Toviaz

DRUG DESCRIPTION

Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist.

Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is:

Toviaz® (fesoterodine fumarate) Structural Formula Illustration

The asterisk (*) indicates the chiral carbon.

Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.

What are the possible side effects of fesoterodine (Toviaz)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fesoterodine and call your doctor at once if you have any of these serious side effects:

  • chest pain, fast or uneven heart rate;
  • swelling of your hands or feet;
  • urinating less than usual or not at all; or
  • painful or difficult urination.

Less serious side effects may include:

  • dry mouth, dry...

Read All Potential Side Effects and See Pictures of Toviaz »

What are the precautions when taking fesoterodine fumarate extended-release tablets (Toviaz)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: problems emptying your bladder (urinary retention), severe blockage of stomach/intestines (gastric obstruction/retention).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (such as bladder outflow obstruction, enlarged prostate), slowed movement of stomach/intestines,...

Read All Potential Precautions of Toviaz »


Toviaz Consumer (continued)

SIDE EFFECTS: Dry mouth, dry eyes, constipation, dizziness, drowsiness, or blurred vision may occur. If any of these effects persist or worsen, 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, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (such as stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: 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).

Seek immediate medical attention if any of these rare but serious side effects occur: fast heartbeat, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following signs of a serious allergic reaction: 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.

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: problems emptying your bladder (urinary retention), severe blockage of stomach/intestines (gastric obstruction/retention).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (such as bladder outflow obstruction, enlarged prostate), slowed movement of stomach/intestines, stomach/intestinal disease (such as ulcerative colitis), severe constipation, a certain eye condition (narrow-angle glaucoma), kidney disease, liver disease, a certain muscle disease (myasthenia gravis).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication can cause decreased sweating. Avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities since heatstroke may occur.

Kidney function declines as you grow older. This medication is removed by the kidneys. Older adults may be more sensitive to the 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 not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.


Toviaz Patient Information Including Side Effects

Brand Names: Toviaz

Generic Name: fesoterodine (Pronunciation: FES oh TER oh deen)

  • What is fesoterodine (Toviaz)?
  • What are the possible side effects of fesoterodine (Toviaz)?
  • What is the most important information I should know about fesoterodine (Toviaz)?
  • What should I discuss with my healthcare provider before taking fesoterodine (Toviaz)?
  • How should I take fesoterodine (Toviaz)?
  • What happens if I miss a dose (Toviaz)?
  • What happens if I overdose (Toviaz)?
  • What should I avoid while taking fesoterodine (Toviaz)?
  • What other drugs will affect fesoterodine (Toviaz)?
  • Where can I get more information?

What is fesoterodine (Toviaz)?

Fesoterodine reduces spasms of the bladder muscles.

Fesoterodine is used to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence.

Fesoterodine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fesoterodine (Toviaz)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fesoterodine and call your doctor at once if you have any of these serious side effects:

  • chest pain, fast or uneven heart rate;
  • swelling of your hands or feet;
  • urinating less than usual or not at all; or
  • painful or difficult urination.

Less serious side effects may include:

  • dry mouth, dry eyes;
  • blurred vision;
  • dizziness, drowsiness;
  • constipation;
  • stomach pain or upset;
  • cough, dry throat;
  • back pain; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fesoterodine (Toviaz)?

Do not take this medication if you are allergic to fesoterodine, if you have uncontrolled glaucoma, or if you have a blockage of the urinary tract, stomach, or intestines.

Before taking fesoterodine, tell your doctor if you have urination problems, myasthenia gravis, severe constipation, liver or kidney disease, glaucoma, or a personal or family history of "Long QT syndrome."

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Fesoterodine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Fesoterodine can decrease perspiration and you may be more prone to heat stroke.

Avoid drinking alcohol. It can increase some of the side effects of fesoterodine.

There are many other medicines that can interact with fesoterodine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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