DRUG INTERACTIONS

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®). Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. 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. 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.

Side Effect	Frequency	Severity	Notes
Headache	Common	Mild	Usually temporary
Flushing	Common	Mild	Facial redness
Indigestion	Common	Mild	Can be avoided with food
Muscle aches	Less common	Mild	Usually transient
Vision changes	Rare	Mild	Blurred or color vision

[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.

4.1 Nitrates

8.1 Pregnancy

5.3 Prolonged Erection

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.

Product	Dosage	Quantity + Bonus	Price
Cialis Super Active	20mg	30 + 6 Pills	128.09€ 121.99€	Buy
Cialis Generic	60mg	10 Pills	41.22€ 39.26€	Buy
Cialis Original	20mg	8 Pills	61.70€ 58.76€	Buy
Cialis Generic	20mg	270 + 10 Pills	335.21€ 319.25€	Buy
Cialis Generic	10mg	20 Pills	48.23€ 45.93€	Buy
Cialis Generic	60mg	20 Pills	65.61€ 62.49€	Buy
Cialis Soft Tabs	20mg	180 + 8 Pills	353.17€ 336.35€	Buy
Cialis Professional	20mg	10 Pills	48.29€ 45.99€	Buy
Cialis Generic	20mg	360 + 10 Pills	427.34€ 406.99€	Buy
Cialis Original	20mg	34 + 2 Pills	183.99€ 175.23€	Buy
Cialis Professional	40mg	270 + 6 Pills	898.37€ 855.59€	Buy
Cialis Generic	60mg	270 + 10 Pills	443.96€ 422.82€	Buy

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 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including CIALIS, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

5.8 Hepatic Impairment

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®). Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. 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. 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. [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.

5.6 Alpha-blockers and Antihypertensives

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. 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 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including CIALIS, and seek medical attention in the event of a sudden loss of vision in one or both eyes. 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. 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 patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. 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 CIALIS, 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 CIALIS, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

14.4 CIALIS 5 mg for Once Daily Use for ED and BPH

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 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. 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, 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 cialis for sale cheap 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 CIALIS 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 CIALIS and alpha-blockers is not recommended for the treatment of BPH. 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. 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 patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.

8.3 Females and Males of Reproductive Potential

[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 CIALIS for once daily use for the treatment of BPH.5.7 Renal ImpairmentCIALIS for Use as NeededCIALIS 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. [see Use in Specific Populations (8.7)].CIALIS for Once Daily UseEDDue 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 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, CIALIS 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 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 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 impairment.

5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies

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. 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 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. In patients taking potent inhibitors of CYP3A4 and CIALIS 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 CIALIS and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take CIALIS with other PDE5 inhibitors, including ADCIRCA.5.12 Effects on BleedingStudies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. Although CIALIS has 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 CIALIS offers no protection against sexually transmitted diseases.

Drug Interactions

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 CIALIS, 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 CIALIS, and seek prompt medical attention in the event of sudden decrease or loss of hearing. 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 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. 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, 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.

Use Case	Description	Notes
Erectile Dysfunction (ED)	Improves ability to achieve/maintain erection	Most common use
Pulmonary Arterial Hypertension	Reduces blood pressure in lungs	Prescribed under different dose
Benign Prostatic Hyperplasia	Relieves urinary symptoms	Off-label use
Raynaud's Phenomenon	Relaxes blood vessels	Experimental treatment

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 cialis for sale cheap depletion and other antihypertensive drugs.

• Cialis works by increasing cyclic GMP levels in the penis.
• This causes smooth muscle relaxation, enhancing erections.
• Unlike Viagra, Cialis can be effective even after fatty meals.
• The onset of Cialis action can take 30 to 60 minutes.
• Cialis can be used by men of various ages under doctor supervision.
• Interactions with other medications should be carefully evaluated.
• Alcohol consumption may increase side effects of Cialis.
• Cialis is sometimes preferred for spontaneous sexual activity.
• The drug is not an aphrodisiac and requires sexual stimulation.
• Cialis tablets are typically oval and yellow in color.
• The medication should be stored at room temperature.
• A prescription is required to obtain Cialis legally.

[see Dosage and Administration (2.7) and Drug Interactions (7.1)].BPHThe efficacy of the coadministration of an alpha-blocker and CIALIS 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 CIALIS 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.

5.7 Renal Impairment

)].Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting CIALIS for once daily use for the treatment of BPH.5.7 Renal ImpairmentCIALIS for Use as NeededCIALIS 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. [see Use in Specific Populations (8.7)].CIALIS for Once Daily UseEDDue 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 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, CIALIS for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min.

2.3 CIALIS for Once Daily Use for Benign Prostatic Hyperplasia

In patients with creatinine clearance 30 – 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 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 impairment. 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. 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 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. In patients taking potent inhibitors of CYP3A4 and CIALIS 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 CIALIS and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied.

• The Cialis patent expired in many countries by the mid-2020s.
• Generic tadalafil versions became widely accessible to patients.
• Market competition led to reduced prices for Cialis and generics.
• Lilly continues research on improved formulations of tadalafil.
• Online pharmacies sell Cialis; caution is advised to avoid counterfeits.
• The drug should only be purchased through licensed distributors.
• Awareness campaigns educate about safe use of Cialis.
• Side effect profiles remain similar between brand and generic versions.
• Pharmacovigilance monitors adverse events linked to Cialis use.
• Cialis remains an important option in ED treatment algorithms.
• The medication plays a role in men's sexual health discussions.
• Physicians frequently review Cialis use during follow-up visits.

Inform patients not to take CIALIS with other PDE5 inhibitors, including ADCIRCA.5.12 Effects on BleedingStudies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5.

17.3 Cardiovascular Considerations

14.2 CIALIS for Once Daily Use for ED

Although CIALIS has 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 CIALIS offers no protection against sexually transmitted diseases.