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Fluoxetine Hydrochloride (Fluoxetine)

Trade Name : Fluoxetine

Pharmaceutical Associates, Inc.

SOLUTION

Strength 20 mg/5mL

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 Hydrochloride (Fluoxetine) which is also known as Fluoxetine and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 20 mg/5mL 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.

Read more
  • No data
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thinking and behavior in children, adolescents, 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
  • No data
  • Fluoxetine is indicated for the treatment of:
  • Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
  • Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
  • Acute and maintenance treatment of Major Depressive Disorder (MDD) (n n n )n n n
  • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (n n n )n n n
  • Acute and maintenance treatment of Bulimia Nervosa (n n n )n n n
  • Acute treatment of Panic Disorder, with or without agoraphobia (n n n )n n n
  • No data
  • A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications (n n n )n n n
  • No data
  • Oral solution: 20 mg per 5 mL (n n n )n n n
  • No data
  • 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 (n n 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 n n
  • Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine (n n n , n n n , n n n , n n n )n n n
  • No data
  • 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
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • 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 (n n n )n nn
  • 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):
  • Drugn- s Metabolized by CYP2D6
  • Tricyclic Antidepressants (TCAs):
  • CNn- S Acting Drugs:
  • Benzodiazepines:
  • Antipsychotics:
  • Anticonvulsants
  • Serotonergic Drugs
  • Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin, Warfarin)
  • Drugs Tightly Bound to Plasma Proteins
  • Drugs that Prolong the QT Interval
  • No data
  • Pregnancy:
  • Nurn- sn- ing 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 Oral Solution USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (u00b1)-N-methyl-3-phenyl-3-[(u03b1,u03b1,u03b1-trifluoro-n n n -tolyl)oxy]propylamine hydrochloride and has the empirical formula of Cn n n Hn n n Fn n n NOu2219HCl. Its molecular weight is 345.79. The structural formula is:n nn
  • Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
  • The oral solution contains fluoxetine hydrochloride equivalent to 20 mg per 5 mL (64.7 u00b5mol) of fluoxetine. It also contains the following inactive ingredients: glycerin, purified water, sodium benzoate, spearmint flavoring agent, and sucrose, and may contain hydrochloric acid and/or sodium hydroxide to adjust the pH.
  • No data
  • No data
  • No data
  • No data
  • See the n n n .n n n
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluoxetine.
  • Literature revised April 2017
  • MANUFACTURED BY
  • Arrayn- Pharmaceuticaln n n Associates, Inc.n n n
  • Fluoxetine Oral Solution USP
  • (floo ox' e teen)
  • Read the Medication Guide that comes with fluoxetine 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?
  • Fluoxetine 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:
  • 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.
  • 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 without first talking to your healthcare provider.
  • What is fluoxetine?
  • Fluoxetine is 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:
  • Major Depressive Disorder (MDD)n n n Obsessive Compulsive Disorder (OCD)n n n Bulimia Nervosa*n n n Panic Disorder*n nn
  • *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?
  • Do not take fluoxetine if you:
  • People who take fluoxetine 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? Ask if you are not sure.
  • Before starting fluoxetine, 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 with your other medicines. Do not start or stop any medicine while taking fluoxetine without talking to your healthcare provider first.
  • If you take fluoxetine, you should not take any other medicines that contain fluoxetine hydrochloride including:
  • How should I take fluoxetine?
  • u2022 Take fluoxetine exactly as prescribed. Your healthcare provider may need to change the dose of fluoxetine until it is the right dose for you.n n n u2022 Fluoxetine may be taken with or without food.n n n u2022 If you miss a dose of fluoxetine, take the missed dose as soon as you remember.u00a0If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluoxetine at the same time.n n n u2022 If you take too much fluoxetine, call your healthcare provider or poison control center right away, or get emergency treatment.n nn
  • Array
  • What should I avoid while taking fluoxetine?
  • Fluoxetine 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 affects you. Do not drink alcohol while using fluoxetine.
  • What are the possible side effects of fluoxetine?
  • Fluoxetine may cause serious side effects, including:
  • Common possible side effects in people who take fluoxetine 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. 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?
  • Keep fluoxetine and all medicines out of the reach of children.
  • General information about fluoxetine
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine for a condition for which it was not prescribed. Do not give fluoxetine to other people, even if they have the same condition. It may harm them.
  • This Medication Guide summarizes the most important information about fluoxetine. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluoxetine that is written for healthcare professionals.
  • For more information about fluoxetine call 1-800-845-8210 or visit www.paipharma.com.
  • What are the ingredients in fluoxetine oral solution USP?
  • Active ingredient: fluoxetine hydrochloride
  • Inactive ingredients: glycerin, purified water, sodium benzoate, spearmint flavoring agent, and sucrose, and may contain hydrochloric acid and/or sodium hydroxide to adjust the pH.
  • *Prozacn n n Weekly, Symbyaxn n n and Sarafemn n n are registered trademarks of Eli Lilly and Companyn nn
  • R04/17n n n MG072110417n nn
  • Arrayn- Pharmaceuticaln n n Associates, Inc.n n n
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Medication Guide revised, April, 2017
  • NDC 0121-0721-04
  • Fluoxetinen n n Oral Solution USPn n n
  • 20 mg/5 mL
  • PHARMACIST:
  • Rx ONLYn n n 120 mLn n n
  • Arrayn- Pharmaceuticaln n n Associates, Inc.n n n
  • Delivers n n n n NDC 0121-4721-05n nn
  • Arrayn- Fn n n n On n n Sn n n USPn n n
  • 20 mg per 5 mL
  • Rx ONLYn n n FOR INSTITUTIONAL USE ONLYn n n n- SEE INSERT
  • A47210500

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