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Please note: that prescription orders to RD addresses will incur additional $2.95 due to the recent changes in freight by the courier company.
Classification
Prescription Only Medicine
Dosage
The recommended dose is 2mg twice a day. In the case of troublesome side-effects the dose may be reduced from 2mg to 1mg twice a day.
The recommended dose is 1mg twice a day for patients with impaired renal function, impaired liver function, or receiving concomitant ketoconazole or other potent CYP3A inhibitors.
After six months the need for further treatment should be considered.
Safety and effectiveness in children have not been established.
Ingredients
Tolterodine L-tartrate 1mg tablets
Purpose/Usage
DETRUSITOL is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency and/or urge incontinence.
Precautions
Tolterodine is contraindicated in patients with:
Urinary retention
Uncontrolled narrow angle glaucoma
Known hypersensitivity to tolterodine or excipients
Myasthenia Gravis
Severe ulcerative colitis
Toxic megacolon
Tolterodine should be used with caution in the following patients:
at risk for urinary retention
at risk for decreased gastrointestinal motility with impaired renal function. The recommended total daily dose is 2mg (see DOSAGE AND ADMINISTRATION)
With impaired hepatic function. The recommended total daily dose is 2mg (see DOSAGE AND ADMINISTRATION)
Autonomic neuropathy
Hiatus hernia
The recommended total daily dose of tolterodine is 2mg for patients on concomitant medication with potent CYP3A inhibitors, such as macrolide antibiotics (e.g. erythromycin and clarithromycin) or azole antifungal agents (e.g. ketoconazole, itraconazole and miconazole)[see DOSAGE AND ADMINISTRATION].
Organic reasons for urge and frequency should be considered before treatment.
Pregnancy and lactation: Clinical experience from pregnant women is lacking. Studies in mice have shown that high doses caused reduced foetal weight, embryolethality and increased incidence of foetal abnormalities. Until more information is available pregnant women should not be treated with tolterodine.
Women of child-bearing potential should be considered for treatment only if using adequate contraception.
Use of tolterodine during lactation should be avoided since no data on excretion into breast milk in humans are available.
Effect on ability to drive and use machines: Since tolterodine may cause accommodation disturbances and influence reaction time, the ability to drive and use machines may be negatively affected.
The antimuscarinic effect of tolterodine may become more pronounced when administered to patients receiving other drugs with antimuscarinic effects e.g. antidepressants. Conversely the therapeutic effect of tolterodine may be reduced by concomitant administration of muscarinic cholinergic receptor agonists. The effect of prokinetics like metoclopramide and cisapride may be decreased by tolterodine.
Pharmacokinetic interactions are possible with other drugs metabolised by or inhibiting cytochrome P450 2D6 (CYP2D6) or CYP3A4. Concomitant treatment with fluoxetine does not result in a clinically significant interaction.
Ketoconazole, a potent inhibitor or CYP3A, significantly increased plasma concentrations of tolterodine when coadministered to poor metabolisers (i.e. persons devoid of CYP2D6 metabolic pathway). For patients receiving ketoconazole or other potent CYP3A inhibitors, the recommended total daily dose is 2mg (see DOSAGE AND ADMINISTRATION).
Clinical studies have shown no interactions with warfarin or combined oral contraceptives (ethinyl oestradiol/levonorgestrel).
A clinical study with metabolic probe drugs has not given any evidence that the activity of CYP2D6, 2C19, 3A4 or 1A2 will be inhibited by tolterodine.
Overdosage: The highest dose of tolterodine tartrate given to human volunteers was 12.8mg as a single dose. The most severe adverse events observed were accommodation disturbances and micturition difficulties.
Overdosage with tolterodine can potentially result in severe central antimuscarinic effects and should be treated accordingly.
Adverse Effects
Tolterodine may cause mild-to-moderate antimuscarinic effects, like dryness of the mouth, dyspepsia and reduced lacrimation.
Clinical Trials:
Adverse events considered potentially drug-related from studies of tolterodine are provided below.
10% or more: Dry mouth
1% to 10%: Headache, constipation, dizziness/vertigo, abdominal pain, dyspepsia, fatigue, dry eyes, somnolence, abnormal vision (including abnormal accommodation), flatulence, dysuria.
In patients receiving tolterodine tartrate tablets the following events were also considered to be potentially drug related: chest pain, dry skin, bronchitis, increased weight.
1% Urinary retention, confusion, gastrooesophageal reflux, flushed skin, allergic reactions.
Post-marketing Surveillance:
The following events have been reported in association with tolterodine use in clinical practice: anaphylactoid reactions, tachycardia, peripheral oedema.
In toxicity, genotoxicity, carcinogenicity and safety pharmacology studies no clinically relevant effects have been observed, except those related to the pharmacological effect of the medicine.
Reduced foetal weight, embryolethality and increased incidence of foetal malformations have been observed in pregnant mice treated with high doses. No effects were observed at a systemic exposure (measured as Cmax or AUC for unbound tolterodine and its active metabolite) 9-50 times higher than in humans after the highest recommended dose.
In dogs a slight prolongation of the QT interval has been observed at high concentrations of tolterodine or its main metabolite (50-100 times therapeutic levels). In clinical trials, no QT internal prolongation has been found in a large and representative patient material, on recommended doses of DETRUSITOL.
More Information
Detrusitol prescriptions info from Pharmacia
Medicines have benefits and some may have risks. Always read the label
carefully and use strictly as directed. If symptoms continue or you have
side effects consult your pharmacist or doctor immediately.
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