Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2474
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Fluvoxamine Maleate (Tablet)
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Dosage for Adults: The recommended starting dose for fluvoxamine maleate tablets in adult patients is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of fluvoxamine maleate tablets in OCD, patients were titrated within a dose range of 100 to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day. It is advisable that a total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.<br/>Dosage for Pediatric Population (children and adolescents): The recommended starting dose for fluvoxamine maleate tablets in pediatric populations (ages 8 to 17 years) is 25 mg, administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of fluvoxamine maleate tablets in OCD, pediatric patients (ages 8 to 17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to7 days, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 200 mg per day. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.<br/>Dosage for Elderly or Hepatically Impaired Patients: Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.<br/>Maintenance/Continuation Extended Treatment: Although the efficacy of fluvoxamine maleate tablets beyond 10 weeks of dosing for OCD has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to fluvoxamine maleate tablets and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding . When treating pregnant women with fluvoxamine maleate tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering fluvoxamine maleate tablets in thethird trimester.<br/>Discontinuation of Treatment with Fluvoxamine Maleate Tablets: Symptoms associated with discontinuation of other SSRIs and SNRIs have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
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Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated as 5-methoxy-4'-(trifluoromethyl)valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the molecular formula CHONF���CHO. Its molecular weight is 434.4. The structural formula is: Fluvoxamine maleate, USP is a white or off white, odorless, crystalline powder which is sparingly soluble in water, freely soluble in ethanol and chloroform and practically insoluble in diethyl ether. Fluvoxamine Maleate Tablets, USP are available in 25 mg, 50 mg and 100 mg strengths for oral administration. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Yellow No. 6 aluminum lake, hypromellose, mannitol, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium stearyl fumarate, titanium dioxide and triacetin.
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Pharmacodynamics: The mechanism of action of fluvoxamine maleate in Obsessive Compulsive Disorder is presumed to be linked to its specific serotonin reuptake inhibition in brain neurons. In preclinical studies, it was found that fluvoxamine inhibited neuronal uptake of serotonin. In in vitro studies fluvoxamine maleate had no significant affinity for histaminergic, alpha-adrenergic or beta-adrenergic, muscarinic, or dopaminergic receptors. Antagonism of some of these receptors is thought to be associated with various sedative, cardiovascular, anticholinergic, and extrapyramidal effects of some psychotropic drugs.<br/>Pharmacokinetics:<br/>Bioavailability: The absolute bioavailability of fluvoxamine maleate is 53%. Oral bioavailability is not significantly affected by food. In a dose proportionality study involving fluvoxamine maleate at 100, 200 and 300 mg/day for 10 consecutive days in 30 normal volunteers, steady-state was achieved after about a week of dosing. Maximum plasma concentrations at steady-state occurred within 3 to 8 hours of dosing and reached concentrations averaging 88, 283 and 546 ng/mL, respectively. Thus, fluvoxamine had nonlinear pharmacokinetics over this dose range, i.e., higher doses of fluvoxamine maleate produced disproportionately higher concentrations than predicted from the lower dose.<br/>Distribution/Protein Binding: The mean apparent volume of distribution for fluvoxamine is approximately 25 L/kg, suggesting extensive tissue distribution. Approximately 80% of fluvoxamine is bound to plasma protein, mostly albumin, over a concentration range of 20 to 2000 ng/mL.<br/>Metabolism: Fluvoxamine maleate is extensively metabolized by the liver; the main metabolic routes are oxidative demethylation and deamination. Nine metabolites were identified following a 5 mg radiolabelled dose of fluvoxamine maleate, constituting approximately 85% of the urinary excretion products of fluvoxamine. The main human metabolite was fluvoxamine acid which, together with its N-acetylated analog, accounted for about 60% of the urinary excretion products. A third metabolite,fluvoxethanol, formed by oxidative deamination, accounted for about 10%. Fluvoxamine acid and fluvoxethanol were tested in an in vitro assay of serotonin and norepinephrine reuptake inhibition in rats; they were inactive except for a weak effect of the former metabolite on inhibition of serotonin uptake (one to two orders of magnitude less potent than the parent compound). Approximately 2% of fluvoxamine was excreted in urine unchanged.