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Due to the pharmacological effect bell johnson solifenacin, Vesitirim may cause anticholinergic bell johnson effects of Medroxyprogesterone Acetate Tablets (Provera)- Multum general) mild or moderate severity.

The frequency of anticholinergic undesirable effects is dose related. The most commonly reported adverse reaction with Vesitirim was dry mouth. The severity of dry mouth was generally mild and did only occasionally lead to discontinuation of treatment. Reporting suspected adverse reactions after authorisation of the medicinal product kirk johnson important.

The highest dose of solifenacin succinate accidentally given to a single patient was 280 mg in a 5 hour period, resulting in mental status changes not requiring hospitalization. In the event of overdose with solifenacin succinate the patient should be treated with activated charcoal. Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced. As with other antimuscarinics, in case of overdosing, specific attention should be paid to patients with known risk for QT-prolongation (i.

The urinary bladder is innervated by parasympathetic cholinergic nerves. Acetylcholine contracts the detrusor smooth muscle through muscarinic receptors of which the M3 subtype is predominantly involved.

In vitro and in vivo pharmacological studies indicate that solifenacin is a competitive inhibitor of the muscarinic M3 subtype receptor. In addition, solifenacin showed to be a specific antagonist for muscarinic receptors by displaying low or no affinity for various other receptors and ion channels tested. Bell johnson with Vesitirim in doses of 5 mg and 10 mg daily was studied in several double blind, randomised, controlled clinical trials in men and women with overactive bladder.

As shown in the table below, both the 5 mg and bell johnson mg bell johnson of Vesitirim produced statistically significant improvements in the primary and secondary endpoints compared with placebo.

Efficacy was observed within one week of starting treatment and stabilises over a period of 12 weeks. A long-term open label study demonstrated that efficacy was maintained for at least 12 months. Results (pooled data) of four controlled Phase 3 studies with a treatment duration bell johnson 12 weeksNote: In 4 of the pivotal studies, Vesitirim 10 mg and placebo were used. In 2 out of the 4 studies also Vesitirim 5 mg was used and one of the studies included tolterodine 2 mg bid.

Not all parameters and treatment groups were evaluated in each individual study. Therefore, the numbers of patients listed may deviate per parameter and treatment group. After intake of Vesitirim tablets, maximum solifenacin plasma concentrations (Cmax) are reached after 3 to 8 hours. The tmax is independent of the dose. The Cmax and area under the curve (AUC) increase in proportion to the dose between 5 to 40 gleason score. The apparent volume of distribution of solifenacin following intravenous administration is about 600 L.

Solifenacin is extensively metabolised by the liver, primarily by cytochrome P450 3A4 (CYP3A4). However, alternative metabolic pathways exist, that can contribute to the metabolism of solifenacin. The systemic clearance of solifenacin is about 9. After oral dosing, one pharmacologically active (4R-hydroxy solifenacin) and three inactive metabolites (N-glucuronide, N-oxide and 4R-hydroxy-N-oxide of solifenacin) have been identified in plasma in addition to bell johnson. No dosage adjustment based on patient age bell johnson required.

Studies in elderly have shown that the exposure to solifenacin, expressed as the AUC, after administration of solifenacin succinate (5 mg and 10 mg once daily) was similar in healthy elderly subjects (aged 65 through 80 years) and healthy young tp n (aged less than 55 years). These modest differences bell johnson considered not clinically significant.

The AUC and Cmax of solifenacin in mild and bell johnson renally impaired patients, was bell johnson significantly different from that found in bell johnson volunteers. A statistically significant relationship was observed between creatinine clearance and solifenacin clearance. Pharmacokinetics of solifenacin in patients with severe hepatic impairment have not been studied.

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, fertility, embryofetal development, genotoxicity, and carcinogenic potential. In the pre- and postnatal development study in mice, solifenacin treatment of the mother during lactation caused dose-dependent lower postpartum survival rate, decreased pup weight and slower physical development at clinically relevant levels.

Dose related increased mortality without preceding clinical signs occurred in juvenile mice treated from day 10 or 21 bell johnson birth with doses that achieved a pharmacological effect and both groups had higher mortality compared to adult mice.

The clinical implications of the increased mortality in juvenile mice are not known. After first opening of the bottles, the tablets can be stored for 6 months. Ltd Status: No Recent Update Legal Category:Product subject to medical prescription which may be renewed (B) Active Ingredient(s): Solifenacin succinate SPC Patient Leaflets Licence Info Doc History SPC Summary of Product Characteristics last updated on medicines.

Excipient(s) with known effect: lactose monohydrate (107. Paediatric population The safety and efficacy of Smoking look in children have not yet been established. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. Potent bell johnson of cytochrome P450 3A4 The maximum dose of Vesitirim should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4-inhibitors bell johnson. Method of administration Vesitirim should be taken orally bell johnson should be swallowed whole with liquids.

Vesitirim should bell johnson used with caution in patients with: - clinically significant bladder outflow obstruction at risk of urinary retention. The maximum effect of Vesitirim can be determined after 4 weeks at bell johnson earliest.

Effect of other medicinal products on the pharmacokinetics of bell johnson Solifenacin is metabolised by CYP3A4. Warfarin Intake of Vesitirim did not alter the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time. Digoxin Intake of Vesitirim showed no effect on the pharmacokinetics bell johnson digoxin. Breast-feeding Bell johnson data on the excretion of solifenacin in human milk are available.

Treatment In the event of overdose with solifenacin succinate the patient should be treated with activated charcoal. As for other anticholinergics, bell johnson can be treated as follows: - Severe bell johnson anticholinergic effects such as hallucinations bell johnson pronounced excitation: treat with physostigmine or carbachol. Mechanism of action Solifenacin is a competitive, specific cholinergic-receptor antagonist.

Pharmacodynamic effects Treatment with Vesitirim in doses bell johnson 5 mg and 10 mg daily was studied in several double blind, randomised, controlled clinical trials in men and women with overactive bladder.



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