Fluvoxamine Maleate description, usages, side effects, indications, overdosage, supplying and lots more!

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Fluvoxamine Maleate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING


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 maleate tablets 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 to placebo 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 psyctiatric 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 observation and communication with the prescriber. Fluvoxamine Maleate tablets are not approved for use in pediatric patients except for patients with obsessive complusive disorder (OCD)(SeeWarnings: Clinical Worsening and Suicide Risk,Precautions: Information for Patients, andPrecautions: Pediatric Use)

FLUVOXAMINE MALEATE DESCRIPTION



Fluvoxamine Maleate




CLINICAL PHARMACOLOGY


Pharmacodynamics



Pharmacokinetics

Bioavailability




Distribution/Protein Binding



Metabolism

PRECAUTIONS-Drug Interactions

Elimination



Elderly Subjects



Pediatric Subjects
tabletable


Pharmacokinetic Parameter (Body weight corrected)Dose=200 mg/day (100 mg/day bid)Dose=300 mg/day (150 mg bid)Children (n=10)Adolescent (n=17)Adolescents (n=13)Adults (n=16)

Pharmacokinetic Parameter (Body weight corrected)Dose =200 mg/day (100 mg bid)Male children (n=7)Female children (n=3)
Hepatic and Renal Disease
PRECAUTIONS-Use in Patients with Concomitant Illness

Clinical Trials

Adult OCD Studies



Outcome ClassificationFluvoxamine (N = 120)Placebo (N = 134)

Pediatric OCD Study



Outcome ClassificationFluvoxamine (N = 38)Placebo (N = 36)Pharmacokinetics

INDICATIONS & USAGE


Clinical TrialsCLINICAL PHARMACOLOGY

DOSAGE AND ADMINISTRATION

FLUVOXAMINE MALEATE CONTRAINDICATIONS

WARNINGSPRECAUTIONS


WARNINGS

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 MaleateTablets not be used in combination with a MAOI, or within 14 days of discontinuing treatment with a MAOI. After stopping Fluvoxamine MaleateTablets, at least 2 weeks should be allowed before starting a MAOI.

Potential Interaction with Thioridazine
The effect of fluvoxamine (25 mg bid for one week) on thioridazine steady-state concentrations was evaluated in 10 male inpatients with schizophrenia. Concentrations of thioridazine and its two active metabolites, mesoridazine and sulforidazine, increased threefold following co-administration of fluvoxamine.
Thioridazine administration produces a dose-related prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes-type arrhythmias, and sudden death. It is likely that this experience underestimates the degree of risk that might occur with higher doses of thioridazine. Moreover, the effect of fluvoxamine may be even more pronounced when it is administered at higher doses.
Therefore, fluvoxamine and thioridazine should not be co-administered (seeCONTRAINDICATIONSandPRECAUTIONS).

Potential Terfenadine, Astemizole, Cisapride, and Pimozide Interactions
Terfenadine, astemizole, cisapride, and pimozide are all metabolized by the cytochrome P4503A4 isozyme, and it has been demonstrated that ketoconazole, a potent inhibitor of 3A4, blocks the metabolism of these drugs, resulting in increased plasma concentrations of parent drug. Increased plasma concentrations of terfenadine, astemizole, cisapride, and pimozide cause QT prolongation and have been associated with torsades de pointes-type ventricular tachycardia, sometimes fatal. As noted below, a substantial pharmacokinetic interaction has been observed for fluvoxamine in combination with alprazolam, a drug that is known to be metabolized by the 3A4 isozyme. Although, it has not been definitively demonstrated that fluvoxamine is a potent 3A4 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 terfenadine, astemizole, cisapride, or pimozide (seeCONTRAINDICATIONSandPRECAUTIONS).

