13 NONCLINICAL TOXICOLOGY

This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].

• Cost-saving strategies include using a pill splitter for higher-dose tablets.
• Splitting a 20mg tablet is sometimes prescribed to create two 10mg doses.
• Only split tablets if your doctor and pharmacist confirm it is appropriate.
• Not all tablets are designed to be split; check for a score line.
• Using a manufacturer's coupon or savings card can reduce out-of-pocket costs.
• Consider 90-day mail-order prescriptions for chronic use to save money.
• Patient assistance programs from manufacturers may offer free medication.
• Eligibility is often based on income and lack of insurance coverage.
• Discuss financial concerns openly with your doctor or pharmacist.

is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA).

• Absorption is not significantly affected by food, unlike some other ED drugs.
• A high-fat meal may delay the time to reach maximum concentration.
• For predictable timing, take on an empty stomach or with a light meal.
• Maximum plasma concentration is reached approximately 2 hours after dosing.
• The medication is highly protein-bound in the bloodstream.
• It is not removed by dialysis, so dose adjustment is critical in renal failure.
• In mild to moderate renal impairment, a maximum dose of 10mg is often advised.
• In severe renal impairment, the maximum recommended dose is 5mg.
• For patients on dialysis, use is not recommended.

5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction 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.

• Cialis 20mg is not suitable for use by women or minors.
• Discuss all medications and supplements with your doctor before use.
• Use Cialis 20mg at least 24 hours apart to avoid overdose.
• Your doctor may recommend blood tests before starting Cialis.
• Cialis 20mg may cause flushing, especially in hot weather.
• Maintain open communication with your healthcare provider about treatment progress.
• Avoid using Cialis 20mg with other ED medications unless advised.
• Sexual activity is safe for most people taking Cialis 20mg.
• The medication should be taken as part of a comprehensive ED treatment plan.
• Keep a record of any side effects or reactions during therapy.

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 hypertension (>170/100 mm Hg)stroke 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. In a clinical pharmacology study, tadalafil 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects [see Clinical Pharmacology (12.2)].

Ingredient	Quantity per Tablet	Function
Tadalafil	20 mg	Active ingredient
Microcrystalline cellulose	50 mg	Fillers
Croscarmellose sodium	10 mg	Disintegrant
Magnesium stearate	5 mg	Lubricant

While this effect should not be of consequence in most patients, prior to prescribing CIALIS, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily UsePhysicians should be aware that CIALIS for once daily use provides continuous plasma tadalafil levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol [see Drug Interactions (7.1), (7.2), (7.3)].5.3 Prolonged ErectionThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue.

Step	Instruction	Notes
Taking the Tablet	Swallow whole with water	Do not crush or split
Timing	Take at least 30 minutes before activity	Can be taken up to 36 hours before
Daily Limit	Do not exceed once per day	Risks of overdose

Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.CIALIS should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).5.4 EyePhysicians should advise patients to stop use of all PDE5 inhibitors, including CIALIS, and seek medical attention in the event of a sudden cialis sublingual 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 permanent loss of vision that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or other factors.

• Cialis 20mg is available by prescription and should be used responsibly.
• It helps improve blood flow to the penis for a firmer erection.
• Dosage can be adjusted based on medical history and response.
• Cialis 20mg may cause dizziness; avoid driving if affected.
• Alcohol consumption can reduce the effectiveness of Cialis 20mg.
• Patients with kidney or liver issues should discuss usage with their doctor.
• The medication is not a hormone and does not affect libido directly.
• Cialis 20mg should not be used recreationally or past prescribed dosage.
• Immediate medical attention is needed if an erection lasts over 4 hours.
• Combining Cialis 20mg with other ED medications is not recommended.

Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors [see Adverse Reactions (6.2)].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 CIALIS, 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 CIALIS. 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) and (6.2)].5.6 Alpha blockers and AntihypertensivesPhysicians should discuss with patients the potential for CIALIS 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 CIALIS, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects.

Proper Use

While this effect should not be of consequence in most patients, prior to prescribing CIALIS, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily UsePhysicians should be aware that CIALIS for once daily use provides continuous plasma tadalafil levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol [see Drug Interactions (7.1), (7.2), (7.3)].5.3 Prolonged ErectionThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.CIALIS should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).5.4 EyePhysicians should advise patients to stop use of all PDE5 inhibitors, including CIALIS, and seek medical attention in the event of a sudden cialis sublingual 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 permanent loss of vision that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors.

