Erectile Dysfunction

CIALIS is indicated for the treatment of erectile dysfunction.

Erectile Dysfunction

CIALIS for Use as Needed

• The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
• The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
• CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.

CIALIS for Once Daily Use

• The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
• The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

Use with Food

CIALIS may be taken without regard to food.

Use in Special Populations

Renal Insufficiency

CIALIS for Use as Needed

• 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 and Use In Specific Populations].

CIALIS for Once Daily Use

• Mild (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 and Use In Specific Populations].

Hepatic Impairment

CIALIS for Use as Needed

• Mild 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 and Use In Specific Populations].

CIALIS for Once Daily Use

• 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.
• Severe (Child Pugh Class C): The use of CIALIS is not recommended [see WARNINGS and PRECAUTIONS and Use In Specific Populations].

Geriatrics

• No dose adjustment is required in patients > 65 years of age.

Concomitant Medications

Nitrites

• Concomitant use of nitrates in any form is contraindicated [see CONTRAINDICATIONS]. Alpha Blockers
• 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, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

CYP3A4 Inhibitors

CIALIS for Use as Needed – For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CIALIS is 10 mg, not to exceed once every 72 hours [see WARNINGS and PRECAUTIONS and DRUG INTERACTIONS].

CIALIS for Once Daily Use – For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the dose should not exceed 2.5 mg [see WARNINGS and PRECAUTIONS and DRUG INTERACTIONS].

Dosage Forms And Strengths

Four strengths of film-coated, almond-shaped tablets (not scored) are available in different sizes and different shades of yellow: 2.5-mg tablets debossed with “C 2 1/2″

5-mg tablets debossed with “C 5″

10-mg tablets debossed with “C 10″

20-mg tablets debossed with “C 20″

CIALIS (tadalafil) is supplied as follows:

Four strengths of film-coated, almond-shaped tablets (not scored) are available in different sizes and different shades of yellow, and supplied in the following package sizes:

2.5 mg tablets debossed with “C 2 1/2″

Blisters of 2 x 15……………………. NDC 0002-4465-34

5-mg tablets debossed with “C 5″

Bottles of 30……………………. NDC 0002-4462-30
Blisters of 2 x 15……………………. NDC 0002-4462-34

10-mg tablets debossed with “C 10″

Bottles of 30……………………. NDC 0002-4463-30

20-mg tablets debossed with “C 20″

Bottles of 30……………………. NDC 0002-4464-30

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.