Fluoxetine Hydrochloride (Fluoxetine)

Trade Name : Fluoxetine

Proficient Rx LP

CAPSULE

Strength 20 mg/1

FLUOXETINE HYDROCHLORIDE Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Disclaimer

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 Hydrochloride (Fluoxetine) which is also known as Fluoxetine and Manufactured by Proficient Rx LP. It is available in strength of 20 mg/1 per ml. Read more

Fluoxetine Hydrochloride (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
  • 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 ().
  • Warnings and Precautions: Serotonin Syndromeu00a0u00a0u00a0u00a0u00a0u00a001/2017
  • Fluoxetine is indicated for the treatment of:
  • Fluoxetine and Olanzapine in Combination is indicated for the treatment of:
  • Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.n n n
  • Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:
  • Fluoxetine capsules and olanzapine in combination for treatment of:
  • Fluoxetine capsules and olanzapine in combination:
  • u2022 Fluoxetine capsules, USP 10 mg** are white to off white powder filled in size u201c4u201d hard gelatin capsules with opaque light blue colored cap and opaque light orange colored body imprinted u201cSGu201d on cap and u201c113u201d on body with black ink.n u2022 Fluoxetine capsules, USP 20 mg** are white to off white powder filled in size u201c2u201d hard gelatin capsules with opaque light blue colored cap and opaque light green colored body imprinted u201cSGu201d on cap and u201c114u201d on body with black ink.n u2022 Fluoxetine capsules, USP 40 mg** are white to off white powder filled in size u201c0u201d hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted u201cSGu201d on cap and u201c115u201d on body with black ink.n **Fluoxetine base equivalent.
  • u2022
  • 3
  • When using fluoxetine capsules 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.
  • Suicidal thoughts and Behaviors in Children, Adolescents, and Young Adults:
  • Serotonin Syndrome: n- , n- Serotonin Syndrome: n- ,
  • 5.2n- 5.2
  • 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 (u22655% 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 Vensun Pharmaceuticals, Inc. at 1-800-385-1540 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • 6.1
  • 6
  • 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. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is designated (u00b1)-N-methyl-3-phenyl-3-[(u03b1,u03b1,u03b1-trifluoro--tolyl)oxy]propylamine hydrochloride and has the empirical formula of CHFNOu2022HCl. Its molecular weight is 345.79. The structural formula is:u00a0
  • Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water.n Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 u03bcmol), 20 mg (64.7 u03bcmol), or 40 mg (129.3 u03bcmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition, 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.
  • 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
  • No data
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Fluoxetine Capsules, USP u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0(floo-ox-e-teen)u00a0 n Read the Medication Guide that comes with fluoxetine 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 with your healthcare provider if there is something you do not understand or want to learn more about.n n n n Fluoxetine capsules and other antidepressant medicines may cause serious side effects, including:u00a0n n n
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.u00a0n n n
  • 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:n- 2.u00a0 Serotonin Syndrome. This condition can be life-threatening and may include:
  • 3.n- Severe allergic reactions:u00a0
  • 4. Abnormal bleeding: n- 5. 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.
  • 6. Seizures or convulsions
  • 7. Manic episodes:
  • 8. Changes in appetite or weight.n- 9. Low salt (sodium) levels in the blood.
  • 10.u00a0 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 capsules without first talking to your healthcare provider.
  • What are fluoxetine capsules?
  • *Not approved for use in childrenn Talk to your healthcare provider if you do not think that your condition is getting better with fluoxetine capsules treatment.u00a0n n n n n 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.
  • Tell your healthcare provider about all the medicines that you take,
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
  • NDC 71205-125-30
  • 30 Capsules
  • Fluoxetine Capsules, USP
  • 20 mg
  • PHARMACIST:
  • Rx only

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