Trade Name: Symbyax

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

Manufacturer: Eli Lilly and Company

Presentation: CAPSULE, HUMAN PRESCRIPTION DRUG

Strength: 3; 25 mg/1; mg/1

Storage and handling

OLANZAPINE; FLUOXETINE HYDROCHLORIDE Atypical Antipsychotic [EPC],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
  • No data
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. SYMBYAX is not approved for use in children less than 10 years of age (, , ).
  • Monitor for worsening and emergence of suicidal thoughts and behaviors (, ).
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SYMBYAX is not approved for the treatment of patients with dementia-related psychosis (, , ).
  • SYMBYAX is indicated for the treatment of:n
  • SYMBYAX combines olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of:n
  • Acute Depressive Episodes Associated with Bipolar I Disorder ()n
  • Treatment Resistant Depression ()n
  • No data
  • Adult Starting Dose: 6u00a0mg olanzapine with 25u00a0mg fluoxetine (6u00a0mg/25u00a0mg, once daily in the evening (, )
  • Adult Maximum Dose: 12u00a0mg/50u00a0mg once daily (, ).n
  • Pediatric Bipolar Depression Starting Dose: 3u00a0mg/25u00a0mg once daily (for ages 10 to 17 years) ().n
  • Pediatric Bipolar Depression Maximum Dose: 12u00a0mg/50u00a0mg ()n
  • Starting dose in patients predisposed to hypotensive reactions, hepatic impairment, or with potential for slowed metabolism: 3u00a0mg/25u00a0mg to 6u00a0mg/25u00a0mg . Escalate dose cautiously ()n
  • Capsules (mg olanzapine/mg equivalent fluoxetine):
  • Capsules: 3u00a0mg/25u00a0mg, 6u00a0mg/25u00a0mg, 6u00a0mg/50u00a0mg, and 12u00a0mg/50u00a0mg (mg olanzapine/mg equivalent fluoxetine) ()n
  • No data
  • Monoamine Oxidase Inhibitors (MAOI)
  • Pimozide
  • Thioridazine
  • No data
  • Neuroleptic Malignant Syndrome:
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS):
  • Metabolic Changes:
  • Serotonin Syndrome:
  • Angle-Closure Glaucoma:
  • Allergic Reactions and Rash:
  • Activation of Mania/Hypomania:
  • Tardive Dyskinesia:
  • Orthostatic Hypotension:
  • Leukopenia, Neutropenia, and Agranulocytosis:
  • Seizures:
  • Abnormal Bleeding:
  • Hyponatremia:
  • Potential for Cognitive and Motor Impairment:
  • QT Prolongation:
  • Hyperprolactinemia:
  • Long Elimination Half-Life of Fluoxetine:
  • The following adverse reactions are discussed in more detail in other sections of the labeling:n
  • Most common adverse reactions (u22655% and at least twice that for placebo) in adults: sedation, weight increased, appetite increased, dry mouth, fatigue, edema, tremor, disturbance in attention, blurred vision. Children and adolescents: sedation, weight increased, appetite increased, tremor, triglyceride increased, hepatic enzymes increased ()n
  • To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • The risks of using SYMBYAX in combination with other drugs have not been extensively evaluated in systematic studies. The drug-drug interactions sections of fluoxetine and olanzapine are applicable to SYMBYAX. 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. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status .
  • Monoamine Oxidase Inhibitor (MAOI)n- :
  • 2.4n- 2.5n- 4.1n- 5.6n- 7.1
  • Drugs Metabolized by CYP2D6n- :
  • Tricyclic Antidepressants (TCAs)n- :
  • 5.6n- 7.7
  • CNS Acting Drugsn- :
  • Antihypertensive Agentn- :
  • Levodopa and Dopamine Agonistsn- :
  • Benzodiazepines:
  • Clozapinen- :
  • Haloperidoln- :
  • Carbamazepinen- :
  • Phenytoinn- :
  • Alcoholn- :
  • Serotonergic Drugsn- :
  • 2.4n- 2.5n- 4.1n- 5.6n- 7.3
  • Fluvoxaminen- :
  • Drugs that Interfere with Hemostasis:n- (e.g., NSAIDs, Aspirin, Warfarin, etc.):
  • Drugs Tightly Bound to Plasma Proteinsn- : Fluoxetine
  • Drugs that Prolong the QT Intervaln- :
  • 4.2n- 5.20n- 7.7n- 7.8
  • No data
  • Pregnancyn- :
  • Nursing Mothersn- :
  • Pediatric Usen- :
  • Hepatic Impairment:
  • SYMBYAX, as with fluoxetine and olanzapine, has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While the clinical studies did not reveal any tendency for 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 SYMBYAX (e.g.,u00a0development of tolerance, incrementation of dose, drug-seeking behavior).
  • In studies in rats and rhesusu00a0monkeys designed to assess abuse and dependence potential, olanzapine alone was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence at oral doses up to 15u00a0(rat) and 8u00a0(monkey) times the MRHDu00a0(20u00a0mg) on a mg/m basis.
  • No data
  • SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac, Prozac Weekly, and Sarafem).
  • Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10-thieno[2,] [1,5]benzodiazepine. The molecular formula is CHNS, which corresponds to a molecular weight of 312.44.
  • Fluoxetine hydrochloride is a selective serotonin reuptake inhibitoru00a0(SSRI). The chemical designation is (u00b1)-N-methyl-3-phenyl-3-[(u03b1,u03b1,u03b1-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is CHFNOu2022HCl, which corresponds to a molecular weight ofu00a0345.79.
  • The chemical structures are:
  • Olanzapine is a yellow crystalline solid, which is practically insoluble in water.
  • Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14u00a0mg/mL in water.
  • SYMBYAX capsules are available for oral administration in the following strength combinations:
  • Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide.
  • No data
