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.trihexyphenidylMonitor Closely (1)fesoterodine and trihexyphenidyl both decrease cholinergic effects/transmission. Use Caution/Monitor. Potential for additive anticholinergic effects.trimipramineMonitor Closely (1)fesoterodine and trimipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.trospium chlorideMonitor Closely (1)fesoterodine and trospium chloride both decrease cholinergic effects/transmission. Use Caution/Monitor.vecuroniumMonitor Closely (1)fesoterodine and vecuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.venlafaxineMinor (1)venlafaxine will increase the level or effect of fesoterodine by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.verapamilMonitor Closely (1)verapamil will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.voriconazoleMonitor Closely (1)voriconazole will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.zafirlukastMonitor Closely (1)zafirlukast will increase the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.ziprasidoneMonitor Closely (3)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.zotepineMonitor Closely (2)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. >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 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 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 productionPregnancy 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. 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%) 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 BRAND FORM. UNIT PRICE PILL IMAGE fesoterodine oral- 8 mg tabletToviaz oral- 4 mg tabletToviaz oral- 8 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationfesoterodine 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