16 HOW SUPPLIED/STORAGE AND HANDLING

CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown [see Clinical Studies (14.3)]. 2 DOSAGE AND ADMINISTRATION Do not split CIALIS tablets; entire dose should be taken.2.1 CIALIS for Use as Needed for Erectile DysfunctionThe recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.2.2 CIALIS for Once Daily Use for Erectile DysfunctionThe recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.2.3 CIALIS for Once Daily Use for Benign Prostatic HyperplasiaThe recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day.When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic HyperplasiaThe recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.2.6 Use in Specific PopulationsRenal ImpairmentCIALIS for Use as NeededCreatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].CIALIS for Once Daily UseBenign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic HyperplasiaCreatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].Hepatic ImpairmentCIALIS for Use as NeededMild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.Severe (Child Pugh weekend cialis Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].CIALIS for Once Daily UseMild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients.Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].2.7 Concomitant MedicationsAlpha-BlockersED — When CIALIS is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

Do not split CIALIS tablets; entire dose should be taken. The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability.

5.4 Effects on the Eye

Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours. Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)]. Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia Creatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response. Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Benign prostatic hyperplasia

Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of CIALIS once per day has not generic cialis 40 mg been extensively evaluated in patients with hepatic impairment and therefore, caution is advised. Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)]. Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients. The maximum recommended dosing frequency is once per day in most patients.

CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration. The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

5.8 Hepatic Impairment

The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.

Mild side effects

The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day. When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks. The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day. When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

• Cialis 5 mg may be prescribed for men with certain health risks.
• It is important to discuss any concurrent medications with your doctor.
• Cialis 5 mg tablets are scored for easier division if needed.
• Overdose symptoms may include severe dizziness or blood pressure issues.

The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours. Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)]. Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia Creatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.

• Cialis 5 mg daily can be taken long term if effective and tolerated.
• Periodic reassessment of need and response is recommended.
• No evidence of tolerance buildup or dependency.
• Discontinuation does not cause withdrawal symptoms.
• Erectile function may return to baseline after stopping.
• For BPH, symptoms may recur if treatment is stopped.
• Consult doctor before stopping or changing dose.
• Maintain regular follow-up appointments.

Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Related/similar drugs

In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking CIALIS 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 CIALIS, and therefore until further information is available, CIALIS is not recommended for the following groups of patients:myocardial infarction within the last 90 daysunstable angina or angina occurring during sexual intercourseNew York Heart Association Class 2 or greater heart failure in the last 6 monthsuncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertensionstroke within the last 6 months.As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of CIALIS once per day has not generic cialis 40 mg been extensively evaluated in patients with hepatic impairment and therefore, caution is advised. Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)]. Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients. ED — When CIALIS is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. 4 CONTRAINDICATIONS 4.1 NitratesAdministration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsCIALIS is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA®).

5.6 Alpha-blockers and Antihypertensives

Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)]. Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, cost of cialis 40mg CIALIS was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)].

5.12 Effects on Bleeding

CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown [see Clinical Studies (14.3)]. 2 DOSAGE AND ADMINISTRATION Do not split CIALIS tablets; entire dose should be taken.2.1 CIALIS for Use as Needed for Erectile DysfunctionThe recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing.

Drug forms and strengths: 2.5 mg, 5 mg, 10 mg, 20 mg

Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.2.2 CIALIS for Once Daily Use for Erectile DysfunctionThe recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.2.3 CIALIS for Once Daily Use for Benign Prostatic HyperplasiaThe recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day.When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic HyperplasiaThe recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.2.6 Use in Specific PopulationsRenal ImpairmentCIALIS for Use as NeededCreatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].CIALIS for Once Daily UseBenign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic HyperplasiaCreatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].Hepatic ImpairmentCIALIS for Use as NeededMild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.Severe (Child Pugh weekend cialis Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].CIALIS for Once Daily UseMild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients.Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].2.7 Concomitant MedicationsAlpha-BlockersED — When CIALIS is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Do not split CIALIS tablets; entire dose should be taken. CIALIS is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA®). 5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.Before prescribing CIALIS, it is important to note the following:5.1 CardiovascularPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. 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 CIALIS. In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking CIALIS 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 CIALIS, and therefore until further information is available, CIALIS is not recommended for the following groups of patients:myocardial infarction within the last 90 daysunstable angina or angina occurring during sexual intercourseNew York Heart Association Class 2 or greater heart failure in the last 6 monthsuncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertensionstroke within the last 6 months.As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure.

2.7 Concomitant Medications

ED — When CIALIS is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. 4 CONTRAINDICATIONS 4.1 NitratesAdministration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsCIALIS is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA®). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)]. Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated.

Dosage for erectile dysfunction (ED)

In clinical pharmacology studies, cost of cialis 40mg CIALIS was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)]. CIALIS is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA®). 5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.Before prescribing CIALIS, it is important to note the following:5.1 CardiovascularPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. 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 CIALIS.