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Fluvoxamine maleateThis page contains recent news articles, when available, and an overview of Fluvoxamine maleate but does not offer medical advice. You should contact your physician with regard to any health issues or concerns.Overview: Fluvoxamine maleate (when available) Fluvoxamine is one of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). It is used to treat the depression associated with mood disorders. It is also used on occassion in the treatment of body dysmorphic disorder and anxiety. The antidepressant, antiobsessive-compulsive, and antibulimic actions of Fluvoxamine are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. In vitro studies show that Fluvoxamine is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. Fluvoxamine has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors; antagonism of such receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. The chronic administration of Fluvoxamine was found to downregulate brain norepinephrine receptors, as has been observed with other drugs effective in the treatment of major depressive disorder. Fluvoxamine does not inhibit monoamine oxidase. For treatment of depression and for Obsessive Compulsive Disorder (OCD) Mechanism Of Action: The antidepressant, antiobsessive-compulsive, and antibulimic actions of Fluvoxamine are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. Fluvoxamine blocks the reuptake of serotonin at the serotonin reuptake pump of the neuronal membrane, enhancing the actions of serotonin on 5HT1A autoreceptors. SSRIs bind with significantly less affinity to histamine, acetylcholine, and norepinephrine receptors than tricyclic antidepressant drugs. News Articles on Fluvoxamine FDA Safety Changes: Luvox, Tigan, Lotronex - Aug 27, 2008 Identify the risk associated with concomitant use of fluvoxamine maleate and anticoagulants. Describe dose adjustments that should be considered in renally Medscape (subscription) Jazz Pharmaceuticals Inc reports offering of common shares - Jul 17, 2008 The company plans to use the net proceeds primarily to fund commercial activities in support of Once Daily LUVOX CR (fluvoxamine maleate) Extended Release Trading Markets (press release), Jazz Pharmaceuticals Announces $26.0 Million Registered Direct ... - Jul 16, 2008 ...from this offering primarily to fund commercial activities in support of Once Daily LUVOX(R) CR (fluvoxamine maleate) Extended Release Capsules, PharmaLive.com (press release), Pharmacotherapeutic Options for the Treatment of Depression in ... - Jul 20, 2008 Efficacy and pharmacokinetics of fluvoxamine maleate in patients with mild depression undergoing hemodialysis. Psychiatry and Clinical Neurosciences, 58, RedOrbit, MEIJI SEIKA OFFERS ANTIDEPRESSANT DEPROMEL IN 75MG TABLETS - Jun 30, 2008 Depromel is Meiji Seika's brand name for fluvoxamine maleate. Meiji Seika developed the compound in cooperation with Solvay Seiyaku KK, which has also Trading Markets (press release), Jazz Pharmaceuticals, Inc. Announces First Quarter 2008 Financial ... - May 14, 2008 Once-Daily LUVOX CR(R) (fluvoxamine maleate) Extended-Release Capsules was approved by the US Food and Drug Administration (FDA) on February 28, PharmaLive.com (press release), Jazz Pharmaceuticals' LUVOX CR Is Now Available for Patients With ... - Apr 14, 2008 LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients. Earthtimes, FDA Approves LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release ... - Feb 28, 2008 LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients. PR-Inside.com (Pressemitteilung), /CORRECTION -- Jazz Pharmaceuticals, Inc./ - Feb 29, 2008 ..."The approval of Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules for social anxiety disorder and obsessive compulsive disorder is FOXBusiness Once-Daily Fluvoxamine Approved for Treatment of SAD and OCD - Mar 7, 2008 Identify the appropriate indications for once-daily, controlled-release fluvoxamine maleate capsules. Describe the appropriate use of fluvoxamine Medscape (subscription) Solvay Gets Good News on Luvox CR - Mar 4, 2008 Solvay granted US marketing rights for Luvox CR (fluvoxamine maleate) to Jazz Pharmaceuticals in January 2007. Last December, the FDA issued