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Fluoxetine (Fluoxetine)

Trade Name : Fluoxetine

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 40 mg/1

FLUOXETINE HYDROCHLORIDE 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 Fluoxetine (Fluoxetine) which is also known as Fluoxetine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 40 mg/1 per ml. Read more

Fluoxetine (Fluoxetine) 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 () t01/2017
  • When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning
  • When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.
  • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ().
  • Monitor for worsening and emergence of suicidal thoughts and behaviors ().
  • Fluoxetine Capsules are indicated for the treatment of:
  • Fluoxetine Capsules and Olanzapine in Combination are indicated for the treatment of:
  • Fluoxetine Capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
  • When using Fluoxetine Capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
  • Fluoxetine Capsules are a selective serotonin reuptake inhibitor indicated for:
  • Fluoxetine Capsules and olanzapine in combination
  • Fluoxetine and olanzapine in combination
  • Fluoxetine Capsules USP, 40 mg contain fluoxetine hydrochloride, USP equivalent to 40 mg fluoxetine, and are available as hard gelatin capsules with a blue cap and orange body. The body of the #2 capsule is imprinted u201c7198u201d and the cap is imprinted u201cTEVA.u201d
  • Capsules: 40 mg ()
  • When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax.
  • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue ()
  • Pimozide: Do not use. Risk of QT prolongation and drug interaction (, , , )
  • Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine (, , , )
  • When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax ()
  • When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax
  • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults:
  • Serotonin Syndrome:
  • Allergic Reactions and Rash:
  • Activation of Mania/Hypomania:
  • Seizures:
  • Altered Appetite and Weight:
  • Abnormal Bleeding:
  • Angle-Closure Glaucoma:
  • Hyponatremia:
  • Anxiety and Insomnia:
  • QT Prolongation:
  • Potential for Cognitive and Motor Impairment:
  • Long Half-Life:
  • Fluoxetine and Olanzapine in Combination:
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.
  • Most common adverse reactions (u2265 5% and at least twice that for placebo) associated with:
  • Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia, and Panic Disorder: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn ()
  • Fluoxetine and olanzapine in combination u2013 Also refer to the Adverse Reactions section of the package insert for Symbyax ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility.
  • Monoamine Oxidase Inhibitors (MAOIs):
  • Drugs Metabolized by CYP2D6:
  • Tricyclic Antidepressants (TCAs):
  • CNS Acting Drugs:
  • Benzodiazepines:
  • Antipsychotics:
  • Anticonvulsants:
  • Serotonergic Drugs:
  • Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, Warfarin):
  • Drugs Tightly Bound to Plasma Proteins:
  • Olanzapine:
  • Drugs that Prolong the QT Interval:
  • When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax.
  • Pregnancy:
  • Nursing Mothers:
  • Pediatric Use:
  • Hepatic Impairment:
  • Fluoxetine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the premarketing clinical experience with fluoxetine did not reveal any tendency for a withdrawal syndrome or any drug seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of fluoxetine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).
  • No data
  • Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor for oral administration. They are also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is designated (u00b1)--methyl-3-phenyl-3-[(u03b1,u03b1,u03b1-trifluoro--tolyl)oxy]propylamine hydrochloride and has the following structural formula:
  • CHFNOu2022HCl M.W. 345.79
  • Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
  • Each capsule contains fluoxetine hydrochloride, USP equivalent to 40 mg (129.3 u03bcmol) of fluoxetine. In addition, the capsules also contain the following inactive ingredients: colloidal silicon dioxide, pregelatinized corn starch, and simethicone. The capsule shell contains D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, and titanium dioxide. The imprinting ink contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, D&C Yellow #10 aluminum lake, iron oxide black and shellac glaze, and may contain propylene glycol.
  • This product meets USP Dissolution Test 2.
  • No data
  • No data
  • Efficacy for fluoxetine was established for the:
  • Efficacy for fluoxetine and olanzapine in combination was established for the:
  • When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
  • No data
  • See the FDA-approved Medication Guide.
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluoxetine as monotherapy or in combination with olanzapine. When using fluoxetine and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.
  • FLUOXETINE (floo-OX-e-teen)
  • CAPSULES
  • Read the Medication Guide that comes with fluoxetine capsules 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 fluoxetine capsules?
  • Fluoxetine capsules and other antidepressant 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 if 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 if an emergency. Fluoxetine capsules may be associated with these serious side effects:
  • 2. Serotonin Syndrome. This condition can be life-threatening and may include:
  • 3. Severe allergic reactions:
  • 4. Abnormal bleeding:
  • 5. Visual problems:
  • 6. Seizures or convulsions
  • 7. Manic episodes:
  • 8. Changes in appetite or weight.
  • 9. Low salt (sodium) levels in the blood.
  • 10. Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including torsade de pointes). This condition can be life threatening. The symptoms may include:
  • Do not stop fluoxetine capsules without first talking to your healthcare provider.
  • What are fluoxetine capsules?
  • Fluoxetine capsules are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
  • Fluoxetine capsules are used to treat:
  • * Not approved for use in children
  • Talk to your healthcare provider if you do not think that your condition is getting better with fluoxetine capsule treatment.
  • Who should not take fluoxetine capsules?
  • Do not take fluoxetine capsules if you:
  • People who take fluoxetine 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 fluoxetine capsules? Ask if you are not sure.
  • Before starting fluoxetine 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 fluoxetine capsules with your other medicines. Do not start or stop any medicine while taking fluoxetine capsules without talking to your healthcare provider first.
  • If you take fluoxetine capsules, you should not take any other medicines that contain fluoxetine hydrochloride including:
  • How should I take fluoxetine capsules?
  • What should I avoid while taking fluoxetine capsules?
  • Fluoxetine 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 fluoxetine capsules affect you. Do not drink alcohol while using fluoxetine capsules.
  • What are the possible side effects of fluoxetine capsules?
  • Fluoxetine capsules may cause serious side effects, including:
  • Common possible side effects in people who take fluoxetine capsules 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 fluoxetine 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 THE FDA AT 1-800-FDA-1088.
  • How should I store fluoxetine capsules?
  • Keep fluoxetine capsules and all medicines out of the reach of children.
  • General information about fluoxetine capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine capsules for a condition for which they were not prescribed. Do not give fluoxetine capsules to other people, even if they have the same condition. They may harm them.
  • This Medication Guide summarizes the most important information about fluoxetine capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluoxetine capsules that is written for healthcare professionals.
  • For more information about fluoxetine capsules call 1-888-838-2872.
  • What are the ingredients in fluoxetine capsules?
  • Active ingredient: fluoxetine hydrochloride
  • Inactive ingredients: colloidal silicon dioxide, pregelatinized corn starch, and simethicone. The capsule shell contains D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, and titanium dioxide. The imprinting ink contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, D&C Yellow #10 aluminum lake, iron oxide black and shellac glaze, and may contain propylene glycol.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Czech Republic By:
  • Teva Czech Industries, s.r.o.
  • Opava-Komarov, Czech Republic
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. K 1/2017
  • NDCn- 7198
  • FLUOXETINEn- Capsules USPn- 40 mg*
  • PHARMACIST: Dispense the accompanyingMedication Guide to each patient.
  • Rx only
  • 30 CAPSULES
  • TEVA

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