<br/>Elimination: Following aC-labelled oral dose of fluvoxamine maleate (5 mg), an average of 94% of drug-related products was recovered in the urine within 71 hours. The mean plasma half-life of fluvoxamine at steady-state after multiple oral doses of 100 mg/day in healthy, young volunteers was 15.6 hours.<br/>Elderly Subjects: In a study of fluvoxamine maleate tablets at 50 and 100 mg comparing elderly (ages 66 to 73) and young subjects (ages 19 to 35), mean maximum plasma concentrations in the elderly were 40% higher. The multiple-dose elimination half-life of fluvoxamine was 17.4 and 25.9 hours in the elderly compared to 13.6 and 15.6 hours in the young subjects at steady-state for 50 and 100 mg doses, respectively. In elderly patients, the clearance of fluvoxamine was reduced by about 50% and, therefore, fluvoxamine maleate tablets should be slowly titrated during initiation of therapy.<br/>Pediatric Subjects: The multiple-dose pharmacokinetics of fluvoxamine were determined in male and female children (ages 6 to 11) and adolescents (ages 12 to 17). Steady-state plasma fluvoxamine concentrations were 2- to 3-fold higher in children than in adolescents. AUC and Cin children were 1.5- to 2.7-fold higher than that in adolescents (see table below). As in adults, both children and adolescents exhibited nonlinear multiple-dose pharmacokinetics. Female children showed significantly higher AUC (0 to 12) and Ccompared to male children and, therefore, lower doses of fluvoxamine maleate tablets may produce therapeutic benefit (see table below). No gender differences were observed in adolescents. Steady-state plasma fluvoxamine concentrations were similar in adults and adolescents at a dose of 300 mg/day, indicating that fluvoxamine exposure was similar in these two populations (see table below). Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit.<br/>Hepatic and Renal Disease: A cross-study comparison (healthy subjects vs. patients with hepatic dysfunction) suggested a 30% decrease in fluvoxamine clearance in association with hepatic dysfunction. The mean minimum plasma concentrations in renally impaired patients (creatinine clearance of 5 to 45 mL/min) after 4 and 6 weeks of treatment (50 mg bid, N = 13) were comparable to each other, suggesting no accumulation of fluvoxamine in these patients.<br/>Clinical Trials:<br/>Adult OCD Studies: The effectiveness of fluvoxamine maleate tablets for the treatment of Obsessive Compulsive Disorder (OCD) was demonstrated in two 10 week multicenter, parallel group studies of adult outpatients. Patients in these trials were titrated to a total daily fluvoxamine maleate dose of 150 mg/day over the first 2 weeks of the trial, following which the dose was adjusted within a range of 100 to 300 mg/day (on a bidschedule), on the basis of response and tolerance. Patients in these studies had moderate to severe OCD (DSM-III-R), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), total score of 23. Patients receiving fluvoxamine maleate experienced mean reductions of approximately four to five units on the Y-BOCS total score, compared to a two unit reduction for placebo patients. The following table provides the outcome classification by treatment group on the Global Improvement item of the Clinical Global Impression (CGI) scale for both studies combined. Exploratory analyses for age and gender effects on outcomes did not suggest any differential responsiveness on the basis of age or sex.<br/>Pediatric OCD Study: The effectiveness of fluvoxamine maleate tablets for the treatment of OCD was also demonstrated in a 10 week multicenter, parallel group study in a pediatric outpatient population (children and adolescents, ages 8 to 17). Patients in this study were titrated to a total daily fluvoxamine dose of approximately 100 mg/day over the first 2 weeks of the trial, following which the dose was adjusted within a range of 50 to 200 mg/day (on a bid schedule) on the basis of response and tolerance. Patients in these studies had moderate to severe OCD (DSM-III-R) with mean baseline ratings on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) total score of 24. Patients receiving fluvoxamine maleate experienced mean reductions of approximately six units on the CY-BOCS total score, compared to a three unit reduction for placebo patients. The following table provides the outcome classification by treatment group on the Global Improvement item of the Clinical Global Impression (CGI) scale for the pediatric study. Post hoc exploratory analyses for gender effects on outcomes did not suggest any differential responsiveness on the basis of gender. Further exploratory analyses revealed a prominent treatment effect in the 8 to 11 age group and essentially no effect in the 12 to 17 age group. While the significance of these results is not clear, the 2- to 3-fold higher steady-state plasma fluvoxamine concentrations in children compared to adolescents (see Pharmacokinetics) is suggestive that decreased exposure in adolescents may have been a factor, and dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit.
