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Tadalafil (Caliberi) orodispersible film is for oral administration. The film must be placed on the tongue and dissolved on the tongue. It must be immediately used once taken out from the pouch. It can be dissolved on the tongue without any water. Absorption is through the digestive tube.
Benign prostatic hyperplasia: 5 mg orally once daily at the same time each day; for up to 26 weeks when used with finasteride for initiation of benign prostatic hyperplasia treatment.
Benign prostatic hyperplasia - Erectile dysfunction: 5 mg ORALLY once daily at the same time each day.
Erectile dysfunction: Once daily use: 2.5 mg ORALLY once daily at the same time each day; may increase to 5 mg ORALLY once daily based on efficacy and tolerability.
As needed use: 10 mg ORALLY prior to anticipated sexual activity; may increase to 20 mg ORALLY or decrease to 5 mg ORALLY based on efficacy and tolerability; maximum frequency is once daily.
Pulmonary hypertension: 40 mg orally once daily with or without food.
Administration in hepatic impairment: Exposure to tadalafil in patients with mild to moderate hepatic impairment is comparable to healthy subjects when a dose of 10 mg is used. Regular daily dosing has not been evaluated.
Mild to moderate hepatic impairment (Child-Pugh Class A or B): the maximum dose is 10 mg; regular daily dosing has not been evaluated.
Severe hepatic impairment (Child-Pugh Class C): insufficient data are available; in the UK, caution is advised, and in the USA use in this group is not recommended.
Administration in renal impairment: The clearance of tadalafil is reduced in renal impairment.
In the UK, licensed product information recommends the following: Mild to moderate renal impairment: no dose adjustment.
Severe renal impairment: the maximum dose is 10 mg; regular daily dosing is not recommended in these patients.
In the USA, the dose recommendations for tadalafil, when used as needed, in patients with renal impairment based on creatinine clearance (CC) are: Mild (CC 51 to 80 mL/minute): no dose adjustment.
Moderate (CC 31 to 50 mL/minute): an initial dose of 5 mg not more than once daily, with a maximum dose of 10 mg in 48 hours.
Severe (CC less than 30 mL/minute or on hemodialysis): a maximum dose of 5 mg not more than once in every 72 hours.
For patients taking tadalafil on a regular daily basis: Mild (CC 51 to 80 mL/minute): no dose adjustment.
Moderate (CC 31 to 50 mL/minute): no dose adjustment.
Severe (CC less than 30 mL/minute or on hemodialysis): not recommended.
High-altitude disorders: Hypoxic pulmonary hypertension associated with high altitude may respond to tadalafil.
A small study has shown some promising results in adults with a history of high-altitude pulmonary edema.
Although the use of tadalafil with an alpha blocker is not recommended in the UK, the combination may be used in the USA; in patients stabilized on alpha blocker therapy a starting dose of tadalafil 5 mg may be used. In patients taking potent inhibitors of the cytochrome P450 isoenzyme CYP3A4, such as ketoconazole or ritonavir-boosted HIV-protease inhibitors, the dose of tadalafil when used as needed should not exceed 10 mg once every 72 hours; when used on a regular daily basis, the dose should not exceed 2.5 mg.
