Fesoterodine

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. ( 1.1 ) 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. …

• In Adults : The recommended starting dosage is 4 mg orally once daily
• Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily
• Adult Patients with Renal Impairment : Refer to the full prescribing information for recommended dosage
• Dosage Modifications Due to Strong CYP3A4 Inhibitors : Refer to the full prescribing information for recommended dosage
• Administration : Swallow whole with liquid
• Do not chew, divide, or crush
• Take with or without food
• 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
• 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
• 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 ]

Extended-release tablets: 4 mg, light blue colored, oval shaped, and film-coated; debossed with “A 69” on one side and plain on the other side. 8 mg, blue colored, oval shaped, and film-coated; debossed with “A 70” on one side and plain on the other side. Extended-release tablets: 4 mg and 8 mg (3)

• Advise the patient to read the FDA-Approved Patient Labeling ( Patient Information )
• Angioedema Inform patients and/or their caregivers that fesoterodine may cause angioedema, which could result in life-threatening airway obstruction
• Advise patients and/or their caregivers to promptly discontinue fesoterodine therapy and seek immediate medical attention if they experience edema of the lips, tongue or laryngopharynx, or difficulty breathing
• Antimuscarinic Effects Inform patients that fesoterodine fumarate, like other antimuscarinic agents, may produce clinically significant adverse effects related to antimuscarinic pharmacological activity including constipation and urinary retention. …

• 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 ]
• Reactions have included angioedema [see Warnings and Precautions ] . …

7.1 Antimuscarinic Drugs Co-administration of fesoterodine fumarate with other antimuscarinic agents that produce dry mouth, constipation, urinary retention, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. 7.2 CYP3A4 Inhibitors Doses of fesoterodine fumarate greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin [see Dosage and Administration (2.5) ] . …

Angioedema : Promptly discontinue fesoterodine fumarate and provide appropriate therapy. ( 5.1 ) Urinary Retention: Fesoterodine fumarate is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. (5.2) Decreased Gastrointestinal Motility: Fesoterodine fumarate is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. (5.3) Worsening of Narrow-Angle Glaucoma: Use fesoterodine fumarate with caution in patients being treated for narrow-angle glaucoma. (5.4) Central Nervous System Effects : Somnolence has been reported with fesoterodine fumarate. …

The following clinically significant adverse reactions are described elsewhere in labeling: Angioedema [see Warnings and Precautions (5.1) ] Urinary Retention [see Warnings and Precautions (5.2) ] Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3) ] Most frequently reported adverse events with fesoterodine fumarate in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; fesoterodine fumarate 4 mg, 19%; fesoterodine fumarate 8 mg, 35%) and constipation (placebo, 2%; fesoterodine fumarate 4 mg, 4%; fesoterodine fumarate 8 mg, 6%). …

IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data with the use of fesoterodine fumarate in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. …

Overdosage with fesoterodine fumarate can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended.

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.