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Olanzapine And Fluoxetine (Olanzapine And Fluoxetine)

Trade Name : Olanzapine and Fluoxetine

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 325 mg/1mg/1

OLANZAPINE; FLUOXETINE HYDROCHLORIDE Atypical Antipsychotic [EPC],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 Olanzapine And Fluoxetine (Olanzapine And Fluoxetine) which is also known as Olanzapine and Fluoxetine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 3; 25 mg/1; mg/1 per ml. Read more

Olanzapine And Fluoxetine (Olanzapine And 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

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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
  • Arrayn- Suicidal Thoughts and Behaviors
  • In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Olanzapine and fluoxetine capsules are not approved for use in children less than 10 years of age [].
  • Arrayn- Array
  • WARNINGS: 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. Olanzapine and fluoxetine capsules are 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. Olanzapine and fluoxetine capsules are not approved for the treatment of patients with dementia-related psychosis (, , ).
  • Olanzapine and fluoxetine capsules are indicated for the treatment of:
  • Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of:
  • Acute Depressive Episodes Associated with Bipolar I Disorder ()
  • Treatment Resistant Depression ()
  • No data
  • Adult Starting Dose: 6 mg olanzapine with 25 mg fluoxetine (6 mg/25 mg, once daily in the evening) (, )
  • Adult Maximum Dose: 12 mg/50 mg once daily (, ).
  • Pediatric Bipolar Depression Starting Dose: 3 mg/25 mg once daily (for ages 10 to 17 years) ().
  • Pediatric Bipolar Depression Maximum Dose: 12 mg/50 mg ()
  • Starting dose in patients predisposed to hypotensive reactions, hepatic impairment, or with potential for slowed metabolism: 3 mg/25 mg to 6 mg/25 mg. Escalate dose cautiously ()
  • Capsules (mg olanzapine, USP/mg equivalent fluoxetine):
  • Capsules: 3 mg olanzapine/25 mg fluoxetine, 6 mg olanzapine/25 mg fluoxetine, 6 mg olanzapine/50 mg fluoxetine, 12 mg olanzapine/25 mg fluoxetine, and 12 mg olanzapine/50 mg fluoxetine (mg equivalent olanzapine/mg equivalent fluoxetine) ()
  • No data
  • Arrayn- Monoamine Oxidase Inhibitors (MAOI)
  • Arrayn- Pimozide
  • 4.2n- 5.20n- 7.7n- 7.8
  • Arrayn- Thioridazine
  • 4.2n- 5.20n- 7.7n- 7.8
  • No data
  • Arrayn- Neuroleptic Malignant Syndrome
  • Arrayn- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
  • Arrayn- Metabolic Changes
  • Arrayn- Array
  • Arrayn- Serotonin Syndrome
  • Arrayn- Angle-Closure Glaucoma
  • Arrayn- Allergic Reactions and Rash
  • Arrayn- Activation of Mania/Hypomania
  • Arrayn- Tardive Dyskinesia
  • Arrayn- Orthostatic Hypotension
  • Arrayn- Leukopenia, Neutropenia, and Agranulocytosis
  • Arrayn- Seizures
  • Arrayn- Abnormal Bleeding
  • Arrayn- Hyponatremia
  • Arrayn- Potential for Cognitive and Motor Impairment
  • Arrayn- QT Prolongation
  • 4.2n- 5.20
  • Arrayn- Hyperprolactinemia
  • Arrayn- Long Elimination Half-Life of Fluoxetine
  • 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) 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 ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The risks of using olanzapine and fluoxetine capsules 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 olanzapine and fluoxetine capsules. 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 [].
  • Arrayn- Monoamine Oxidase Inhibitor (MAOI)
  • 2.4n- 2.5n- 4.1n- 5.6n- 7.1
  • Arrayn- Drugs Metabolized by CYP2D6
  • Arrayn- Tricyclic Antidepressants (TCAs)
  • 5.6n- 7.7
  • Arrayn- CNS Acting Drugs
  • Arrayn- Antihypertensive Agent
  • Arrayn- Levodopa and Dopamine Agonists
  • Arrayn- Benzodiazepines
  • 7.6n- 7.7
  • Arrayn- Clozapine
  • Arrayn- Haloperidol
  • Arrayn- Carbamazepine
  • Arrayn- Phenytoin
  • Arrayn- Alcohol
  • Arrayn- Serotonergic Drugs
  • 2.4n- 2.5n- 4.1n- 5.6n- 7.3
  • Arrayn- Fluvoxamine
  • Arrayn- Drugs that Interfere with Hemostasis
  • Arrayn- Drugs Tightly Bound to Plasma Proteins
  • Arrayn- Drugs that Prolong the QT Interval
  • 4.2n- 5.20n- 7.7n- 7.8
  • No data
  • Arrayn- Pregnancy
  • Arrayn- Nursing Mothers
  • Arrayn- Pediatric Use
  • Arrayn- Hepatic Impairment
  • Olanzapine and fluoxetine capsules, as with fluoxetine and olanzapine, have not been systematically studied in humans for their 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 olanzapine and fluoxetine capsules (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).
  • In studies in rats and rhesus monkeys 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 15 (rat) and 8 (monkey) times the MRHD (20 mg) on a mg/m basis.
  • Olanzapine and fluoxetine capsules
  • Adverse reactions involving overdose of fluoxetine and olanzapine in combination, and olanzapine and fluoxetine capsules, have been reported. An overdose of combination therapy is defined as confirmed or suspected ingestion of a dose of >20 mg olanzapine in combination with a dose of >80 mg fluoxetine. Adverse reactions associated with these reports included somnolence (sedation), impaired consciousness (coma), impaired neurologic function (ataxia, confusion, convulsions, dysarthria), arrhythmias, lethargy, essential tremor, agitation, acute psychosis, hypotension, hypertension, and aggression. Fatalities have been confounded by exposure to additional substances including alcohol, thioridazine, oxycodone, and propoxyphene.
