Cialis Indications and Dosage
- erectile dysfunction (ED)
Cialis Indications and Dosage
For the treatment of male erectile dysfunction (ED), including ED patients with diabetes mellitus or following radical prostatectomy:
Oral dosage:
Adult males: The recommended starting dose in most patients is 10 mg PO, 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. If coadministering with an alpha blocker, patients should be stable on alpha blocker therapy before starting tadalafil, and tadalafil should be started at the lowest recommended dose. The usual onset of action is within 30 to 45 minutes and the usual duration is up to 36 hours. Tadalafil improved ED compared to placebo up to 36 hours following dosing; therefore, when advising patients on optimal use, this should be taken into consideration. Phase III data report that doses of 20 mg PO improved sexual function in 64% of diabetics with ED. In one clinical study, positive responses were noted at doses of 2, 5, 10, and 25 mg. Doses >= 5 mg were superior to placebo in inducing and maintaining erections adequate for penetration. Once daily treatment with 50 mg PO every morning has also been effective and may promote spontaneity, thereby eliminating the need to plan sexual activity; however, this dosage regimen has not been evaluated as thoroughly as on-demand dosing.
Adult males taking potent CYP3A4 inhibitors such as ritonavir or ketoconazole: The maximum recommended dose is 10 mg PO once every 72 hours.
Maximum Dosage Limits:
- Adults: 20 mg/day PO; 10 mg PO every 72 hours if taking potent CYP3A4 inhibitor (e.g. ketoconazole or ritonavir).
- Elderly: 20 mg/day PO; 10 mg PO every 72 hours if taking potent CYP3A4 inhibitor (e.g. ketoconazole or ritonavir).
- Adolescents: Safe and effective use has not been established.
- Children: Safe and effective use has not been established.
Patients with hepatic impairment:
For patients with mild or moderate hepatic impairment (Child-Pugh Class A or B), the tadalafil dose should not exceed 10 mg PO once daily. In patients with severe hepatic impairment (Child-Pugh Class C), tadalafil use is not recommended.
Patients with renal impairment:
CrCl > 50 ml/min: No dosage adjustment needed.
CrCl 31-50 ml/min: A starting dose of 5 mg PO not more than once daily is recommended; maximum dose should be limited to 10 mg not more than once in every 48 hours.
CrCl < 30 ml/min: The maximum recommend dose is 5 mg PO.
Intermittent hemodialysis:
The maximum recommended dose is 5 mg PO.
[ Last revised: 4/19/2005 10:52:00 AM ]
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