WARNINGSIn patients receiving another serotonin reuptake inhibitor drug in combination with monoamine oxidase inhibitors (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have discontinued that drug and have been started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, it is recommended that LUVOX Tablets not be used in combination with MAOIs, or within 14 days of discontinuing treatment with a MAOI. After stopping LUVOX Tablets, at least 2 weeks should be allowed before starting a MAOI.
PRECAUTIONS
Activiation of Mania/Hypomania: During premarketing studies involving primarily depressed patients, hypomania or mania occurred in approximately 1% of patients treated with fluvoxamine. In a 10 week pediatric OCD study, 2 out of 57 patients (4%) treated with fluvoxamine experienced manic reactions compared to none of 63 placebo patients. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorder who were treated with other marketed antidepressants. As with all antidepressants, LUVOX Tablets should be used cautiously in patients with a history of mania.
Seizures: During premarketing studies, seizures were reported in 0.2% of fluvoxamine -treated patients. LUVOX Tablets should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops Seizures.
Suicide: The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depressive or in association with another primary disorder such as O.D. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for LUVOX Tablets should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.
Use in Patients with Concomitant Illness: Closely monitored clinical experience with LUVOX Tablets in patients with concomitant systemic illness is limited. Caution is advised in administering LUVOX Tablets to patients with diseases or conditions that could affect hemodynamic responses or metabolism. LUVOX Tablets have not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were systematically excluded from many clinical studies during the product's premarketing testing. Evaluation of the electrocardiograms for patients with depression or OCD who participated in premarketing studies revealed no differences between fluvoxamine and placebo in the emergence of clinically important ECG changes.
In patients with liver dysfunction, fluvoxamine clearance was decreased by approximately 30%, LUVOX Tablets should be slowly titrated in patients with liver dysfunction during the initiation of treatment.
Interesting Stuff Your Doctor Probably Won't Tell You:
First of all, if you smoke you'll increase the metabolism of Luvox by 25%. That's out of the PI sheet, and a recent study confirms it. So you'll get more out of it and it'll make discontinuation easier. Somehow that's apt for a med that is officially approved only for OCD, as nicotine is an effective treatment for OCD, so you'll get a synergistic effect going if you're willing to risk all the crap that comes with smoking. As always when tobacco is involved I recommend cigars - way more nicotine and far less added crap. Or pipes, as you can just get a small amount of tobacco as required, and still less crap. Once again, you can tell that I'm a freak.
Secondly mixing Luvox and benzodiazepines can be really tricky. With some, like Ativan (lorazepam), there's no problem at all. But with others, like Xanax (alprazolam) and Valium (diazepam), you wind up making either or both meds work much, much better. Surprise! But you don't know how much better, and it can vary from day to day, especially with Valium, so it's not a good idea. This is spelled out in the PI sheet, but double check with your doctor and pharmacist.
Finally, and this is news to me, mixing caffeine and Luvox can be intensely unpleasant. The first study back in 1996 states, "The results indicate that intake of caffeine during fluvoxamine treatment may lead to caffeine intoxication." Your one cup of joe will suddenly become like five cups, and the effects will last six times as long. These effects have been confirmed by subsequent studies, including one that shows these effects with just 10mg of fluvoxamine. Don't mix coffee and fluvoxamine! Thanks to one this site's readers for e-mailing the first study to me.
