DOCSLIB.ORG

Urinary-Incontinence-Treatment Executive

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Urinary-Incontinence-Treatment Executive Comparative Effectiveness Review Number 36 Effective Health Care Program Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness Executive Summary Background Effective Health Care Program Urinary incontinence (UI) is the The Effective Health Care Program involuntary loss of urine.1 About was initiated in 2005 to provide 25 percent of young women,2 44 to valid evidence about the comparative to 57 percent of middle-aged and effectiveness of different medical postmenopausal women,3 and about interventions. The object is to help 75 percent of older women experience consumers, health care providers, some involuntary urine loss.4 UI can and others in making informed affect women’s physical, psychological, choices among treatment alternatives. and social well-being, and sometimes Through its Comparative Effectiveness imposes significant lifestyle restrictions. Reviews, the program supports The effects of UI range from slightly systematic appraisals of existing bothersome to debilitating. scientific evidence regarding The cost of incontinence care in the treatments for high-priority health United States averaged $19.5 billion conditions. It also promotes and in 2004.5 Six percent of nursing home generates new scientific evidence by admissions of older women are identifying gaps in existing scientific attributable to UI,5 and by one estimate, evidence and supporting new research. the annualized cost of women’s nursing The program puts special emphasis home admissions due to UI was on translating findings into a variety $3 billion.6 of useful formats for different Nonpharmacological therapies target stakeholders, including consumers. strengthening the pelvic floor and The full report and this summary are changing behaviors that influence bladder available at www.effectivehealthcare. function, whereas pharmacological ahrq.gov/reports/final.cfm. therapies address innervating the bladder and sphincter. The etiology of incontinence is multifactorial; risk factors constipation.7 Assessments of women include age, pregnancy, pelvic floor complaining of UI begin with exclusion trauma after vaginal delivery, menopause, of underlying causes such as pelvic organ hysterectomy, obesity, urinary tract prolapse, urinary tract infection, and poor infections, functional and/or cognitive bladder emptying,8 all of which are beyond impairment, chronic cough, and the scope of this review, as is neurogenic Effective Health Care 1 UI associated with spinal cord injury or stroke.9 We focus stress UI, surgical treatments.1 In addition, several drugs specifically on women with stress UI associated with have been approved for adults with overactive bladder, sphincter function, and with urgency UI, often associated with or without urgency UI.1 Clinical interventions to with overactive bladder (Table 1 in the full report). reduce the frequency of UI episodes in women have been 8,11 Incontinence types are distinguished by their baseline extensively reviewed in recent years, but the reviews mechanisms. Stress incontinence is associated with did not emphasize continence or women’s perceptions of impaired sphincter function, and results in an inability treatment success and satisfaction. Continence (complete 9 voluntary control of the bladder) has been considered a to retain urine during coughing or sneezing. Urgency 8,12 incontinence is defined as involuntary loss of urine primary goal in UI treatment and is the most important outcome associated with quality of life in women with associated with the sensation of a sudden compelling urge 13 9 UI; yet, it is rarely examined as a primary outcome in to void that is difficult to defer. Mixed UI is the term 14 applied when both stress and urgency UI are present. These syntheses of evidence. Thus, we focus on continence and definitions reflect the consensus definitions developed quality of life as primary outcomes for this Comparative by the International Urogynecological Association/ Effectiveness Review. International Continence Society.9 Overactive bladder is While definitions of continence are similar, the definitions defined as urinary urgency with or without incontinence, most commonly applied to improvement in UI vary and usually accompanied by frequency and nocturia (the need include different degrees of change in frequency and to urinate at night).9 Approximately one-third of women severity of symptoms.15 Furthermore, improvement with overactive bladder also experience urgency UI. in UI has been viewed very differently by women and The types of UI imply different attendant risk factors by researchers. Women define improvement according and recommended treatments; however, UI etiology to reduced lifestyle restrictions or improved overall is frequently mixed.8 Stress UI is more common in perception of bladder symptoms, especially resolution of younger women in association with pelvic floor trauma urine leakage, whereas researchers define improvement as and uterine prolapse, both of which are often related to a decrease in the amount of lost urine during pad tests, or 7 any statistically significant decrease in the frequency of vaginal delivery and may require surgical treatments. 