Potential Tizanidine Interaction
Fluvoxamine is a potent inhibitor of CYP1A2 and tizanidine is a CYP1A2 substrate. The effect of fluvoxamine (100 mg daily for 4 days) on the pharmacokinetics and pharmacodynamics of a single 4 mg dose of tizanidine has been studied in 10 healthy subjects. Tizanidine Cmax was increased approximately 12-fold (range 5-fold to 32-fold), elimination half-life was increased by almost 3-fold, and AUC increased 33-fold (range 14-fold to 103-fold). The mean maximal effect on blood pressure was a 35 mm Hg decrease in systolic blood pressure, a 20 mm Hg decrease in diastolic blood pressure, and a 4 beat/min decrease in heart rate. Drowsiness was significantly increased and performance on a psychomotor task was significantly impaired. Fluvoxamine and tizanidine should not be used together. (SeeContraindicationsandPrecautions).

Potential Alosetron Interaction
Fluvoxamine, an inhibitor of several CYP isozymes, has been shown to increase mean alosetron plasma concentrations (AUC) approximately 6-fold and prolonged the half-life by approximately 3-fold. Consequently, it is recommended that fluvoxamine not be used in combination with alosetron (SeeContraindications,Precautions, and Lotronex(alosetron) package insert).

Clinical Worsening and Suicide Risk



Age RangeDrug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.


PRECAUTIONSDOSAGE AND ADMINISTRATION - Discontinuation of Treatment with Fluvoxamine Maleate Tablets
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.

Screening Patients for Bipolar Disorder


Other Potentially Important Drug Interactions
PRECAUTIONS - Drug Interactions

Benzodiazepines


Alprazolam

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 Maleate 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 Maleate Tablets.

Diazepam
The co-administration of Fluvoxamine Maleate 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 (N=8), 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 this experience significantly underestimates the degree of accumulation that might occur with repeated 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.

Mexiletine
The effect of steady-state fluvoxamine (50 mg BID for 7 days) on the single dose pharmacokinetics of mexiletene (200 mg) was evaluated in 6 healthy Japanese males. The clearance of mexiletine was reduced by 38% following co-administration with fluvoxamine compared to mexiletene alone. If fluvoxamine and mexiletene are co-administered, serum mexiletene levels should be monitored.

Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome may occur with fluvoxamine treatment particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
The concomitant use of fluvoxamine with MAOIs intended to treat depression is contraindicated (seeCONTRAINDICATIONSandWARNINGSPotential for Interaction with Monoamine Oxidase Inhibitors.)
If concomitant treatment of fluvoxamine with 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (seePRECAUTIONSDrug Interactions).
The concomitant use of fluvoxamine with serotonin precursors (such a tryptophan) is not recommended (seePRECAUTIONSDrug Interactions).

Neuroleptic Malignant Syndrome (NMS) or NMS-Like Events
Rare instances of neuroleptic malignant syndrome (NMS) or NMS-like events have been reported in association with fluvoxamine treatment when co-administered with antipsychotic. Additionally, a small number of such cases have been reported with fluvoxamine treatment in the absence of antipsychotic co-administration. These serious and sometimes fatal events can include hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes. As these events may result in potentially life-threatening conditions, patients receiving this combination of therapy should be monitored for the emergence of NMS-like signs and symptoms. Treatment with fluvoxamine and any concomitant antipsychotic agent should be discontinued immediately if such event occurs and supportive symptomatic treatment should be initiated.

Theophylline
The effect of steady-state fluvoxamine (50 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 be monitored. No dosage adjustment is required for Fluvoxamine Maleate 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 Maleate Tablets should have their prothrombin time monitored and their anticoagulant dose adjusted accordingly. No dosage adjustment is required for Fluvoxamine Maleate Tablets.

PRECAUTIONS

General

Discontinuation of Treatment with Fluvoxamine Maleate Tablets
DOSAGE AND ADMINISTRATION

Abnormal Bleeding
Drug Interactions

Activation of Mania/Hypomania



Seizures


Hyponatremia
Geriatric Use


Use in Patients with Concomitant Illness




INFORMATION FOR PATIENTS





Clinical Worsening and Suicidal Risk


Interference with Cognitive or Motor Performance


Pregnancy


Nursing
PRECAUTIONS - Nursing Mothers

Concomitant Medication




Alcohol


Allergic Reactions


LABORATORY TESTS



DRUG INTERACTIONS

Potential Interactions with Drugs that Inhibit or are Metabolized by Cytochrome P450 Isozymes