a second FDA news (subscription), Theravance falls most since going public - Mar 4, 2008 The product is called Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules offers proven efficacy and tolerability in SAD and OCD. San Jose Mercury News, Jazz Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year ... - Feb 14, 2008 The increase in both periods was primarily due to spending in preparation for the anticipated launch of Once-A-Day LUVOX CR (fluvoxamine maleate) Lifescience-online, Jazz Pharmaceuticals, Inc. Announces Submission of Complete ... - Feb 1, 2008 LUVOX CR is an extended-release formulation of fluvoxamine maleate, a selective serotonin reuptake inhibitor. Jazz Pharmaceuticals, Inc. is a specialty FOXBusiness JAZZ: FDA Accepts Complete Response re Approvable Letter for LUVOX ... - Feb 1, 2008 ...of the response by Solvay Pharmaceuticals, Inc. to the FDA approvable letter for Once-A-Day LUVOX(R) CR (fluvoxamine maleate) Extended-Release Capsules. Trading Markets (press release), Jazz Pharmaceuticals, Inc. Announces Third Quarter 2007 Financial ... - Nov 6, 2007 The increase was primarily due to spending in preparation for the anticipated launch of Luvox(R) CR (fluvoxamine maleate extended release capsules), CNNMoney.com FDA Accepts Complete Responses to Approvable Letters for Luvox - Aug 3, 2007 FDA news (subscription),The new drug application for Luvox CR (fluvoxamine maleate) seeks marketing approval for the treatment of obsessions and compulsions in patients with Antidepressants linked to suicide risk in young adults - May 5, 2007 Food Consumer,Prozac (fluoxetine), Zoloft (sertraline), and fluvoxamine maleate are approved for use in children and adolescents for the treatment of obsessive compulsive FDA - all antidepressants need new warning labels - May 3, 2007 News-Medical.net,Products involved include: Anafranil, Asendin, Aventyl, Celexa, Cymbalta, Desyrel, Elavil, Effexor, Emsam, Etrafon, fluvoxamine maleate, Lexapro, Limbitrol, Caraco says gets approval to market fluvoxamine maleate Feb 24, 2006 ...(CPD.A: Quote, Profile, Research) on Friday said the US Food and Drug Administration has approved marketing of its fluvoxamine maleate tablets for patients ... - Reuters Caraco Pharmaceutical Laboratories Ltd. Announces FDA Approval to ... Feb 27, 2006 US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Fluvoxamine Maleate 25mg, 50mg ... - dBusinessNews Detroit, Caraco gets go-ahead for generic Luvox Feb 27, 2006 The FDA has granted final approval for Detroit-based Caraco Pharmaceutical to market fluvoxamine maleate 25mg, 50mg and 100mg strength tablets for the ... - Pharmaceutical Business Review (PRN) - GoJet Pilots Unanimously Choose Teamster Representation .. ... Feb 24, 2006 Obesity ... [+. PRN) - Caraco Pharmaceutical Laboratories Ltd. Announces FDA Approval to Market Fluvoxamine Maleate Tablets ... [+. PRN ... - Bolsamania.com, Caraco OK'd for generic OCD drug Feb 24, 2006 DETROIT, Feb. 24 (UPI) -- Caraco said Friday it is OK'd to sell fluvoxamine maleate tablets, equivalent to formerly marketed Solvay's Luvox. ... - United Press International Brand Names/Synonyms: Fluvoxamine maleate is also known by the following brand names and/or synonymsCHEMBANK1746; Dumirox; Faverin; Fevarin; Floxyfral; Fluvoxamina [Inn-Spanish]; Fluvoxamine; Fluvoxamine Maleate; Fluvoxaminum [Inn-Latin]; Luvox; MK-264; Maveral Drug Category: Fluvoxamine maleate is categorized under the following by the FDA: Antidepressants; Anti-anxiety Agents; Second-Generation; Selective Serotonin Reuptake Inhibitors (SSRIs); ATC:N06AB08 Dosage Forms: TABLET Absorption: Well absorbed, bioavailability of fluvoxamine maleate is 53%. Interactions: Interactions for Fluvoxamine: Potential for Interaction with Monoamine Oxidase Inhibitors In 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 Fluvoxamine Tablets not be used in combination with MAOIs, or within 14 days of discontinuing treatment with a MAOI. After stopping Fluvoxamine Tablets, at least 2 weeks should be allowed before starting a MAOI. Potential Terfenadine, Astemizole, and Cisapride Interactions Terfenadine, astemizole and cisapride are all metabolized by the cytochrome P450IIIA4 isozyme, and it has been demonstrated that ketoconazole, a potent inhibitor