16 HOW SUPPLIED/STORAGE AND HANDLING

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.

1.2 Benign Prostatic Hyperplasia

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. 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.

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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. 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.

2.1 CIALIS for Use as Needed for Erectile Dysfunction

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)]. Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. 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.

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	20mg	90 + 6 Pills	154.71€ 147.34€	Buy
Cialis Generic	2.5mg	10 Pills	28.51€ 27.15€	Buy
Cialis Generic	40mg	270 + 10 Pills	382.19€ 363.99€	Buy
Cialis Generic	60mg	60 + 4 Pills	145.06€ 138.15€	Buy
Cialis Generic	10mg	360 + 10 Pills	388.49€ 369.99€	Buy
Cialis Professional	20mg	90 + 2 Pills	241.49€ 229.99€	Buy
Cialis Super Active	20mg	270 + 30 Pills	661.49€ 629.99€	Buy
Cialis Original	20mg	120 + 8 Pills	497.29€ 473.61€	Buy
Cialis Original	20mg	22 + 2 Pills	129.20€ 123.05€	Buy
Cialis Generic	20mg	120 + 8 Pills	188.15€ 179.19€	Buy
Cialis Generic	2.5mg	270 + 10 Pills	199.64€ 190.13€	Buy
Cialis Super Active	20mg	20 + 4 Pills	92.35€ 87.95€	Buy
Cialis Professional	20mg	120 + 4 Pills	291.68€ 277.79€	Buy
Cialis Generic	60mg	120 + 8 Pills	240.18€ 228.74€	Buy
Cialis Generic	5mg	20 Pills	41.99€ 39.99€	Buy

Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

CIALIS should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION (5.4, 6.2). Patients should stop CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5). Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.14). Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1).

5.6 Alpha-blockers and Antihypertensives

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or CIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (7.1). ketoconazole, ritonavir) increase CIALIS exposure (2.7, 5.10, 7.2) requiring dose adjustment: CIALIS for use as needed: no more than 10 mg every 72 hoursCIALIS for once daily use: dose not to exceed 2.5 mg CIALIS for use as needed: no more than 10 mg every 72 hours CIALIS for once daily use: dose not to exceed 2.5 mg Hepatic Impairment (2.6, 5.8, 8.6): Mild or Moderate: Dosage adjustment may be needed. Renal Impairment (2.6, 5.7, 8.7): Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed. Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Cialis Dosage and Administration

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 cialis pill appearance 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)]. 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. Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS.

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

Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day (2.1). ED: Starting dose: 10 mg as needed prior to sexual activity. CIALIS may be taken without regard to food (2.5). Administration of CIALIS to patients using any form of organic nitrate is contraindicated.

4.2 Hypersensitivity Reactions

CIALIS was shown to potentiate the hypotensive effect of nitrates (4.1). History of known serious hypersensitivity reaction to CIALIS or ADCIRCA® (4.2). Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3). Patients should not use CIALIS if sex is inadvisable due to cardiovascular status (5.1). Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9).

8.1 Pregnancy

CIALIS is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers. (2.7, 5.6, 7.1, 12.2) Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism (5.3). Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). 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.

Condition	Explanation	Notes
Menusen with nitrates	Risk of severe hypotension	Absolute contraindication
Severe liver impairment	Reduced metabolism leading to increased effects	Medical consultation needed
Retinitis pigmentosa	Potential risk of vision loss	Use with caution
Allergic reactions	Hypersensitivity to tadalafil or excipients	Discontinue if occurs

In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring.

Dosage	Recommended Patient Group	Notes
10 mg daily	Adults with ED, as needed	30 minutes before activity
5 mg daily	Men with prostate symptoms	Once daily, at same time each day
20 mg as needed	Occasional use, ED episodes	Max dose per 24 hours
Adjustments	Liver or kidney impairment	Lower doses recommended

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)].

5.8 Hepatic Impairment

Three strengths of almond-shaped tablets are available in different sizes and different shades of yellow: 5 mg tablets debossed with “C 5” 10 mg tablets debossed with “C 10” 20 mg tablets debossed with “C 20” Administration 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)]. CIALIS 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)]. Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. 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.

• Cialis prescription guidelines emphasize age and health status evaluation.
• The medication is contraindicated in men advised against sexual activity.
• Prior to Cialis, medical history should be reviewed thoroughly.
• Cialis enables more spontaneous and confidence-building intimacy.
• Treatment success is higher with proper adherence to dosing schedules.
• Patient-reported outcome measures monitor Cialis effectiveness.
• Cialis has been featured in numerous clinical practice guidelines.
• Fertility effects of Cialis have been studied but show no major risk.
• The drug is usually well tolerated across diverse populations.
• Treatment discontinuation can occur due to side effects or lack of efficacy.
• Lilly offers educational resources for healthcare professionals.
• Cialis complements lifestyle modification for ED treatment.

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 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)].

• Cialis introduction changed the landscape of erectile dysfunction treatment.
• It offered an alternative with longer duration than prior PDE5 inhibitors.
• Market acceptance was driven by favorable patient and clinician feedback.
• Some men prefer Cialis due to reduced planning for sexual activity.
• The drug's patent provided Lilly a commercial advantage for years.
• Extensive advertising targeted both physicians and consumers.
• Patient support groups often discuss experiences with Cialis.
• Alternative ED treatments include injections, vacuum pumps, and surgery.
• Cialis fits a broad spectrum of ED severity levels.
• Diabetes, hypertension, and heart disease are common conditions with Cialis use.
• Lilly continues efforts to educate about safe sexual health practices.
• Ongoing clinical trials explore broader uses of tadalafil.

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.

2.6 Use in Specific Populations

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 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 cialis 5 miligramos 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)].