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brand toviaz er 8 mg tablet

In stock Manufacturer PFIZER US PHARM 00069024430
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Uses

Overactive Bladder

Fesoterodine fumarate is used in the management of overactive bladder for the relief of symptoms associated with voiding such as urge urinary incontinence, urgency, and frequency.

Safety and efficacy of fesoterodine for this indication were established in two 12-week, phase 3, randomized, double-blind, placebo-controlled studies in more than 1900 patients with symptoms of urinary incontinence, urgency, and urinary frequency that had persisted for at least 6 months. In both studies, patients received fesoterodine fumarate 4 or 8 mg once daily or placebo; in one of these studies, 290 patients were randomized to an active control arm (an oral antimuscarinic agent). In these studies, fesoterodine fumarate 4 or 8 mg daily was more effective than placebo in reducing the number of micturitions and urge incontinence episodes per 24 hours and increasing the volume of urine voided per micturition. Urinary frequency was decreased from baseline by 1.74-1.94 or 1.02 micturitions per 24 hours, urge incontinence episodes were decreased from baseline by 1.77-2.42 or 1-1.2 occurrences per 24 hours, and urine volume voided per micturition was increased by 17-33 or 8-10 mL per micturition in patients receiving fesoterodine or placebo, respectively. A reduction in the number of urge incontinence episodes per 24 hours was observed for both dosages as compared with placebo as early as 2 weeks after starting fesoterodine therapy. In a pooled analysis of data from these 2 studies, the 8-mg daily dosage was more effective than the 4-mg daily dosage in improving urge incontinence episodes, treatment response, volume of urine voided, and number of continent days per week.

In addition to objective improvements, a beneficial effect on health-related quality-of-life scores has been demonstrated with fesoterodine compared with placebo. In an analysis of pooled data from two 12-week studies in patients with overactive bladder, treatment with fesoterodine fumarate 4 or 8 mg daily was associated with improvements in many aspects of health-related quality of life (e.g., incontinence impact, role limitations, physical limitations, sleep/energy, severity/coping, emotions, social limitations, personal relationships [ 8-mg dosage only]).

Dosage and Administration

Administration

Fesoterodine fumarate is administered orally once daily without regard to meals. Fesoterodine fumarate extended-release tablets should be administered with liquids and swallowed whole; the tablets should not be chewed, crushed, or divided.

Dosage

For the management of overactive bladder, the recommended initial dosage of fesoterodine fumarate in adults is 4 mg once daily. Depending on individual response and tolerability, dosage may be increased to 8 mg once daily.

Special Populations

In patients with severe renal impairment (creatinine clearance less than 30 mL/minute), dosage of fesoterodine fumarate should not exceed 4 mg daily. The manufacturer does not recommend any dosage adjustments for patients with mild or moderate renal impairment; however, some clinicians recommend caution when increasing the dosage from 4 mg to 8 mg daily in such patients.(See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Use of fesoterodine is not recommended in patients with severe hepatic impairment (Child-Pugh class C).(See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.) The manufacturer does not recommend any dosage adjustments for patients with mild or moderate hepatic impairment. However, some clinicians recommend caution when increasing the dosage from 4 mg to 8 mg daily in patients with mild hepatic impairment (Child-Pugh class A) and a maximum dosage of 4 mg daily in patients with moderate hepatic impairment (Child-Pugh class B).

Dosages exceeding 4 mg daily are not recommended in patients receiving fesoterodine fumarate concomitantly with clarithromycin, itraconazole, ketoconazole, or other potent inhibitors of cytochrome P-450 (CYP) isoenzyme 3A4.(See Drug Interactions: Drugs Affecting Hepatic Microsomal Enzymes.)

Dosage adjustment is not necessary in geriatric patients.(See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Cautions

Contraindications

Urinary retention, gastric retention, or uncontrolled angle-closure glaucoma.

Known hypersensitivity to fesoterodine fumarate or any ingredient in the formulation.

Warnings/Precautions

General Precautions

Urinary Retention

Because of the risk of urinary retention, fesoterodine should be used with caution in patients with clinically important bladder outflow obstruction.

Decreased GI Motility

Fesoterodine should be used with caution in patients with decreased GI motility (e.g., patients with severe constipation).

Controlled Angle-closure Glaucoma

Fesoterodine should be used with caution in patients being treated for angle-closure glaucoma and only when the potential benefits outweigh the risks of such therapy.(See Cautions: Contraindications.)

Myasthenia Gravis

Fesoterodine should be used with caution in patients with myasthenia gravis.

Specific Populations

Pregnancy

Category C.

Lactation

It is not known whether fesoterodine is distributed into milk in humans. The manufacturer states that the drug should not be used during breast-feeding unless the benefit to the woman outweighs the potential risk to the infant.

Pediatric Use

Safety and efficacy of fesoterodine have not been established in pediatric patients.

