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      Drugs & Diseases

      fesoterodine (Rx)

      Brand and Other Names:Toviaz
      • Print

      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

      No Results

         activity indicator 
        No Interactions Found
        Interactions Found

        Contraindicated

          Serious - Use Alternative

            Significant - Monitor Closely

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                 activity indicator 

                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
                fesoterodine oral
                -
                		8 mg tablet
                Toviaz oral
                -
                		4 mg tablet
                Toviaz 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 provided by your pharmacist before you start using fesoterodine and each time you get a refill. If you have any questions regarding the information, consult 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.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.Inform 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), severe blockage of stomach/intestines (gastric obstruction/retention), stomach/intestinal disease (such as ulcerative colitis, slowed movement of stomach/intestines), a certain eye condition (narrow-angle glaucoma), severe constipation, 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).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 drugs that can cause dry mouth and constipation (including anticholinergic medications such as atropine/scopolamine, antihistamines such as diphenhydramine, other antispasmodics including dicyclomine, belladonna alkaloids).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 July 2022. 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.

                View explanations for tiers and restrictions
                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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                Code Definition
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