fesoterodine (Rx)

Brand and Other Names:Toviaz

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, extended-release

  • 4mg
  • 8mg

Overactive Bladder

Indicated for overactive bladder with urge incontinence, urgency, and frequency

4 mg PO qDay; may increase 8 mg PO qDay based upon individual response and tolerability

Dosage Modifications

Concomitant use with CYP3A4 inhibitors

  • Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin): Not to exceed 4 mg PO qDay
  • Moderate CYP3A4 inhibitors (eg, erythromycin, fluconazole, diltiazem, verapamil, grapefruit juice): No dosage adjustment necessary
  • Weak CYP3A4 inhibitors (eg, cimetidine): Safety and efficacy has not been established

Renal impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min): Not to exceed 4 mg PO qDay

Hepatic impairment

  • Mild-to-moderate (Child Pugh A to B): No dosage adjustment necessary
  • Severe (Child Pugh C): Not recommended

Dosage Forms & Strengths

tablet, extended-release

  • 4mg
  • 8mg

Pediatric Neurogenic Detrusor Overactivity

Indicated for treatment of neurogenic detrusor overactivity (NDO)

<6 years: Not established

≥6 years ≤25 kg: Not established

≥6 years >25-35 kg: 4 mg PO qDay; may increase dose to 8 mg PO qDay if needed

≥6 years >35 kg: 4 mg PO qDay, initially; increase to 8 mg PO qDay after one week

Dosage Modifications

Concomitant use with CYP3A4 inhibitors

  • ≥6 years >25-35 kg
    • Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin): Not recommended
  • ≥6 years >35 kg
    • Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin): Not to exceed 4 mg PO qDay

Renal impairment

  • Estimate GFR using a validated GFR estimating equation for the pediatric age range of the approved indication
  • ≥6 years >25-35 kg
    • eGFR 30-89 mL/min/1.73m2: 4 mg PO qDay
    • eGFR <30 mL/min/1.73m2 or requiring dialysis: Not recommended
  • ≥6 years >35 kg
    • eGFR 30 to 89 mL/min/1.73m2: 4 mg PO qDay, initially; increase to 8 mg PO qDay after one week
    • eGFR 15 to <30 mL/min/1.73m2: 4 mg PO qDay
    • eGFR <15 mL/min/1.73m2 or requiring dialysis: Not recommended

Next:

Interactions

Interaction Checker

and fesoterodine

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • itraconazole

              itraconazole will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration in patients with renal or hepatic impairment may result in increased fesoterodine levels and increased risk for potentially fatal adverse events.

            Serious - Use Alternative (17)

            • carbamazepine

              carbamazepine will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • cimetidine

              cimetidine will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • clarithromycin

              clarithromycin will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin base

              erythromycin base will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • givosiran

              givosiran will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2D6 substrates with givosiran. If unavoidable, decrease the CYP2D6 substrate dosage in accordance with approved product labeling.

            • glycopyrronium tosylate topical

              glycopyrronium tosylate topical, fesoterodine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.

            • ketoconazole

              ketoconazole will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • levoketoconazole

              levoketoconazole will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • pramlintide

              pramlintide, fesoterodine. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Synergistic inhibition of GI motility.

            • revefenacin

              revefenacin and fesoterodine both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.

            • rifabutin

              rifabutin will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifampin

              rifampin will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • secretin

              fesoterodine decreases effects of secretin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Concomitant use of anticholinergic drugs may cause a hyporesponse to stimulation testing with secretin. Discontinue anticholinergic drugs at least 5 half-lives before administering secretin.

            • St John's Wort

              St John's Wort will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            Monitor Closely (160)

            • abobotulinumtoxinA

              abobotulinumtoxinA increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .

            • aclidinium

              fesoterodine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • amantadine

              fesoterodine, amantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Potential for increased anticholinergic adverse effects.

            • amitriptyline

              fesoterodine and amitriptyline both decrease cholinergic effects/transmission. Modify Therapy/Monitor Closely.