15 Urgency and mixed UI are more common in older women UI episodes. Treatments for overactive bladder aim to in association with overactive bladders with or without decrease the frequency and intensity of urgency sensations, sphincter dysfunction.1,7 as well as the frequency of urgency UI episodes. Previous reviews of treatments for overactive bladder have Although UI can be diagnosed based on patients’ reports of considered clinical success as any statistically significant involuntary urine leakage,7 researchers have also proposed decrease in the frequency of UI episodes and voiding, clinical methods for objective diagnosis of different UI irrespective of whether women perceived improvement.14 types. Urodynamic diagnosis of pure stress UI without Measurement of treatment outcomes should be patient detrusor overactivity has demonstrated usefulness for centered and based on factors important to women, rather women undergoing surgery for stress UI.9 Diagnostic than on the results of invasive tests.12 Thus, treatment studies use multichannel urodynamics as a reference success and failure should be evaluated according to standard test to compare with noninvasive tests applicable what women report in validated questionnaires or scales. to ambulatory care. However, researchers disagree on Ultimately, discussions of UI are complicated by the wide whether urodynamic examination represents the gold variety of measures used to describe the problem and its standard for UI diagnosis.8 Furthermore, urodynamic treatment outcomes. This review examines improvement examination is not possible in ambulatory primary care. thresholds of clinical importance in validated scales Previously published systematic reviews have reported a and checklists that can be applied to judge UI treatment weak association between urodynamic test results and self- success according to women’s own perceptions. reported symptoms,10 but these reviews did not focus on the most appropriate methods to distinguish different types This report synthesizes published evidence about of UI in ambulatory care settings. The role of invasive diagnosis and management of UI in adult women. We diagnostic methods in predicting which patients will focused on adult women in ambulatory care settings benefit from specific treatments for UI remains unclear. and on nonsurgical nonpharmacological treatments and pharmacological agents available in the United States. Standard UI treatments for women include lifestyle This report is intended as a companion piece to an earlier changes, pelvic floor muscle training, and, for predominant Evidence-based Practice Center report7 that examined a 2 wide range of treatment alternatives, including surgery. self-reports of UI during a clinical examination, We focus on techniques appropriate to primary care pad tests, and ultrasound—when compared with ambulatory practice and nonsurgical interventions for multichannel urodynamics? women with refractory UI. 2. What are the diagnostic values of different methods— Our report also addresses the role of urodynamic testing, questionnaires, checklists, scales, self-reports of which is not typically performed in primary care. We UI during a clinical examination, pad tests, and include it here primarily as background information ultrasound—when compared with a bladder diary? for primary care practitioners, and because it raises 3. What are the diagnostic values of the methods listed a conundrum. As we have emphasized, the primary above for different types of UI, including stress, outcome for UI should be patient-centered reports of the urgency, and mixed incontinence? UI experience, especially the presence or absence of UI. Although we typically think of physiological testing as 4. What is the association between patient outcomes more objective than patient reports, these results are, at (continence, severity and frequency of UI, quality of best, akin to intermediate outcomes. In the diagnostic life) and UI diagnostic methods? context, physiological testing can inform in one of three Key Question 2. How effective is the pharmacological ways: (1) establishing a diagnosis, (2) determining an treatment of UI in women? etiology with therapeutic implications, and (3) generating a prognosis. In the case of UI, it is unclear whether 1. How do pharmacologic treatments affect continence,
Load more

Recommended publications
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.
    [Show full text]
  • Solifenacin Succinate Tablets PI
    465mm (18.31”) 32mm (1.26”) HIGHLIGHTS OF PRESCRIBING • Gastrointestinal Disorders: Use with 3 DOSAGE FORMS AND STRENGTHS Table 1. Percentages of Patients With Identified Adverse Reactions, Derived From Multiple dose studies of solifenacin succinate in elderly volunteers (65 to 80 years) FDA Approved Patient Labeling FDA Approved Patient Labeling INFORMATION caution in patients with decreased Solifenacin succinate tablets are available as follows: All Adverse Events Exceeding Placebo Rate and Reported by 1% or More Patients showed that Cmax, AUC and t1/2 values were 20 to 25% higher as compared to the These highlights do not include gastrointestinal motility (5.3) 5 mg – white, round, standard, normal convex, film-coated, unscored tablets, debossed for Combined Pivotal Studies younger volunteers (18 to 55 years). Solifenacin Succinate Tablets Solifenacin Succinate Tablets all the information needed to • Central Nervous System Effects: with “TV” on one side of the tablet and with “2N” on the other side of the tablet. Placebo Solifenacin Succinate Solifenacin Succinate 8.6 Renal Impairment Read the Patient Information that comes with Read the Patient Information that comes with use SOLIFENACIN SUCCINATE Somnolence has been reported with 10 mg – light-pink to pink, round, standard, normal convex, film-coated, unscored (%) 5 mg (%) 10 mg (%) Solifenacin succinate should be used with caution in patients with renal impairment. TABLETS safely and effectively. solifenacin succinate tablets before you start solifenacin succinate tablets before you start solifenacin succinate. Advise patients not tablets, debossed with “TV” on one side of the tablet and with “3N” on the other side Number of Patients 1216 578 1233 There is a 2.1 fold increase in AUC and 1.6 fold increase in t1/2 of solifenacin in patients See full prescribing information for to drive or operate heavy machinery until of the tablet.
