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What is Detrol (tolterodine)?
Urine coming from the kidneys fills the bladder and causes it to stretch like a balloon. As it stretches, pressure in the bladder increases and when the bladder reaches a certain level of stretch, an urge to urinate is felt. Nerves in the muscular wall of the bladder release acetylcholine, a chemical that attaches to receptors on the muscle cells and causes the cells to contract (tighten).
This contributes further to the increase in pressure within the bladder and the desire to urinate. Normally, urination is under conscious control but in some individuals normal control as well as normal sensation are lost. The desire to urinate may be felt when there is little urine in the bladder, and urination may occur without warning or control.
By blocking the effect of acetylcholine on the muscle cells, Detrol slows the build-up of pressure in the bladder, reduces the sensation to urinate, and prevents uncontrolled urination.
Common side effects of Detrol include:
Caution is recommended for patients with narrow-angle glaucoma, obstruction to the flow of urine, or poor emptying of the stomach since Detrol may worsen these medical conditions.
Drug interactions of Detrol include the following, which raise Detrol blood levels and lead to side effects:
At doses much greater than those used in humans, Detrol causes fetal abnormalities in animals, but there are no studies with Detrol in pregnant women. Detrol should only be given to pregnant women if benefits are felt to outweigh potential risks.
What are the important side effects of Detrol (tolterodine)?
The most common side effects of tolterodine are:
Tolterodine also may cause blurred vision. Caution is recommended for patients with narrow-angle glaucoma, obstruction to the flow of urine, or poor emptying of the stomach since tolterodine may worsen these medical conditions.
Detrol (tolterodine) side effects list for healthcare professionals
The Phase 2 and 3 clinical trial program for Detrol Tablets included 3071 patients who were treated with Detrol (N=2133) or placebo (N=938). The patients were treated with 1, 2, 4, or 8 mg/day for up to 12 months. No differences in the safety profile of tolterodine were identified based on age, gender, race, or metabolism.
The data described below reflect exposure to Detrol 2 mg bid in 986 patients and to placebo in 683 patients exposed for 12 weeks in five Phase 3, controlled clinical studies. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and approximating rates.
Sixty-six percent of patients receiving Detrol 2 mg bid reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving Detrol were:
Expected side effects of antimuscarinic agents are:
- dry mouth,
- abnormal vision (accommodation abnormalities),
- urinary retention, and
Dry mouth was the most frequently reported adverse event for patients treated with Detrol 2 mg bid in the Phase 3 clinical studies, occurring in 34.8% of patients treated with Detrol and 9.8% of placebo-treated patients. One percent of patients treated with Detrol discontinued treatment due to dry mouth.
The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Seven percent of patients treated with Detrol 2 mg bid discontinued treatment due to adverse events versus 6% of placebo patients. The most common adverse events leading to discontinuation of Detrol were dizziness and headache.
Three percent of patients treated with Detrol 2 mg bid reported a serious adverse event versus 4% of placebo patients. Significant ECG changes in QT and QTc have not been demonstrated in clinical-study patients treated with Detrol 2 mg bid. Table 5 lists the adverse events reported in 1% or more of the patients treated with Detrol 2 mg bid in the 12-week studies. The adverse events are reported regardless of causality.
Table 5: Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in > 1% of Patients Treated with Detrol Tablets (2 mg bid) in 12-week, Phase 3 Clinical Studies
|Body System||Adverse Event||% Detrol|
N = 986
|Autonomic Nervous||accommodation abnormal||2||1|
|* in nearest integer.|
The following events have been reported in association with tolterodine use in worldwide post-marketing experience:
Reports of aggravation of symptoms of dementia (e.g., confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.
Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of tolterodine in their causation cannot be reliably determined.
What drugs interact with Detrol (tolterodine)?
Ketoconazole, an inhibitor of the drug metabolizing enzyme CYP3A4, significantly increased plasma concentrations of tolterodine when coadministered to subjects who were poor metabolizers, Variability in Metabolism and Drug-Drug Interactions). For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as other azole antifungals (e.g., itraconazole, miconazole) or macrolide antibiotics (e.g., erythromycin, clarithromycin) or cyclosporine or vinblastine, the recommended dose of Detrol is 1 mg twice daily.
