12 CLINICAL PHARMACOLOGY

Which Makes You Harder?
Brand Name
2.3 Use in Special Populations
Key Takeaways: Cialis vs Tadalafil

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 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 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.

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 soft tab cialis 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).

Feature	Description	Notes
Active Ingredient	Tadalafil	Used for erectile dysfunction
Dosage Strength	20 mg	Higher strength option
Typical Onset of Action	30-60 minutes	Varies with individual
Duration of Effect	Up to 36 hours	Long-lasting effect
Common Side Effects	Headache, flushing, indigestion	Usually mild

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.

Which Makes You Harder?

[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.

Cialis has different strengths, typically 2.5 mg, 5 mg, 10 mg, and 20 mg tablets.
The starting dose for most users is 10 mg before sexual activity.
For daily use, a lower dose like 2.5 mg or 5 mg is usually prescribed.
Cialis should not be taken more than once per day to prevent overdose.
Consult your healthcare provider if erections last longer than 4 hours.

Use Case	Patient Profile	Additional Info
Erectile Dysfunction (ED)	Men aged 40-70	Approved by FDA
Pulmonary Hypertension	Adults with PAH	Off-label use
BPH (Benign Prostatic Hyperplasia)	Men with urinary symptoms	Sometimes combined with other drugs
Exercise Performance Enhancement	No approved use	Not recommended

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.

Product	Dosage	Quantity + Bonus	Price
Cialis Super Active	20mg	270 + 30 Pills	661.49€ 629.99€
Cialis Original	20mg	48 + 4 Pills	224.69€ 213.99€
Cialis Generic	20mg	270 + 10 Pills	335.21€ 319.25€
Cialis Super Active	20mg	60 + 8 Pills	230.32€ 219.35€
Cialis Original	20mg	4 Pills	41.99€ 39.99€
Cialis Generic	2.5mg	10 Pills	28.51€ 27.15€
Cialis Generic	40mg	120 + 8 Pills	206.98€ 197.12€
Cialis Generic	5mg	60 + 4 Pills	86.02€ 81.92€
Cialis Generic	60mg	60 + 4 Pills	145.06€ 138.15€
Cialis Professional	40mg	270 + 6 Pills	898.37€ 855.59€
Cialis Original	20mg	76 + 4 Pills	319.19€ 303.99€
Cialis Black	80mg	20 Pills	71.83€ 68.41€
Cialis Generic	10mg	10 Pills	31.41€ 29.91€

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)]. In patients taking potent inhibitors of CYP3A4 and CIALIS for once daily use, the dose of CIALIS should not exceed 2.5 mg [see Dosage and Administration (2.4)].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. Therefore, the use of such combinations is not recommended.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.

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

CIALIS cialis woman has not been administered to patients with bleeding disorders or significant active peptic ulceration. 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.

Brand Name

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 20mg cialis pill 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.

Erectile Dysfunction

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)]. In patients taking potent inhibitors of CYP3A4 and CIALIS for once daily use, the dose of CIALIS should not exceed 2.5 mg [see Dosage and Administration (2.4)].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. Therefore, the use of such combinations is not recommended.5.12 Effects on BleedingStudies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5.

Does Cialis work and is it safe?

When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time, relative to aspirin alone. CIALIS cialis woman has not been administered to patients with bleeding disorders or significant active peptic ulceration. 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. 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 should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. 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 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: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.

Missing doses or irregular use may reduce Cialis’s effectiveness.
It is crucial to understand potential drug interactions before starting therapy.
Keep a medication schedule to avoid accidental overdose or missed doses.
Regular follow-ups with your doctor can help optimize treatment outcomes.
Use Cialis responsibly to maintain good health and safety.

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.

2.3 Use in Special Populations

Before prescribing CIALIS, 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 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.

Are you currently using Tadalafil (Cialis, Adcirca, and others)?

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 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 (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg) As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.

Canadian Brand Name

[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 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 (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg) As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.

Key Takeaways: Cialis vs Tadalafil

Will I need to take this drug long term?

Off-label use for Cialis

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. 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. [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.