Trade Name: Fluoxetine

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: CAPSULE, HUMAN PRESCRIPTION DRUG

Strength: 20 mg/1

Storage and handling

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

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
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  • Warnings and Precautions:n n n n
  • u00a0u00a0u00a0u00a0u00a0u00a0 Serotonin Syndrome (n n n )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2017n nn
  • u00a0
  • Arrayn- When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thinking and behavior in children, adolescents, n- and young adults taking antidepressants (n n n ).n n n
  • Monitor for worsening and emergence of suicidal thoughts and behaviors (n n n ).n n n
  • Fluoxetine capsules are indicated for the treatment of:
  • Fluoxetine capsules and Olanzapine in Combinationu00a0are indicated for the treatment of:
  • Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.n n n n n
  • Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:
  • Fluoxetin
  • e capsules
  • and olanzapine in combination:
  • Fluoxetine Capsules USP, 10 mg* are opaque green cap/opaque green body, size u20183u2019 hard gelatin capsule filled with white to off-white granular powder and imprinted with u2018Eu2019 on opaque green cap and u201888u2019 on opaque green body with black ink.n n n n Fluoxetine Capsules USP, 20 mg* are opaque green cap/opaque off white body, size u20183u2019 hard gelatin capsule filled with white to off-white granular powder and imprinted with u2018Eu2019 on opaque green cap and u201891u2019 on opaque off white body with black ink.n n n n Fluoxetine Capsules USP, 40 mg* are opaque green cap/opaque orange body, size u20182u2019 hard gelatin capsule filled with white to off-white granular powder and imprinted with u2018Eu2019 on opaque green cap and u201892u2019 on opaque orange body with black ink.n n n n *Fluoxetine base equivalent.n nn
  • Capsules: 10 mg, 20 mg, and 40 mg n n n n
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  • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine capsules or within 5 weeks of stopping treatment with fluoxetine capsules. Do not use fluoxetine capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine capsules in a patient who is being treated with linezolid or intravenous methylene blue n n n n
  • Pimozide: Do not use. Risk of QT prolongation and drug interaction n n n , n n n , n n n , n n n n
  • Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels.u00a0Do not use thioridazine within 5 weeks of discontinuing fluoxetine n n n , n n n , n n n , n n n u00a0n n n
  • When using fluoxetine capsules and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyaxu00a0n n n u00a0n n n
  • No data
  • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults:
  • Serotonin Syndrome: n- , n- u00a0
  • 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:
  • u00a0n n n n u00a0n nn
  • Most common adverse reactions (u22655% and at least twice that for placebo) associated with:n n n n 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 n n n n Fluoxetine and olanzapine in combination - Also refer to the Adverse Reactions section of the package insert for Symbyax n n n n n n
  • 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:
  • No data
  • 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).
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  • Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafemn n n , fluoxetine hydrochloride). It is designated (u00b1)-N-methyl-3-phenyl-3-[(u03b1,u03b1,u03b1-trifluoro-n n n -tolyl)oxy]propylamine hydrochloride and has the molecular formula of Cn n n Hn n n Fn n n NOu2022HCl. Its molecular weight is 345.79. The structural formula is:u00a0n nn
  • Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.n n n 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: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg 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.n nn
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  • 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.
  • NDC 66267-488-30 Bottles of 30
  • See the n n n .n n n
  • Fluoxetine Capsules, USPn n n n (floo ox' e teen)n n n n- What is the most important information I should know about fluoxetine capsules?n- 1. Suicidal thoughts or actions:
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.u00a0n n n n n n
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Fluoxetine capsules n- 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. n- 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. n- Seizures or convulsions
  • Array
  • 7. n- Manic episodes:
  • 8. Changes in appetite or weight.n- 9. Low salt (sodium) levels in the blood.
  • Arrayn- Array
  • Do not stop fluoxetine capsules n- without first talking to your healthcare provider.
  • What are fluoxetine capsules?
  • *Not approved for use in childrenn n n n 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:n nn
  • 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:n n n n n n
  • u00a0u00a0
  • 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,
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Fluoxetine Hydrochloride (Fluoxetine) which is also known as Fluoxetine and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 20 mg/1.

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.

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