TOFRANIL 25 mg Milligram Tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

IMIPRAMINE HYDROCHLORIDE

Prieinama:

Novartis Pharmaceuticals UK Ltd

INN (Tarptautinis Pavadinimas):

IMIPRAMINE HYDROCHLORIDE

Dozė:

25 mg Milligram

Vaisto forma:

Tablets

Autorizacija statusas:

Withdrawn

Leidimo data:

2006-03-30

Prekės savybės

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tofranil Coated Tablets 25 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg imipramine hydrochloride.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Coated tablets. 
Red-brown, biconvex, sugar coated tablet imprinted with the word
'GEIGY'.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
In the management of endogenous depression, reactive depression,
involutional depression; childhood enuresis. As an 
adjunct in the management of chronic rheumatic pain.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Depression
Adults: 1 x 25mg up to three times daily, increasing stepwise to
150-200mg. This should be reached by the end of the 
first week and maintained
until definite improvement has occurred. The subsequent maintenance dose should
be 
individually determined by gradually reducing the dosage, usually to
about 50-100mg daily.
Hospitalised patients i.e. severe cases the dose may
be increased to 100mg three times daily until a distinct 
improvement has been achieved. Again
the subsequent maintenance dose should be determined individually
by 
reducing the dosage, usually to about 100mg daily.
Elderly: Patients over 60 years of age may respond to
lower doses of Tofranil than those recommended above.
Treatment should be initiated with 10mg daily, gradually increasing
to 30-50mg daily.
The optimum dose should be reached after about 10 days and then
continued until the end of treatment.
Children: Not for use in children under 6
years. (For nocturnal enuresis only, in children under 12).
6 - 7 years (weight 20-25kg or 44-55lbs) 25mg 
8 - 11 years (weight 25-35kg or 55-77lbs) 25 - 50mg 
Over 11 years (weight 35-54kg or 77-119lbs) 50 - 75mg 
A daily dosage of 2.5mg/kg should not be exceeded in
children. The dose should be taken just before bedtime. The 
maximum