    [Show full text]
  • Solifenacin-Induced Delirium and Hallucinations☆
    General Hospital Psychiatry 35 (2013) 682.e3–682.e4 Contents lists available at ScienceDirect General Hospital Psychiatry journal homepage: http://www.ghpjournal.com Case Report Solifenacin-induced delirium and hallucinations☆ Matej Štuhec, Pharm.D. ⁎ Ormoz Psychiatric Hospital, Department for Clinical Pharmacy, Slovenia, Ptujska Cesta 33, Ormoz, Slovenia article info abstract Article history: Solifenacin-induced cognitive adverse effects have not been reported frequently, but solifenacin-induced Received 11 April 2013 delirium and hallucinations with successful switching to darifenacin, without additional drug, have not been Revised 5 June 2013 reported in the literature. In this case report, we present an 80-year-old Caucasian male with insomnia and Accepted 5 June 2013 anxiety symptoms and overactive bladder who developed delirium and hallucinations when treated with Keywords: solifenacin and trazodone. After solifenacin discontinuation and switching to darifenacin, symptoms significantly improved immediately. Such a case has not yet been described in literature; however, an Solifenacin Delirium adverse effect associated with solifenacin can occur, as this report clearly demonstrates. Hallucinations © 2013 Elsevier Inc. All rights reserved. Darifenacin Antimuscarinic adverse effect Case report 1. Introduction tion of Diseases, 10th Revision (ICD-10)], and depression with psychotic features was ruled out with differential diagnosis. Patient reported Solifenacin is a competitive muscarinic receptor antagonist, which insomnia, fear, fatigue, nausea, chest pain, shortness of breath and is used for overactive bladder (OAB) treatment. It acts as an headache. Solifenacin (Vesicare) 5 mg daily in morning dose was antimuscarinic agent, showing the highest affinity for the muscarinic prescribed to him 1 week earlier by his physicians because of OAB. M(3) receptor, which mediates urinary bladder contraction.
    [Show full text]
  • 1: Gastro-Intestinal System
    1 1: GASTRO-INTESTINAL SYSTEM Antacids .......................................................... 1 Stimulant laxatives ...................................46 Compound alginate products .................. 3 Docuate sodium .......................................49 Simeticone ................................................... 4 Lactulose ....................................................50 Antimuscarinics .......................................... 5 Macrogols (polyethylene glycols) ..........51 Glycopyrronium .......................................13 Magnesium salts ........................................53 Hyoscine butylbromide ...........................16 Rectal products for constipation ..........55 Hyoscine hydrobromide .........................19 Products for haemorrhoids .................56 Propantheline ............................................21 Pancreatin ...................................................58 Orphenadrine ...........................................23 Prokinetics ..................................................24 Quick Clinical Guides: H2-receptor antagonists .......................27 Death rattle (noisy rattling breathing) 12 Proton pump inhibitors ........................30 Opioid-induced constipation .................42 Loperamide ................................................35 Bowel management in paraplegia Laxatives ......................................................38 and tetraplegia .....................................44 Ispaghula (Psyllium husk) ........................45 ANTACIDS Indications:
    [Show full text]
  • 170 Limited Use of Anticholinergic Drugs For
    170 Penning-van Beest F1, Sukel M1, Reilly K2, Kopp Z2, Erkens J1, Herings R1 1. PHARMO Institute, 2. Pfizer Inc LIMITED USE OF ANTICHOLINERGIC DRUGS FOR OVERACTIVE BLADDER: A PHARMO STUDY Hypothesis / aims of study The aim of the study was to determine the prevalence of use of anticholinergic drugs for overactive bladder (OAB) in men and women in the Netherlands in the period 1998-2003. Study design, materials and methods Data were obtained from the PHARMO Record Linkage System, which includes patient centric data of drug-dispensing records and hospital records of more than one million patients in the Netherlands. Currently four anticholinergic drugs are available on the Dutch market for the treatment of OAB: tolterodine immediate release (IR), since 1998, tolterodine extended release (ER), since 2001, oxybutynin, since 1986, and flavoxate, since 1979. All patients who were ever prescribed these OAB drugs in the period January 1998 until December 2003 were included in the study cohort. The prevalence of use of tolterodine ER, tolterodine IR, oxybutynin and flavoxate was determined per calendar year, stratified by gender, by counting the number of patients having a dispensing with a duration of use including a single fixed day a year. Results The number of OAB drug users included in the study cohort increased from about 3,800 in 1998 to 5,000 in 2003. About 60% of the OAB drug users in the study cohort were women and about 42% of the OAB drug users were 70 years or older. The use of OAB drugs increased from 100 users per 100,000 men in 1998 to 140 users per 100,000 men in 2003 (table).