WARNINGS
1A22C93A42C19


CONTRAINDICATIONSWARNINGS

CNS Active Drugs

Alcohol


Alprazolam
WARNINGS

Antipsychotics
WARNINGS-Other Potentially Important Drug InteractionsNeuroleptic Malignant Syndrome (NMS) or NMS-Like Events

Diazepam
WARNINGS

Carbamazepine


Clozapine


Lithium


Lorazepam


Methadone
Significantly increased methadone (plasma level:dose) ratios have been reported when fluvoxamine maleate was administered to patients receiving maintenance methadone treatment, with symptoms of opioid intoxication in one patient. Opioid withdrawal symptoms were reported following fluvoxamine maleate discontinuation in another patient.

Monoamine Oxidase Inhibitors
SeeWARNINGS

Serotonergic Drugs
Based on the mechanism of action of fluvoxamine and the potential for serotonin syndrome, caution is advised when fluvoxamine is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John's Wort (seeWARNINGSSerotonin Syndrome). The concomitant use of fluvoxamine with other SSRIs, SNRIs or tryptophan is not recommended (seePRECAUTIONSDrug Interactions).

Sumatriptan
There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (eg. fluoxetine, fluvoxamine, paroxetine, sertraline) is clinically warranted, appropriate observation of the patient is advised.

Tacrine
In a study of 13 healthy, male volunteers, a single 40 mg dose of tacrine added to fluvoxamine 100 mg/day administered at steady-state was associated with five- and eight-fold increases in tacrine Cmax and AUC, respectively, compared to the administration of tacrine alone. Five subjects experienced nausea, vomiting, sweating, and diarrhea following co-administration, consistent with the cholinergic effects of tacrine.

Thioridazine
SeeCONTRAINDICATIONSandWARNINGS

Tizanidine
SeeCONTRAINDICATIONSandWARNINGS

Tricyclic Antidepressants (TCAs)


Triptans
There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of fluvoxamine with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (seeWARNINGSSerotonin Syndrome).

Tryptophan
Tryptophan may enhance the serotonergic effects of fluvoxamine, and the combination should, therefore, be used with caution. Severe vomiting has been reported with the co-administration of fluvoxamine maleate and tryptophan.

Other Drugs
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin potentiated the risk of bleeding. Thus, patients should be cautioned about the use of such drugs concurrently with fluvoxamine.

Theophylline
SeeWARNINGS

Warfarin
SeeWARNINGS

Alosetron
Because alosetron is metabolized by a variety of hepatic CYP drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance of alosetron. Fluvoxamine is a known potent inhibitor of CYP1A2 and also inhibits CYP3A4, CYP2C9, and CYP2C19. In a pharmacokinetic study, 40 healthy female subjects received fluvoxamine in escalating doses from 50 to 200 mg a day for 16 days, with coadministration of alosetron 1 mg on the last day. Fluvoxamine increased mean alosetron plasma concentrations (AUC) approximately 6-fold and prolonged the half-life by approximately 3-fold. (SeeContraindications,Precautions, and Lotronex(alosetron) package insert.)

Digoxin
Administration of fluvoxamine maleate 100 mg daily for 18 days (N=8) did not significantly affect the pharmacokinetics of a 1.25 mg single intravenous dose of digoxin.

Diltiazem
Bradycardia has been reported with the co-administration of fluvoxamine maleate and diltiazem.

Propranolol and Other Beta-Blockers
Co-administration of fluvoxamine maleate 100 mg per day and propranolol 160 mg per day in normal volunteers resulted in a mean five-fold increase (range 2 to 17) in minimum propranolol plasma concentrations. In this study, there was a slight potentiation of the propranolol-induced reduction in heart rate and reduction in the exercise diastolic pressure.
One case of bradycardia and hypotension and a second case of orthostatic hypotension have been reported with the co-administration of fluvoxamine and metoprolol.
If propranolol or metoprolol is co-administered with Fluvoxamine Maleate tablets, a reduction in the initial beta-blocker dose and more cautious dose titration is recommended. No dosage adjustment is required for Fluvoxamine Maleate Tablets.
Co-administration of fluvoxamine maleate 100 mg per day with atenolol 100 mg per day (N=6) did not affect the plasma concentrations of atenolol. Unlike propranolol and metoprolol which undergo hepatic metabolism, atenolol is eliminated primarily by renal excretion.

