Pronunciation:

fes-oh-TER-oh-deen

Brand Names:

• Toviaz

Dosage Forms:

• Tablet, Extended Release

Classifications:

Therapeutic—

Urinary Antispasmodic

Pharmacologic—

Antimuscarinic

Uses of This Medicine:

Fesoterodine is used to treat bladder problems, including neurogenic detrusor overactivity and symptoms of an overactive bladder, such as incontinence (loss of bladder control), a strong need to urinate right away, or a frequent need to urinate. It works on the muscles of the bladder to increase the amount of urine your bladder can hold and prevent them from causing incontinence.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fesoterodine in children with symptoms of overactive bladder or in children younger than 6 years of age or weighing 25 kilograms (kg) or less with neurogenic detrusor overactivity. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fesoterodine in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, constipation, dizziness, dry mouth, upset stomach, or urinary tract infection), or age-related liver or kidney problems, which may require caution in patients receiving fesoterodine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Itraconazole
• Potassium
• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amantadine
• Amifampridine
• Boceprevir
• Buprenorphine
• Bupropion
• Clarithromycin
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Donepezil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Idelalisib
• Indinavir
• Ketoconazole
• LetibotulinumtoxinA-wlbg
• Lopinavir
• Methacholine
• Nefazodone
• Nelfinavir
• Oliceridine
• Oxycodone
• Posaconazole
• Quetiapine
• Revefenacin
• Ritonavir
• Saquinavir
• Scopolamine
• Secretin Human
• Sufentanil
• Tapentadol
• Telaprevir
• Telithromycin
• Tiotropium
• Tramadol
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glaucoma, narrow-angle or
• Myasthenia gravis (severe muscle weakness) or
• Stomach or bowel problems (eg, severe constipation) or
• Urinary problems (eg, blockage)—Use with caution. May make these conditions worse.

• Glaucoma, narrow-angle, uncontrolled or
• Liver disease, severe or
• Stomach problems (eg, gastric retention) or
• Urinary retention—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

This medicine may be taken with or without food.

Swallow the extended-release tablet whole with a full glass of water. Do not split, crush, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  • For neurogenic detrusor overactivity:
    • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighing more than 35 kilograms (kg)—At first, 4 milligrams (mg) once a day. Your doctor may increase the dose to 8 mg once a day after 1 week.
      • Weighing more than 25 and up to 35 kg—At first, 4 mg once a day. Your doctor may increase the dose as needed and tolerated. However the dose is usually not more than 8 mg once a day.
    • Children younger than 6 years of age or weighing 25 kg or less—Use and dose must be determined by your doctor.
  • For symptoms of an overactive bladder:
    • Adults—At first, 4 milligrams (mg) once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 8 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to check for unwanted effects.

This medicine may cause a serious allergic reaction, called angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs after using this medicine.

This medicine may increase your risk of having urinary retention (trouble passing urine or not fully emptying the bladder). Check with your doctor if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine (dribbling), or painful urination.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

Avoid drinking alcohol while you are taking this medicine.

This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficulty having a bowel movement

dry mouth

Less common

Bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

body aches or pain

burning feeling while urinating

chills

cough

decrease in frequency of urination

decrease in urine volume

difficult or painful urination

difficulty in breathing

difficulty in passing urine (dribbling)

dry eyes

ear congestion

fever

frequent urge to urinate

headache

loss of voice

lower back or side pain

rapid weight gain

runny or stuffy nose

sneezing

sore throat

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Blurred vision

fast, irregular, pounding, or racing heartbeat or pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back pain

belching

dry throat

heartburn

indigestion

nausea

rash

stomach discomfort, upset, or pain

trouble sleeping

Incidence not known

Dizziness

itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.