and ED/BPHDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablet for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min. In patients with creatinine clearance 30 mL/min to 50 mL/min, start dosing at 2.5 mg once daily, and increase the dose to 5 mg once daily based upon individual response [see Dosage and Administration (2.6), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].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.

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Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications (4.1) and Patient Counseling Information (17.1)]. 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 (<90mm Hg/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.

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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 (8.6)].Tadalafil Tablet for Once Daily UseTadalafil tablet 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 tablet in this group is not recommended [see Use in Specific Populations (8.6)].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 liquid viagra potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Clinical Pharmacology (12.2)].5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)Tadalafil tablets are metabolized predominantly by CYP3A4 in the liver.

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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 (7.2)]. In patients taking potent inhibitors of CYP3A4 and tadalafil tablet for once daily use, the maximum recommended dose is 2.5 mg [see Dosage and Administration (2.7)].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.

The bottom line

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Tadalafil 50mg viagra tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration.

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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. Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications (4.1) and Patient Counseling Information (17.1)]. 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.

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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 (6.2)].Physicians should consider whether their patientswith 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. 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.

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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 (6.1, 6.2)].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 (7.1) and Clinical Pharmacology (12.2)].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. 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 (7.1) and Clinical Pharmacology (12.2)], which may lead to symptomatic hypotension (e.g., fainting). Consideration should be given to the following:EDPatients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.

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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, generic viagra professional sildenafil 100mg 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 (2.7) and Drug Interactions (7.1)].BPHThe 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 (2.7), Drug Interactions (7.1), and Clinical Pharmacology (12.2. )].Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting tadalafil tablet 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 mL/min to 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 (8.7)].TadalafilTablet for Once Daily UseEDDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablet for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min [see Use in Specific Populations (8.7)].BPH and ED/BPHDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablet for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min. 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 (<90mm Hg/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.

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