Drug interactions -summary-

CYP2A4 inhibitors (eg rifampin) + Fesotetrodune -
Co admin decreased festerodine Cmax and AUC . No dosing adjustments are recommended

CYP3A4 inhibitors (eg clarithromycin ,erythromycin , itraconazole, ketoconazole ) + Fesotrodine-
Coadmin of potent CYP3A4 increase  the Cmax and AUC of active metabolite of festerodine
doses of festerodine more than 4mg are not recommended

Fesoterodine + Anticholinergic agents/ Anticholinergic agents + fesoterodine-
concomittant use may increase frequency and and severity of antichilnergic effects eg. dry mouth,urinary retention. Anicholinergic agents may alter the absorption of some co-administred drugs

Overactive Bladder

Adverse reactions-

GI -   abdominal pain   1%       constipation 2%    dry mouth  6%  nausea  1%

GU -  urinary tract infection    3%

Lab test abnormalities-   ALT increased 0.9%

Respiratory -    cough 0.5%    dry throat  0.5%     upper respiratory tract infection 2%

Miscellaneous-    back pain  0.4%      edema peripheral  0.6%   insomnia  0.5%  rash 0.5%

Urinary retention, gastric irritation

Special Precautions-
Bladder outlet obstruction-  administer festerodine with caution on patients with clinically
significant bladder outlet obstruction

GI motility-  use with caution in patients with decreased gastric motility such as those with severe
constipation

Myasthenia gravis-  use fesoterodine with caution in patients with myasthenia gravis

Controlled narrow -angle glaucoma - use fesoteridine  with caution in patients treated for narrow
angle glaucoma   

Renal function impairment- doses of fesoterodine more than 4mg are not recommended

Hepatic function impairment- not recommended for use in this population

Pregnancy-use fesoteridine during pregnancy only if needed

Lactation- do ot administer during breast feeding unless the potential  benefit outweighs
the potential risk to the fetus.

Children- safety and effectiveness in children have not been established 

Elderly- increase in urinary tract infection was higher in patients over 75 years of age than
 as compared to younger patients

Indication-
Overactive Bladder

Dosage-
8mg once daily based on indivudual response and tolerability

Initial dosage- 4mg once daily

Concomittant treatment- the daily dose should not exceed 4mg in patients taking potent CYP3A4
inhibitors eg. clarithromycin, itraconazole, ketaconazole

Renal function impairment - doses more than 4mg are not recommended

Hepatic function impairment- fesoterodine is not recommended for use in with severe hepatic
function impairment

1. Inform patients that fesoterdine like other antimuscarnic agents may produce clinically
   significant reactions to antimuscranic pharmacological acitivity including constipation
   and urinary retention

Pregnancy-
Use fesoteridine during pregnancy only if needed

Lactation-
Do ot administer during breast feeding unless the potential  benefit outweighs
the potential risk to the fetus.

Children-
Safety and effectiveness in children have not been established 

Elderly-
Increase in urinary tract infection was higher in patients over 75 years of age than
 as compared to younger patients