Effects of Smoking on Fluvoxamine Metabolism
Smokers had a 25% increase in the metabolism of fluvoxamine compared to nonsmokers.

Electroconvulsive Therapy (ECT)
There are no clinical studies establishing the benefits or risks of combined use of ECT and fluvoxamine maleate.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis



Mutagenesis


Impairment of Fertility


PREGNANCY

Teratogenic Effects

Pregnancy Category C


Nonteratogenic Effects
Neonates exposed to fluvoxamine and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on postmarketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (seeWARNINGS).
Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN is associated with substantial neonatal morbidity and mortality. In a case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. PPHN occurs in 1-2 per 1000 live births in the general population.
When treating a pregnant woman with fluvoxamine during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment (seeDOSAGE AND ADMINISTRATION). Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.

LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE

BOX WARNINGWARNINGSClinical Worsening and Suicide Risk
WARNINGSClinical Worsening and Suicide RiskADVERSE REACTIONSDOSAGE AND ADMINISTRATION



GERIATRIC USE

PRECAUTIONS, HyponatremiaPharmacokineticsCLINICAL PHARMACOLOGY

FLUVOXAMINE MALEATE ADVERSE REACTIONS

Associated with Discontinuation of Treatment


BODY SYSTEM/ ADVERSE EVENTPERCENTAGE OF PATIENTSFLUVOXAMINEPLACEBO
Incidence in Controlled Trials

Commonly Observed Adverse Events in Controlled Clinical Trials



Adverse Events Occurring at an Incidence of 1%



*
Percentage Of Patients Reporting EventBODY SYSTEM/ ADVERSE EVENTFLUVOXAMINEPLACEBO N = 892N = 778* ###
Adverse Events in OCD Placebo Controlled Studies Which are Markedly Different (defined as at least a two-fold difference) in rate from the Pooled Event Rates in OCD and Depression Placebo Controlled Studies



Other Adverse Events in OCD Pediatric Population


Male and Female Sexual Dysfunction with SSRIs




Fluvoxamine Maleate Tablets N=892Placebo N=778* **



Vital Sign Changes


Laboratory Changes


ECG Changes


Other Events Observed During the Premarketing Evaluation of Fluvoxamine Maleate Tablets



Body as a Whole:
Cardiovascular System:
Digestive System:
Endocrine System:
Hemic and Lymphatic Systems:
Metabolic and Nutritional Systems:
Musculoskeletal System:
Nervous System:
Respiratory System:
Skin:
Special Senses:
Urogenital System:1111111 12, oliguria.

1Based on the number of females.
2Based on the number of males.

Postmarketing 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 co- administered with antipsychotic medication.

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychological Dependence



OVERDOSAGE

Human Experience



Management of Overdose



Tricyclic Antidepressants (TCAs)PRECAUTIONS


DOSAGE & ADMINISTRATION


Dosage for Adults


Dosage for Pediatric Population (children and adolescents)


Dosage for Elderly or Hepatically Impaired Patients


Maintenance/Continuation Extended Treatment


Treatment of Pregnant Women During the Third Trimester
PRECAUTIONS

Discontinuation of Treatment with Fluvoxamine Maleate Tablets
PRECAUTIONS

HOW SUPPLIED






STORAGE AND HANDLING






INFORMATION FOR PATIENTS




Clinical Worsening and Suicide Risk
Boxed Warning

Serotonin Syndrome


Interference with Cognitive or Motor Performance


Pregnancy


Nursing


Concomitant Medication





Alcohol


Allergic Reactions


SPL MEDGUIDE

Fluvoxamine (Flu-VOX-ah-meen)
Maleate (mal-ee-eyt)
Tablets USP

What is the most important information I should know about fluvoxamine maleate tablets?

