Caliberi Dosage/Direction for Use

For oral use. CALIBERI ODF should be taken without food. CALIBERI ODF must be immediately used once taken out of the pouch and it can be dissolved on the tongue, with or without any water.
Erectile Dysfunction in adult men: CALIBERI ODF for Use as Needed: The recommended dose is 10mg (2x 5mg CALIBERI ODF) taken prior to anticipated sexual activity. In those patients in whom CALIBERI ODF 10mg does not produce an adequate effect, the maximum dose is 20mg and the maximum dosing frequency is once per day. It may be taken from 30 minutes to 36 hours prior to sexual activity. CALIBERI ODF 10mg and 20mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
CALIBERI ODF for Once Daily Use: In patients who anticipate a frequent use of CALIBERI ODF (i.e. at least twice weekly) a once daily regimen with the lowest doses of CALIBERI ODF might be considered suitable, based on patient choice and the physician's judgement. The maximum recommended dose is 5mg (one 5mg CALIBERI ODF) once a day, taken at approximately the same time every day, without regard to timing of sexual activity. The appropriateness of continued use of the daily regimen should be reassessed periodically.
Benign Prostatic Hyperplasia: The recommended dose is 5mg, taken at approximately the same time every day.
Erectile Dysfunction and Benign Prostatic Hyperplasia: The recommended dose is 5mg, taken at approximately the same time every day, without regard to timing of sexual activity.
Use in elderly men: Dose adjustments are not required in elderly patients.
Use in men with renal impairment: CALIBERI ODF for Use as Needed: Mild (creatinine clearance 51 to 80mL/min): No dose adjustment is required.
Moderate (creatinine clearance 31 to 50mL/min): A starting dose of 5mg not more than once per day is recommended, and the maximum dose is 10mg not more than once in every 48 hours.
Severe (creatinine clearance <30mL/min or on hemodialysis): The maximum dose is 5mg not more than once in every 72 hours (see Precautions and Pharmacology: Pharmacokinetics under Actions).
CALIBERI ODF for Once Daily Use: Mild (creatinine clearance 51 to 80mL/min): No dose adjustment is required.
Moderate (creatinine clearance 31 to 50mL/min): No dose adjustment is required.
Severe (creatinine clearance <30mL/min or on hemodialysis): CALIBERI ODF for once daily use is not recommended (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Use in men with hepatic impairment: CALIBERI ODF for Use as Needed: The recommended dose is 10mg taken prior to anticipated sexual activity. There is limited clinical data on the safety of CALIBERI ODF in patients with severe hepatic impairment (Child‐Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10mg of CALIBERI ODF to patients with hepatic impairment.
CALIBERI ODF for Once Daily Use: Once‐a‐day dosing has not been extensively evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Use in men with diabetes: Dose adjustments are not required in diabetic patients.
Paediatric population: CALIBERI ODF should not be used in individuals below 18 years of age.
Use in patients taking CYP3A4 Inhibitors: CALIBERI ODF for Use as Needed: For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CALIBERI ODF is 10mg, not to exceed once every 72 hours (see Precautions and Interactions).
CALIBERI ODF for Once Daily Use: For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CALIBERI ODF is 2.5mg (see Precautions and Interactions). Caliberi ODF should not be used in these patients since the 2.5mg film dosage is unavailable.