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Fluvoxamine Maleate (Fluvoxamine Maleate)

Trade Name : Fluvoxamine Maleate

Actavis Pharma, Inc.

CAPSULE, EXTENDED RELEASE

Strength 100 mg/1

FLUVOXAMINE MALEATE Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluvoxamine Maleate (Fluvoxamine Maleate) which is also known as Fluvoxamine Maleate and Manufactured by Actavis Pharma, Inc.. It is available in strength of 100 mg/1 per ml. Read more

Fluvoxamine Maleate (Fluvoxamine Maleate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Serotonin Syndrome () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2017
  • 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 extended-release capsules 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 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 observation and communication with the prescriber. n
  • WARNING: SUICIDALITY AND ANTIDEPRESSANTS
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders ().
  • Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. 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 obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
  • The efficacy of fluvoxamine maleate extended-release capsules was demonstrated in one 12-week trial in adults with fluvoxamine maleate extended-release capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8 to 17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-Ru00a0.
  • The efficacy of fluvoxamine for long-term use was established in one maintenance study in adults with immediate-release fluvoxamine tablets . The health care provider who elects to prescribe fluvoxamine maleate extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient .
  • Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) (). Efficacy was demonstrated in:
  • One 12-week study with fluvoxamine maleate extended-release capsules in adults ().
  • Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents (, ).
  • One maintenance study with IR fluvoxamine tablets ().
  • No data
  • Adults: Recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum effect, not to exceed 300 mg/day ().
  • Pediatric patients nau00efve to fluvoxamine maleate: The lowest available dose of fluvoxamine maleate extended-release capsules may not be appropriate ().u00a0
  • Hepatically impaired: Decreased clearance may require modified dose and titration ().
  • Extended treatment: Adjust dose to maintain lowest effective dose; reassess patients periodically ().
  • Discontinuation: Gradual dose reduction is recommended (, see ).
  • Fluvoxamine maleate extended-release capsules are available as:
  • 100 mg u2013 Each #2 capsule with olive opaque cap and gray opaque body, imprinted with and 2848 on both cap and body in black ink contains 100 mg of fluvoxamine maleate, USP.
  • 150 mg u2013 Each #1 capsule with olive opaque cap and white opaque body, imprinted with and 2849 on both cap and body in black ink contains 150 mg of fluvoxamine maleate, USP.
  • 100 mg and 150 mg Extended-Release Capsules ()
  • Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated .
  • The use of MAOIs intended to treat psychiatric disorders with fluvoxamine maleate extended-release capsules or within 14 days of stopping treatment with fluvoxamine maleate extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of fluvoxamine maleate extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated .
  • Starting fluvoxamine maleate extended-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome and n .
  • Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon ().
  • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluvoxamine maleate extended-release capsules or within 14 days of stopping treatment with fluvoxamine maleate extended-release capsules. Do not use fluvoxamine maleate extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluvoxamine maleate extended-release capsules in a patient who is being treated with linezolid or intravenous methylene blue ().
  • No data
  • Clinical Worsening/Suicide Risk:
  • Bipolar Disorder:
  • Serotonin Syndrome:
  • Angle Closure Glaucoma: n- ().
  • Other Potentially Important Drug Interactions: n- Benzodiazepines:n- Clozapine:n- Methadone:n- Mexiletine:n- Theophylline:n- Warfarin:
  • 5.9n- 5.9n- 5.9n- 5.9n- 5.9n- 5.9
  • Discontinuation:
  • Abnormal Bleeding:
  • Activation of Mania/Hypomania
  • Seizures:
  • Hyponatremia:
  • Concomitant Illness:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
  • Most common reactions in controlled trials with OCD patients and patients from another studied population (incidence greater than or equal to 5% and at least twice that for placebo) were and (). The following additional reactions occurred: in the OCD population; and and in another studied population.
  • To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or n
  • Drug Interactions (not described in Contraindications or Warnings and Precautions) include the following:
  • max
  • Specific populations not discussed in or include:
  • Pregnancy: Consider both potential risks and benefits when treating a pregnant woman. Infants exposed to SSRIs in pregnancy have developed various complications and may be at risk for persistent pulmonary hypertension of the newborn (PPHN) (, ).
  • Nursing mothers: Fluvoxamine is secreted in human breast milk ().
  • Geriatric: Use of a lower starting dose may be warranted. Titrate slowly during initiation of therapy (, .