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Fluvoxamine Maleate Tablets, USP are available containing 25 mg, 50 mg and 100 mg of fluvoxamine maleate, USP. The 25 mg tablets are orange film-coated, oval, unscored tablets debossed with M407 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0407-01bottles of 100 tablets NDC 0378-0407-05bottles of 500 tablets The 50 mg tablets are orange film-coated, oval, scored tablets debossed with M412 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0412-01bottles of 100 tablets NDC 0378-0412-05bottles of 500 tablets The 100 mg tablets are orange film-coated, oval, scored tablets debossed with M414 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0414-01bottles of 100 tablets NDC 0378-0414-05bottles of 500 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Protect from high humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared toplacebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observationand communication with the prescriber. Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients and Precautions: Pediatric Use.)
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dailymed-ingredient:FD&C_yellow_no._6_aluminum_lake,
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:hypromellose,
dailymed-ingredient:mannitol,
dailymed-ingredient:polydextrose,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:povidone,
dailymed-ingredient:pregelatinized_starch,
dailymed-ingredient:sodium_stearyl_fumarate,
dailymed-ingredient:titanium_dioxide,
dailymed-ingredient:triacetin
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Human Experience: Worldwide exposure to fluvoxamine maleate includes over 45,000 patients treated in clinical trials and an estimated exposure of 23,000,000 patients treated during worldwide marketing experience (circa 1999). Of the 462 cases of deliberate or accidental overdose involving fluvoxamine maleate reported from this population, there were 44 deaths. Of these, six were in patients taking fluvoxamine maleate alone and the remaining 38 were in patients taking fluvoxamine maleate along with other drugs. Among nonfatal overdose cases, 373 patients had complete recovery; four patients experienced adverse sequelae of overdosage, to include persistent mydriasis, unsteady gait, kidney complications (from trauma associated with overdose), and bowel infarction requiring a hemicolectomy. In the remaining 41 patients, the outcome was unknown. The largest known ingestion of fluvoxamine maleate involved 12000 mg (equivalent to 2 to 3 months' dosage). The patient fullyrecovered. However, ingestions as low as 1400 mg have been associated with lethal outcome, indicating considerable prognostic variability. Commonly (���5%) observed adverse events associated with fluvoxamine maleate overdose include coma, hypokalemia, hypotension, nausea, respiratory difficulties, somnolence, tachycardia and vomiting. Other notable signs and symptoms seen with fluvoxamine maleate overdose (single or multiple drugs) include, bradycardia, ECG abnormalities, (such as heart arrest, QT interval prolongation, first-degree atrioventricular block, bundle branch block, and junctional rhythm), convulsions, tremor, diarrhea, and increased reflexes.<br/>Management of Overdose: Treatment should consist of those general measures employed in the management of overdosage with any antidepressant. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for fluvoxamine are known. A specific caution involves patients taking, or recently having taken, fluvoxamine who might ingest excessive quantities of a tricyclic antidepressant. In such a case, accumulation of the parent tricyclic and/or an active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation (see Tricyclic Antidepressants (TCAs) under PRECAUTIONS). In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference (PDR).
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Fluvoxamine Maleate
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Fluvoxamine Maleate (Tablet)
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Associated with Discontinuation of Treatment: Of the 1,087 OCD and depressed patients treated with fluvoxamine maleate in controlled clinical trials conducted in North America, 22% discontinued treatment due to an adverse event. The most common events (���1%) associated with discontinuation and considered to be drug-related (i.e., those events associated with dropout at a rate at least twice that of placebo) included:<br/>Incidence in Controlled Trials:<br/>Commonly Observed Adverse Events in Controlled Clinical Trials: Fluvoxamine maleate tablets have been studied in controlled trials of OCD (N = 320) and depression (N = 1,350). In general, adverse event rates were similar in the two data sets as well as in the pediatric OCD study. The most commonly observed adverse events associated with the use of fluvoxamine maleate tablets and likely to be drug-related (incidence of 5% or greater and at least twice that for placebo) derived from Table 3 were: somnolence, insomnia, nervousness, tremor, nausea, dyspepsia, anorexia, vomiting, abnormal ejaculation, asthenia, and sweating. In a pool of two studies involving only patients with OCD, the following additional events were identified using the above rule: dry mouth, decreased libido, urinary frequency, anorgasmia, rhinitis, and taste perversion. In a study of pediatric patients with OCD, the following additional events were identified using the above rule: agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash.