Pronunciation:

tol-TER-oh-deen TAR-trate

Brand Names:

• Detrol
• Detrol LA

Dosage Forms:

• Capsule, Extended Release
• Tablet

Classifications:

Therapeutic—

Urinary Antispasmodic

Pharmacologic—

Tolterodine

Uses of This Medicine:

Tolterodine is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.

Tolterodine belongs to the group of medicines called antispasmodics. It helps decrease muscle spasms of the bladder and the frequent urge to urinate caused by these spasms.

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 performed to date have not demonstrated that tolterodine is useful in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tolterodine in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require an adjustment in the dose for patients receiving tolterodine.

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.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Potassium Citrate
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Abiraterone Acetate
• Adagrasib
• Amantadine
• Amiodarone
• Amisulpride
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Atazanavir
• Buprenorphine
• Bupropion
• Buserelin
• Ceritinib
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Codeine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Domperidone
• Donepezil
• Duloxetine
• Efavirenz
• Encorafenib
• Entrectinib
• Escitalopram
• Fedratinib
• Fexinidazole
• Fingolimod
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gepirone
• Givosiran
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Macimorelin
• Methacholine
• Metronidazole
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Quetiapine
• Quizartinib
• Relugolix
• Revefenacin
• Ribociclib
• Scopolamine
• Secretin Human
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Solifenacin
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tapentadol
• Tiotropium
• Tocilizumab
• Trazodone
• Triclabendazole
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine
• Erythromycin
• Galantamine
• Miconazole
• Propafenone
• Quinidine
• Rivastigmine
• Vinblastine
• Warfarin

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:

• Heart rhythm problems (e.g., QT prolongation), or history of or
• Intestinal or stomach problems (e.g., blockage, intestinal atony, pyloric stenosis) or
• Myasthenia gravis (severe muscle weakness) or
• Narrow-angle glaucoma, controlled or
• Urinary problems (e.g., blockage)—Use with caution. May make these conditions worse.

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

• Liver disease, severe—Use is not recommended for patients taking tolterodine extended-release capsules.

• Narrow-angle glaucoma, uncontrolled or
• Stomach problems (e.g., gastric retention) or
• Urinary retention (hard to pass urine)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed. 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. To do so may increase the chance of side effects. Also, do not change your dose without checking first with your doctor.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food.

Swallow the extended-release capsule whole with water. Do not crush, open, or chew it.

Take this medicine at the same time each day.

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 bladder problems:
  • For oral dosage form (tablets):
    • Adults—At first, 2 milligrams (mg) two times a day. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release capsules):
    • Adults—4 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Tolterodine may cause serious types of allergic reactions, including anaphylaxis and angioedema. Anaphylaxis and angioedema can be life-threatening and require immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble breathing; trouble swallowing; or any swelling of your hands, face, mouth, or throat after using this medicine.

This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well.

This medicine may cause dryness in 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

Abnormal vision, including difficulty with adjusting to distances

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

Less common

Chest pain

chills

cough

diarrhea

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

pain or tenderness around the eyes and cheekbones

shivering

shortness of breath or troubled breathing

sore throat

stuffy or runny nose

sweating

tightness of the chest or wheezing

trouble with sleeping

vomiting

Incidence not known

Being forgetful

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

confusion about identity, place, and time

difficulty with swallowing

dizziness

fast, pounding, or irregular heartbeat or pulse

hives

itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

mood or mental changes

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

seeing, hearing, or feeling things that are not there

skin rash

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

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:

More common

Abdominal or stomach pain

constipation

drowsiness

dry eyes

dry mouth

upset stomach

Less common

Acid or sour stomach

belching

blurred vision

difficulty with moving

dizziness or lightheadedness

dry skin

fear or nervousness

feeling of constant movement of self or surroundings

heartburn

indigestion

sensation of spinning

sleepiness or unusual drowsiness

stomach discomfort

weight gain

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.