1. Suicidal thoughts or actions:
  • ●     Fluvoxamine maleate tablets and antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within thefirst few months of treatment or when the dose is changed
  • ●     Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • ●     Watch for these changes and call your healthcare provider right away if you notice:
  • ●               New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • ●               Pay particular attention to such changes when fluvoxamine maleate tablets are started or when the dose is changed.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • ●     attempts to commit suicide
  • ●     acting on dangerous impulses
  • ●     acting aggressive or violent
  • ●     thoughts about suicide or dying
  • ●     new or worse depression
  • ●     new or worse anxiety or panic attacks
  • ●     feeling agitated, restless, angry or irritable
  • ●     trouble sleeping
  • ●     an increase in activity or talking more than what is normal for you
  • ●     other unusual changes in behavior or mood
Tell your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Fluvoxamine maleate tablets may be associated with these serious side effects:
2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:
  • ●     agitation, hallucinations, coma or other changes in mental status
  • ●     coordination problems or muscle twitching (overactive reflexes)
  • ●     racing heartbeat, high or low blood pressure
  • ●     sweating or fever
  • ●     nausea, vomiting, or diarrhea
  • ●     muscle rigidity
3. Severe allergic reactions:
  • ●     trouble breathing
  • ●     swelling of the face, tongue, eyes, or mouth
  • ●     rash, itchy welts (hives) or blisters, alone or with fever or joint pain
4. Abnormal bleeding:
5. Seizures or convulsions
6. Manic episodes:
  • ●     greatly increased energy
  • ●     severe trouble sleeping
  • ●     racing thoughts
  • ●     reckless behavior
  • ●     unusually grand ideas
  • ●     excessive happiness or irritability
  • ●     talking more or faster than usual
7. Changes in appetite or weight.
8. Low salt (sodium) levels in the blood.
  • ●     headache
  • ●     weakness or feeling unsteady
  • ●     confusion, problems concentrating or thinking or memory problems
Do not stop fluvoxamine maleate tablets without first talking to your healthcare provider.

  • ●     anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
  • ●     headache, sweating, nausea, dizziness
  • ●     electric shock-like sensations, shaking, confusion
What are fluvoxamine maleate tablets?


Who should not take fluvoxamine maleate tablets?

  • ●     are allergic to fluvoxamine maleate or any of the ingredients in fluvoxamine maleate tablets. See the end of this Medication Guide for a complete list of ingredients in fluvoxamine maleate tablets.
  • ●     take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • ●               Do not take an MAOI within 2 weeks of stopping fluvoxamine maleate tablets.
  • ●               Do not start fluvoxamine maleate tablets if you stopped taking an MAOI in the last 2 weeks.
People who take fluvoxamine maleate tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • ●     high fever
  • ●     uncontrolled muscle spasms
  • ●     stiff muscles
  • ●     rapid changes in heart rate or blood pressure
  • ●     confusion
  • ●     loss of consciousness (pass out)
  • ●      take Mellaril(thioridazine). Do not take Mellarilwithin 2 weeks of stopping fluvoxamine maleate tablets because this can cause serious heart rhythm problems or sudden death.
  • ●     take Orap(pimozide) because taking this drug with fluvoxamine maleate tablets can cause serious heart rhythm problems or sudden death.
  • ●      take Zanaflex(tizanidine).Fluvoxamine maleate tablets could increase the amount of Zanaflex in your body, which could increase its actions and side effects. This could include drowsiness and a drop in blood pressure and affecting how well you do things that require alertness.
  • ●      Take Lotronex(alosetron).Fluvoxamine maleate tablets may increase the amount of Lotronex in your body, which could increase its actions and side effects.
What should I tell my healthcare provider before taking fluvoxamine maleate tablets? Ask if you are not sure.