  • No carcinogenicity, mutagenicity, or fertility studies were conducted with SYMBYAX. The following data are based on findings in studies performed with the individual components, therefore all dose multiples (based on body surface area) reflect the maximum recommended human dose (MRHD) of 20 mg olanzapine, or 80 mg fluoxetine, when each drug is administered separately.
  • Efficacy for SYMBYAX was established for the:n
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking SYMBYAX.
  • Medication Guide
  • SYMBYAX nttttttt(SIM-be-ax)(olanzapine and fluoxetine)Capsule
  • Read the Medication Guide that comes with SYMBYAX 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 doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about SYMBYAX.
  • What is the most important information I should know about SYMBYAX?
  • SYMBYAX may cause serious side effects, including:
  • These serious side effects are described below.
  • What is SYMBYAX?
  • SYMBYAX is a prescription medicine used for:n
  • SYMBYAX contains two medicines, olanzapine and fluoxetine hydrochloride.n
  • It is not known if SYMBYAX is safe and effective in children under the age of 10.n
  • The symptoms of Bipolaru00a0I Disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep. With treatment, some of your symptoms of Bipolaru00a0I Disorder may improve.n
  • The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior. With treatment, some of your symptoms of treatment resistant depression may improve.n
  • If you do not think you are getting better, call your doctor.n
  • Who should not take SYMBYAX?
  • People who take SYMBYAX close in time to an MAOI can have serious and life-threatening side effects, with symptoms including:
  • What should I tell my doctor before taking SYMBYAX?
  • SYMBYAX may not be right for you. Before starting SYMBYAX, tell your doctor about all your medical conditions, including if you have or had any of the following:n
  • Before starting SYMBYAX, n includingn
  • SYMBYAX and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take SYMBYAX with your other medicines. Do not start or stop any medicine while taking SYMBYAX without talking to your doctor first.n
  • If you take SYMBYAX, you should not take any other medicines that contain:
  • You could take too much medicine (overdose).n
  • How should I take SYMBYAX?
  • What should I avoid while taking SYMBYAX?
  • What are the possible side effects of SYMBYAX?
  • Other possible serious risks:
  • Common possible side effects of SYMBYAX include:
  • Tell your doctor about any side effect that bothers you or that does not go away.n
  • These are not all the possible side effects with SYMBYAX. For more information, ask your doctor or pharmacist.n
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
  • How should I store SYMBYAX?
  • Keep SYMBYAX and all medicines out of the reach of children.
  • General information about SYMBYAX
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYMBYAX for a condition for which it was not prescribed. Do not give SYMBYAX to other people, even if they have the same condition. It may harm them.n
  • This Medication Guide summarizes the most important information about SYMBYAX. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about SYMBYAX that was written for healthcare professionals. For more information about SYMBYAX call 1-800-Lilly-Rx (1-800-545-5979).n
  • What are the ingredients in SYMBYAX?
  • Active ingredients:
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Medication Guide revised October 24, 2016n
  • Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA
  • Copyright u00a9 2009, 2016, Eli Lilly and Company. All rights reserved.n
  • SYM-0004-MG-20161024n
  • nPACKAGE LABEL u2013 SYMBYAX 3mg/25mg capsules, bottle of 30
  • nNDC 0002-3230-30n
  • n30 CAPSULESn
  • nNo. 3230n
  • nSymbyaxn
  • nOlanzapine and Fluoxetine Capsulesn
  • n3 mg/25 mgn
  • nEach capsule contains 3 mg olanzapine and 25 mg fluoxetine*n
  • nRx onlyn
  • nLillyn
  • nPACKAGE LABEL u2013 SYMBYAX 6mg/25mg capsules, bottle of 30
  • nNDC 0002-3231-30n
  • n30 CAPSULESn
  • nNo. 3231n
  • nSymbyaxn
  • nOlanzapine and Fluoxetine Capsulesn
  • n6 mg/25 mgn
  • nEach capsule contains 6 mg olanzapine and 25 mg fluoxetine*n
  • nRx onlyn
  • nLillyn
  • nPACKAGE LABEL u2013 SYMBYAX 12mg/25mg capsules, bottle of 30
  • nNDC 0002-3232-30n
  • n30 CAPSULESn
  • nNo. 3232n
  • nSymbyaxn
  • nOlanzapine and Fluoxetine Capsulesn
  • n12 mg/25 mgn
  • nEach capsule contains 12 mg olanzapine and 25 mg fluoxetine*n
  • nRx onlyn
  • nLillyn
  • nPACKAGE LABEL u2013 SYMBYAX 6mg/50mg capsules, bottle of 30
  • nNDC 0002-3233-30n
  • n30 CAPSULESn
  • nNo. 3233n
  • nSymbyaxn
  • nOlanzapine and Fluoxetine Capsulesn
  • n6 mg/50 mgn
  • nEach capsule contains 6 mg olanzapine and 50 mg fluoxetine*n
  • nRx onlyn
  • nLillyn
  • nPACKAGE LABEL u2013 SYMBYAX 12mg/50mg capsules, bottle of 30
  • nNDC 0002-3234-30n
  • n30 CAPSULESn
  • nNo. 3234n
  • nSymbyaxn
  • nOlanzapine and Fluoxetine Capsulesn
  • n12 mg/50 mgn
  • nEach capsule contains 12 mg olanzapine and 50 mg fluoxetine*n
  • nRx onlyn
  • nLillyn

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Olanzapine and Fluoxetine hydrochloride (Symbyax) which is also known as Symbyax and Manufactured by Eli Lilly and Company. It is available in strength of 3; 25 mg/1; mg/1.

Olanzapine and Fluoxetine hydrochloride (Symbyax) 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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