of IIIA4, blocks the metabolism of these drugs, resulting in increased plasma concentrations of parent drug. Increased plasma concentrations of terfenadine, astemizole, and cisapride cause QT prolongation and have been associated with torsades de pointes-type ventricular tachycardia, sometimes fatal. As noted below, a sub- for fluvoxamine in combination with alprazolam, a drug that is known to be metabolized by the IIIA4 isozyme. Although it has not been definitively demonstrated that fluvoxamine is a potent IIIA4 inhibitor, it is likely to be, given the substantial interaction of fluvoxamine with alprazolam. Consequently, it is recommended that fluvoxamine not be used in combination with either terbinafine, astemizole, or cisapride. Other Potentially Important Drug Interactions: Benzodiazepines: Benzodiazepines metabolized by hepatic oxidation (e.g., alprazolam, midazolam, triazolam elc.) should be used with caution because the clearance of these drugs is likely to be reduced by fluvoxamine. The clearance of benzodiazepines metabolized by glucuronidation (e. g., lorazepam, oxazepam, temazepam) is unlikely to be affected by fluvoxamine. Alprazolam: When fluvoxamine maleate (100 mg qd) and alprazolam (1 mg q.d. were co-administered to steady state, plasma concentration and other pharmacokinetics parameters (AUC, Cmax, T1/2,) of alprazolam were approximately twice those observed when alprazolam was administered alone; oral clearance was reduced by about 50%. The elevated plasma alprazolam concentrations resulted in decreased psychomotor performance and memory. This interaction, which has not been investigated using higher doses of fluvoxamine, may be more pronounced if a 300 mg daily dose is co-administered, particularly since fluvoxamine exhibits non-linear pharmacokinetics over the dosage range 100-300 mg. If alprazolam is co-administered with Fluvoxamine Tablets, the initial alprazolam dosage should be at least halved and titration to the lowest effective dose is recommended. No dosage adjustment is required for Fluvoxamine Tablets. Diazepam: The co-administration of Fluvoxamine Tablets and diazepam is generally not advisable. Because fluvoxamine reduces the clearance of both diazepam and its active metabolite, N-desmethyldiazepam, there is a strong likelihood of substantial accumulation of both species during chronic co-administration. Evidence supporting the conclusion that it is inadvisable to co-administer fluvoxamine and diazepam is derived from a study in which healthy volunteers taking 150 mg/day of fluvoxamine were administered a single oral dose of 10 mg of diazepam. In these subjects (R= B), the clearance of diazepam was reduced by 65% and that of N-desmethyldiazepam to a level that was too low to measure over the course of the 2 week long study. It is likely that experience significantly underestimates the degree of accumulation that might occur with repealed diazepam administration. Moreover, as noted with alprazolam, the effect of fluvoxamine may even be more pronounced when it is administered at higher doses. Accordingly, diazepam and fluvoxamine should not ordinarily be co-administered. Theophylline: The effect of steady-state fluvoxamine l50 mg bid on the pharmacokinetics of a single dose of Theophylline (375 mg) as 442 mg aminophylline was evaluated in 12 healthy non-smoking, male volunteers. The clearance of theophylline was decreased approximately 3-fold. Therefore, if theophylline is co-administered with fluvoxamine maleate, its dose should be reduced to one third of the usual daily maintenance dose and plasma concentrations of theophylline should to monitored. No dosage adjustment is required for Fluvoxamine Tablets. Warfarin: When fluvoxamine maleate (50 mg tid) was administered concomitantly with warfarin for two weeks, warfarin plasma concentrations increased by 98% and prothrombin times were prolonged. Thus patients receiving oral anticoagulants and Fluvoxamine Tablets should have their prothrombin time monitored and their anticoagulant dose adjusted accordingly. No dosage adjustment is required for Fluvoxamine Tablets. Chemical IUPAC Name: 2-[5-methoxy-1-[4-(trifluoromethyl)phenyl]-pentylidene]aminooxyethanamine : |
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