11 DESCRIPTION

Cialis > cialis tablets


Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1, 6.2). 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 See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

  • Cialis can be part of comprehensive ED treatment including counseling.
  • Psychological counseling may help address performance anxiety issues.
  • Vacuum devices and injections are alternative ED treatment options.
  • Penile implants remain surgical option for Cialis non-responders.
  • Lifestyle changes can reduce ED severity and medication requirements.

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction2 DOSAGE AND ADMINISTRATION2.1 Erectile Dysfunction2.2 Use with Food2.3 Use in Special Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use5.3 Prolonged Erection5.4 Eye5.5 Sudden Hearing Loss5.6 Alpha blockers and Antihypertensives5.7 Renal Insufficiency5.8 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 Diseases6 ADVERSE REACTIONS6.1 Clinical Studies 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 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Insufficiency10 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 Needed14.2 CIALIS for Once Daily Use16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Cardiovascular Considerations17.3 Concomitant Use with Drugs Which Lower Blood Pressure17.4 Potential for Drug Interactions When Taking CIALIS for Once Daily Use17.5 Priapism17.6 Vision17.7 Sudden Hearing Loss17.8 Alcohol17.9 Sexually Transmitted Disease17.10 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed.

Special Cases

Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1, 6.2). 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 See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction2 DOSAGE AND ADMINISTRATION2.1 Erectile Dysfunction2.2 Use with Food2.3 Use in Special Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use5.3 Prolonged Erection5.4 Eye5.5 Sudden Hearing Loss5.6 Alpha blockers and Antihypertensives5.7 Renal Insufficiency5.8 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 Diseases6 ADVERSE REACTIONS6.1 Clinical Studies 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 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Insufficiency10 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 Needed14.2 CIALIS for Once Daily Use16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Cardiovascular Considerations17.3 Concomitant Use with Drugs Which Lower Blood Pressure17.4 Potential for Drug Interactions When Taking CIALIS for Once Daily Use17.5 Priapism17.6 Vision17.7 Sudden Hearing Loss17.8 Alcohol17.9 Sexually Transmitted Disease17.10 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. 2 DOSAGE AND ADMINISTRATION 2.1 Erectile DysfunctionCIALIS for Use as NeededThe 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.

Can Cialis be crushed, split, or chewed?

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.2.3 Use in Special PopulationsRenal InsufficiencyCIALIS for Use as NeededMild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours.Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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)].CIALIS for Once Daily UseMild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required.Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use In Specific Populations (8.7)].Hepatic ImpairmentCIALIS for Use as NeededMild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency and therefore, caution is advised.Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].CIALIS for Once Daily UseMild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients.Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].2.4 Concomitant MedicationsAlpha BlockersWhen CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1) and Clinical Pharmacology (12.2)]. The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.

What if I miss a dose?

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. Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 Erectile DysfunctionCIALIS for Use as NeededThe 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.2.3 Use in Special PopulationsRenal InsufficiencyCIALIS for Use as NeededMild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours.Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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)].CIALIS for Once Daily UseMild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required.Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use In Specific Populations (8.7)].Hepatic ImpairmentCIALIS for Use as NeededMild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency and therefore, caution is advised.Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].CIALIS for Once Daily UseMild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency.

  • Cialis is not indicated for use by women despite off-label attempts.
  • No clinical evidence supports Cialis for enhanced female sexual function.
  • Pediatric use is strictly prohibited except in rare research settings.
  • Elderly patients may be more sensitive to side effects and require lower doses.
  • Renal impairment dosage adjustment is necessary for patients with CKD.

Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients.Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].2.4 Concomitant MedicationsAlpha BlockersWhen CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1) and Clinical Pharmacology (12.2)].

  • Cialis can cause priapism, a prolonged erection requiring emergency care.
  • Sudden vision loss in one or both eyes is a rare but serious side effect.
  • Hearing changes or sudden decrease/loss have been reported in some cases.
  • Not approved for use by women or children under 18 years of age.
  • Only available with a prescription from a licensed healthcare provider.