    [Show full text]
  • Magellan Anticholinergic Risk Scale
    Magellan Anticholinergic Risk Scale 1 POINT 2 POINTS 3 POINTS GENERIC BRAND GENERIC BRAND GENERIC BRAND Alprazolam Xanax® Amantadine Symmetrel® Amitriptyline Elavil® Aripiprazole Abilify® Baclofen Lioresal® Amoxapine Asendin® Asenapine Saphris® Carbamazepine Tegretol® Atropine -- Captopril Capoten® Carisoprodol Soma® Benztropine Cogentin® Chlordiazepoxide Librium® Cetirizine Zyrtec® Brompheniramine Respa-BR® Chlorthalidone Diuril® Cimetidine Tagamet® Carbinoxamine Arbinoxa® Clonazepam Klonopin® Clidinium & Librax® Chlorpheniramine Chlor-Trimeton® Chlordiazepoxide Clorazepate Tranxene® Cyclizine Cyclivert® Chlorpromazine Thorazine® Codeine -- Cyclobenzaprine Flexeril® Clemastine Tavist® Diazepam Valium® Cyproheptadine Periactin® Clomipramine Anafranil® Digoxin Lanoxin® Disopyramide Norpace® Clozapine Clozaril® Dipyridamole Persantine® Fluphenazine Prolixin® Darifenacin Enablex® Famotidine Pepcid® Loperamide Diamode® Desipramine Norpramin® Fentanyl Duragesic® Loratadine Claritin® Dicyclomine Bentyl® Fluoxetine Prozac® Loxapine Loxitane® Dimenhydrinate Dramamine® Flurazepam Dalmane® Meperidine Demerol® Diphenhydramine Benadryl® Fluvoxamine Luvox® Methocarbamol Robaxin® Doxepin Sinequan® Furosemide Lasix® Oxcarbazepine Trileptal® Flavoxate Urispas® Haloperidol Haldol® Pimozide Orap® Glycopyrrolate Robinul® Hydralazine Apresoline® Prochlorperazine Compazine® Hydroxyzine Atarax® Iloperidone Fanapt® Pseudoephedrine Sudafed® Hyoscyamine Anaspaz® Isosorbide Imdur® Quetiapine Seroquel® Imipramine Tofranil® Mirtazapine Remeron® Trimethobenzamide
    [Show full text]
  • 121 Comparative Evaluation of Human Mucosa And
    121 Oki T1, Luvsandorj O1, Suzuki K1, Kageyama A1, Otsuka A2, Shinbo H2, Ozono S2, Yamada S1 1. Department of Pharmacokinetics and Pharmacodynamics, Sch of Pharm Sci, University of Shizuoka, 2. Department of Urology, Hamamatsu University School of Medicine COMPARATIVE EVALUATION OF HUMAN MUCOSA AND DETRUSOR MUSCARINIC RECEPTOR BINDING BY ANTICHOLINERGIC AGENTS IN THE TREATMENT OF OVERACTIVE BLADDER Hypothesis / aims of study The urothelium is the epithelial lining of the urinary tract. Our traditional understanding of the function of this region was simply that of passive barrier between the urinary tract and its contents. In recent years, the urothelium exhibits neuron-like properties that contribute to sensory function. Although the function of such an innervation may be unclear, recent studies in humans and animals have indicated that muscarinic receptors (mAChRs) are present on both mucosa and detrusor of the urinary bladder [1, 2]. The mucosal mAChRs may represent a novel site of action of agents for the treatment of bladder disorders. Anticholinergic agents such as oxybutynin and propiverine are widely used for the treatment of overactive bladder. Tolterodine and darifenacin have been currently developed as novel anticholinergic agents that may exhibit pharmacological selectivity in the bladder. Furthermore, oxybutynin, propiverine and tolterodine are metabolized in the intestine and liver to form active metabolites, N-desethyl-oxybutynin (DEOB), 1- methyl-4-piperidyl benzilate N-oxide (DPr-P-4(N→O)) and 5-hydroxymethyl metabolite (5-HM), respectively. Although these metabolites are assumed to contribute to the mAChR blockade of parent compounds, their mAChR binding characteristics in the mucosa have not been examined.
