17 PATIENT COUNSELING INFORMATION

All of these Phosphodiesterase 5 inhibitors work in a similar way: the relaxation of the penile blood vessels to support expansion, which gives a stronger erection during arousal. What varies between them is the dosage, bioavailability, the length of time their effect takes to kick in, the amount of time they last for, and the side effect profiles. The main benefit of Tadalafil is how long it can last — up to 36 hours, as opposed to the roughly 4-6 hours for Sildenafil or Viagra. It also has the most variable possible dosage, making it quite a versatile treatment.

6.2 Postmarketing Experience

Over a weekend away, that would mean potentially as little as 30 minutes of waiting time for a stronger erection. As opposed to at least twice that on daily medicine. Among the non-pharmaceutical measures are a lot of good common sense ideas that are great to combine with some medical support. As we’ve outlined in other articles, taking care of yourself with a balanced diet and getting enough rest and exercise can only help you in the battle against ED. They will also give medicines like Tadalafil a strong base to build upon.

Presidents Award

You may have heard of the Cialis brand first, but that doesn’t mean it should necessarily be your first port of call. For those of you who are looking for a medication you can simply take and forget about for the weekend, Tadalafil offers this benefit for the most competitive price. Order from a reputable and accredited supplier, and follow the advice in the medication leaflet. Each individual is different, but now you can be sure that Tadalafil and Cialis are medical equivalents. While we've ensured that everything you read on the Health Centre is medically reviewed and approved, information presented here is not intended to be a substitute for professional medical advice, diagnosis, or treatment. A lower dose could be taken every day, for example. Avanafil and Spedra kick in a little quicker, making them suitable for “on-demand” use shortly prior to anticipated sexual intercourse.

But they also don’t last as long as Tadalafil — which is a major drawback for some men. Vardenafil (Levitra) and Sildenafil both have the downside of being effective for less time than Tadalafil. That said, they work well and if you’re looking for something for less than 36 hours, they’re good options for most men. Tadalafil also takes the same amount of time to take effect as some shorter-acting options, but it provides support for much longer.

5.5 Sudden Hearing Loss

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).

Pulmonary arterial hypertension

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. (2.7, 5.6, 7.1, 12.2) Patients should seek emergency treatment if an erection lasts >4 hours. Over a weekend away, that would mean potentially as little as 30 minutes of waiting time for a stronger erection.

• Clinical trials for Cialis involved thousands of men with ED or BPH.
• Studies demonstrated significant improvement in erectile function scores.
• For BPH, trials showed improved urine flow and reduced symptom scores.
• The drug was well-tolerated in most long-term studies.
• Research also explored its potential in pulmonary arterial hypertension.
• Lilly conducted extensive post-marketing surveillance for safety.
• Trial data supported its approvals for multiple indications.

As opposed to at least twice that on daily medicine. Among the non-pharmaceutical measures are a lot of good common sense ideas that are great to combine with some medical support. As we’ve outlined in other articles, taking care of yourself with a balanced diet and getting enough rest and exercise can only help you in the battle against ED. They will also give medicines like Tadalafil a strong base to build upon. You may have heard of the Cialis brand first, but that doesn’t mean it should necessarily be your first port of call. For those of you who are looking for a medication you can simply take and forget about for the weekend, Tadalafil offers this benefit for the most competitive price. Order from a reputable and accredited supplier, and follow the advice in the medication leaflet. Each individual is different, but now you can be sure that Tadalafil and Cialis are medical equivalents.

Drug Label Information

Caution is advised cialis for sale cheap 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). 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).ADVERSE REACTIONSMost 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 INTERACTIONSCIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (7.1).CYP3A4 inhibitors (e.g.

Phi Lambda Sigma

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 mgCYP3A4 inducers (e.g. rifampin) decrease CIALIS exposure (7.2).USE IN SPECIFIC POPULATIONSHepatic Impairment (2.6, 5.8, 8.6):Mild or Moderate: Dosage adjustment may be needed.Severe: Use is not recommended.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. Once daily use is not recommended.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2026 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. Not to be taken more than once per day (2.1). While we've ensured that everything you read on the Health Centre is medically reviewed and approved, information presented here is not intended to be a substitute for professional medical advice, diagnosis, or treatment.

• Legal and regulatory history includes patent litigation and FDA reviews.
• Eli Lilly and ICOS received FDA approval for Cialis in November 2003.
• Key patents expired in the 2010s, allowing generic competition.
• There were numerous legal battles over patent extensions and challenges.
• The FDA has issued safety communications regarding PDE5 inhibitors.
• Regulations govern direct-to-consumer advertising of prescription drugs.
• The medication is a controlled prescription item in all countries.

It should never be relied upon for specific medical advice. If you have any questions or concerns, please talk to your doctor. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS.CIALIS (tadalafil) tablets, for oral useInitial U.S. Approval: 2003INDICATIONS AND USAGECIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:erectile dysfunction (ED) (1.1)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).DOSAGE AND ADMINISTRATION 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).CIALIS for once daily use:CIALIS may be taken without regard to food (2.5).DOSAGE FORMS AND STRENGTHSTablets: 5 mg, 10 mg, 20 mg (3).CONTRAINDICATIONSAdministration 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).WARNINGS AND PRECAUTIONSPatients 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.

