Driptane tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

oxybutynin (oxybutynin hydrochloride)

Available from:

Recipharm Fontaine

ATC code:

G04BD04

INN (International Name):

oxybutynin (oxybutynin hydrochloride)

Dosage:

5mg

Pharmaceutical form:

tablets

Units in package:

(30/1x30/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-10-22

Summary of Product characteristics

1/7
Abbott
Confidential information
SUMMARY OF PRODUCTS CHARACTERISTIC
Oxybutynin
hydrochloride
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, urgency and frequency in the unstable bladder,
whether due to neurogenic
bladder disorders (detrusor hyperreflexia) in conditions such as
multiple sclerosis and spina bifida, or
to idiopathic detrusor instability (motor urge incontinence).
Pediatric Population
Oxybutynin hydrochloride is indicated in children over 5 years of age
for:
-
Urinary
incontinence,
urgency
and
frequency
in
unstable
bladder
conditions
due
to
idiopathic overactive bladder or neurogenic bladder disorders
(detrusor overactivity).
-
Nocturnal enuresis associated with detrusor overactivity, in
conjunction with non-drug therapy,
when other treatment has failed.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
The usual dose is 5mg two or three times a day. This may be increased
to a maximum of 5mg four
times a day to obtain a clinical response provided that the side
effects are tolerated.
Elderly
The elimination half-life is increased in the elderly; therefore, a
dose of 2.5mg twice a day,
particularly, if the patient is frail, is likely to be adequate. This
dose may be titrated upwards to 5mg
two times a day to obtain a clinical response provided the side
effects are well tolerated.
Children (over 5 years of age)
Neurogenic bladder instability: the usual dose is 2.5mg twice a day.
This dose may be titrated upwards
to 5mg two or three times a day to obtain a clinical response provided
that the side effects are well
2/7
Abbott
Confidential information
SUMMARY OF PRODUCTS CHARACTERISTIC
O