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Fluvoxamine Maleate (Fluvoxamine Maleate)

Trade Name : Fluvoxamine Maleate

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 25 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 Mylan Pharmaceuticals Inc.. It is available in strength of 25 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.

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About GNH

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 ()u00a0u00a0u00a0u00a0u00a01/2017
  • 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 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 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. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) 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 tablets are not approved for use in pediatric patients except those with obsessive compulsive disorder ().
  • Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
  • 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 efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17), and one maintenance trial in adults n
  • Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) ().
  • No data
  • [see ]
  • Fluvoxamine Maleate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of fluvoxamine maleate, USP.
  • u2022
  • 3
  • No data
  • Serotonin Syndrome and MAOIs:
  • No data
  • Suicidality:
  • Bipolar Disorder:
  • Serotonin Syndrome:
  • Angle Closure Glaucoma:
  • Other Potentially Important Drug Interactions: n- Benzodiazepines: n- Clozapine: n- Methadone: n- Mexiletine: n- Ramelteon: n- Theophylline: n- Warfarin: n- Other Drugs Affecting Hemostasis: n- See .
  • 5.8n- 5.8n- 5.8n- 5.8n- 5.8n- 5.8n- 5.8n- 5.8n- 5.10
  • Discontinuation: n- See .
  • Activation of Mania/Hypomania
  • Seizures:
  • Hyponatremia:
  • Concomitant Illness:
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • u2022
  • 6.2
  • Drug Interactions (not described in Contraindications or Warnings and Precautions) include the following:
  • max
  • Specific populations not discussed in Dosage and Administration or Warnings and Precautions include:
  • 2.4n- 8.1
  • 2.3n- 8.5
  • No data
  • No data
  • Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones.
  • It is chemically designated as 5-Methoxy-4u2032-(trifluoromethyl)valerophenone ()--(2-aminoethyl)oxime, maleate (1:1) and has the molecular formula CHONFu2022CHO. 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 or 100 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, 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 (corn), sodium stearyl fumarate, titanium dioxide and triacetin.
  • No data
  • No data
  • No data
  • No data
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluvoxamine maleate tablets and should counsel them in the appropriate use. A patient Medication Guide about u201cAntidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actionsu201d is available for fluvoxamine maleate tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read 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 tablets.
  • Fluvoxamine Maleate Tablets, USPn- (floo voxu2032 a meen malu2032 ee ate)
  • Read the Medication Guide that comes with fluvoxamine maleate tablets before you start taking them 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 with 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 fluvoxamine maleate tablets?
  • Fluvoxamine is the same kind of medicine as those used to treat depression and may cause serious side effects, including:
  • 1.u00a0u00a0u00a0u00a0Suicidal thoughts or actions:
  • 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.u00a0u00a0u00a0u00a0Serotonin Syndrome: This condition can be life-threatening and may include
  • 3.u00a0u00a0u00a0u00a0Visual problems
  • 4.u00a0u00a0u00a0u00a0Severe allergic reactions:
  • 5.u00a0u00a0u00a0u00a0Abnormal bleeding:
  • 6.u00a0u00a0u00a0u00a0Seizures or convulsions
  • 7.u00a0u00a0u00a0u00a0Manic episodes:
  • 8.u00a0u00a0u00a0u00a0u00a0Changes in appetite or weight.
  • 9.u00a0u00a0u00a0u00a0Low salt (sodium) levels in the blood.
  • Do not stop fluvoxamine maleate tablets without first talking to your healthcare provider
  • Stopping fluvoxamine maleate tablets too quickly may cause serious symptoms including:
  • What are fluvoxamine maleate tablets?
  • Fluvoxamine maleate tablets are a prescription medicine used to treat obsessive compulsive disorder (OCD). 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 tablets treatment.
  • Who should not take fluvoxamine maleate tablets?
  • Do not take fluvoxamine maleate tablets if you:
  • What should I tell my healthcare provider before taking fluvoxamine maleate tablets? Ask if you are not sure.
  • Before starting fluvoxamine maleate tablets, 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 tablets with your other medicines. Do not start or stop any medicine while taking fluvoxamine maleate tablets without talking to your healthcare provider first.
  • How should I take fluvoxamine maleate tablets?
  • What should I avoid while taking fluvoxamine maleate tablets?
  • Fluvoxamine maleate tablets 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 tablets affect you. Do not drink alcohol while using fluvoxamine maleate tablets.
  • What are the possible side effects of fluvoxamine maleate tablets?
  • Fluvoxamine maleate tablets may cause serious side effects, including:
  • Common possible side effects in people who take fluvoxamine maleate tablets include:
  • Other side effects in children and adolescents 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 tablets. 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 fluvoxamine maleate tablets?
  • Store fluvoxamine maleate tablets at room temperature between 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).
  • Keep fluvoxamine maleate tablets and all medicines out of the reach of children.
  • General information about fluvoxamine maleate tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluvoxamine maleate tablets for a condition for which they were not prescribed. Do not give fluvoxamine maleate tablets to other people, even if they have the same condition. They may harm them.
  • This Medication Guide summarizes the most important information about fluvoxamine maleate tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluvoxamine maleate tablets that is written for healthcare professionals.
  • For more information about fluvoxamine maleate tablets, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
  • What are the ingredients in fluvoxamine maleate tablets?
  • Active ingredient: fluvoxamine maleate
  • Inactive ingredients: colloidal silicon dioxide, FD&C Yellow No. 6 Aluminum Lake, hypromellose, mannitol, polydextrose, polyethylene glycol, povidone, pregelatinized starch (corn), sodium stearyl fumarate, titanium dioxide and triacetin.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • The brands listed are trademarks of their respective owners.
  • Mylan Pharmaceuticals Inc.
  • Revised: 4/2018FLVX:R27m/MG:FLVX:R5m
  • NDC 0378-0407-01
  • Fluvoxaminen- Maleaten- Tablets, USPn- 25 mg
  • PHARMACIST: Dispense the accompanying n- Medication Guide to each patient.
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each film-coated tablet contains: Fluvoxamine maleate, USPu00a0u00a0u00a0u00a0u00a025 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from high humidity.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM0407A6
  • NDC 0378-0412-01
  • Fluvoxaminen- Maleaten- Tablets, USPn- 50 mg
  • PHARMACIST: Dispense the accompanying n- Medication Guide to each patient.
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each film-coated tablet contains: Fluvoxamine maleate, USPu00a0u00a0u00a0u00a0u00a050 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from high humidity.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM0412A6
  • NDC 0378-0414-01
  • Fluvoxaminen- Maleaten- Tablets, USPn- 100 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each film-coated tablet contains: Fluvoxamine maleate, USPu00a0u00a0u00a0u00a0u00a0100 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from high humidity.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM0414A6

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