    [Show full text]
  • Guideline for Preoperative Medication Management
    Guideline: Preoperative Medication Management Guideline for Preoperative Medication Management Purpose of Guideline: To provide guidance to physicians, advanced practice providers (APPs), pharmacists, and nurses regarding medication management in the preoperative setting. Background: Appropriate perioperative medication management is essential to ensure positive surgical outcomes and prevent medication misadventures.1 Results from a prospective analysis of 1,025 patients admitted to a general surgical unit concluded that patients on at least one medication for a chronic disease are 2.7 times more likely to experience surgical complications compared with those not taking any medications. As the aging population requires more medication use and the availability of various nonprescription medications continues to increase, so does the risk of polypharmacy and the need for perioperative medication guidance.2 There are no well-designed trials to support evidence-based recommendations for perioperative medication management; however, general principles and best practice approaches are available. General considerations for perioperative medication management include a thorough medication history, understanding of the medication pharmacokinetics and potential for withdrawal symptoms, understanding the risks associated with the surgical procedure and the risks of medication discontinuation based on the intended indication. Clinical judgement must be exercised, especially if medication pharmacokinetics are not predictable or there are significant risks associated with inappropriate medication withdrawal (eg, tolerance) or continuation (eg, postsurgical infection).2 Clinical Assessment: Prior to instructing the patient on preoperative medication management, completion of a thorough medication history is recommended – including all information on prescription medications, over-the-counter medications, “as needed” medications, vitamins, supplements, and herbal medications. Allergies should also be verified and documented.
    [Show full text]
  • Anticholinergics for Overactive Bladder Evidence, Clinical Issues and Comparisons
    Anticholinergics for Overactive Bladder Evidence, Clinical Issues and Comparisons RxFiles Academic Detailing Program March 2008 Saskatoon City Hospital 701 Queen Street, Saskatoon, SK S7K 0M7 www.RxFiles.ca Recent Guidelines: Overactive Bladder – Background • Special caution should be used for the elderly who Canadian Urological1: • Overactive bladder (OAB) is also known as urge are especially sensitive to side effects from ACs. Can J Urol. 2006;13(3):3127-38 incontinence and occurs when there is an inability Some with dementia or cognitive impairment may 2 not tolerate ACs at all. If using an AC in the NICE (UK) 2006 : to delay voiding when an urge is perceived. elderly, start at the lowest dose, titrate up and www.nice.org.uk/nicemedia/pdf/CG • OAB is differentiated from stress urinary 40fullguideline.pdf reassess for effectiveness and adverse effects. incontinence (SUI) which is associated with a loss of Remember that many drugs contribute to the total urine secondary to intra-abdominal pressure such as anticholinergic load (e.g. antidepressants, antipsychotics).14 Systematic Reviews: occurs with coughing, sneezing and exercise.9 Cochrane: Hay-Smith J et al. • ACs should not be used with acetylcholinesterase • Anticholinergics (ACs) are useful drugs for Which anticholinergics drug for inhibitors (e.g. ARICEPT, REMINYL, EXELON) given treating OAB, however their use is limited by the overactive bladder symptoms in their opposing mechanisms.23 adults. Cochrane Systematic side effects of dry mouth and constipation. 3 Reviews 2005, Issue 3. 4 Oregon 2005 : Are non-drug treatment options effective? Oxybutynin (Oxy) vs Tolterodine (Tol) • A Cochrane systematic review found 3: www.ohsu.edu/drugeffectiveness/rep • Bladder training (a gradual time lengthening orts/documents/OAB%20Final%20 no statistically significant differences for Report%20Update%203.pdf between voids) or urge suppression may be useful 10 patient perceived improvement, leakage Canada in OAB, especially in addition to ACs.
