Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Viatris Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276
LUVOX Fluvoxamine maleate.
| Pharmaceutical Form |
|---|
|
UVOX (fluvoxamine maleate) 50 mg: Round, biconvex, scored, white to off-white film coated tablet inscribed on one face with 291 on either side of the score line and other face plain. LUVOX (fluvoxamine maleate) 100 mg: Oval, biconvex, scored, white to off-white film coated tablet inscribed on one face with 313 on either side of the score line and other face plain. |
Each tablet of LUVOX contains 50 mg or 100 mg of fluvoxamine maleate.
Fluvoxamine is a member of a class of antidepressant agents known as selective serotonin reuptake inhibitors (SSRI). It is chemically unrelated to the tricyclic antidepressants, and to other serotonin reuptake inhibitors as it is a monocyclic compound.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
MW = 434.4
Fluvoxamine maleate is chemically identified as (E)-5-methoxy-4’-trifluoromethylvalerophenone 0-2-aminoethyloxime maleate.
Fluvoxamine maleate is a white to slightly off-white, odourless, crystalline powder, sparingly soluble in water, freely soluble in ethanol and chloroform, practically insoluble in diethylether. It has a partition coefficient (noctanol/water, own pH) P=38.7.
CAS Number: 61718-82-9
| Active Ingredient | Description | |
|---|---|---|
| Fluvoxamine |
The mechanism of action of fluvoxamine is thought to be related to selective serotonin re-uptake inhibition in brain neurones. There is minimum interference with noradrenergic processes. Receptor binding studies have demonstrated that fluvoxamine has negligible binding capacity to alpha adrenergic, beta adrenergic, histaminergic, muscarine cholinergic, dopaminergic or serotonergic receptors. |
| List of Excipients |
|---|
|
The inactive ingredients are: mannitol, maize starch, pregelatinised potato starch, sodium stearylfumarate, colloidal anhydrous silica, hypromellose, macrogol 6000, purified talc, titanium dioxide. |
LUVOX tablets are available in blister packs (PVC/PVDC/Al).
50 mg tablets: packs of 60^*^, 30 and 10 (sample pack).
100 mg tablets: packs of 30 and 10 (sample pack).
* Not distributed in Australia
AUST R 57632 – LUVOX fluvoxamine maleate 50mg tablet blister pack.
AUST R 57633 – LUVOX fluvoxamine maleate 100mg tablet blister pack.
Viatris Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276
1/04/1997
| Drug | Countries | |
|---|---|---|
| LUVOX | Australia, Brazil, Canada, Ecuador, Japan, Mexico, New Zealand, South Africa |
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