            • amobarbital

              amobarbital will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • amoxapine

              fesoterodine and amoxapine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • anticholinergic/sedative combos

              anticholinergic/sedative combos and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • aprepitant

              aprepitant will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • aripiprazole

              fesoterodine decreases levels of aripiprazole by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of aripiprazole by pharmacodynamic antagonism. Use Caution/Monitor.

              aripiprazole increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • armodafinil

              armodafinil will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • artemether/lumefantrine

              artemether/lumefantrine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              artemether/lumefantrine will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • atazanavir

              atazanavir will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • atracurium

              atracurium and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • atropine

              atropine and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • atropine IV/IM

              atropine IV/IM and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • belladonna alkaloids

              belladonna alkaloids and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • belladonna and opium

              fesoterodine and belladonna and opium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • benperidol

              fesoterodine decreases levels of benperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of benperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              benperidol increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • benztropine

              benztropine and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor. Additive anticholinergic adverse effects may be seen with concurrent use.

            • bethanechol

              bethanechol increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • bosentan

              bosentan will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • budesonide

              budesonide will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • bupropion

              bupropion will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • butabarbital

              butabarbital will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • butalbital

              butalbital will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • carbachol

              carbachol increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • cevimeline

              cevimeline increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • chlorpromazine

              fesoterodine decreases levels of chlorpromazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of chlorpromazine by pharmacodynamic antagonism. Use Caution/Monitor.

              chlorpromazine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • cisatracurium

              cisatracurium and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • clomipramine

              fesoterodine and clomipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • clozapine

              fesoterodine decreases levels of clozapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of clozapine by pharmacodynamic antagonism. Use Caution/Monitor.

              clozapine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • conivaptan

              conivaptan will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • cortisone

              cortisone will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • crizotinib

              crizotinib increases levels of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

            • cyclizine

              cyclizine and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • cyclobenzaprine

              cyclobenzaprine and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • cyclosporine

              cyclosporine will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • darifenacin

              darifenacin will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              darifenacin and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • darunavir

              darunavir will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dasatinib

              dasatinib will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • deferasirox

              deferasirox will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • desvenlafaxine

              desvenlafaxine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Desvenlafaxine inhibits CYP2D6; with higher desvenlafaxine doses (ie, 400 mg) decrease the CYP2D6 substrate dose by up to 50%; no dosage adjustment needed with desvenlafaxine doses <100 mg

            • dexamethasone

              dexamethasone will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • DHEA, herbal

              DHEA, herbal will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dicyclomine

              dicyclomine and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • diltiazem

              diltiazem will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • diphenhydramine

              diphenhydramine and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • donepezil

              donepezil increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • donepezil transdermal

              donepezil transdermal, fesoterodine. Either decreases effects of the other by pharmacodynamic antagonism. Use Caution/Monitor.

            • dosulepin

              fesoterodine and dosulepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • doxepin

              fesoterodine and doxepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • dronedarone

              dronedarone will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • droperidol

              fesoterodine decreases levels of droperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of droperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              droperidol increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • duloxetine

              duloxetine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • echothiophate iodide

              echothiophate iodide increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • efavirenz

              efavirenz will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • etravirine

              etravirine will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • flavoxate

              fesoterodine and flavoxate both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • fluconazole

              fluconazole will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fludrocortisone

              fludrocortisone will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fluoxetine

              fluoxetine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • fluphenazine

              fesoterodine decreases levels of fluphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of fluphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

              fluphenazine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • fluvoxamine

              fluvoxamine will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fosamprenavir

              fosamprenavir will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fosaprepitant

              fosaprepitant will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • galantamine

              galantamine increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • glycopyrrolate

              fesoterodine and glycopyrrolate both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • glycopyrrolate inhaled

              fesoterodine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • grapefruit

              grapefruit will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • griseofulvin

              griseofulvin will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • haloperidol

              fesoterodine decreases levels of haloperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of haloperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              haloperidol increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • henbane

