Drugplain

Toviaz 4 mg/1

fesoterodine fumarate · TABLET, FILM COATED, EXTENDED RELEASE · Pfizer Laboratories Div Pfizer Inc

No Recall History
Plain English

Toviaz is a tablet, film coated, extended release containing fesoterodine fumarate at 4 mg/1, taken oral. Manufactured by Pfizer Laboratories Div Pfizer Inc.

Key Facts

Brand Name
Toviaz
Generic Name
fesoterodine fumarate
NDC Code (Product)
0069-0242
Manufacturer
Pfizer Laboratories Div Pfizer Inc
Strength
4 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA022030
Marketing Start
10/31/2008

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,668 reports
dry mouth823 reports
fall530 reports
off label use511 reports
fatigue510 reports
constipation504 reports
urinary retention502 reports
pain446 reports
headache421 reports
dizziness394 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Toviaz is indicated for the treatment of: • Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2 ) 1.1 Adult Overactive Bladder Toviaz is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity Toviaz is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • OAB in Adults : The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily. ( 2.1 ) • NDO in Pediatric Patients 6 Years and Older : • Pediatric Patients Weighing Greater than 25 kg and up to 35 kg: The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily. ( 2.2 ) • Pediatric Patients Weighing Greater than 35 kg: The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily. ( 2.2 ) • Adult or Pediatric Patients with Renal Impairment : Refer to the full prescribing information for recommended dosage. ( 2.3 , 2.4 ) • Dosage Modifications Due to Strong CYP3A4 Inhibitors : Refer to the full prescribing information for recommended dosage. ( 2.5 ) • Administration : Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food. ( 2.6 ) 2.1 Recommended Dosage for Adult Patients With OAB The recommended starting dosage of Toviaz in adults is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosa…

Contraindications

4 CONTRAINDICATIONS Toviaz is contraindicated in patients with any of the following: • known or suspected hypersensitivity to Toviaz or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see Clinical Pharmacology (12.1) ] . Reactions have included angioedema [see Warnings and Precautions (5.1) ] • urinary retention [see Warnings and Precautions (5.2) ] • gastric retention [see Warnings and Precautions (5.3) ] • uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.4) ] • Known or suspected hypersensitivity to Toviaz or any of its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. ( 4 ) • Urinary retention ( 4 ) • Gastric retention ( 4 ) • Uncontrolled narrow-angle glaucoma. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 Antimuscarinic Drugs Coadministration of Toviaz with other antimuscarinic agents that produce dry mouth, constipation, urinary retention, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. 7.2 CYP3A4 Inhibitors Doses of Toviaz greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin [see Dosage and Administration (2.5) ]. The Toviaz dose in pediatric patients taking strong CYP3A4 inhibitors is recommended to be reduced to 4 mg once daily in patients >35 kg and is not recommended in patients weighing greater than 25 kg and up to 35 kg [see Dosage and Administration (2.5) ]. In a study in adults, coadministration of the strong CYP3A4 inhibitor ketoconazole with fesoterodine led to approximately a doubling of the maximum concentration (C max ) and area under the concentration versus time curve (AUC) of 5-hydroxymethyl tolterodine (5-HMT), the active metabolit…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Angioedema [see Warnings and Precautions (5.1) ] • Urinary Retention [see Warnings and Precautions (5.2) ] • Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3) ] • Most frequently reported adverse events with Toviaz in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; Toviaz 4 mg, 19%; Toviaz 8 mg, 35%) and constipation (placebo, 2%; Toviaz 4 mg, 4%; Toviaz 8 mg, 6%). ( 6.1 ) • Most frequently reported adverse reactions with Toviaz in pediatric patients (≥2%) with NDO were: diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, weight increased, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Overactive Bladde…

Frequently Asked Questions

What is Toviaz used for?

Toviaz contains fesoterodine fumarate. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Toviaz a controlled substance?

Toviaz is not classified as a controlled substance by the DEA.

What is the generic name for Toviaz?

The generic name for Toviaz is fesoterodine fumarate. There are 10 other brand versions of fesoterodine fumarate.

What is the NDC code for Toviaz 4 mg/1?

The NDC (National Drug Code) for Toviaz 4 mg/1 is 0069-0242, listed by Pfizer Laboratories Div Pfizer Inc.

Product NDC

0069-0242

Package NDC

0069-0242-30

Other Toviaz Dosages

Other Fesoterodine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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