OXYBUTYNIN Tablets 5 Milligram

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

OXYBUTYNIN CHLORIDE

Beschikbaar vanaf:

Generics (UK) Limited

Dosering:

5 Milligram

farmaceutische vorm:

Tablets

Autorisatie datum:

1998-09-18

Productkenmerken

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
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_Date Issued