Fesoterodine

Fesoterodine is used in adults to treat overactive bladder, which includes symptoms like urinary frequency, urgency, and incontinence.

Fesoterodine is also used to treat neurogenic detrusor overactivity in children who are at least 6 years old and weigh more than 55 pounds (25 kilograms).

Fesoterodine may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take fesoterodine with liquid, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your child's doctor may change your child's dose after the first week if:

• the child weighs more than 77 pounds (35 kilograms); and
• the child has severe kidney problems or is taking certain medicines.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use fesoterodine if you are allergic to fesoterodine or tolterodine, or if you have:

• a blockage of the urinary tract (difficulty urinating);
• a bladder obstruction or other urination problems;
• a blockage in your stomach or intestines; or
• untreated or uncontrolled narrow-angle glaucoma.

Tell your doctor if you have ever had:

• glaucoma;
• a stomach or intestinal disorder, including severe constipation;
• liver or kidney disease; or
• myasthenia gravis (may worsen while you are taking fesoterodine).

Tell your doctor if you are pregnant or breastfeeding.

Not approved for use by anyone younger than 6 years old or anyone who weighs less than 55 pounds.

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

Fesoterodine may cause serious side effects. Call your doctor right away if you have:

• severe stomach pain or constipation;
• a weak stream of urine, or trouble emptying your bladder;
• little or no urination; or
• headache, dizziness, drowsiness.

Older adults may be more likely to experience side effects such as dry mouth, constipation, upset stomach, increased urination, dizziness, or painful urination.

Common side effects of fesoterodine may include:

• painful urination;
• blurred vision;
• weight gain;
• dry mouth; or
• stomach pain, diarrhea, constipation.

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.

Usual Adult Dose for Urinary Incontinence:

4 mg orally once a day; based on individual response and tolerability, the dose may be escalated to 8 mg orally once a dayMaximum dose: 8 mg once a dayComments:-This drug can be administered with or without food.-This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).-Full effect is usually observed between 2 and 8 weeks; therefore, it is recommended to reevaluate efficacy after 8 weeks of therapy.Use: For overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency

Usual Adult Dose for Urinary Frequency:

4 mg orally once a day; based on individual response and tolerability, the dose may be escalated to 8 mg orally once a dayMaximum dose: 8 mg once a dayComments:-This drug can be administered with or without food.-This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).-Full effect is usually observed between 2 and 8 weeks; therefore, it is recommended to reevaluate efficacy after 8 weeks of therapy.Use: For overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency

Usual Pediatric Dose for Neurogenic Bladder:

6 Years and Older:Weighing greater than 25 kg and up to 35 kg:4 mg orally once a day, the dose may be increased to 8 mg orally once a dayWeighing greater than 35 kg:4 mg orally once a day, increase the dose to 8 mg orally once a day, after one weekComments:-This drug can be taken with or without food.-This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).Use: 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

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Fesoterodine can cause blurred vision, dizziness, and drowsiness. Avoid driving or doing dangerous activities until you know how fesoterodine will affect you. Your reactions could be impaired.

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

Avoid drinking alcohol or you could have increased drowsiness.

Tell your doctor about all your current medicines. Many drugs can affect fesoterodine, especially:

• other medicine to treat overactive bladder;
• an antibiotic or antifungal medicine to treat infection;
• antiviral medicine for HIV or hepatitis C;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• cancer medicine;
• glaucoma medicine;
• medicine to treat Parkinson's disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may affect fesoterodine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.