  • Smokers: Smokers had a 25% increase in fluvoxamine metabolism ().
  • No data
  • No data
  • Fluvoxamine maleate extended-release capsules for oral administration contain fluvoxamine maleate, USP, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones.
  • Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the molecular formula CHONFu2022CHO. Its molecular weight is 434.41.
  • The structural formula is:
  • Fluvoxamine maleate, USP is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether.
  • Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, USP, each capsule contains the following inactive ingredients: ammonio methacrylate copolymer, type A, ammonio methacrylate copolymer, type B, black iron oxide, FD&C blue #1, gelatin, hydroxypropyl cellulose, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, yellow iron oxide. The capsules are imprinted with black Tek-Print ink SW-9008 and SW-9009 which contain black iron oxide, potassium hydrochloride, propylene glycol and shellac.
  • No data
  • Carcinogenesis:
  • in vitro
  • Impairment of Fertility:
  • No data
  • No data
  • See FDA-Approved .
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluvoxamine maleate extended-release capsules and should counsel them in the appropriate use. A patient Medication Guide discussing antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions and other important information about Fluvoxamine Maleate Extended-Release Capsules is available for fluvoxamine maleate extended-release capsules. The prescriber or health professional should instruct patients, their families, and their caregivers to read both sections of the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluvoxamine maleate extended-release capsules.
  • Clinical Worsening and Suicide Risk
  • Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patientu2019s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patientu2019s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate the need for very close monitoring and possibly changes in the medication .
  • Serotonin Syndrome
  • Patients should be cautioned about the risk of serotonin syndrome particularly with the concomitant use of fluvoxamine with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. Johnu2019s Wort) n
  • Contraindicated Medications
  • Patients should be advised that the following medications should not be used while taking fluvoxamine maleate extended-release capsules:
  • In addition, MAOIs should not be taken within 14 days (2 weeks) after stopping fluvoxamine maleate extended-release capsules, and fluvoxamine maleate extended-release capsules should not be taken within two weeks after stopping treatment with an MAOI .n
  • Other Potentially Hazardous Drug Interactions
  • Patients should be advised that the use of fluvoxamine maleate extended-release capsules with any of the following medications may produce clinically significant adverse reactions. Patients should inform their physician if they are taking any of these medications before starting treatment with fluvoxamine maleate extended-release capsules. Patients should also inform their physician prior to taking any of these medications while receiving fluvoxamine maleate extended-release capsule therapy.
  • In addition, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for clinically important interactions with fluvoxamine maleate extended-release capsules.
  • Abnormal Bleeding
  • Patients should be advised that fluvoxamine maleate extended-release capsules may increase the risk of bleeding events, which have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk n
  • Angle Closure Glaucoma
  • Patients should be advised that taking fluvoxamine maleate extended-release capsules can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible (see )
  • Interference with Cognitive or Motor Performance
  • Since any psychoactive drug may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain that fluvoxamine maleate extended-release capsules therapy does not adversely affect their ability to engage in such activities.
  • Pregnancy
  • Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy with fluvoxamine maleate extended-release capsules .
  • Nursing
  • Patients receiving fluvoxamine maleate extended-release capsules should be advised to notify their physicians if they are breast-feeding an infant. n
  • Alcohol
  • As with other psychotropic medications, patients should be advised to avoid alcohol while taking fluvoxamine maleate extended-release capsules.
  • Allergic Reactions
  • Patients should be advised to notify their physicians if they develop a rash, hives, or a related allergic phenomenon during therapy with fluvoxamine maleate extended-release capsules.
  • Brands listed are the trademarks of their respective owners.
  • Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • 40-9109
  • Revised u2013 November 2017
  • MEDICATION GUIDEn n- Fluvoxamine Maleate u00a0n n- Extended-Release Capsules
  • Read the Medication Guide that comes with fluvoxamine maleate extended-release capsules before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider if there is something you do not understand or want to learn more about.
  • What is the most important information I should know about n- fluvoxamine maleate extended-release capsules?
