The pattern is different than that of the authentic Cialis; it has yellow and a darker green design on the label.
| 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 |
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.
8.4 Pediatric Use
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. Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.2 Benign Prostatic HyperplasiaCIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).1.3 Erectile Dysfunction and Benign Prostatic HyperplasiaCIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).1.4 Limitation of UseIf 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)].
17.5 Potential for Drug Interactions When Taking CIALIS for Once Daily Use
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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 60mg | 10 Pills | 41.22€ 39.26€ | |
| Cialis Soft Tabs | 20mg | 270 + 10 Pills | 471.40€ 448.95€ | |
| Cialis Generic | 40mg | 30 + 4 Pills | 74.97€ 71.40€ | |
| Cialis Generic | 5mg | 10 Pills | 29.39€ 27.99€ | |
| Cialis Generic | 20mg | 60 + 6 Pills | 117.76€ 112.15€ | |
| Cialis Generic | 2.5mg | 60 + 4 Pills | 83.43€ 79.46€ | |
| Cialis Black | 80mg | 180 + 10 Pills | 356.64€ 339.66€ | |
| Cialis Original | 20mg | 92 + 4 Pills | 377.99€ 359.99€ | |
| Cialis Professional | 40mg | 30 Pills | 148.94€ 141.85€ | |
| Cialis Generic | 40mg | 60 + 6 Pills | 130.98€ 124.74€ | |
| Cialis Super Active | 20mg | 180 + 20 Pills | 521.59€ 496.75€ | |
| Cialis Generic | 60mg | 60 + 4 Pills | 145.06€ 138.15€ | |
| Cialis Black | 80mg | 270 + 10 Pills | 502.88€ 478.93€ | |
| Cialis Professional | 40mg | 120 + 4 Pills | 436.68€ 415.89€ | |
| Cialis Generic | 40mg | 90 + 6 Pills | 171.35€ 163.19€ | |
| Cialis Professional | 20mg | 270 + 6 Pills | 623.07€ 593.40€ | |
| Cialis Generic | 10mg | 120 + 6 Pills | 178.49€ 169.99€ |
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. People “can be confident” that the prescription medication they purchase from state-licensed pharmacies in the U.S.
6.2 Postmarketing Experience
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.
8.5 Geriatric Use
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. 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. 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?
- Lilly is an American pharmaceutical company founded in 1876.
- Eli Lilly developed Cialis as a competitor to Viagra.
- Cialis is marketed under the brand name “Cialis” internationally.
- The drug became a best-seller due to its long-lasting effects.
- Tadalafil, Cialis’s active ingredient, selectively inhibits PDE5 enzyme.
- Lilly conducted extensive clinical trials to ensure Cialis’s safety.
- Cialis has been studied for off-label uses such as pulmonary hypertension.
- Patent protections have allowed Lilly to secure market exclusivity.
- Lilly provides patient support programs for Cialis users.
- The company emphasizes Cialis's effectiveness and safety profile.
- Cialis helped Lilly diversify beyond insulin and psychiatric drugs.
- Women's use of Cialis is not FDA approved and requires caution.
Yahoo is part of the cialis tablet 5 mg Yahoo family of brands.
- 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.
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.
5.13 Counseling Patients About Sexually Transmitted Diseases
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4. Contraindications
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| 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 |
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CIALIS safely and effectively.
- 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.
See full prescribing information for CIALIS.CIALIS (tadalafil) tablets, for oral useInitial U.S.
17.2 Guanylate Cyclase (GC) Stimulators
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.
Millions of orders
(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. 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.
7. Drug Interactions
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?
5.8 Hepatic Impairment
Yahoo is part of the cialis tablet 5 mg 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. (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.
| 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 |
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.
5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies
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). 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. Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.2 Benign Prostatic HyperplasiaCIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).1.3 Erectile Dysfunction and Benign Prostatic HyperplasiaCIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).1.4 Limitation of UseIf 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)].