Be aware of fake Cialis pills

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). 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).

International Pharmaceutical Students' Federation

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. Caution is advised cialis for sale cheap 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). 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).ADVERSE REACTIONSMost 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 INTERACTIONSCIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (7.1).CYP3A4 inhibitors (e.g. 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 mgCYP3A4 inducers (e.g.

• Special populations require careful dosing and monitoring.
• For elderly patients (over 65), a lower starting dose is often recommended.
• Patients with mild to moderate kidney or liver impairment need dose adjustments.
• It is not studied or recommended for use in patients on dialysis.
• Safety and efficacy have not been established in pediatric populations.
• Use in women is off-label and not for sexual enhancement.
• A thorough medical history is essential before prescribing.

rifampin) decrease CIALIS exposure (7.2).USE IN SPECIFIC POPULATIONSHepatic Impairment (2.6, 5.8, 8.6):Mild or Moderate: Dosage adjustment may be needed.Severe: Use is not recommended.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. Once daily use is not recommended.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2026 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. 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).

5.1 Cardiovascular

All of these Phosphodiesterase 5 inhibitors work in a similar way: the relaxation of the penile blood vessels to support expansion, which gives a stronger erection during arousal. What varies between them is the dosage, bioavailability, the length of time their effect takes to kick in, the amount of time they last for, and the side effect profiles. The main benefit of Tadalafil is how long it can last — up to 36 hours, as opposed to the roughly 4-6 hours for Sildenafil or Viagra. It also has the most variable possible dosage, making it quite a versatile treatment. A lower dose could be taken every day, for example.

Benign prostatic hyperplasia

Avanafil and Spedra kick in a little quicker, making them suitable for “on-demand” use shortly prior to anticipated sexual intercourse. But they also don’t last as long as Tadalafil — which is a major drawback for some men. Vardenafil (Levitra) and Sildenafil both have the downside of being effective for less time than Tadalafil. That said, they work well and if you’re looking for something for less than 36 hours, they’re good options for most men. Tadalafil also takes the same amount of time to take effect as some shorter-acting options, but it provides support for much longer. 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. (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). 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).

Medical uses

It should never be relied upon for specific medical advice. If you have any questions or concerns, please talk to your doctor. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS.CIALIS (tadalafil) tablets, for oral useInitial U.S.

Customer Relationship Individual Leadership Award

Approval: 2003INDICATIONS AND USAGECIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:erectile dysfunction (ED) (1.1)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).DOSAGE AND ADMINISTRATION 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).CIALIS for once daily use:CIALIS may be taken without regard to food (2.5).DOSAGE FORMS AND STRENGTHSTablets: 5 mg, 10 mg, 20 mg (3).CONTRAINDICATIONSAdministration 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).WARNINGS AND PRECAUTIONSPatients 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. 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.

1.2 Benign Prostatic Hyperplasia

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction1.2 Benign Prostatic Hyperplasia1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia1.4 Limitation of Use2 DOSAGE AND ADMINISTRATION2.1 CIALIS for Use as Needed for Erectile Dysfunction2.2 CIALIS for Once Daily Use for Erectile Dysfunction2.3 CIALIS for Once Daily Use for Benign Prostatic Hyperplasia2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia2.5 Use with Food2.6 Use in Specific Populations2.7 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use5.3 Prolonged Erection5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-blockers and Antihypertensives5.7 Renal Impairment5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with CIALIS7.2 Potential for Other Drugs to Affect CIALIS7.3 Potential for CIALIS to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 CIALIS for Use as Needed for ED14.2 CIALIS for Once Daily Use for ED14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)14.4 CIALIS 5 mg for Once Daily Use for ED and BPH16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Guanylate Cyclase (GC) Stimulators17.3 Cardiovascular Considerations17.4 Concomitant Use with Drugs Which Lower Blood Pressure17.5 Potential for Drug Interactions When Taking CIALIS for Once Daily Use17.6 Priapism17.7 Sudden Loss of Vision17.8 Sudden Hearing Loss17.9 Alcohol17.10 Sexually Transmitted Disease17.11 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed. 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. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction1.2 Benign Prostatic Hyperplasia1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia1.4 Limitation of Use2 DOSAGE AND ADMINISTRATION2.1 CIALIS for Use as Needed for Erectile Dysfunction2.2 CIALIS for Once Daily Use for Erectile Dysfunction2.3 CIALIS for Once Daily Use for Benign Prostatic Hyperplasia2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia2.5 Use with Food2.6 Use in Specific Populations2.7 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use5.3 Prolonged Erection5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-blockers and Antihypertensives5.7 Renal Impairment5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with CIALIS7.2 Potential for Other Drugs to Affect CIALIS7.3 Potential for CIALIS to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 CIALIS for Use as Needed for ED14.2 CIALIS for Once Daily Use for ED14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)14.4 CIALIS 5 mg for Once Daily Use for ED and BPH16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Guanylate Cyclase (GC) Stimulators17.3 Cardiovascular Considerations17.4 Concomitant Use with Drugs Which Lower Blood Pressure17.5 Potential for Drug Interactions When Taking CIALIS for Once Daily Use17.6 Priapism17.7 Sudden Loss of Vision17.8 Sudden Hearing Loss17.9 Alcohol17.10 Sexually Transmitted Disease17.11 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed.