Fesoterodine fumarate

What is Fesoterodine fumarate?

• Fesoterodine fumarate (Toviaz) a competitive muscarinic receptor antagonist with muscle relaxant and urinary antispasmodic properties used to treat overactive bladder syndrome (OAB), Neurogenic detrusor overactivity (NDO).

Fesoterodine

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What are the uses of this medicine?

Fesoterodine fumarate (Toviaz) is a prescription medicine used:

• in adults to treat symptoms of a condition called overactive bladder (OAB), including urge urinary incontinence (leaking or wetting accidents due to a strong need to urinate), urinary urgency (having a strong need to urinate right away), or urinary frequency (having to urinate too often).
• in children 6 years of age and older with a body weight greater than 55 pounds (25 kg) to treat neurogenic detrusor overactivity (NDO). TOVIAZ is used to increase the amount of urine your bladder can hold and reduce urine leakage.

How does this medicine work?

• Fesoterodine (fes" oh ter' oh deen) is anticholinergic agent which blocks the muscarinic acetylcholine receptors, particularly those found in the smooth muscle of the bladder.
• Fesoterodine increases bladder capacity and decreases bladder contractions and the urgency of urination.
• Fesoterodine is formulated in an extended release formulation and has a quarternary ammonium group that makes it less likely to cross the blood brain barrier.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to TOVIAZ or any of its ingredients.
• are allergic to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules.
• are not able to empty your bladder (urinary retention).
• have delayed or slow emptying of your stomach (gastric retention).
• have an eye problem called uncontrolled narrow-angle glaucoma.

What drug interactions can this medicine cause?

• TOVIAZ may affect the way other medicines work, and other medicines may affect how TOVIAZ works.
• Especially tell your healthcare provider if you are taking antimuscarinic, antibiotics, or antifungal medicines.

Is this medicine FDA approved?

• Fesoterodine was approved for use in the United States in 2008, and indications include urinary urge incontinence and overactive bladder syndrome.

How should this medicine be used?

Recommended dosage: 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 dosage of Toviaz 8 mg once daily.

Pediatric Patients Aged 6 Years and Older With NDO:

Pediatric Patients Weighing Greater than 25 kg and up to 35 kg:

• The recommended dosage of Toviaz is 4 mg orally once daily.
• If needed, dosage may be increased to Toviaz 8 mg orally once daily.

Pediatric Patients Weighing Greater than 35 kg:

• The recommended starting dosage of Toviaz is 4 mg orally once daily.
• After one week, increase to Toviaz 8 mg orally once daily.

Administration:

• Take TOVIAZ exactly as your healthcare provider tells you to take it.
• Your healthcare provider may lower your dose of TOVIAZ if you are an adult with severe kidney problems.
• Your healthcare provider may lower or stop your dose of TOVIAZ if you are a child 6 years of age and older with a body weight greater than 77 pounds (35 kg) and have severe kidney problems or are taking certain medicines.
• Take TOVIAZ with liquid and swallow the tablet whole. Do not chew, divide, or crush the tablet.
• Take TOVIAZ with or without food.
• If you miss a dose of TOVIAZ, begin taking TOVIAZ again the next day. Do not take 2 doses of TOVIAZ in the same day.
• If you take too much TOVIAZ, call your healthcare provider or go to an emergency department right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release tablets: 4 mg and 8 mg

This medicine is available in fallowing brand namesː

• TOVIAZ

What side effects can this medication cause?

The most common side effects of TOVIAZ in adults include:

• dry mouth
• constipation

The most common side effects of TOVIAZ in children 6 years of age and older include:

• diarrhea
• urinary tract infection
• dry mouth
• constipation
• stomach pain
• nausea
• weight gain
• headache

TOVIAZ may cause serious side effects, including:

• serious allergic reactions
• urinary retention
• central nervous system (CNS) effects
• worsening of Myasthenia Gravis symptoms

What special precautions should I follow?

• Angioedema of the face, lips, tongue, and/or larynx has been reported with Toviaz. Promptly discontinue Toviaz and provide appropriate therapy. Toviaz is contraindicated in patients with a known or suspected hypersensitivity to Toviaz or any of its ingredients.
• The use of Toviaz, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction, including patients with urinary retention, may result in further urinary retention and kidney injury. Toviaz is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention.
• Toviaz is associated with decreased gastric motility. Toviaz is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation.
• Toviaz can worsen controlled narrow-angle glaucoma. Use Toviaz with caution in patients being treated for narrow-angle glaucoma.
• Somnolence has been reported with Toviaz. Advise patients not to drive or operate heavy machinery until they know how Toviaz affects them.
• Toviaz should be used with caution in patients with myasthenia gravis due to the risk of worsening of symptoms of the disease.
• Toviaz is associated with anticholinergic central nervous system (CNS) adverse reactions. If a patient experiences anticholinergic CNS effects, Toviaz dose reduction or discontinuation should be considered.
• Fesoterodine has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Overdosage with Toviaz can result in severe anticholinergic effects.

Management of overdosage:

• Treatment should be symptomatic and supportive.
• In the event of overdosage, ECG monitoring is recommended.

Can this medicine be used in pregnancy?

• There are no available data with the use of Toviaz in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• It is not known if TOVIAZ will harm your unborn baby.
• Talk to your healthcare provider if you are pregnant or plan to become pregnant.

Can this medicine be used in children?

• It is not known if TOVIAZ is safe and effective in children younger than 6 years of age or with a body weight 55 pounds (25-kg) or less.

What are the active and inactive ingredients in this medicine?

• Active ingredient: fesoterodine fumarate.
• Inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.

Who manufactures and distributes this medicine?

Distributed by

• Pfizer Labs
• Division of Pfizer Inc, NY, NY

What should I know about storage and disposal of this medication?

• Store TOVIAZ at room temperature between 68° to 77°F (20° to 25°C).
• Protect the medicine from moisture by keeping the bottle closed tightly.
• Keep TOVIAZ and all medicines out of the reach of children.

• Dailymed label info on Fesoterodine fumarate
• FDA Fesoterodine fumarate

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