Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
amitriptyline hydrochloride, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
amitriptyline hydrochloride
Tablet
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 6000; hypromellose; titanium dioxide; brilliant blue FCF aluminium lake; polyvinyl alcohol; macrogol 3350
Oral
1000's, 50's, 250's
(S4) Prescription Only Medicine
For the treatment of major depression. Nocturnal enuresis where organic pathology has been excluded.
Visual Identification: Round blue coloured biconvex tablets debossed AM on one side and 10 on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-11-27
1 AUSTRALIAN PRODUCT INFORMATION – ENTRIP (AMITRIPTYLINE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Amitriptyline hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ENTRIP tablets contain 10 mg, 25 mg or 50mg of amitriptyline hydrochloride. Excipients with known effect: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ENTRIP 10 mg tablet: Round blue coloured biconvex tablets debossed AM on one side and 10 on the other side. ENTRIP 25 mg tablet: Round yellow coloured biconvex tablets debossed AM on one side and 25 on the other side. ENTRIP 50 mg tablet: Round brown coloured biconvex tablets debossed AM on one side and 50 on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the treatment of major depression. ENTRIP 50 mg tablets are indicated only for the maintenance treatment of major depression (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Nocturnal enuresis where organic pathology has been excluded. 4.2 D OSE AND METHOD OF ADMINISTRATION DEPRESSION _Dosage considerations _ 2 Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. _Initial dosage for outpatient adults _ 75 mg a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg a day. Increases are made preferably in the late afternoon and/or bedtime doses. The sedative effect is usually rapidly apparent. The antidepressant activity may be evident within three or four days or may take up to 30 days to develop adequately. Alternative methods for initiating therapy in outpatients are: begin therapy with 50 to 100 mg preferably in the evening or at bedtime; this may be increased by 25 to 50 mg as necessary to a total of 150 mg per day. _Dosage for hospitalised patients _ 100 mg a day may be required initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalised patients may need as mu Đọc toàn bộ tài liệu