              fesoterodine and henbane both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • homatropine

              fesoterodine and homatropine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • huperzine A

              huperzine A increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • hydrocortisone

              hydrocortisone will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • hyoscyamine

              fesoterodine and hyoscyamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • hyoscyamine spray

              fesoterodine and hyoscyamine spray both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • iloperidone

              fesoterodine decreases levels of iloperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of iloperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              iloperidone increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • imipramine

              fesoterodine and imipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • indinavir

              indinavir will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ipratropium

              fesoterodine and ipratropium both decrease cholinergic effects/transmission. Use Caution/Monitor. Due to the poor systemic absorption of ipratropium, interaction unlikely at regularly recommended dosages.

            • isoniazid

              isoniazid will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lapatinib

              lapatinib will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lofepramine

              fesoterodine and lofepramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • loxapine

              fesoterodine decreases levels of loxapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of loxapine by pharmacodynamic antagonism. Use Caution/Monitor.

              loxapine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • loxapine inhaled

              loxapine inhaled increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              fesoterodine decreases levels of loxapine inhaled by pharmacodynamic antagonism. Use Caution/Monitor.

            • lumefantrine

              lumefantrine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              lumefantrine will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • maprotiline

              fesoterodine and maprotiline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • marijuana

              marijuana will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • meclizine

              fesoterodine and meclizine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • methscopolamine

              fesoterodine and methscopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • methylprednisolone

              methylprednisolone will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • metronidazole

              metronidazole will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • miconazole vaginal

              miconazole vaginal will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nafcillin

              nafcillin will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nefazodone

              nefazodone will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • nelfinavir

              nelfinavir will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • neostigmine

              neostigmine increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • nevirapine

              nevirapine will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nifedipine

              nifedipine will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nilotinib

              nilotinib will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nortriptyline

              fesoterodine and nortriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • olanzapine

              fesoterodine decreases levels of olanzapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of olanzapine by pharmacodynamic antagonism. Use Caution/Monitor.

              olanzapine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • oliceridine

              fesoterodine increases toxicity of oliceridine by Other (see comment). Use Caution/Monitor. Comment: Anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor for signs of urinary retention or reduced gastric motility if oliceridine is coadministered with anticholinergics.

            • onabotulinumtoxinA

              onabotulinumtoxinA and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • orphenadrine

              fesoterodine and orphenadrine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • oxybutynin

              fesoterodine and oxybutynin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin topical

              fesoterodine and oxybutynin topical both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin transdermal

              fesoterodine and oxybutynin transdermal both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • paliperidone

              fesoterodine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • pancuronium

              fesoterodine and pancuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • pentobarbital

              pentobarbital will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • perphenazine

              fesoterodine decreases levels of perphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of perphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

              perphenazine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • phenobarbital

              phenobarbital will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • phenytoin

              phenytoin will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • physostigmine

              physostigmine increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pilocarpine

              pilocarpine increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pimozide

              fesoterodine decreases levels of pimozide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of pimozide by pharmacodynamic antagonism. Use Caution/Monitor.

              pimozide increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • posaconazole

              posaconazole will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • prabotulinumtoxinA

              fesoterodine, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.

            • pralidoxime

              fesoterodine and pralidoxime both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • prednisone

              prednisone will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • primidone

              primidone will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • prochlorperazine

              fesoterodine decreases levels of prochlorperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of prochlorperazine by pharmacodynamic antagonism. Use Caution/Monitor.

              prochlorperazine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • promethazine

              fesoterodine decreases levels of promethazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of promethazine by pharmacodynamic antagonism. Use Caution/Monitor.

              promethazine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • propantheline

              fesoterodine and propantheline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • protriptyline

              fesoterodine and protriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • pyridostigmine

              pyridostigmine increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • quetiapine

              fesoterodine decreases levels of quetiapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of quetiapine by pharmacodynamic antagonism. Use Caution/Monitor.

              quetiapine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • quinidine

              quinidine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • quinupristin/dalfopristin

              quinupristin/dalfopristin will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rapacuronium

              fesoterodine and rapacuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • rifapentine

              rifapentine will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • risperidone

              fesoterodine decreases levels of risperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of risperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              risperidone increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • ritonavir

              ritonavir will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rivastigmine

              fesoterodine decreases effects of rivastigmine by cholinergic effects/transmission. Use Caution/Monitor.