  • Fluvoxamine maleate extended-release is the same kind of medicine as those used to treat depression. These medicines may cause serious side effects, including:
  • 1. Suicidal thoughts or actions:
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 in an emergency, especially if they are new, worse, or worry you:
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 in an emergency. n- Fluvoxamine maleate extended-release capsules n- may be associated with these serious side effects:
  • u00a0
  • 2. Serotonin Syndrome. This condition can be life-threatening and may include:
  • u00a0
  • 3n- Visual Problems
  • Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
  • 4. Severe allergic reactions:
  • 5. Abnormal bleeding:
  • 6. Seizures or convulsions
  • 7. Manic episodes:
  • 8. Changes in appetite or weight.
  • 9. Low salt (sodium) levels in the blood.
  • Elderly people may be at greater risk for this.
  • Symptoms may include:
  • Do not stop taking n- fluvoxamine maleate extended-release capsules without first talking to your healthcare provider.
  • What are n- fluvoxamine maleate extended-release capsules?
  • Fluvoxamine maleate extended-release capsules are a prescription medicine used to treat obsessive compulsive disorder (OCD). It is the same kind of drug that is used to treat depression. It is important to talk with your healthcare provider about the risks of treating OCD and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
  • Talk to your healthcare provider if you do not think that your condition is getting better with fluvoxamine maleate extended-release treatment.
  • Who should not take n- fluvoxamine maleate extended-release capsules?
  • Do not take fluvoxamine maleate extended-release capsules if you:
  • People who take n- fluvoxamine maleate extended-release capsules 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:
  • What should I tell my healthcare provider before taking n- fluvoxamine maleate extended-release capsules? Ask if you are not sure.
  • Before starting fluvoxamine maleate extended-release capsules, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines that you take,
  • Your healthcare provider or pharmacist can tell you if it is safe to take fluvoxamine maleate extended-release capsules with your other medicines. Do not start or stop any medicine while taking fluvoxamine maleate extended-release capsules without talking to your healthcare provider first.
  • If you take fluvoxamine maleate extended-release capsules, you should not take any other medicines that contain fluvoxamine maleate including: Fluvoxamine Maleate Immediate-Release Tablets.
  • How should I take n- fluvoxamine maleate extended-release capsules?
  • What should I avoid while taking n- fluvoxamine maleate extended-release capsules?
  • Fluvoxamine maleate extended-release capsules can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how fluvoxamine maleate extended-release capsules affect you. Do not drink alcohol while using fluvoxamine maleate extended-release capsules.
  • What are the possible side effects of n- fluvoxamine maleate extended-release capsules?
  • Fluvoxamine maleate extended-release may cause serious side effects, including all of those described in the section entitled u201cWhat is the most important information I should know about fluvoxamine maleate extended-release capsules?u201d
  • Common possible side effects in people who take fluvoxamine include:
  • Other side effects in children and adolescents taking fluvoxamine include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of fluvoxamine maleate extended-release capsules. For more information, ask your healthcare provider or pharmacist.
  • CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO FDA AT 1-800-FDA-1088.
  • How should I store n- fluvoxamine maleate extended-release capsules?
  • Keep n- fluvoxamine maleate extended-release capsules and all medicines out of the reach of children.
  • General information about n- fluvoxamine maleate extended-release capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluvoxamine maleate extended-release capsules for a condition for which they were not prescribed. Do not give fluvoxamine maleate extended-release capsules to other people, even if they have the same condition. It may harm them.
  • This Medication Guide summarizes the most important information about fluvoxamine maleate extended-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluvoxamine maleate extended-release capsules that is written for healthcare professionals.
  • For more information about fluvoxamine maleate extended-release capsules, call Actavis at 1-800-432-8534.
  • What are the ingredients in n- fluvoxamine maleate extended-release capsules?
  • Active ingredient:
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Brands listed are the trademarks of their respective owners.
  • Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • 40-9109
  • (MG 41-1152/1117)
  • NDC 0228-2848-03
  • Once-a-Day
  • Fluvoxamine Maleate Extended-Release Capsules
  • 100 mg
  • PHARMACIST: Dispense the accompanying Medication Guide to each patient.
  • Actavis
  • 30 Capsules
  • Rx Only
  • NDC 0228-2849-03
  • Once-a-Day
  • Fluvoxamine Maleate Extended-Release Capsules
  • 150 mg
  • PHARMACIST: Dispense the accompanying Medication Guide to each patient.
  • Actavis
  • 30 Capsules
  • Rx Only

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