DOSAGE FORMS AND STRENGTHS

Pregnancy & Lactation
1.1 Erectile Dysfunction
16.1 How Supplied
16.2 Storage
5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)
5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use

Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration. Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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)]. Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required. Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use In Specific Populations (8.7)]. Mild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency 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 insufficiency. Therefore, caution is cialis tablets advised if CIALIS for once daily use is prescribed to these patients. When CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, 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)].

Instructions	Details	Precautions
Dosage Timing	Once per day, at same time each day	Do not double doses
Food Interactions	Take with or without food	High-fat meals may delay absorption
Alcohol Consumption	Limit alcohol intake	Excess alcohol can increase side effects
Missed Dose	Skip missed dose, do not double

4 CONTRAINDICATIONS 4.1 NitratesAdministration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated.

Pregnancy & Lactation

In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].4.2 Hypersensitivity Reactionsis contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA).

Product	Dosage	Quantity + Bonus	Price
Cialis Professional	20mg	360 + 6 Pills	807.03€ 768.60€
Cialis Original	20mg	92 + 4 Pills	377.99€ 359.99€
Cialis Generic	20mg	90 + 6 Pills	154.71€ 147.34€
Cialis Professional	40mg	20 Pills	110.24€ 104.99€
Cialis Generic	2.5mg	10 Pills	28.51€ 27.15€
Cialis Professional	40mg	270 + 6 Pills	898.37€ 855.59€
Cialis Original	20mg	12 Pills	78.32€ 74.59€
Cialis Soft Tabs	20mg	30 + 4 Pills	87.43€ 83.27€
Cialis Original	20mg	14 + 2 Pills	95.75€ 91.19€
Cialis Generic	10mg	10 Pills	31.41€ 29.91€
Cialis Generic	5mg	120 + 6 Pills	132.92€ 126.59€
Cialis Generic	5mg	10 Pills	29.39€ 27.99€
Cialis Black	80mg	270 + 10 Pills	502.88€ 478.93€
Cialis Soft Tabs	20mg	180 + 8 Pills	353.17€ 336.35€
Cialis Generic	40mg	30 + 4 Pills	74.97€ 71.40€
Cialis Generic	5mg	270 + 10 Pills	205.81€ 196.01€
Cialis Generic	60mg	360 + 10 Pills	570.52€ 543.35€

1.1 Erectile Dysfunction

Therefore, caution is cialis tablets advised if CIALIS for once daily use is prescribed to these patients. When CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, 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. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].4.2 Hypersensitivity Reactionsis contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA).

The Bottom Line

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. 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. 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.

16.1 How Supplied

Dosing Modifications

Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use In Specific Populations (8.7)]. Mild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency 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 insufficiency. 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.

Medication	Dosage Forms	Onset Time	Duration	Price (approx.)
Cialis 20mg	Tablets	30-60 minutes	Up to 36 hours	Moderate
Viagra 50mg	Tablets	30-60 minutes	4-6 hours	Moderate
Levitra 10mg	Tablets	30 minutes	4-5 hours	Slightly higher
Stendra 100mg	Tablets	15-30 minutes	6 hours	Higher

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)].

16.2 Storage

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 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 cialis lilly brand 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.

Incidence not known

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)], 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. 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.

Cialis was approved by the FDA for erectile dysfunction in 2003.
It is marketed under the brand name Cialis and as a generic tadalafil.
The medication is available in tablet form, usually prescribed in a bottle.
Cialis's trademark status is owned by Eli Lilly and Company.
Proper hydration can help reduce some minor side effects.

Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue.

5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)

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.

Can women take Cialis?

Cialis can be taken daily or as needed, depending on the prescription.
It may improve the quality of erections but does not increase sexual desire.
Avoid alcohol while taking Cialis, as it can cause dizziness and lower blood pressure.
Inform your doctor about any heart conditions before starting Cialis.
Store Cialis in a cool, dry place away from children and pets.

When vasodilators are used in combination, an additive effect on blood pressure may be anticipated.

Cialis is a medication used to treat erectile dysfunction and benign prostatic hyperplasia.
It contains the active ingredient tadalafil, which increases blood flow.
Cialis typically lasts up to 36 hours, offering long-lasting effects.
The drug can be taken with or without food for convenience.
Side effects may include headache, flushing, or nasal congestion.

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)], which may lead to symptomatic hypotension (e.g., fainting).

5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use

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.

Mechanism of Action

[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)]. 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. 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.