Will I need to take this drug long term?

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors [see Adverse Reactions (6.2)].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 CIALIS, 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 CIALIS. 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) and (6.2)].5.6 Alpha blockers and AntihypertensivesPhysicians should discuss with patients the potential for CIALIS 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 CIALIS, 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 Clinical Pharmacology (12.2) and Drug Interactions (7.1)], cialis soft online which may lead to symptomatic hypotension (e.g., fainting).

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Consideration should be given to the following: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.

Warnings & Precautions

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 Clinical Pharmacology (12.2) and Drug Interactions (7.1)], cialis soft online which may lead to symptomatic hypotension (e.g., fainting). Consideration should be given to the following: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.

Does Cialis increase the size of a man’s penis?

[See Dosage and Administration (2.4) and Drug Interactions (7.1)].5.7 Renal InsufficiencyCIALIS for Use as NeededCIALIS should be limited to 5 mg not more than once in every 72 hours in patients with severe renal insufficiency or end-stage renal disease on hemodialysis. The starting dose of CIALIS in patients with a moderate degree of renal insufficiency 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. No dose adjustment is required in patients with mild renal insufficiency [see Use in Specific Populations (8.7)].CIALIS for Once Daily UseDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, CIALIS for once daily use is not recommended in patients with severe renal insufficiency. No dose adjustment is required in patients with mild or moderate renal insufficiency [see Use in Specific Populations (8.7)].5.8 Hepatic ImpairmentCIALIS for Use as NeededIn patients with mild or moderate hepatic impairment, the dose of CIALIS should not exceed 10 mg. Because of insufficient information in patients with severe hepatic impairment, use of CIALIS in this group is not recommended [see Use In Specific Populations (8.6)].CIALIS for Once Daily UseCIALIS for once daily use has not been extensively evaluated in patients with mild or moderate hepatic insufficiency. 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.

17.6 Vision

Because of insufficient information in patients with severe hepatic impairment, use of CIALIS in this group is not recommended [see Use In Specific Populations (8.6)].5.9 AlcoholPatients should be made aware that both alcohol and CIALIS, 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 CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)CIALIS is metabolized predominantly by CYP3A4 in the liver. The dose of CIALIS 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)].

Erectile dysfunction explained

[See Dosage and Administration (2.4) and Drug Interactions (7.1)].5.7 Renal InsufficiencyCIALIS for Use as NeededCIALIS should be limited to 5 mg not more than once in every 72 hours in patients with severe renal insufficiency or end-stage renal disease on hemodialysis. The starting dose of CIALIS in patients with a moderate degree of renal insufficiency 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. No dose adjustment is required in patients with mild renal insufficiency [see Use in Specific Populations (8.7)].CIALIS for Once Daily UseDue to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, CIALIS for once daily use is not recommended in patients with severe renal insufficiency. No dose adjustment is required in patients with mild or moderate renal insufficiency [see Use in Specific Populations (8.7)].5.8 Hepatic ImpairmentCIALIS for Use as NeededIn patients with mild or moderate hepatic impairment, the dose of CIALIS should not exceed 10 mg. Because of insufficient information in patients with severe hepatic impairment, use of CIALIS in this group is not recommended [see Use In Specific Populations (8.6)].CIALIS for Once Daily UseCIALIS for once daily use has not been extensively evaluated in patients with mild or moderate hepatic insufficiency. Because of insufficient information in patients with severe hepatic impairment, use of CIALIS in this group is not recommended [see Use In Specific Populations (8.6)].5.9 AlcoholPatients should be made aware that both alcohol and CIALIS, 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 CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)CIALIS is metabolized predominantly by CYP3A4 in the liver.

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This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA). 5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction 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.

Cialis and other medications

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 hypertension (>170/100 mm Hg)stroke 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. In a clinical pharmacology study, tadalafil 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects [see Clinical Pharmacology (12.2)]. The dose of CIALIS 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)].

Question	Answer
Can I take Cialis daily?	Usually not; consult your doctor for daily use plans
Is Cialis 20mg safe for everyone?	No, contraindicated in some conditions; see doctor
How long does the effect last?	Up to 36 hours depending on individual factors
Can I drink alcohol with Cialis?	Moderate alcohol is generally safe; excessive alcohol can increase side effects