<br/>Adverse Events Occurring at an Incidence of 1%: Table 3 enumerates adverse events that occurred in adults at a frequency of 1% or more, and were more frequent than in the placebo group, among patients treated with fluvoxamine maleate tablets in two short-term placebo-controlled OCD trials (10 week) and depression trials (6 week) in which patients were dosed in a range of generally 100 to 300 mg/day. This table shows the percentage of patients in each group whohad at least one occurrence of an event at some time during their treatment. Reported adverse events were classified using a standard COSTART-based Dictionary terminology. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors may differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.<br/>Adverse Events in OCD Placebo-Controlled Studies Which are Markedly Different (defined as at least a 2-fold difference) in Rate from the Pooled Event Rates in OCD and Depression Placebo-Controlled Studies: The events in OCD studies with a 2-fold decrease in rate compared to event rates in OCD and depression studies were dysphagia and amblyopia (mostly blurred vision). Additionally, there was an approximate 25% decrease in nausea. The events in OCD studies with a 2-fold increase in rate compared to event rates in OCD and depression studies were: asthenia, abnormal ejaculation (mostly delayed ejaculation), anxiety, infection, rhinitis, anorgasmia (in males), depression, libido decreased, pharyngitis, agitation, impotence, myoclonus/twitch, thirst, weight loss, leg cramps, myalgia, and urinary retention. These events are listed in order of decreasing rates in the OCD trials.<br/>Other Adverse Events in OCD Pediatric Population: In pediatric patients (N = 57) treated with fluvoxamine maleate tablets, the overall profile of adverse events was generally similar to that seen in adult studies, as shown in Table 3. However, the following adverse events, not appearing in Table 3, were reported in two or more of the pediatric patients and were more frequent with fluvoxamine maleate tablets than with placebo: abnormal thinking, cough increase, dysmenorrhea, ecchymosis, emotional lability, epistaxis, hyperkinesia, infection, manic reaction, rash, sinusitis, and weight decrease.<br/>Male and Female Sexual Dysfunction with SSRIs: Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder and with aging, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence. The table below displays the incidence of sexual side effects reported by at least 2% of patients taking fluvoxamine maleate in placebo-controlled trials in depression and OCD. There are no adequate and well controlled studies examining sexual dysfunction with fluvoxamine treatment. Fluvoxamine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae and upon discontinuation of fluvoxamine. While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.<br/>Vital Sign Changes: Comparisons of fluvoxamine maleate and placebo groups in separate pools of short-term OCD and depression trials on (1) median change from baseline on various vital signs variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various vital signs variables revealed no important differences between fluvoxamine maleate and placebo.<br/>Laboratory Changes: Comparisons of fluvoxamine maleate and placebo groups in separate pools of short-term OCD and depression trials on (1) median change from baseline on various serum chemistry, hematology, and urinalysis variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various serum chemistry, hematology, and urinalysis variables revealed no important differences between fluvoxamine maleate and placebo.<br/>ECG Changes: Comparisons of fluvoxamine maleate and placebo groups in separate pools of short-term OCD and depression trials on (1) mean change from baseline on various ECG variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various ECG variables revealed no important differences between fluvoxamine maleate and placebo.<br/>Other Events Observed During the Premarketing Evaluation of Fluvoxamine Maleate Tablets: During premarketing clinical trials conducted in North America and Europe, multiple doses of fluvoxamine maleate were administered for a combined total of 2,737 patient exposures in patients suffering OCD or Major Depressive Disorder. Untoward events associated with this exposure were recorded by clinical investigators using descriptive terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a limited (i.e., reduced) number of standard event categories. In the tabulations which follow, a standard COSTART-based Dictionary terminology has been used to classify reported adverse events. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. The frequencies presented, therefore, represent the proportion of the 2,737 patient exposures to multiple doses of fluvoxamine maleate who experienced an event of the type cited on at least one occasion while receiving fluvoxamine maleate. All reported events are included in the list below, with the following exceptions: 1) those events already listed in Table 3, which tabulates incidence rates of common adverse experiences in placebo-controlled OCD and depression clinical trials, are excluded; 2) those events for which adrug cause was considered remote (i.e., neoplasia, gastrointestinal carcinoma, herpes simplex, herpes zoster, application site reaction, and unintended pregnancy) are omitted; and 3) events which were reported in only one patient and judged to not be potentially serious are not included. It is important to emphasize that, although the events reported did occur during treatment with fluvoxamine maleate, a causal relationship to fluvoxamine maleate has not been established. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring between 1/100 and 1/1,000 patients; and rare adverse events are those occurring in less than 1/1,000 patients. Body as a Whole: Frequent: accidental injury, malaise; Infrequent: allergic reaction, neck pain, neck rigidity, overdose, photosensitivity reaction, suicide attempt; Rare: cyst, pelvic pain, sudden death Cardiovascular System: Frequent: hypertension, hypotension, syncope, tachycardia; Infrequent: angina pectoris, bradycardia, cardiomyopathy, cardiovascular disease, cold extremities, conduction delay, heart failure, myocardial infarction, pallor, pulse irregular, ST segment changes; Rare: AV block, cerebrovascular accident, coronary artery disease, embolus, pericarditis, phlebitis, pulmonary infarction, supraventricular extrasystoles Digestive System: Frequent: elevated liver transaminases; Infrequent: colitis, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal ulcer, gingivitis, glossitis, hemorrhoids, melena, rectal hemorrhage, stomatitis; Rare: biliary pain, cholecystitis, cholelithiasis, fecal incontinence, hematemesis, intestinal obstruction, jaundice Endocrine System: Infrequent: hypothyroidism; Rare: goiter Hemic and Lymphatic Systems: Infrequent: anemia, ecchymosis, leukocytosis, lymphadenopathy, thrombocytopenia; Rare: leukopenia, purpura Metabolic and Nutritional Systems: Frequent: edema, weight gain, weight loss; Infrequent: dehydration, hypercholesterolemia; Rare: diabetes mellitus, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, lactate dehydrogenase increased Musculoskeletal System: Infrequent: arthralgia, arthritis, bursitis, generalized muscle spasm, myasthenia, tendinous contracture, tenosynovitis; Rare: arthrosis, myopathy, pathological fracture Nervous System: Frequent: amnesia, apathy, hyperkinesia, hypokinesia, manic reaction, myoclonus, psychotic reaction; Infrequent: agoraphobia, akathisia, ataxia, CNS depression, convulsion, delirium, delusion, depersonalization, drug dependence, dyskinesia, dystonia, emotional lability, euphoria, extrapyramidal syndrome, gait unsteady, hallucinations, hemiplegia, hostility, hypersomnia, hypochondriasis, hypotonia, hysteria, incoordination, increased salivation, increased libido, neuralgia, paralysis, paranoid reaction, phobia, psychosis, sleep disorder, stupor, twitching, vertigo; Rare: akinesia, coma, fibrillations, mutism, obsessions, reflexes decreased, slurred speech, tardive dyskinesia, torticollis, trismus, withdrawal syndrome Respiratory System: Frequent: cough increased, sinusitis; Infrequent: asthma, bronchitis, epistaxis, hoarseness, hyperventilation; Rare: apnea, congestion of upper airway, hemoptysis, hiccups, laryngismus, obstructive pulmonary disease, pneumonia Skin: Infrequent: acne, alopecia, dry skin, eczema, exfoliative dermatitis, furunculosis, seborrhea, skin discoloration, urticaria Special Senses: Infrequent: accommodation abnormal, conjunctivitis, deafness, diplopia, dry eyes, ear pain, eye pain, mydriasis, otitis media, parosmia, photophobia, taste loss, visual field defect; Rare: corneal ulcer, retinal detachment Urogenital System: Infrequent: anuria, breast pain, cystitis, delayed menstruation, dysuria, female lactation, hematuria, menopause, menorrhagia, metrorrhagia, nocturia, polyuria, premenstrual syndrome, urinary incontinence, urinary tract infection, urinary urgency, urination impaired, vaginal hemorrhage, vaginitis; Rare: kidney calculus, hematospermia, oliguria<br/>Post-marketing Reports: Voluntary reports of adverse events in patients taking fluvoxamine maleate tablets that have been received since market introduction and are of unknown causal relationship to fluvoxamine maleate tablets use include: ventricular tachycardia (including Torsades de pointes), porphyria, toxic epidermal necrolysis, Stevens-Johnson Syndrome, Henoch-Schoenlein purpura, bullous eruption, priapism, agranulocytosis, aplastic anemia, anaphylactic reaction, angioedema, vasculitis, hyponatremia, acute renal failure, hepatitis, pancreatitis, ileus, serotonin syndrome, neuropathy, laryngismus, and severe akinesia with fever when fluvoxamine was coadministered with antipsychotic medication.
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Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD), as defined in the DSM-III-R. The obsessions or compulsions cause marked distress, are time consuming, or significantly interfere with social or occupational functioning. The efficacy of fluvoxamine maleate tablets was established in three 10 week trials with obsessive compulsive outpatients with the diagnosis of Obsessive Compulsive Disorder as defined in DSM-III-R. Obsessive Compulsive Disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of fluvoxamine maleate tablets for long-term use, i.e., for more than 10 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluvoxamine maleate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
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Fluvoxamine Maleate
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