Interactions between tolterodine and laboratory tests have not been studied.
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Related Disease Conditions
Urinary Tract Infection (UTI)
A urinary tract infection (UTI) is an infection of the bladder, kidneys, ureters, or urethra. E. coli, a type of bacteria that lives in the bowel and near the anus, causes most UTIs. UTI symptoms include pain, abdominal pain, mild fever, urinary urgency and frequency. Treatment involves a course of antibiotics.
Bladder Infection (Cystitis)
Bladder infection is an infection of the bladder, usually caused by bacteria or, rarely, by Candida. Certain people, including females, the elderly, men with enlarged prostates, and those with chronic medical conditions are at increased risk for bladder infection. Bladder infections are treated with antibiotics, but cranberry products and adequate hydration may help prevent bladder infections.
Urinary retention (inability to urinate) may be caused by nerve disease, spinal cord injury, prostate enlargement, infection, surgery, medication, bladder stone, constipation, cystocele, rectocele, or urethral stricture. Symptoms include discomfort and pain. Treatment depends upon the cause of urinary retention.
Urinary Incontinence in Women
Millions of women suffer from urinary incontinence (UI). UI occurs twice as often in women as in men. There are many types of urinary incontinence: stress incontinence, urge incontinence, overactive bladder, functional incontinence, overflow incontinence, transient incontinence, and mixed incontinence.
Is a Urinary Tract Infection (UTI) Contagious?
Bacteria such as E. coli or Pseudomonas can cause a urinary tract infection (UTI). The incubation period for a UTI ranges from three to eight days.
Urinary Tract Infections in Children
Urinary tract infections (UTIs) are very common in children. Symptoms and signs include fever and abdominal pain. Associated symptoms and signs include flank pain, vomiting, and blood in the urine. Treatment for a UTI involves antibiotic therapy.
There are many types of urinary incontinence (UI), which is the accidental leakage of urine. These types include stress incontinence, urge incontinence, and overflow incontinence. Urinary incontinence in men may be caused by prostate or nerve problems. Treatment depends upon the type and severity of the UI and the patient's lifestyle.
Urinary Tract Infection in Adults
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Urinary Incontinence in Children
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Sex, Urinary, and Bladder Problems of Diabetes
Having diabetes can mean early onset and increased severity of bladder symptoms (urinary incontinence and urinary tract infections) and changes in sexual function. Men may have erectile dysfunction; and women may have problems with sexual response and vaginal lubrication. Keep your diabetes under control, and you can lower your risk of sexual and urologic problems.
Urinary Incontinence in Children
Urinary incontinence in children (enuresis) is twice as common in boys as in girls and may occur during the daytime or nighttime. Nighttime urinary incontinence is also called bedwetting and sleepwetting. The cause of nighttime incontinence in children is unknown. Daytime incontinence in children may be caused by an overactive bladder. Though many children overcome urinary incontinence naturally, it may be necessary to treat incontinence with medications, bladder training and moisture alarms, which wake the child when he or she begins to urinate.
Yeast Infection vs. Urinary Tract Infection (UTI)
Candida albicans typically causes vaginal yeast infections. Bacterial infections typically cause urinary tract infections (UTIs). Thick white cottage-cheese like vaginal discharge characterizes vaginal yeast infections. Painful, frequent urination characterize urinary tract infections. Antifungal medications treat yeast infections while prescription antibiotics treat UTIs.
Overactive Bladder (OAB)
Overactive bladder is a sudden involuntary contraction of the muscle wall of the bladder causing urinary urgency (an immediate unstoppable need to urinate). Overactive bladder is is a form of urinary incontinence. Treatment options may include Kegel exercises, biofeedback, vaginal weight training, pelvic floor electrical stimulation, behavioral therapy, and medications.
People who have bladder spasms, the sensation occurs suddenly and often severely. A spasm itself is the sudden, involuntary squeezing of a muscle. A bladder spasm, or "detrusor contraction," occurs when the bladder muscle squeezes suddenly without warning, causing an urgent need to release urine. The spasm can force urine from the bladder, causing leakage. When this happens, the condition is called urge incontinence or overactive bladder.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.