8 USE IN SPECIFIC POPULATIONS

January 22, 2015By Jessica Wilson, BioSpace.com Breaking News Staff The U.S. Food and Drug Administration (FDA) has alerted the public that counterfeit versions of the erectile dysfunction drug Cialis were found in the mail on its way to a consumer. FDA lab analysis showed the counterfeit drug contained “multiple active ingredients, which if used could result in adverse effects or harm”, the FDA said in a statement. The FDA is concerned that other shipments could exist and has posted pictures of the counterfeit package as compared to the authentic package of Cialis on the agency’s website. The counterfeit bottle includes “AUSTR81137” on the front and does not have an NDC number or the tablet strength in a colored box. The pattern is different than that of the authentic Cialis; it has yellow and a darker green design on the label. In addition, the following misspellings appear on the side of the bottle, “CLALIS is a product of: Eli Lilly Australia PTY Limited.” Further identifying features include the location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle and “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle. Though an address is listed, the FDA stated the counterfeit Cialis is from an “unknown source.” The FDA stated it was not aware of any “consumer adverse events” due to the use of the counterfeit Cialis, however, the agency recommends people speak to their health care professionals if they have received a counterfeit product. People are asked to report adverse reactions to the FDA’s MedWatch Adverse Event Reporting program. Eli Lilly and Company makes the authentic Cialis and, according to the FDA, there is no indication its supply chain is at risk.

• Cialis tablets come with different packaging, including blister packs and bottles.
• Eli Lilly provides comprehensive patient information leaflets with Cialis.
• Cialis is sometimes prescribed off-label for Raynaud’s phenomenon.
• The medication has a bioavailability of about 80%.
• Food intake has minimal impact on Cialis absorption.
• Cialis is metabolized primarily by the liver enzyme CYP3A4.
• Dose adjustments might be necessary for patients with kidney impairment.
• Cialis’s half-life is approximately 17.5 hours, contributing to long effect.
• Lilly has faced generic competition for Cialis in many markets.
• The drug’s patent expiration allowed entry of tadalafil generics.
• Cialis is included in some clinical guidelines for ED management.
• Monitoring for rare but serious side effects is part of patient care.

People “can be confident” that the prescription medication they purchase from state-licensed pharmacies in the U.S.

14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)

People “can be confident” that the prescription medication they purchase from state-licensed pharmacies in the U.S. is “safe and effective.” “Lily does not manufacture Cialis in Australia,” said Eli Lilly spokeswoman Celeste Stanley in a statement earlier this month. “In fact, Lilly does not currently operate a manufacturing site in Australia for any of its products. Thus, any Cialis product with packaging stating it is from Lilly in Australia is not genuine.” Stanley further stated that Lilly stopped manufacturing human drugs in Australia in 1985. “Lilly has never manufactured Cialis in Australia,” she said.

8.6 Hepatic Impairment

Pharmaceuticals are among the top five counterfeit products seized in the U.S., according to a March 2014 article in USA Today. BioSpace Temperature PollWhat Are Your Predictions for the Price Bidding War? The market has been buzzing about an escalating price war between large payers like Express Scripts and Big Pharma. Multiple deals last week showed Gilead forming exclusive pacts and smaller companies like Kite Pharma starting talks early. What do you think will be the effect on prices? is “safe and effective.” “Lily does not manufacture Cialis in Australia,” said Eli Lilly spokeswoman Celeste Stanley in a statement earlier this month.

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	60mg	120 + 8 Pills	240.18€ 228.74€	Buy
Cialis Generic	2.5mg	90 + 6 Pills	112.43€ 107.08€	Buy
Cialis Original	20mg	8 Pills	61.70€ 58.76€	Buy
Cialis Generic	10mg	270 + 10 Pills	308.71€ 294.01€	Buy
Cialis Professional	20mg	180 + 4 Pills	423.11€ 402.96€	Buy
Cialis Super Active	20mg	270 + 30 Pills	661.49€ 629.99€	Buy
Cialis Black	80mg	180 + 10 Pills	356.64€ 339.66€	Buy
Cialis Black	80mg	60 + 4 Pills	150.98€ 143.79€	Buy
Cialis Black	80mg	10 Pills	43.27€ 41.21€	Buy
Cialis Original	20mg	34 + 2 Pills	183.99€ 175.23€	Buy
Cialis Generic	60mg	30 + 2 Pills	85.33€ 81.27€	Buy
Cialis Black	80mg	120 + 8 Pills	264.77€ 252.16€	Buy
Cialis Original	20mg	14 + 2 Pills	95.75€ 91.19€	Buy
Cialis Professional	20mg	270 + 6 Pills	623.07€ 593.40€	Buy
Cialis Generic	20mg	10 Pills	31.49€ 29.99€	Buy
Cialis Super Active	20mg	30 + 6 Pills	128.09€ 121.99€	Buy

“In fact, Lilly does not currently operate a manufacturing site in Australia for any of its products. Thus, any Cialis product with packaging stating it is from Lilly in Australia is not genuine.” Stanley further stated that Lilly stopped manufacturing human drugs in Australia in 1985. “Lilly has never manufactured Cialis in Australia,” she said. Pharmaceuticals are among the top five counterfeit products seized in the U.S., according to a March 2014 article in USA Today.

