Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nortriptyline hydrochloride
Flamingo Pharma (UK) Ltd
N06AA10
Nortriptyline hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5060464500749 5060464502040
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 Đọc toàn bộ tài liệu