Fesoterodine Fumarate

FESOTERODINE FUMARATE- fesoterodine fumarate tablet, extended release
Dr.Reddy’s Laboratories Inc.,

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1 INDICATIONS AND USAGE

1.1 Adult Overactive Bladder

Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.

Pediatric use information is approved for Pfizer Inc.’s TOVIAZ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adult Patients with OAB

The recommended starting dosage of fesoterodine fumarate extended-release tablets in adults is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of fesoterodine fumarate extended-release tablets 8 mg once daily. For administration instructions, see Dosage and Administration (2.6).

Pediatric use information is approved for Pfizer Inc.’s TOVIAZ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.3 Recommended Dosage in Adult Patients with Renal Impairment

The recommended dosage of fesoterodine fumarate extended-release tablets in adult patients with renal impairment is described in Table 1 [see Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.6).

Table 1: Fesoterodine Fumarate Extended-Release Tablets Recommended Dose in Adult Patients with Renal Impairment (Administered Orally Once Daily)

Estimated Creatinine Clearance1 Recommended Dose
CLcr 30 to 89 mL/min 8 mg
CLcr 15 to 29 mL/min 4 mg
CLcr˂ 15 mL/min 4 mg

1 Calculate CLcr using the Cockcroft-Gault formula

Pediatric use information is approved for Pfizer Inc.’s TOVIAZ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.5 Fesoterodine fumarate Dosage Modifications Due to Strong CYP3A4 Inhibitors

Adult Patients with OAB

The maximum recommended dosage is fesoterodine fumarate extended-release tablets 4 mg orally once daily in adult patients taking strong CYP3A4 inhibitors [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. For administration instructions, see Dosage and Administration (2.6).

Pediatric use information is approved for Pfizer Inc.’s TOVIAZ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.6 Administration Instructions

Swallow fesoterodine fumarate extended-release tablets whole with liquid. Do not chew, divide, or crush. Take with or without food [see Clinical Pharmacology (12.3) ].

3 DOSAGE FORMS AND STRENGTHS

Fesoterodine fumarate extended-release tablets, 4 mg are light blue colored, oval shaped, biconvex, film-coated, debossed with ‘logo1 ’ on one side and ‘FS’ on the other side.

Fesoterodine fumarate extended-release tablets, 8 mg are blue colored, oval shaped, biconvex, film-coated, debossed with ‘logo1 ’ on one side and ‘FT’ on the other side.

4 CONTRAINDICATIONS

Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following,

  • known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see Clinical Pharmacology (12.1) ].
  • Reactions have included angioedema [see Warnings and Precautions (5.1) ].
  • urinary retention [see Warnings and Precautions (5.2) ]
  • gastric retention [see Warnings and Precautions (5.3) ]
  • uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.4) ]

5 WARNINGS AND PRECAUTIONS

5.1 Angioedema

Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine fumarate extended-release tablets . In some cases, angioedema occurred after the first dose; however, cases have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life-threatening.

Fesoterodine fumarate extended-release tablets contraindicated in patients with a known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients [see Contraindications (4) ]. If involvement of the tongue, hypopharynx, or larynx occurs, fesoterodine fumarate should be promptly discontinued and appropriate therapy and/or measures to ensure a patent airway should be promptly provided.

5.2 Urinary Retention in Adult Patients with Bladder Outlet Obstruction

The use of fesoterodine fumarate extended-release tablets, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction, including patients with urinary retention, may result in further urinary retention and kidney injury. The use of fesoterodine fumarate is not recommended in patients with clinically significant bladder outlet obstruction, and is contraindicated in patients with urinary retention [see Contraindications (4) and Adverse Reactions ( 6.1) ].

5.3 Decreased Gastrointestinal Motility

Fesoterodine fumarate extended-release tablets are associated with decreased gastric motility. Fesoterodine fumarate extended-release tablets are contraindicated in patients with gastric retention [see Contraindications (4) ]. The use of Fesoterodine fumarate extended-release tablets are not recommended in patients with decreased gastrointestinal motility, such as those with severe constipation.

5.4 Worsening of Narrow-Angle Glaucoma

Fesoterodine fumarate extended-release tablets can worsen controlled narrow-angle glaucoma. Fesoterodine fumarate extended-release tablets are contraindicated in patients with uncontrolled narrow-angle glaucoma [see Contraindications (4)]. Fesoterodine fumarate should be used with caution in patients being treated for narrow-angle glaucoma..

5.5 Central Nervous Systems Effects

Fesoterodine fumarate is associated with anticholinergic central nervous system (CNS) adverse reactions [see Adverse Reactions ( 6.1)]. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how fesoterodine fumarate affects them. If a patient experiences anticholinergic CNS effects, fesoterodine fumarate extended-release tablets dose reduction or discontinuation should be considered.

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