            • rocuronium

              fesoterodine and rocuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • rufinamide

              rufinamide will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • scopolamine

              fesoterodine and scopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • secobarbital

              secobarbital will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • solifenacin

              fesoterodine and solifenacin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • succinylcholine

              succinylcholine increases and fesoterodine decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • terbinafine

              terbinafine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Assess need to reduce dose of CYP2D6-metabolized drug.

            • thioridazine

              fesoterodine decreases levels of thioridazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of thioridazine by pharmacodynamic antagonism. Use Caution/Monitor.

              thioridazine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • thiothixene

              fesoterodine decreases levels of thiothixene by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of thiothixene by pharmacodynamic antagonism. Use Caution/Monitor.

              thiothixene increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • tiotropium

              fesoterodine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • tolterodine

              fesoterodine and tolterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • topiramate

              topiramate will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • trifluoperazine

              fesoterodine decreases levels of trifluoperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of trifluoperazine by pharmacodynamic antagonism. Use Caution/Monitor.

              trifluoperazine increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • trihexyphenidyl

              fesoterodine and trihexyphenidyl both decrease cholinergic effects/transmission. Use Caution/Monitor. Potential for additive anticholinergic effects.

            • trimipramine

              fesoterodine and trimipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • trospium chloride

              fesoterodine and trospium chloride both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • vecuronium

              fesoterodine and vecuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • verapamil

              verapamil will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • voriconazole

              voriconazole will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • zafirlukast

              zafirlukast will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ziprasidone

              fesoterodine decreases levels of ziprasidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of ziprasidone by pharmacodynamic antagonism. Use Caution/Monitor.

              ziprasidone increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • zotepine

              fesoterodine decreases levels of zotepine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of zotepine by pharmacodynamic antagonism. Use Caution/Monitor.

            Minor (31)

            • amiodarone

              amiodarone will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • asenapine

              asenapine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • celecoxib

              celecoxib will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • chloroquine

              chloroquine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • cimetidine

              cimetidine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • darifenacin

              darifenacin will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • desipramine

              fesoterodine and desipramine both decrease cholinergic effects/transmission. Minor/Significance Unknown.

            • dimenhydrinate

              dimenhydrinate increases toxicity of fesoterodine by pharmacodynamic synergism. Minor/Significance Unknown. Additive anticholinergic effects.

            • diphenhydramine

              diphenhydramine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • donepezil

              donepezil decreases effects of fesoterodine by pharmacodynamic antagonism. Minor/Significance Unknown.

            • dronedarone

              dronedarone will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • galantamine

              galantamine decreases effects of fesoterodine by pharmacodynamic antagonism. Minor/Significance Unknown.

            • haloperidol

              haloperidol will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • imatinib

              imatinib will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • levodopa

              fesoterodine, levodopa. Other (see comment). Minor/Significance Unknown. Comment: Anticholinergic agents may enhance the therapeutic effects of levodopa; however, anticholinergic agents can exacerbate tardive dyskinesia. In high dosage, anticholinergics may decrease the effects of levodopa by delaying its GI absorption. .

            • maraviroc

              maraviroc will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • marijuana

              marijuana will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • nilotinib

              nilotinib will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • parecoxib

              parecoxib will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • paroxetine

              paroxetine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • perphenazine

              perphenazine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • propafenone

              propafenone will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • quinacrine

              quinacrine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • ranolazine

              ranolazine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • ritonavir

              ritonavir will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • sertraline

              sertraline will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • thioridazine

              thioridazine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • tipranavir

              tipranavir will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • trazodone

              fesoterodine and trazodone both decrease cholinergic effects/transmission. Minor/Significance Unknown.

