No increase in tumors was found in either mice or rats. No mutagenic effects of tolterodine were detected in a battery of in vitro tests, including bacterial mutation assays Ames test in 4 strains of Salmonella typhimurium and in 2 strains of Escherichia coli , a gene mutation assay in LY mouse lymphoma cells, and chromosomal aberration tests in human lymphocytes.
Tolterodine was also negative in vivo in the bone marrow micronucleus test in the mouse. Based on AUC values, the systemic exposure was about fold higher in animals than in humans. At these doses, the AUC values were about to fold higher than in humans. Rabbits treated subcutaneously at a dose of 0.
This dose did not result in any embryotoxicity or teratogenicity. There are no studies of tolterodine in pregnant women. In poor metabolisers the reduced clearance leads to significantly higher serum concentrations of tolterodine about 7-fold and negligible concentrations of the 5- hydroxymethyl metabolite are observed.
The 5- hydroxymethyl metabolite is pharmacologically active and equipotent with tolterodine. Because of the differences in the protein-binding characteristics of tolterodine and the 5- hydroxymethyl metabolite, the exposure AUC of unbound tolterodine in poor metabolisers is similar to the combined exposure of unbound tolterodine and the 5- hydroxymethyl metabolite in patients with CYP2D6 activity given the same dosage regimen.
The safety, tolerability and clinical response are similar irrespective of phenotype. The pharmacokinetics is linear in the therapeutic dosage range. About 2-fold higher exposure of unbound tolterodine and the 5- hydroxymethyl metabolite is found in subjects with liver cirrhosis see section 4.
The plasma levels of other metabolites were markedly up to fold increased in these patients. The clinical relevance of the increased exposure of these metabolites is unknown. There is no data in mild to moderate renal impairment see section 4. Paediatric population The exposure of the active moiety per mg dose is similar in adults and adolescents. The mean exposure of the active moiety per mg dose is approximately two-fold higher in children between years than in adults see sections 4. Reproduction studies have been performed in mice and rabbits.
In mice, there was no effect of tolterodine on fertility or reproductive function. Tolterodine produced embryo death and malformations at plasma exposures Cmax or AUC 20 or 7 times higher than those seen in treated humans. Drug-Laboratory-Test Interactions Interactions between tolterodine and laboratory tests have not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with tolterodine were conducted in mice and rats. Thus, tolterodine exposure in the carcinogenicity studies was 9- to fold higher than expected in humans.
No increase in tumors was found in either mice or rats. No mutagenic effects of tolterodine were detected in a battery of in vitro tests, including bacterial mutation assays Ames test in 4 strains of Salmonella typhimurium and in 2 strains of Escherichia coli, a gene mutation assay in LY mouse lymphoma cells, and chromosomal aberration tests in human lymphocytes. Tolterodine was also negative in vivo in the bone marrow micronucleus test in the mouse.
Based on AUC values, the systemic exposure was about fold higher in animals than in humans. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, bottle label and blister after EXP. The expiry date refers to the last day of that month. No special precautions for storage.
Do not throw away any medicines via wastewater or household waste. What is in this leaflet: Driving and using machines 1. What Tolterodine Tartrate is and what it is used for 2. What you need to know before you take Tolterodine Tartrate 3. How to take Tolterodine Tartrate 4.
It tolterodine not recommended to use tolterodine in combination with: Dry mouth, tolterodine tablets 1 mg, constipation, abnormal tolterodine accommodation abnormalitiesurinary retention, and xerophthalmia are expected side effects of antimuscarinic tablets. About 2-fold higher exposure of unbound tolterodine and the 5- hydroxymethyl tablet is found in subjects with liver cirrhosis see section 4. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. The safety, tolerability and clinical response are similar irrespective of phenotype. The clinical relevance of the increased exposure of these metabolites is unknown, tolterodine tablets 1 mg. The half-life for tolterodine given as the tablet is hours in extensive and about 10 hours in poor metabolisers devoid of CYP2D6. There are no studies of tolterodine in pregnant women. No special precautions for storage. For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as other azole antifungals e. How to store Tolterodine tartrate Tolterodine tartrate contains the active substance tolterodine. No increase in tumors was found in either mice or rats. In case of tolterodine overdose, the following symptoms are reported. In mice, there was no effect of tolterodine on fertility or reproductive tylenol 3 with codeine or percocet. Carcinogenesis, Mutagenesis, tolterodine tablets 1 mg, Impairment of Fertility Carcinogenicity studies with tolterodine were conducted in mice and rats.
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