Nortriptyline 10mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Nortriptyline hydrochloride

から入手可能:

Flamingo Pharma (UK) Ltd

ATCコード:

N06AA10

INN（国際名）:

Nortriptyline hydrochloride

投薬量:

10mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04030100; GTIN: 5060464500749 5060464502040

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nortriptyline 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nortriptyline hydrochloride equivalent to
nortriptyline 10mg
Excipient with known effect
The tablet also contains lactose monohydrate.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White to off-white round biconvex tablets, debossed ‘NO’ on one
side and
‘10’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nortriptyline is indicated for the treatment of Major Depressive
Episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS: The usual adult dose is 25mg three or four times daily. Dosage
should begin
at a low level (50mg once daily or 25mg 2-3 times daily). If
necessary, dose could be
gradually increased in 25mg increments no more rapidly than every
other day to be
added to the morning dose. When doses above 100mg daily are
administered,
monitoring of plasma levels of nortriptyline should be considered and
maintained in
the optimum range of 50 to 150ng/ml. Doses above 150mg per day are not
recommended.
Lower than usual dosages are recommended for elderly patients. Lower
dosages are
also recommended for outpatients than for hospitalised patients who
will be under
close supervision. The physician should initiate dosage at a low level
and increase it
gradually, noting carefully the clinical response and any evidence of
intolerance.
Following remission, maintenance medication may be required for a
longer period of
time. The maintenance dose should be the same as the optimal
therapeutic dose.
If a patient develops minor side-effects, the dosage should be
reduced. The drug
should be discontinued promptly if adverse effects of a serious nature
or allergic
manifestations occur.
ELDERLY: 30 to 50mg/day in divided doses. Dosage should begin at a low
level (10 –
20 mg daily) and be increased as required to the maximum dose of 50mg.
If it is
considered necessary to use higher dosing in an elderly pat