            • venlafaxine

              venlafaxine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Adult overactive bladder

            • Dry mouth (18.8-34.6%)

            Pediatric neurogenic detrusor overactivity

            • Diarrhea (7.1-11.9%)

            1-10%

            Adult overactive bladder

            • Constipation (4.2-6%)
            • Dyspepsia (1.6-2.3%)
            • Urinary tract infection (3.2-4.2%)
            • Xerophthalmia (1.4-3.7%)
            • Upper respiratory tract infection (1.8-2.5%)
            • Dysuria (1.3-1.6%)
            • Urinary retention (1.1-1.4%)
            • Dry throat (0.9-2.3%)
            • Insomnia (0.4-1.3%)
            • Back pain (0.9-2%)
            • Nausea (0.7-1.9%)
            • ncreased ALT (0.5-1.2%)
            • Increased GGT (0.4-1.2%)
            • Peripheral edema (0.7-1.2%)
            • Upper abdominal pain (0.5-1.1%)
            • Rash (0.7-1.1%)

            Pediatric neurogenic detrusor overactivity

            • Urinary tract infection (2.4-9.5%)
            • Dry mouth (7.1-9.5%)
            • Constipation (7.1-7.1%)
            • Abdominal pain (4.8-2.4%)
            • Weight increased (0-4.8%)
            • Headache (4.8-7.1%)
            • Ophthalmological reactions (6.1%)
            • Increased heart rate compared to baseline (8.1-12.2%, week 4; 7.6-11.4%, week 12; 3.3-2.7% week 24)

            Postmarketing Reports

            General disorders and administrative site conditions: Hypersensitivity reactions, including angioedema with airway obstruction, face edema

            Central nervous system disorders: Dizziness, headache, somnolence

            Skin and subcutaneous tissue disorders: Urticaria, pruritus

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            Warnings

            Contraindications

            Hypersensitivity to drug or ingredients

            Urinary or gastric retention

            Uncontrolled narrow-angle glaucoma

            Cautions

            Use caution in reduced hepatic/renal function, and autonomic neuropathy

            Therapy can worsen controlled narrow-angle glaucoma; contraindicated in patients with uncontrolled narrow-angle glaucoma; should be used with caution in patients being treated for narrow-angle glaucoma; use only when potential benefits outweigh risks

            Anticholinergic CNS effects (eg, headache, dizziness, somnolence) reported; monitor for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing dose; advise patients not to drive or operate heavy machinery until they adjust to therapy; consider dose reduction or drug discontinuation if a patient experiences anticholinergic CNS effects

            Caution with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction, bladder flow obstruction; therapy may worsen symptoms

            Heat prostration may occur in the presence of increased environmental temperature

            Angioedema

            • Angioedema of face, lips, tongue, and/or larynx reported
            • In some cases, angioedema reported to occur after first dose; however, may also occur after multiple doses
            • Angioedema associated with upper airway swelling may be life-threatening
            • If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue drug and promptly provide appropriate therapy and/or measures to ensure patent airway

            Urinary retention in adults with bladder outlet obstruction

            • Use in patients with clinically significant bladder outlet obstruction, including patients with urinary retention, may result in further urinary retention and kidney injury
            • Use is not recommended in patients with clinically significant bladder outlet obstruction, and is contraindicated in patients with urinary retention

            Gastric motility

            • Therapy is associated with decreased gastric motility
            • Use is not recommended in patients with decreased gastrointestinal motility, such as those with severe constipation

