ADVERSE REACTIONS
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.
Society and culture
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 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 generic cialis lilly uncontrolled hypertension As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure.
5.7 Renal Impairment
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. Physicians 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)]. There 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. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34).
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 10mg | 10 Pills | 31.41€ 29.91€ | |
| Cialis Generic | 20mg | 180 + 10 Pills | 254.09€ 241.99€ | |
| Cialis Professional | 20mg | 360 + 6 Pills | 807.03€ 768.60€ | |
| Cialis Original | 20mg | 76 + 4 Pills | 319.19€ 303.99€ | |
| Cialis Black | 80mg | 90 + 6 Pills | 207.88€ 197.98€ | |
| Cialis Generic | 2.5mg | 90 + 6 Pills | 112.43€ 107.08€ | |
| Cialis Generic | 20mg | 120 + 8 Pills | 188.15€ 179.19€ | |
| Cialis Professional | 40mg | 20 Pills | 110.24€ 104.99€ | |
| Cialis Professional | 20mg | 120 + 4 Pills | 291.68€ 277.79€ | |
| Cialis Professional | 20mg | 30 Pills | 104.57€ 99.59€ | |
| Cialis Generic | 60mg | 20 Pills | 65.61€ 62.49€ | |
| Cialis Professional | 20mg | 180 + 4 Pills | 423.11€ 402.96€ | |
| Cialis Generic | 40mg | 20 Pills | 59.47€ 56.64€ | |
| Cialis Professional | 20mg | 20 Pills | 78.33€ 74.60€ | |
| Cialis Generic | 60mg | 90 + 6 Pills | 196.67€ 187.30€ |
A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20).
13.2 Animal Toxicology and/or Pharmacology
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.
5.6 Alpha-blockers and Antihypertensives
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.
5.4 Effects on the Eye
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. Other risk factors for NAION, such as the presence of "crowded" optic disc, may have contributed to the occurrence of NAION in these studies.
- Cialis was part of a class of drugs known as PDE5 inhibitors.
- These drugs revolutionized the treatment of erectile dysfunction.
- Lilly invested heavily in development and patent protection for Cialis.
- The medication is generally safe when used as prescribed.
- Cialis use should be avoided if heart conditions preclude sexual activity.
- The medication can have interactions with certain medications like alpha-blockers.
- Men often seek Cialis consultations to improve sexual confidence.
- Treatments like Cialis allow restoration of intimacy in relationships.
- Physician follow-up ensures optimal dosing and safety monitoring.
- Cialis’s approval marked a significant advancement in sexual medicine.
- The drug’s marketing often includes education about ED causes.
- Cialis remains a subject of scientific and clinical interest.
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)].
| Region | Typical Price per Tablet | Availability |
|---|---|---|
| United States | $15 - $30 | Widely available |
| Europe | €12 - €25 | Available via prescription |
| Asia | $8 - $20 | Over-the-counter in some countries |
| Australia | AUD 20 - AUD 40 | Prescription required |
| Online pharmacies | Varies | Check for legitimacy |
Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.
7.2 Potential for Other Drugs to Affect CIALIS
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). Physicians 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. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and 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. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including CIALIS, should be used with caution in these patients and only when the anticipated benefits outweigh the risks.
- Patient reviews often highlight Cialis’s efficacy and duration.
- The medication is praised for enabling spontaneity in sexual activity.
- Side effects like headache tend to diminish with ongoing use.
- Cialis use requires medical supervision to ensure safety.
- The medication can improve quality of life in men with ED.
- Cialis is part of many men’s long-term health management plans.
- Regular cardiovascular evaluation is important for Cialis users.
- Cialis allows flexibility in managing erectile dysfunction.
- The drug’s development involved collaboration across research centers.
- Lilly maintains a portfolio including other sexual health drugs.
- Cialis use should follow professional medical advice.
- Patient education about Cialis contributes to treatment success.
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.
| 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 |
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.
Search for questions
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 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)].
Warnings and Precautions
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 cialis lilly brand 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.
What are the most common side effects of tadalafil?
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. 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. Physicians 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.
| Attribute | Description | Notes |
|---|---|---|
| Generic Name | Tadalafil | Main active ingredient |
| Brand Name | Cialis (by Lilly) | Commercial name |
| Dosage Forms | Tablets, oral | Available forms |
| Typical Dose | 5 mg, 10 mg, 20 mg | Varies per prescription |
| Onset of Action | 30-60 minutes | Time to effect |
| Duration of Effect | Up to 36 hours | Pharmacological window |
These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including CIALIS.