  • ●     Are taking certain drugs such as:
  • ●                Monoamine oxidase inhibitors such as Emsam(selegiline), Nardil(phenelzine), or Parnate(tranylcypromine)
  • ●               Mellaril(thioridazine): used to treat mental or mood problems
  • ●               Zanaflex(tizanidine): used to treat spasticity (a condition in which muscles keep tightening and cramping)
  • ●               Orap(pimozide): used to treat Tourette Syndrome (a brain condition causing tics)
  • ●               Lotronex(alosetron): used to treat a condition with diarrhea, continuing stomach pain, cramps, and bloating
  • ●               Triptans: used to treat migraine headache
  • ●               Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, or antipsychotics
  • ●               Tramadol: used to reduce pain
  • ●               Benzodiazepines: used to reduce anxiety, stress, emotional upset, or seizures; helps you sleep; helps with alcohol withdrawal; reduces restlessness; and relaxes muscles
  • ●               Methadone: used to relieve pain or to help with addiction
  • ●               Clozapine: used to treat mental disorders.
  • ●               Mexiletine: used to treat abnormalities in heart rhythm.
  • ●               Theophylline used to treat swollen air passages in your lungs, to relax the muscles in your chest to ease shortness of breath, often to treat asthma
  • ●               Warfarin and other drugs that affect how your blood clots
  • ●               Diuretics to treat high blood pressure, congestive heart failure, or swelling
  • ●               Over-the-counter supplements such as tryptophan or St. John's Wort
  • ●     have liver problems
  • ●     have kidney problems
  • ●     have heart problems
  • ●     have or had seizures or convulsions
  • ●     have bipolar disorder or mania
  • ●     have low sodium levels in your blood
  • ●     have a history of a stroke
  • ●     have high blood pressure
  • ●     have or had bleeding problems
  • ●     are pregnant or plan to become pregnant. It is not known if fluvoxamine maleate tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating OCD during pregnancy.
  • ●     are breast-feeding or plan to breast-feed. Some fluvoxamine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking fluvoxamine maleate tablets.
Tell your healthcare provider about all the medicines that you take,





How should I take fluvoxamine maleate tablets?
  • ●     Take fluvoxamine maleate tablets exactly as prescribed. Your healthcare provider may need to change the dose of fluvoxamine maleate tablets until it is the right dose for you.
  • ●     Fluvoxamine maleate tablets may be taken with or without food.
  • ●     If you miss a dose of fluvoxamine maleate tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluvoxamine maleate tablets at the same time.
  • ●     If you take too many fluvoxamine maleate tablets, call your healthcare provider or poison control center right away, or get emergency treatment.
What should I avoid while taking fluvoxamine maleate tablets?

What are the possible side effects of fluvoxamine maleate tablets?

  • ●     SeeWhat is the most important information I should know about fluvoxamine maleate tablets?
  • ●      Feeling anxious or trouble sleeping

  • ●     nausea
  • ●     sleepiness
  • ●     weakness
  • ●     indigestion
  • ●     sweating
  • ●     loss of appetite
  • ●     shaking
  • ●     vomiting
  • ●     delayed ejaculation
  • ●     inability to have an orgasm
  • ●     decreased sex drive
  • ●     dry mouth
  • ●     stuffy nose
  • ●     unusual taste
  • ●     frequent urination

  • ●     agitation or abnormal increase in activity
  • ●     feeling depressed or sad
  • ●     excessive gas
  • ●     heavy menstrual periods
  • ●     rash
  • ●     possible slowed growth rate and weight change.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO TEVA USA, PHARMACOVIGILANCE
1-888-838-2872, X6351 or FDA AT 1-800-FDA-1088.
How should I store fluvoxamine maleate tablets?

  • ●     Keep fluvoxamine maleate tablets away from high humidity.
  • ●     Keep fluvoxamine maleate tablets bottle closed tightly.
Keep fluvoxamine maleate tablets and all medicines out of the reach of children.
General information about fluvoxamine maleate tablets



What are the ingredients in fluvoxamine maleate tablets?






This Medication Guide has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Fluvoxamine Maleate

Fluvoxamine Maleate

Fluvoxamine Maleate

Fluvoxamine Maleate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-828(NDC:0555-0968)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FLUVOXAMINE MALEATE FLUVOXAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
mannitol
METHYLCELLULOSE (15 CPS)
SILICON DIOXIDE
STARCH, CORN
SODIUM STEARYL FUMARATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
ALUMINUM OXIDE
HYPROMELLOSE 2208 (15000 MPA.S)
polyethylene glycol
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
yellow 12 mm b;968;50 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-828-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075893 2011-11-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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