Fesoterodine Fumarate Tablet, Film Coated, Extended Release
Product Images NDC 65862-767

Figure 1 shows the change in the number of times an individual urinates in a 24-hour period, as observed in Study 1. The study involved 3 groups of participants: those who were given a placebo (N=279), those who were given fesoterodine fumarate extended-release tablets of 4 mg (N=265), and those who were given fesoterodine fumarate extended-release tablets of 8 mg (N=276). The results were observed over a period of 2 weeks to 8 weeks.*

The text provides data on the mean change from baseline in urge incontinence episodes per 24 hours for a study that evaluated the effectiveness of Fesoterodine fumarate extended-release tablets. The data is presented in a graph (Figure 2) that shows the change in episodes over a period of 12 weeks with a placebo group (N=211) and two groups taking different doses of Fesoterodine fumarate extended-release tablets (4mg and 8mg, N=199 and N=223 respectively).*

This is a statistical analysis of a clinical trial comparing the effects of a placebo to different doses of fesoterodine fumarate extended-release tablets on the number of micturitions per 24 hours. The mean change from baseline is illustrated in Figure 3 for Study 2, which was conducted over a period of 12 weeks with a sample size of N=267 for each dose of the medication and the placebo group.*

The text provides data on the mean change from baseline regarding urge incontinence episodes per 24 hours in Study 2, observed at Weeks 8 to 12. The data shows that the placebo group did not experience any significant changes while the groups that were administered fesoterodine fumarate extended-release tablets experienced a mean reduction of 2.5 episodes per 24 hours for the 4mg dosage and 3 episodes per 24 hours for the 8mg dosage. Figure 4 shows a graph depicting the change in urge incontinence episodes for the three groups.*

Each tablet of Aurobindo's Fesoterodine Fumarate contains 4 mg of the active ingredient. It is an extended-release tablet that should not be chewed or crushed. The recommended dosage is provided in the accompanying prescribing information. The tablets should be stored at room temperature in a moisture-free environment. This medication is distributed by Aurobindo Pharma USA, Inc. and made in India. The accompanying printing zone coding area is not to be printed.*

This is a description of a medication containing fesoterodine fumarate, which comes in an extended-release tablet form. The medication comes in a package of 30 film-coated tablets and is intended for prescription use only. The usual dosage is not specified and must be obtained from prescribing information. It is important to store the medication at a specific temperature range and protect it from moisture. The medication should be swallowed whole and not chewed, divided, or crushed. The medication is distributed by Aurobindo Pharma USA, Inc., located in East Windsor, NJ and is made in India. The rest of the text contains a code and a dotted line that is not intended for printing.*