7.3 Potential for CIALIS to Affect Other Drugs

January 22, 2015By Jessica Wilson, BioSpace.com Breaking News Staff The U.S. Food and Drug Administration (FDA) has alerted the public that counterfeit versions of the erectile dysfunction drug Cialis were found in the mail on its way to a consumer. FDA lab analysis showed the counterfeit drug contained “multiple active ingredients, which if used could result in adverse effects or harm”, the FDA said in a statement. The FDA is concerned that other shipments could exist and has posted pictures of the counterfeit package as compared to the authentic package of Cialis on the agency’s website. The counterfeit bottle includes “AUSTR81137” on the front and does not have an NDC number or the tablet strength in a colored box.

1 billion products

The pattern is different than that of the authentic Cialis; it has yellow and a darker green design on the label. In addition, the following misspellings appear on the side of the bottle, “CLALIS is a product of: Eli Lilly Australia PTY Limited.” Further identifying features include the location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle and “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle. Though an address is listed, the FDA stated the counterfeit Cialis is from an “unknown source.” The FDA stated it was not aware of any “consumer adverse events” due to the use of the counterfeit Cialis, however, the agency recommends people speak to their health care professionals if they have received a counterfeit product. People are asked to report adverse reactions to the FDA’s MedWatch Adverse Event Reporting program. Eli Lilly and Company makes the authentic Cialis and, according to the FDA, there is no indication its supply chain is at risk. BioSpace Temperature PollWhat Are Your Predictions for the Price Bidding War?

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

The market has been buzzing about an escalating price war between large payers like Express Scripts and Big Pharma.

• Cialis use requires awareness of potential allergic reactions.
• The medication is contraindicated in severe liver impairment.
• Medication adherence improves clinical outcomes with Cialis.
• Dosage may be adjusted based on therapeutic response.
• Cialis effectiveness can decline if underlying health worsens.
• Not all men respond equally to tadalafil treatment.
• Cialis may help in cases of mixed ED and BPH symptoms.
• The medication does not protect against sexually transmitted infections.
• Cialis is not recommended during pregnancy or breastfeeding (not indicated).
• It is essential to disclose all medications to a healthcare provider before use.
• Drug resistance is not a concern with Cialis.
• Lilly updates prescribing information periodically based on research.

Multiple deals last week showed Gilead forming exclusive pacts and smaller companies like Kite Pharma starting talks early. What do you think will be the effect on prices? Yahoo is generic cialis 40 mg part of the Yahoo family of brands. provide our sites and apps to you authenticate users, apply security measures, and prevent spam and abuse, and measure your use of our sites and apps , including 247 who are part of the IAB Transparency & Consent Framework, will also store and / or access information on a device (in other words, use cookies) and use precise geolocation data and other personal data such as and browsing and search data, for analytics, personalised advertising and content, advertising and content measurement, and audience research and services development. If you do not want us and our partners to use cookies and personal data for these additional purposes, click 'Reject all'.

• Cialis’s discovery resulted from targeted medicinal chemistry efforts.
• Eli Lilly’s investment supported large-scale clinical development.
• The drug was approved after successful phase III trials.
• Cialis changed the standard of care for erectile dysfunction.
• Patient safety and efficacy data have been extensively published.
• The medication is designed for once-daily or as-needed use.
• Clinical guidelines endorse Cialis as a treatment choice.
• Patient satisfaction surveys show positive outcomes.
• Lilly’s Cialis marketing emphasizes science and patient benefits.
• Medication errors are reduced with clear prescribing instructions.
• Cialis requires prescription and proper medical evaluation.
• It remains a key option in the global ED treatment market.

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Drug Label Information

Yahoo is generic cialis 40 mg part of the Yahoo family of brands. provide our sites and apps to you authenticate users, apply security measures, and prevent spam and abuse, and measure your use of our sites and apps , including 247 who are part of the IAB Transparency & Consent Framework, will also store and / or access information on a device (in other words, use cookies) and use precise geolocation data and other personal data such as and browsing and search data, for analytics, personalised advertising and content, advertising and content measurement, and audience research and services development. If you do not want us and our partners to use cookies and personal data for these additional purposes, click 'Reject all'. If you would like to customise your choices, click 'Manage privacy settings'. If you are a consumer or patient please visit this version.

6.1 Clinical Trials Experience

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. 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. 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.

1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia

Patient resources

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.

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

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.

17.5 Potential for Drug Interactions When Taking CIALIS for Once Daily Use

(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).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. 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.

2.2 CIALIS for Once Daily Use for Erectile Dysfunction

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). 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. (2.7, 5.6, 7.1, 12.2)Patients should seek emergency treatment if an erection lasts >4 hours.

• Tadalafil is chemically distinct from sildenafil, the active ingredient in Viagra.
• Cialis is often known as the "weekend pill" due to its long effect.
• The medication’s efficacy depends on adequate sexual arousal.
• Drug comparisons show Cialis’s side effect profile is favorable.
• Lilly’s patient assistance programs can reduce cost barriers.
• Daily low-dose Cialis may improve endothelial function in some patients.
• The drug is contraindicated with nitrates used for chest pain.
• Care should be taken when driving or performing tasks after taking Cialis.
• Cialis does not cause immediate permanent changes in sexual function.
• The medication's role in female sexual dysfunction remains unclear.
• Cialis has changed perceptions of male sexual health treatments.
• Safety reviews continue as new data emerge internationally.

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).

8.6 Hepatic Impairment

5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies

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. 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).

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

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.