    [Show full text]
  • Vesicare (Solifenacin Succinate)
    VESIcare® (solifenacin succinate) Tablets Description VESIcare® (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4­ dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2•C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each VESIcare tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each VESIcare tablet also contains the following inert ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg VESIcare tablet) or red ferric oxide (10 mg VESIcare tablet). Clinical Pharmacology Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion. Pharmacokinetics Absorption After oral administration of VESIcare to healthy volunteers, peak plasma levels (Cmax) of solifenacin are reached within 3 to 8 hours after administration, and at steady state ranged from 32.3 to 62.9 ng/mL for the 5 and 10 mg VESIcare tablets, respectively. The absolute bioavailability of solifenacin is approximately 90%, and plasma concentrations of solifenacin are proportional to the dose administered. Effect of food There is no significant effect of food on the pharmacokinetics of solifenacin.
    [Show full text]
  • CONTRAINDICATIONS ------Pediatric Patients (486 on DETROL LA, 224 on Placebo) Is Available
    HIGHLIGHTS OF PRESCRIBING INFORMATION • Controlled Narrow-Angle Glaucoma: use caution in patients being These highlights do not include all the information needed to use Detrol® treated for narrow-angle glaucoma. (5.3) LA safely and effectively. See full prescribing information for Detrol LA. • Myasthenia Gravis: use caution in patients with myasthenia gravis. (5.6) • QT Prolongation: Consider observations from the thorough QT study in ® Detrol LA (tolterodine tartrate extended release capsules) clinical decisions to prescribe DETROL LA to patients with a known For oral administration history of QT prolongation or to patients who are taking Class IA (e.g., Initial U.S. Approval: December 2000 quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications (5.7) ----------------------------INDICATIONS AND USAGE--------------------------- Detrol LA is an antimuscarinic indicated for the treatment of overactive ------------------------------ADVERSE REACTIONS------------------------------- bladder with symptoms of urge urinary incontinence, urgency, and frequency. The most common adverse reactions (incidence >4% and >placebo) were dry (1) mouth , headache, constipation and abdominal pain. (6.1) ----------------------DOSAGE AND ADMINISTRATION----------------------- • 4 mg capsules taken orally once daily with water and swallowed To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at whole. (2.1) 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. • 2 mg capsules taken orally once daily with water and swallowed whole in the presence of: ------------------------------DRUG INTERACTIONS------------------------------- o mild to moderate hepatic impairment (Child-Pugh • Potent CYP3A4 inhibitors: Co-administration may increase systemic class A or B) (2.2) exposure to DETROL LA. Reduce DETROL LA dose to 2 mg once o severe renal impairment [Creatinine Clearance (CCr) daily.
    [Show full text]
  • Solifenacin Succinate Tablets, 5 Mg and 10 Mg
    Solifenacin Succinate Tablets, 5 mg and 10 mg S.No. Category Question Answer Clinical Particulars 1 Use/Indication What is the product Solifenacin succinate tablet is a muscarinic antagonist indicated for? indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency 2 Dosage What is the • 5 mg tablet taken once daily, and if well tolerated may be recommended increased to 10 mg once daily. dosage? • Do not exceed 5 mg tablet once daily in patients with: Severe renal impairment [Creatinine Clearance](CLcr <30 ml/min). Moderate hepatic impairment (Child-Pugh B). Concomitant use of potent CYP3A4 inhibitors. • Use of solifenacin succinate tablets is not recommended in patients with severe hepatic impairment (Child-Pugh C) 3 Administration What do I do if I If you miss a dose of solifenacin succinate tablets, begin miss a dose? taking solifenacin succinate tablets again the next day. Do not take 2 doses of solifenacin succinate tablets the same day. 4 Administration Use in Pediatric The safety and effectiveness of solifenacin succinate in Population pediatric patients have not been established. 5 Administration Use in Geriatric No overall differences in safety and efficacy were Population observed between these patients and younger patients. 6 Mechanism Mechanism of Solifenacin is a competitive muscarinic receptor Action antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion. 7 Warning Black Box Warning No black box warning 8 Lactation Use in Lactation Solifenacin succinate should not be administered during nursing.
    [Show full text]