Fluvoxamine

Source: UK SPC (eMC) for Faverin 100 mg Film-coated Tablets, §4.2 (https://www.medicines.org.uk/emc/product/6603/smpc). DEPRESSION: dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation and thereafter as judged clinically appropriate; although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose the response is insufficient some patients may benefit from a gradual increase up to a maximum of 300 mg a day. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. OCD: if a good therapeutic response is obtained, treatment can be continued at an individually adjusted dosage; OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients; long-term efficacy (more than 24 weeks) has not been demonstrated in OCD; the need for treatment should be reassessed periodically. In both indications, dosage adjustments should be made carefully on an individual patient basis to maintain patients at the lowest effective dose. DISCONTINUATION: abrupt discontinuation should be avoided — reduce the dose gradually over a period of at least one or two weeks to reduce the risk of withdrawal reactions; if intolerable symptoms occur after a dose decrease or on discontinuation, resuming the previously prescribed dose may be considered, then decreasing more gradually. ELDERLY (§4.4): no indication of clinically significant differences in normal daily dosages compared with younger subjects, but upward dose titration should be done more slowly and dosing should always be done with caution. PAEDIATRIC (not a per-kg dose, so not expressed as mg/kg — verify any under-18 use against a children's formulary): fluvoxamine should NOT be used in children and adolescents under 18 years for major depressive episode (efficacy and safety not established). For OCD in children over 8 years and adolescents there is limited data on a dose of up to 100 mg b.i.d. for 10 weeks: the starting dose is 25 mg per day, increased every 4–7 days in 25 mg increments as tolerated until an effective dose is achieved; the maximum dose in children should not exceed 200 mg/day; a total daily dose of more than 50 mg should be given in two divided doses, and if the two divided doses are not equal the larger dose should be given at bedtime. METHOD OF ADMINISTRATION: tablets should be swallowed with water and without chewing. §4.4 was truncated at the source-fetch limit and §4.5 was not retrieved in this bundle — verify the complete interactions section (interactions listed below are from §4.3 of the UK SPC and the US label's drug-interaction summary, as marked).