            Drug interactions overview

            • Anticholinergic agents may potentially alter absorption of fesoterodine owing to decreased GI motility
            • Coadministration of potent CYP3A4 inhibitors ketoconazole with fesoterodine led to approximately a doubling of peak plasma concentration and area under the concentration versus time curve of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of fesoterodine (see Dosage Modifications)
            • Coadministration of moderate CYP3A4 inhibitors had no clinically relevant effect on the pharmacokinetics of fesoterodine
            • Coadministration of rifampin 600 mg/day, a CYP3A4 inducer, Cmax and AUC of active metabolite of fesoterodine decreased by ~70% and 75% after fesoterodine 8 mg dose
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            Pregnancy & Lactation

            Pregnancy

            There are no data with fesoterodine use in pregnant women to inform a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes

            In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively, the maximum recommended human dose (MRHD) of 8 mg/day based on AUC

            Lactation

            There is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Competitive muscarinic receptor antagonist; inhibition of receptors in the bladder prevent symptoms of urgency and frequency

            Absorption

            Bioavailability: 52%

            Protein Bound: 50%

            Vd: 169 L (5-HMT active metabolite)

            Metabolism

            Rapidly hydrolyzed to active metabolite, and THEN by liver CYP3A4 and CYP2D6 to inactive metabolites

            Elimination

            Half-Life: 7 hr

            Excretion: Urine (70%); feces (7%)

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            Administration

            Oral administration

            Take with liquid and swallowed whole

            Administer with or without food Should not be chewed, divided, or crushed

            Missed dose: Resume taking fesoterodine the next day; do not take 2 doses of fesoterodine in the same day

            Storage

            Extended-release tablets: Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

            Protect from moisture

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Toviaz oral
            -
            4 mg tablet
            Toviaz oral
            -
            8 mg tablet
            fesoterodine oral
            -
            4 mg tablet
            fesoterodine oral
            -
            8 mg tablet
            fesoterodine oral
            -
            8 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            fesoterodine oral

            FESOTERODINE EXTENDED-RELEASE - ORAL

            (FES-oh-TER-oh-deen)

            COMMON BRAND NAME(S): Toviaz

            USES: This medication is used to treat certain bladder problems (overactive bladder, neurogenic detrusor overactivity). Overactive bladder is a problem with how your bladder stores urine. Neurogenic detrusor overactivity is a bladder control condition caused by brain, spinal cord, or nerve problems. Symptoms of these conditions may include frequent urination, strong sudden urges to urinate that are hard to control, or involuntary loss of urine (incontinence). By relaxing the muscles in the bladder, fesoterodine improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using fesoterodine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once a day. Take each dose with a full glass of liquid. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.The dosage is based on your medical condition, other medications you are taking, and response to treatment. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). For children, the dosage may also be based on their weight.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased.Tell your doctor if your condition does not improve or if it worsens.

            SIDE EFFECTS: Dry mouth, dry eyes, constipation, dizziness, drowsiness, or blurred vision may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: constipation lasting 3 or more days, severe stomach/abdominal pain, trouble urinating, signs of kidney infection (such as burning/painful urination, lower back pain, fever).Get medical help right away if you have any very serious side effects, including: fast heartbeat, fainting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking fesoterodine, tell your doctor or pharmacist if you are allergic to it; or to tolterodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems emptying your bladder (urinary retention, bladder outflow obstruction), stomach/intestinal problems (such as blockage, constipation, ulcerative colitis, slowed movement of stomach/intestines), a certain eye condition (narrow-angle glaucoma), kidney disease, liver disease, a certain muscle disease (myasthenia gravis).This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication can cause decreased sweating. Avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities since heatstroke may occur.Older adults may be more sensitive to the side effects of this drug, especially dizziness, dry mouth, and constipation.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: pramlintide, potassium tablets/capsules.Other medications can affect the removal of fesoterodine from your body, which may affect how fesoterodine works. Examples include certain azole antifungals (such as itraconazole, ketoconazole), mifepristone, among others.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that can cause drowsiness, constipation or blurred vision. Ask your pharmacist about the safe use of those products.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe drowsiness or unconsciousness, unusual excitement, mental/mood changes.

            NOTES: Do not share this medication with others.

            MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised August 2023. Copyright(c) 2023 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.