Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
OXYBUTYNIN CHLORIDE
Generics (UK) Limited
5 Milligram
Tablets
1998-09-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxybutynin Hydrochloride Tablets 5 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxybutynin hydrochloride 5 mg per tablet. For excipients see 6.1 3 PHARMACEUTICAL FORM Tablet Blue, round, biconvex, uncoated tablets, marked OB scored breakline 5 on one side and G on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Urinary incontinence, urgency and frequency in unstable bladder conditions. This may be due to idiopathic detrusor instability or due to neurogenic bladder disorders. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION General Oxybutynin tablets are for oral use and may be taken with a glass of water on an empty stomach. The tablets may also be taken during meals or with some milk if gastric irritation occurs. Adults The initial dose is 2.5mg three times daily which if necessary may be titrated to the lowest effective dosage to obtain a satisfactory clinical response. The usual dose is 5mg two or three times a day with the maximum dosage of 5mg four times a day. Elderly In the elderly the elimination half life may be increased, hence the initial dose is 2.5mg twice daily which if necessary may be titrated to the lowest effective dosage to obtain a satisfactory clinical response. A usual dose of 10mg in two divided doses is likely to be sufficient, particularly if the patient is frail. Children (older than 5 years of age) Starting with 2.5mg twice a day, the dosage should be individually titrated to the lowest effective dosage to obtain a satisfactory clinical response. The recommended dose is 0.3 - 0.4 mg/kg body weight per day, the maximum dose adapted for body-weight is stated in the following table: IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued Läs hela dokumentet