The products discussed herein may have different product labeling in different countries. Detrusitol xl prolonged-release capsules are packed in either blisters made of pvcpvdc and aluminium foil with a heat seal coating of pvdc or hdpe bottles with ldpe closures. In dogs prolongation of the qt interval has been observed after application of tolterodine and its human metabolites (3.
Concomitant medication with other drugs that possess antimuscarinic properties may result in more pronounced therapeutic effect and side-effects. A subset (about 7) of the population is devoid of cyp2d6 activity. Effect of treatment with detrusitol xl 4 mg once daily after 12 weeks, compared with placebo.
The most severe adverse events observed were accommodation disturbances and micturition difficulties. Conversely, the therapeutic effect of tolterodine may be reduced by concomitant administration of muscarinic cholinergic receptor agonists. This especially holds true when taking potent cyp3a4 inhibitors (see section 5.
Significant bladder outlet obstruction at risk of urinary retention multiple oral total daily doses of immediate release 4 mg (therapeutic) and 8 mg (supratherapeutic) tolterodine have been shown to prolong the qtc interval (see section 5. At both doses of tolterodine, no subject, irrespective of their metabolic profile, exceeded 500 msec for absolute qtcf or 60 msec for change from baseline that are considered thresholds of particular concern. Within each group, the patients were randomised to receive either tolterodine or placebo.
Mydriasis treat with pilocarpine eye drops andor place patient in dark room an increase in qt interval was observed at a total daily dose of 8 mg immediate release tolterodine (twice the recommended daily dose of the immediate release formulation and equivalent to three times the peak exposure of the prolonged release capsule formulation) administered over four days. Concomitant treatment with potent cyp3a4 inhibitors should be avoided (see section 4. The clinical effects of tolterodine on qt interval were studied in ecgs obtained from over 600 treated patients, including the elderly and patients with pre-existing cardiovascular disease.
The mean exposure of the active moiety per mg dose is approximately two-fold higher in children between 5-10 years than in adults (see sections 4. The effect of tolterodine on qt-prolongation was investigated further in 48 healthy male and female volunteers aged 18 55 years. Subjects were administered 2 mg bid and 4 mg bid tolterodine as the immediate release formulations. No significant difference between the two groups was observed in either study with regard to change from baseline in total number of incontinence episodesweek. Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.
Tolterodine prolonged-release capsules give a slower absorption of tolterodine than the immediate-release tablets do. ). Steady state concentrations are reached within 4 days after administration of the capsules. Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2. Detrusitol xl prolonged release capsules of 4 mg are available in blister packs of 7, 14, 28, 49, 84, 98 280 capsules and in bottles of 30, 100 and 200 capsules.
Tolterodine is a competitive, specific muscarinic receptor antagonist with a selectivity for the urinary bladder over salivary glands in vivo. Symptomatic treatment of urge incontinence andor increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. Cyp2d6 metabolisers with (subsequent) risk of overdosage (see section 4. Within each group, the patients were randomised to receive either tolterodine or placebo. The recommended dose is 4 mg once daily except in patients with impaired liver function or severely impaired renal function (gfr 30 mlmin) for whom the recommended dose is 2 mg once daily (see sections 4.
In dogs prolongation of the qt interval has been observed after application of tolterodine and its human metabolites (3. The 4 mg prolonged-release capsule is blue with white printing (symbol and 4). Tolterodine should be used with caution in patients with risk factors for qt prolongation including - electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia - relevant pre-existing cardiac diseases (i. Effect of treatment with detrusitol xl 4 mg once daily after 12 weeks, compared with placebo. The carboxylated metabolite and the corresponding dealkylated metabolite account for about 51 and 29 of the urinary recovery, respectively. A pharmacokineticpharmacodynamic model estimated that qtc interval increases in poor metabolisers (devoid of cyp2d6) treated with tolterodine 2mg bid are comparable to those observed in extensive metabolisers receiving 4mg bid. In extensive metabolisers this metabolite contributes significantly to the therapeutic effect (see 5. The clinical effects of tolterodine on qt interval were studied in ecgs obtained from over 600 treated patients, including the elderly and patients with pre-existing cardiovascular disease. No data concerning the excretion of tolterodine into human milk are available. Further metabolism leads to formation of the 5-carboxylic acid and n-dealkylated 5-carboxylic acid metabolites, which account for 51 and 29 of the metabolites recovered in the urine, respectively.Pfizer Products. Jump to: A B C D E F G ... Calan®SR (verapamil hydrochloride) Sustained-Release Oral Caplets. Prescribing Information ... Detrol® LA ( tolterodine tartrate extended release capsules) .... Nicotrol® Inhaler (nicotine inhalation system) 10 mg per cartridge (4 mg delivered) .... Viagra® (sildenafil citrate) tablets.