tial, including nursing women. It is not known whether dutasteride or tamsulosin is excreted in human milk.
8.4 Pediatric Use
JALYN is contraindicated for use in pediatric patients. Safety and effectiveness of JALYN in pediatric patients have not been established.
8.5 Geriatric Use
Of 1,610male subjects treated with coadministered dutasteride and tamsulosin in the CombAT trial, 58% of enrolled subjects were aged 65years and older and 13% of enrolled subjects were aged 75years and older. No overall differences in safety or efficacy were observed between these subjects and younger subjects but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3)].
8.6 Renal Impairment
The effect of renal impairment on dutasteride and tamsulosin pharmacokinetics has not been studied using JALYN. Because no dosage adjustment is necessary for dutasteride or tamsulosin in patients with moderate-to-severe renal impairment (10≤CLcr <30mL/min/1.73m2), no dosage adjustment is necessary for JALYN in patients with moderate-to-severe renal impairment. However, patients with end-stage renal disease (CLcr<10mL/min/1.73m2) have not been studied [see Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
The effect of hepatic impairment on dutasteride and tamsulosin pharmacokinetics has not been studied using JALYN. The following text reflects information available for the individual components.
Dutasteride: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized, exposure could be higher in hepatically impaired patients. However, in a clinical study where 60subjects received 5mg (10times the therapeutic dose) daily for 24weeks, no additional adverse events were observed compared with those observed at the therapeutic dose of 0.5mg [see Clinical Pharmacology (12.3)].
Tamsulosin: Patients with moderate hepatic impairment do not require an adjustment in tamsulosin dosage. Tamsulosin has not been studied in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].
10 OVERDOSAGE
No data are available with regard to overdosage with JALYN. The following text reflects information available for the individual components.
Dutasteride: In volunteer studies, single doses of dutasteride up to 40mg (80times the therapeutic dose) for 7days have been administered without significant safety concerns. In a clinical study, daily doses of 5mg (10times the therapeutic dose) were administered to 60subjects for 6months with no additional adverse effects to those seen at therapeutic doses of 0.5mg.
There is no specific antidote for dutasteride. Therefore, in cases of suspected overdosage symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration.
Tamsulosin: Should overdosage of tamsulosin lead to hypotension [see Warnings and Precautions (5.1), Adverse Reactions (6.1)], support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that tamsulosin is 94% to 99 |
