Cialis ® (tadalafil)

För fullständig produktresumé för Cialis® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Cialis (tadalafil): Nedsatt njur-och leverfunktion

Dosjustering är inte nödvändig för patienter med mild till måttligt nedsatt njurfunktion

Men with Renal Impairment

Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment, 10 mg is the maximum recommended dose.

Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment.

Men with Hepatic Impairment

For the treatment of erectile dysfunction using on-demand Cialis the recommended dose of CIALIS is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of Cialis 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 tadalafil to patients with hepatic impairment.

Once-a-day dosing both for the treatment of erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

Renal and hepatic impairment (tadalafil 2.5 mg and 5 mg)

Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of Cialis is not recommended in patients with severe renal impairment.

There is limited clinical data on the safety of single-dose administration of Cialis in patients with severe hepatic insufficiency (Child-Pugh Class C). Once-a-day administration has not been evaluated in patients with hepatic insufficiency. If Cialis is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

Hepatic impairment (tadalafil 10 mg and 20 mg)

There is limited clinical data on the safety of single-dose administration of Cialis in patients with severe hepatic insufficiency (Child-Pugh Class C). If Cialis is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

Renal Insufficiency

In clinical pharmacology studies using single dose tadalafil (5 to 20mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis. In haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects. Haemodialysis contributes negligibly to tadalafil elimination.

Hepatic Insufficiency

Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered. There is limited clinical data on the safety of Cialis in patients with severe hepatic insufficiency (Child-Pugh class C). If Cialis is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of once-a-day dosing of tadalafil to patients with hepatic impairment. If Cialis is prescribed once-a-day, 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 10 mg of tadalafil to patients with hepatic impairment.

REFERENCE

Cialis [Summary of Product Characteristics]. Utrecht, The Netherlands: Eli Lilly Nederland B.V.

Datum fӧr senaste ӧversyn 2018 M10 29


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