Sanofi and Lilly Agree To Pursue Regulatory Approval Of Nonprescription Cialis
- 17.10 Sexually Transmitted Disease
- 5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies
- 5.9 Alcohol
- 5.8 Hepatic Impairment
- 5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use
- 5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH
Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. This press release contains forward-looking statements about the potential of Cialis for the treatment of benign prostatic hyperplasia and reflects Lilly's current beliefs.
- Cialis has been studied in combination with other ED treatments.
- Research explores effects of Cialis on other vascular diseases.
- The medication’s development highlighted the role of enzyme PDE5.
- Side effect profiles are monitored in post-marketing surveillance.
- Cialis is included in many guidelines as a first-line ED therapy.
- The drug is contraindicated with certain cardiac medications.
- Cost and accessibility remain concerns for some patients.
- Generic versions have improved affordability worldwide.
- Cialis may improve confidence and emotional well-being.
- Ongoing trials explore new indications beyond ED and BPH.
- Patient adherence to therapy is critical for results.
- Lilly’s commitment to sexual health research continues.
However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review.
| Parameter | Value | Details |
|---|---|---|
| Absorption | Rapid, within 30-120 minutes | Food intake can delay absorption |
| Bioavailability | ~40% | Fraction of dose that enters circulation |
| Metabolism | Liver (CYP3A4 enzyme) | Enzymatic processing |
| Half-life | ~17.5 hours | Duration of action in the body |
| Excretion | Feces (~61%), Urine (~36%) | Mainly via hepatic pathways |
There is no guarantee that the product will receive additional regulatory approvals. There is also no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission.
17.10 Sexually Transmitted Disease
Package insert / product label Generic name: tadalafil Dosage form: tablet, film coated Drug class: Impotence medications CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) ED and the signs and symptoms of BPH (ED/BPH) (1.3) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4). CIALIS for use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day (2.1).
Dive Insight:
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. CIALIS was shown to potentiate the hypotensive effect of nitrates (4.1). History of known serious hypersensitivity reaction to CIALIS or ADCIRCA® (4.2).
How should I store tadalafil?
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). 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. Lilly undertakes no duty to update forward-looking statements. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Relationship between lower urinary tract symptoms and erectile dysfunction: results from the Boston Area community Health Survey.
| 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 |
Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Cialis® (tadalafil) Tablets Recommended for Approval for the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia in the European Union Milestone reflects Eli Lilly and Company's commitment to bring new treatment options to millions of men who experience urological conditions INDIANAPOLIS, Sept. 21, 2012 -- Eli Lilly and Company (LLY) announced today it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 60mg | 360 + 10 Pills | 570.52€ 543.35€ | |
| Cialis Professional | 20mg | 270 + 6 Pills | 623.07€ 593.40€ | |
| Cialis Generic | 60mg | 30 + 2 Pills | 85.33€ 81.27€ | |
| Cialis Soft Tabs | 20mg | 20 + 2 Pills | 66.98€ 63.79€ | |
| Cialis Black | 80mg | 30 + 2 Pills | 89.11€ 84.87€ | |
| Cialis Generic | 40mg | 60 + 6 Pills | 130.98€ 124.74€ | |
| Cialis Professional | 20mg | 30 Pills | 104.57€ 99.59€ | |
| Cialis Original | 20mg | 14 + 2 Pills | 95.75€ 91.19€ | |
| Cialis Professional | 40mg | 30 Pills | 148.94€ 141.85€ | |
| Cialis Soft Tabs | 20mg | 90 + 6 Pills | 216.71€ 206.39€ | |
| Cialis Generic | 5mg | 90 + 6 Pills | 115.91€ 110.39€ | |
| Cialis Generic | 10mg | 360 + 10 Pills | 388.49€ 369.99€ | |
| Cialis Professional | 20mg | 10 Pills | 48.29€ 45.99€ | |
| Cialis Professional | 40mg | 10 Pills | 65.09€ 61.99€ | |
| Cialis Generic | 20mg | 90 + 6 Pills | 154.71€ 147.34€ | |
| Cialis Generic | 5mg | 180 + 10 Pills | 159.65€ 152.05€ |
Before taking Cialis, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack high or low blood pressure or have high blood pressure that is not controlled stroke liver or kidney problems or require dialysis retinitis pigmentosa, a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAION stomach ulcers or a bleeding problem a deformed penis shape or Peyronie's disease an erection that lasted more than 4 hours blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Tell your healthcare provider about all the medicines you take especially if you take: medicines called "nitrates" which are often prescribed for chest pain alpha-blockers often prescribed for prostate problems blood pressure medications medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) Cialis is also marketed as Adcirca for the treatment of pulmonary arterial hypertension. cure ED increase a man's sexual desire protect a man or his partner from sexually transmitted diseases, including HIV serve as a male form of birth control For additional information, talk to your doctor and see full Patient Information at and Prescribing Information at or visit for more information. Package insert / product label Generic name: tadalafil Dosage form: tablet, film coated Drug class: Impotence medications CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) ED and the signs and symptoms of BPH (ED/BPH) (1.3) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4). CIALIS for use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. 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. 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). 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.
