Tolterodine (Detrol®, Detrol® LA) Contraindications and Precautions
- breast-feeding
- closed-angle glaucoma
- GI obstruction
- ileus
- pyloric stenosis
- toxic megacolon
- urinary retention
- anticholinergic medications
- autonomic neuropathy
- children
- contact lenses
- driving or operating machinery
- gastroesophageal reflux disease (GERD)
- hepatic disease
- myasthenia gravis
- pregnancy
- prostatic hypertrophy
- renal disease
- renal failure
- renal impairment
- ulcerative colitis
- urinary tract obstruction
Tolterodine (Detrol®, Detrol® LA) Contraindications and Precautions
Tolterodine is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Due to the anticholinergic effects, tolterodine is contraindicated in patients with urinary retention. Anticholinergics may precipitate urinary retention in patients with preexisting urinary tract obstruction or prostatic hypertrophy, so caution is warranted. Altered pharmacokinetics of tolterodine occur in renal impairment (CrCl <= 30 ml/min) and renal failure; dosages should be adjusted (tolterodine_detrol_detrol_la_indications_and_dosage/">see Dosage). Use with caution in other patients with significant renal disease.
Tolterodine may increase intraocular pressure and aqueous outflow resistance in patients with closed-angle glaucoma so caution is advised in patients with treated disease; tolterodine should not be prescribed to patients with uncontrolled closed-angle glaucoma. Tolterodine is not contraindicated in patients with chronic open-angle glaucoma. The anticholinergic effects of tolterodine may make the eyes dry and this can cause irritation for wearers of contact lenses.
The effects of tolterodine may be additive to other anticholinergic medications.
Tolterodine has a direct antispasmodic effect on smooth muscle that can delay gastric emptying, so it should not be used when there is GI obstruction, pyloric stenosis, or ileus present. Tolterodine would not be recommended for use in the setting of toxic megacolon or severe ulcerative colitis. In general, gastroesophageal reflux disease (GERD) may be aggravated by the use of anticholinergic medications.
Hepatic disease (e.g., cirrhosis) can significantly alter the disposition of tolterodine. Patients with significantly reduced hepatic function should dosage reductions (tolterodine_detrol_detrol_la_indications_and_dosage/">see Dosage). Also, dosage reductions may be required in patients receiving medications that reduce the hepatic metabolism of tolterodine (tolterodine_detrol_detrol_la_interactions/">see Drug Interactions).
Patients should be advised to use caution when driving or operating machinery while receiving tolterodine until the effects of the drug are known. Anticholinergic drugs in general can cause blurred vision, dizziness, or somnolence in some patients. However, EEG data show no significant difference with tolterodine vs placebo in psychiatric events reported, even in geriatric patients, so continued precautions with driving or other tasks are not expected. There are no precautions regarding use of tolterodine in the elderly; studies included patients up to 91 years of age, and 42% of patients were >= 65 years old in clinical trials.
Anticholinergics in general may exacerbate the clinical symptoms of patients with myasthenia gravis or autonomic neuropathy.
Tolterodine is classified as FDA pregnancy risk category C. There are no studies of tolterodine in pregnant women. Tolterodine should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.
The manufacturer recommends discontinuation of tolterodine during breast-feeding. Animal data show that tolterodine is excreted into the milk of mice, however, it is not known whether tolterodine is excreted in human milk.
The safe and effective use of tolterodine in children has not been established. As might be expected, ingestion of tolterodine in unintentional overdose in children has resulted in characteristic anticholinergic actions like dry mouth. The efficacy of Detrol® LA (tolterodine extended-release tablets) in children has not been demonstrated. A total of 710 pediatric patients, aged 5-10 years with urinary frequency and urge incontinence were studied in two phase 3 randomized, placebo-controlled, double blind, 12 week studies. The percentage of children with urinary tract infections was higher in patients treated with Detrol® LA (6.6%) compared to children who received placebo (4.5%). Aggressive, abnormal and hyperactive behavior and attention disorders occurred in 2.9% of children treated with Detrol® LA compared to 0.9% of children treated with placebo.
[ Last revised: 5/6/2004 10:35:00 AM ]
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