Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
desvenlafaxine
Medis Pharma Pty Ltd
Desvenlafaxine
Registered
Desvenlafaxine Amneal Version 3 – Jul 18 1 AUSTRALIAN PRODUCT INFORMATION - DESVENLAFAXINE AMNEAL DESVENLAFAXINE 1. NAME OF THE MEDICINE DESVENLAFAXINE AMNEAL desvenlafaxine 50 mg and 100 mg modified release tablets. DESVENLAFAXINE AMNEAL contains the active ingredient desvenlafaxine as the base drug. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Two strengths of DESVENLAFAXINE AMNEAL tablets are available, containing 50 mg and 100 mg of desvenlafaxine. Desvenlafaxine is a white to off-white crystalline powder that is practically insoluble in water and slightly soluble in ethanol and acetone. The solubility of desvenlafaxine is pH dependent. Inactive ingredients are alginic acid, citric acid monohydrate, microcrystalline cellulose, povidone, purified talc, magnesium stearate and hypromellose. The 50 mg tablets are film coated with OPADRY film coating system 03F84770 PINK (ARTG No. 109228) and the 100 mg tablets are coated with OPADRY film coating system 03F86990 BROWN (ARTG No. 109232). 3. PHARMACEUTICAL FORM DESVENLAFAXINE AMNEAL is formulated as a modified release tablet for once-a-day oral administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DESVENLAFAXINE AMNEAL is indicated for the treatment of major depressive disorder, including the prevention of relapse. DESVENLAFAXINE AMNEAL is not indicated for paediatric use. 4.2 DOSE AND METHOD OF ADMINISTRATION Desvenlafaxine should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. _INITIAL TREATMENT_ The recommended dose for desvenlafaxine is 50 mg once daily, with or without food. In clinical trials, no additional benefit was demonstrated at doses greater than 50 mg/day. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur gradually and at intervals of not less than 7 days. The maximum dose should not exceed 200 mg/day. Desvenlafaxine Amneal Version 3 – Jul 18 2 When discontinuing therapy, gradual dose reducti Baca dokumen lengkapnya
Desvenlafaxine Amneal Version 4 – Dec 19 1 AUSTRALIAN PRODUCT INFORMATION - DESVENLAFAXINE AMNEAL (DESVENLAFAXINE) 1. NAME OF THE MEDICINE Desvenlafaxine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Two strengths of DESVENLAFAXINE AMNEAL tablets are available, containing 50 mg and 100 mg of desvenlafaxine. For the full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM DESVENLAFAXINE AMNEAL is formulated as a modified release tablet for once-a-day oral administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DESVENLAFAXINE AMNEAL is indicated for the treatment of major depressive disorder, including the prevention of relapse. DESVENLAFAXINE AMNEAL is not indicated for paediatric use. 4.2 DOSE AND METHOD OF ADMINISTRATION Desvenlafaxine should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. _INITIAL TREATMENT_ The recommended dose for desvenlafaxine is 50 mg once daily, with or without food. In clinical trials, no additional benefit was demonstrated at doses greater than 50 mg/day. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur gradually and at intervals of not less than 7 days. The maximum dose should not exceed 200 mg/day. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimise discontinuation symptoms (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and Section 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)) . _MAINTENANCE/CONTINUATION/EXTENDED TREATMENT_ It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy. Patients should continue on the same dose at which Desvenlafaxine Amneal Version 4 – Dec 19 2 they were stabilised. They should be periodically reassessed to determine the need for continued treatment. CHILDREN AND ADOLESCENTS Safety and efficacy in patients less than 18 years of age have n Baca dokumen lengkapnya