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Fluoxetine (Fluoxetine)

Trade Name : Fluoxetine

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 10 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 Mylan Pharmaceuticals Inc.. It is available in strength of 10 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

Packaging and Delivery

Validated Cold Chain Shipment

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
  • u00a0u00a0
  • Arrayn- 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 is a selective serotonin reuptake inhibitor indicated for:
  • No data
  • u2022
  • 2.7
  • Fluoxetine Tablets, USP are available containing fluoxetine hydrochloride, USP equivalent to 10 mg or 20 mg of fluoxetine.
  • Tablets: 10 mg, 20 mg ()
  • When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax.
  • 4.2n- 5.11n- 7.7n- 7.8
  • 4.2n- 5.11n- 7.7n- 7.8
  • When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
  • Clinical Worsening and Suicide Risk:
  • Serotonin Syndrome:
  • Allergic Reactions and Rash:
  • Activation of Mania/Hypomania:
  • Seizures:
  • Altered Appetite and Weight:
  • Abnormal Bleeding:
  • Angle-Closure Glaucoma:u00a0
  • Hyponatremia:
  • Anxiety and Insomnia:
  • QT Prolongation:
  • Potential for Cognitive and Motor Impairment:
  • Long Half-Life:
  • Fluoxetine and Olanzapine in Combination:
  • 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 Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) 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 is a selective serotonin reuptake inhibitor for oral administration. It is 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 molecular formula of CHFNOu00b7HCl. Its molecular weight is 345.79. The structural formula is:
  • Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
  • Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 u00b5mol) or 20 mg (64.7 u00b5mol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, maize (corn) starch, microcrystalline cellulose, polyethylene glycol, silica colloidal anhydrous, and titanium dioxide.
  • No data
  • No data
  • When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyaxu00ae.
  • No data
  • See the FDA-approved .
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluoxetine as monotherapy. When using fluoxetine and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.
  • Fluoxetine Tablets, USPn- (floo ox' e teen)
  • Read the Medication Guide that comes with fluoxetine tablets 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 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 tablets?
  • Fluoxetine tablets 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 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 Torsades de Pointes). This condition can be life-threatening. The symptoms may include:
  • Do not stop fluoxetine tablets without first talking to your healthcare provider.
  • What are fluoxetine tablets?
  • Fluoxetine tablets 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 is 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 treatment.
  • Who should not take fluoxetine tablets?
  • Do not take fluoxetine tablets if you:
  • People who take fluoxetine 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:
  • What should I tell my healthcare provider before taking fluoxetine tablets? Ask if you are not sure.
  • Before starting fluoxetine 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 fluoxetine tablets with your other medicines. Do not start or stop any medicine while taking fluoxetine tablets without talking to your healthcare provider first.
  • NDC 0378-0734-93
  • Fluoxetinen- Tablets, USPn- 10 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx onlyu00a0u00a0u00a0 30 Tablets
  • Each film-coated tablet containsfluoxetine hydrochloride, USPequivalent to 10 mg of fluoxetine.
  • 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 light.
  • Usual Dosage:
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in Australia
  • Mylan.com
  • 3103/0
  • RALP0734H
  • NDC 0378-0735-93
  • Fluoxetinen- Tablets, USPn- 20 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only u00a0u00a0u00a030 Tablets
  • Each film-coated tablet containsfluoxetine hydrochloride, USPequivalent to 20 mg of fluoxetine.
  • 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 light.
  • Usual Dosage:
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in Australia
  • Mylan.com
  • 3108/0
  • RALP0735H

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