5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies
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. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised. (2.7, 5.6, 7.1, 12.2) Patients should seek emergency treatment if an erection lasts >4 hours.
5.9 Alcohol
(2.7, 5.6, 7.1, 12.2) Patients should seek emergency treatment if an erection lasts >4 hours. Use buy cialis over the counter 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). 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).
8.5 Geriatric Use
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). 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.
Warnings and Precautions
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 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). Use buy cialis over the counter 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).
| 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 |
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). 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.
5.8 Hepatic Impairment
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 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. 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.
5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use
Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. This press release contains forward-looking statements about the potential of Cialis for the treatment of benign prostatic hyperplasia and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the product will receive additional regulatory approvals. There is also no guarantee that the product will continue to be commercially successful.
Indications and Usage for Cialis
For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Relationship between lower urinary tract symptoms and erectile dysfunction: results from the Boston Area community Health Survey.
17.6 Priapism
Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Cialis® (tadalafil) Tablets Recommended for Approval for the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia in the European Union Milestone reflects Eli Lilly and Company's commitment to bring new treatment options to millions of men who experience urological conditions INDIANAPOLIS, Sept. 21, 2012 -- Eli Lilly and Company (LLY) announced today it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Before taking Cialis, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack high or low blood pressure or have high blood pressure that is not controlled stroke liver or kidney problems or require dialysis retinitis pigmentosa, a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAION stomach ulcers or a bleeding problem a deformed penis shape or Peyronie's disease an erection that lasted more than 4 hours blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Tell your healthcare provider about all the medicines you take especially if you take: medicines called "nitrates" which are often prescribed for chest pain alpha-blockers often prescribed for prostate problems blood pressure medications medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) Cialis is also marketed as Adcirca for the treatment of pulmonary arterial hypertension. cure ED increase a man's sexual desire protect a man or his partner from sexually transmitted diseases, including HIV serve as a male form of birth control For additional information, talk to your doctor and see full Patient Information at and Prescribing Information at or visit for more information. 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.
5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH
If CIALIS 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. 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.
Benign prostatic hyperplasia
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. 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.
5.7 Renal Impairment
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. 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. 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. 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)].
- Cialis dosages allow flexibility: starting doses vary per patient need.
- Low-dose daily Cialis supports continuous readiness for sexual activity.
- Higher doses are typically used for occasional use prior to intercourse.
- Cialis clinical trials involved thousands of participants worldwide.
- Lilly’s research focused on minimizing adverse effects and maximizing efficacy.
- Cialis can alleviate symptoms of BPH by relaxing bladder muscles.
- Studies confirmed Cialis improves overall sexual satisfaction scores.
- The drug has a favorable safety profile compared to some alternatives.
- Lilly Armed Cialis with extensive marketing campaigns globally.
- Patient adherence improves if side effects are well managed.
- Cialis is contraindicated in patients with severe cardiovascular disease.
- The drug is monitored for post-marketing surveillance of safety.
Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.