Geriatric Use

In the phase 2 and 3, placebo-controlled, efficacy and safety studies of fesoterodine, approximately 33% of patients were 65 years of age or older and 9% were 75 years of age or older. In patients with overactive bladder, no difference was found in safety or efficacy in those patients 65 years of age or older relative to younger adults; however, the incidence of adverse antimuscarinic events, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (only at a dosage of 8 mg daily) and urinary tract infection, was higher in patients 75 years of age or older compared with younger patients. The pharmacokinetics of fesoterodine are not substantially influenced by age.(See Dosage and Administration: Special Populations.)

Hepatic Impairment

In patients with moderate (Child-Pugh class B) hepatic impairment, the peak plasma concentration and area under the plasma concentration-time curve (AUC) of the active metabolite were increased 1.4 and 2.1-fold, respectively, as compared with those in healthy subjects. Subjects with severe hepatic impairment (Child-Pugh class C) have not been studied; therefore use of fesoterodine is not recommended in these patients.(See Dosage and Administration: Special Populations.)

Renal Impairment

In patients with mild or moderate renal insufficiency (creatinine clearance 30-80 mL/minute), peak plasma concentrations and AUC of the active metabolite were increased up to 1.5 and 1.8-fold, respectively, as compared with those in healthy subjects. In patients with severe renal impairment (creatinine clearance less than 30 mL/minute), peak plasma concentrations and AUC of the active metabolite were increased twofold and 2.3-fold, respectively.(See Dosage and Administration: Special Populations.)

Common Adverse Effects

The most common adverse effects in patients with overactive bladder receiving fesoterodine include dry mouth and constipation, which occurred in about 19 and 4%, respectively, of patients receiving the 4-mg daily dosage and in 35 and 6%, respectively, of patients receiving the 8-mg daily dosage.

Drug Interactions

Drugs Affecting Hepatic Microsomal Enzymes

Fesoterodine is rapidly and extensively metabolized to its active metabolite, 5-hydroxymethyl tolterodine (5-HMT), by nonspecific esterases; the active metabolite is further metabolized to various metabolites in the liver, principally via cytochrome P-450 (CYP) isoenzymes 2D6 and 3A4.

Inhibitors of CYP3A4

Increases in peak plasma concentrations and area under the concentration-time curve (AUC) of the active metabolite were observed when fesoterodine was administered following administration of a potent CYP3A4 inhibitor (ketoconazole 200 mg twice daily for 5 days) in both CYP2D6 extensive metabolizers and CYP2D6 poor metabolizers. Therefore, the manufacturer states that fesoterodine fumarate dosages exceeding 4 mg daily are not recommended in patients concomitantly receiving potent CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole).

The effects of weak or moderate CYP3A4 inhibitors (e.g., erythromycin) on the pharmacokinetics of the active metabolite of fesoterodine have not been studied. However, the manufacturer recommends a careful assessment of tolerability at the 4-mg daily dosage of fesoterodine fumarate prior to increasing the dosage to 8 mg daily in patients receiving weak or moderate CYP3A4 inhibitors, since some pharmacokinetic interaction is expected, albeit less than that observed with potent CYP3A4 inhibitors.

Inducers of CYP3A4

Decreases in peak plasma concentrations and AUC (approximately 70 and 75%, respectively) of the active metabolite of fesoterodine were observed when the drug was administered following rifampin, a CYP3A4 inducer. However, the manufacturer of fesoterodine states that no dosage adjustments are recommended when fesoterodine is administered concomitantly with CYP3A4 inducers.

Inhibitors of CYP2D6

The manufacturer states that the effects of CYP2D6 inhibitors on the pharmacokinetics of the active metabolite of fesoterodine were not tested clinically. In subjects with the poor metabolizer phenotype for CYP2D6, peak plasma concentrations and AUC of the active metabolite of fesoterodine are increased 1.7-fold and twofold, respectively. The manufacturer does not recommend dosage adjustments in the presence of CYP2D6 inhibitors.

Drugs Metabolized by Hepatic Microsomal Enzymes

In vitro studies indicate that 5-HMT, the active metabolite of fesoterodine, does not inhibit CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4 isoenzymes and does not induce CYP 1A2, 2B6, 2C9, 2C19, or 3A4 isoenzymes. Pharmacokinetic interactions are unlikely with substrates of these isoenzymes.

Antimuscarinic Agents

Concomitant use of fesoterodine with other antimuscarinic agents that produce dry mouth, constipation, urinary retention, and other anticholinergic effects may increase the frequency and/or severity of such effects.

Oral Contraceptives

Pharmacokinetic interaction unlikely (no substantial changes observed in plasma concentrations of ethinyl estradiol or levonorgestrel in the presence of fesoterodine).

Orally Administered Drugs

Antimuscarinic drugs such as fesoterodine have the potential to alter GI absorption of some concomitantly administered drugs because of anticholinergic effects on GI motility.

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