Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
oxybutynin (oxybutynin hydrochloride)
Recipharm Fontaine
oxybutynin (oxybutynin hydrochloride)
5mg
tablets
Prescription
SUMMARY OF PRODUCTS CHARACTERISTIC {Oxybutynin hydrochloride } Abbott Confidential information 1/6 This information is confidential 1. NAME OF THE MEDICINAL PRODUCT Driptane, 5 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of oxybutynin hydrochloride Excipients with known effect: lactose For the full list of excipients, see section ‘List of excipients’ 3. PHARMACEUTICAL FORM Tablet. Round white, biconvex tablets with a score mark on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Urinary incontinence, imperative urination or urinary frequency in unstable bladder or as a result of neurogenic bladder dysfunction (detrusor hyperreflexia) in diseases such as multiple sclerosis and spina bifida, or idiopathic detrusor instability (motor urgent urinary incontinence). It is also used for an overactive bladder that may occur after surgical operations on the bladder or prostate, or accompanying cystitis. PEDIATRIC POPULATION Oxybutynin hydrochloride may be used in children older than 5 years if: • urinary incontinence, imperative urination or urination during periods of rapid unstable bladder due to idiopathic overactive bladder or neurogenic bladder dysfunction (detrusor hyperactivity); • nocturnal enuresis associated with detrusor hyperactivity, in combination with non-drug methods of with the ineffectiveness other therapy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Internally (orally). ADULTS The standard dose is 5 mg 2-3 times a day. May increase dose to 5 mg 4 times a day to obtain a clinical response provided the tolerability of side effects. ELDERLY PATIENTS The half-life in elderly patients increases, so dose is 2.5 mg 2 times a day (especially in immunocompromised patients) usually will be adequate. To obtain the clinical-ray dose can be gradually increased to 5 mg 2 times a day, with good tolerability. CHILDREN (OVER 5 YEARS) Neurogenic bladder instability: 2.5 mg 2 times a day. To achieve Clinical effect, the do Прочитать полный документ