1 INDICATIONS AND USAGE
1.1 Erectile Dysfunction
CIALIS is indicated for the treatment of erectile dysfunction.
CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:
CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.
2 DOSAGE AND ADMINISTRATION
2.1 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.
2.2 Use with Food
CIALIS may be taken without regard to food.
2.3 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.
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.
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
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
Geriatrics
No dose adjustment is required in patients >65 years of age.
2.4 Concomitant Medications
Nitrates
Concomitant use of nitrates in any form is contraindicated
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
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
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.
3 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
4 CONTRAINDICATIONS
4.1 Nitrates
Administration 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
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