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.

Product Dosage Quantity + Bonus Price
Cialis Generic2.5mg20 Pills40.73€ 38.79€
Cialis Soft Tabs20mg180 + 8 Pills353.17€ 336.35€
Cialis Black80mg90 + 6 Pills207.88€ 197.98€
Cialis Original20mg12 Pills78.32€ 74.59€
Cialis Original20mg48 + 4 Pills224.69€ 213.99€
Cialis Black80mg360 + 20 Pills639.78€ 609.31€
Cialis Professional20mg360 + 6 Pills807.03€ 768.60€
Cialis Generic2.5mg180 + 10 Pills154.86€ 147.49€
Cialis Generic10mg10 Pills31.41€ 29.91€
Cialis Super Active20mg180 + 20 Pills521.59€ 496.75€
Cialis Professional20mg30 Pills104.57€ 99.59€
Cialis Professional40mg270 + 6 Pills898.37€ 855.59€
Cialis Black80mg120 + 8 Pills264.77€ 252.16€
Cialis Generic60mg180 + 10 Pills313.11€ 298.20€
Cialis Soft Tabs20mg270 + 10 Pills471.40€ 448.95€
Cialis Black80mg20 Pills71.83€ 68.41€
Cialis Generic5mg270 + 10 Pills205.81€ 196.01€

Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration. Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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)]. Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required. Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use cialis order mastercard In Specific Populations (8.7)].

14.2 CIALIS for Once Daily Use

Mild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day.

  • Erectile improvement typically occurs within 30-120 minutes after ingestion.
  • Response may vary based on individual factors and sexual stimulation.
  • Alcohol in moderation is generally acceptable with Cialis use.
  • Smoking may reduce effectiveness by impairing blood vessel function.
  • Regular exercise and healthy diet can complement Cialis treatment.

The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency and therefore, caution is advised.

Dosing & Uses

This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA). 5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.Before prescribing CIALIS, it is important to note the following:5.1 CardiovascularPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS.

What CIALIS looks like

In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention. [See Contraindications (4.1) and Patient Counseling Information (17.1)].Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for CIALIS, and therefore until further information is available, CIALIS is not recommended for the following groups of patients:myocardial infarction within the last 90 daysunstable angina or angina occurring during sexual intercourseNew York Heart Association Class 2 or greater heart failure in the last 6 monthsuncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg)stroke within the last 6 months.As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure.

Overdose symptoms

Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)]. Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency.

2.3 Use in Special Populations

Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients. When CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1) and Clinical Pharmacology (12.2)].

Release Form and Composition

Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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)]. Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required. Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use cialis order mastercard In Specific Populations (8.7)]. Mild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day.

How to take CIALIS

The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency and therefore, caution is advised. Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)]. Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients. When CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1) and Clinical Pharmacology (12.2)].

Pregnancy Categories

4 CONTRAINDICATIONS 4.1 NitratesAdministration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].4.2 Hypersensitivity Reactionsis contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)]. Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. 4 CONTRAINDICATIONS 4.1 NitratesAdministration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].4.2 Hypersensitivity Reactionsis contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)]. Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA). 5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.Before prescribing CIALIS, it is important to note the following:5.1 CardiovascularPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS. In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention.

Form Strengths Packaging Notes
Tablet 5 mg, 10 mg, 20 mg Blister packs of 10, 30 For oral administration
Oral Jelly 20 mg per packet Single packets Alternative form
Chewable Tablet 10 mg Small blister packs For easier ingestion

[See Contraindications (4.1) and Patient Counseling Information (17.1)].Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for CIALIS, and therefore until further information is available, CIALIS is not recommended for the following groups of patients:myocardial infarction within the last 90 daysunstable angina or angina occurring during sexual intercourseNew York Heart Association Class 2 or greater heart failure in the last 6 monthsuncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg)stroke within the last 6 months.As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure.