|
|
CLcr 30 to 89 mL/min |
8 mg |
CLcr 15 to 29 mL/min |
4 mg |
CLcr <15 mL/min |
4 mg |
|
|
|
|
Gastrointestinal disorders Dry mouth Constipation Dyspepsia Nausea |
7 2 0.5 1.3 |
18.8 4.2 1.6 0.7 |
34.6 6 2.3 1.9 |
Abdominal pain upper |
0.5 |
1.1 |
0.5 |
Infections Urinary tract infection |
3.1 |
3.2 |
4.2 |
Upper respiratory tract infection |
2.2 |
2.5 |
1.8 |
Eye disorders Dry eyes |
0 |
1.4 |
3.7 |
Renal and urinary disorders Dysuria Urinary retention |
0.7 0.2 |
1.3 1.1 |
1.6 1.4 |
Respiratory disorders Cough Dry throat |
0.5 0.4 |
1.6 0.9 |
0.9 2.3 |
General disorders Edema peripheral |
0.7 |
0.7 |
1.2 |
Musculoskeletal disorders Back pain |
0.4 |
2 |
0.9 |
Psychiatric disorders Insomnia |
0.5 |
1.3 |
0.4 |
Investigations ALT increased GGT increased |
0.9 0.4 |
0.5 0.4 |
1.2 1.2 |
Skin disorders Rash |
0.5 |
0.7 |
1.1 |
|
|
||||
|
|
|
|
|
|
Cmax (ng/mL) |
1.89 [43%] |
3.45 [54%] |
3.98 [28%] |
6.90 [39%] |
|
AUC0-tz (ng*h/mL) |
21.2 [38%] |
40.5 [31%] |
45.3 [32%] |
88.7 [36%] |
|
tmax (h)a
|
5 [2 to 6] |
5 [5 to 6] |
5 [3 to 6] |
5 [5 to 6] |
|
t½ (h) |
7.31 [27%] |
7.31 [30%] |
8.59 [41%] |
7.66 [21%] |
|
|
|
||||||||||
|
|
|
|
|
|
|
||||||
Number of urge incontinence episodes per 24 hoursa
|
||||||||||||
Baseline |
3.7 |
3.8 |
3.7 |
3.7 |
3.9 |
3.9 |
||||||
Change from baseline |
-1.20 |
-2.06 |
-2.27 |
-1 |
-1.77 |
-2.42 |
||||||
p-value vs. placebo |
- |
0.001 |
< 0.001 |
- |
< 0.003 |
< 0.001 |
||||||
Number of micturitions per 24 hours |
||||||||||||
Baseline |
12 |
11.6 |
11.9 |
12.2 |
12.9 |
12 |
||||||
Change from baseline |
-1.02 |
-1.74 |
-1.94 |
-1.02 |
-1.86 |
-1.94 |
||||||
p-value vs. placebo |
- |
< 0.001 |
< 0.001 |
- |
0.032 |
< 0.001 |
||||||
Voided volume per micturition (mL) |
||||||||||||
Baseline |
150 |
160 |
154 |
159 |
152 |
156 |
||||||
Change from baseline |
10 |
27 |
33 |
8 |
17 |
33 |
||||||
p-value vs. placebo |
- |
< 0.001 |
< 0.001 |
- |
0.150 |
< 0.001 |
|
Read the Patient Information that comes with fesoterodine fumarate extended-release tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. |
Fesoterodine fumarate extended-release tablets are a prescription medicine used:
|
Do not take fesoterodine fumarate extended-release tablets if you:
|
Know all the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. |
|
|
Fesoterodine fumarate extended-release tablets may cause serious side effects, including:
|
Talk to your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of fesoterodine fumarate extended-release tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
|
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use fesoterodine fumarate extended-release tablets for a condition for which it was not prescribed. Do not give fesoterodine fumarate extended-release tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about fesoterodine fumarate extended-release tablets that is written for health professionals. Please address medical inquiries to, (MedicalAffairs@zydususa.com) or Tel.: 1-877-993-8779. |
|
Ahmedabad, India. Pennington, NJ 08534 |
Rev.: 08/22 |