  • Olanzapine
  • Fluoxetine
  • Among 633 adult patients who overdosed on fluoxetine alone, 34 resulted in a fatal outcome, 378 completely recovered, and 15 patients experienced sequelae after overdose, including abnormal accommodation, abnormal gait, confusion, unresponsiveness, nervousness, pulmonary dysfunction, vertigo, tremor, elevated blood pressure, erectile dysfunction, movement disorder, and hypomania. The remaining 206 patients had an unknown outcome. The most common signs and symptoms associated with non-fatal overdose were seizures, somnolence, nausea, tachycardia, and vomiting. The largest known ingestion of fluoxetine in adult patients was 8 grams in a patient who took fluoxetine alone and who subsequently recovered. However, in an adult patient who took fluoxetine alone, an ingestion as low as 520 mg has been associated with lethal outcome, but causality has not been established.
  • Among pediatric patients (ages 3 months to 17 years), there were 156 cases of overdose involving fluoxetine alone or in combination with other drugs. Six patients died, 127 patients completely recovered, 1 patient experienced renal failure, and 22 patients had an unknown outcome. One of the 6 fatalities was a 9-year-old boy who had a history of OCD, Touretteu2019s Syndrome with tics, attention deficit disorder, and fetal alcohol syndrome. He had been receiving 100 mg of fluoxetine daily for 6 months in addition to clonidine, methylphenidate, and promethazine. Mixed-drug ingestion or other methods of suicide complicated all 6 overdoses in children that resulted in fatalities. The largest ingestion in pediatric patients was 3 grams, which was non-lethal.
  • Other important adverse reactions reported with fluoxetine overdose (single or multiple drugs) included coma, delirium, ECG abnormalities (such as nodal rhythm, QT-interval prolongation and ventricular arrhythmias, including torsade de pointes-type arrhythmias), hypotension, mania, neuroleptic malignant syndrome-like reactions, pyrexia, stupor, and syncope.
  • For current information on the management of olanzapine and fluoxetine capsules (olanzapine and fluoxetine) overdose, contact a certified poison control center (1-800-222-1222 or www.poison.org). In managing overdose, consider the possibility of multiple drug involvement. In case of acute overdose, establish and maintain an airway and ensure adequate ventilation, which may include intubation. Induction of emesis is not recommended as the possibility of obtundation, seizures, or dystonic reactions of the head and neck following overdose may create a risk for aspiration. Commence cardiovascular monitoring immediately and include continuous electrocardiographic monitoring to detect possible arrhythmias.
  • A specific precaution involves patients who are taking or have recently taken olanzapine and fluoxetine capsules and may have ingested excessive quantities of a TCA (tricyclic antidepressant). In such cases, accumulation of the parent TCA and/or an active metabolite increases the possibility of serious sequelae and extends the time needed for close medical observation.
  • Due to the large volume of distribution of olanzapine and fluoxetine, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidote for either fluoxetine or olanzapine overdose is known. Treat hypotension and circulatory collapse with appropriate measures such as intravenous fluids and/or sympathomimetic agents. Do not use epinephrine, dopamine, or other sympathomimetics with u03b2-agonist activity, since beta stimulation may worsen hypotension in the setting of olanzapine-induced alpha blockade.
  • Olanzapine and Fluoxetine Capsules USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride, USP (the active ingredient in Prozac, Prozac Weekly, and Sarafem).
  • Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10-thieno[2,3-] [1,5]benzodiazepine.
  • Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (u00b1)-N-methyl-3-phenyl-3-[(u03b1,u03b1,u03b1-trifluoro--tolyl)oxy]propylamine hydrochloride.
  • The chemical structures are:
  • CHNS M.W. 312.44
  • CHFNOu2022HCl M.W. 345.79
  • Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.
  • Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
  • Olanzapine and Fluoxetine Capsules USP are available for oral administration in the following strength combinations:
  • Each capsule also contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C yellow #10 and FD&C yellow #6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C red #28, FD&C blue #1, and FD&C red #40.
  • No data
  • No carcinogenicity, mutagenicity, or fertility studies were conducted with olanzapine and fluoxetine capsules. 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.
  • Carcinogenesis
  • Olanzapine
  • see Warnings and Precautions (
  • )
  • Fluoxetine
  • Mutagenesis
  • Olanzapine
  • in vivo
  • in vivo
  • Fluoxetine
  • in vivo
  • Impairment of Fertility
  • Olanzapine and fluoxetine capsules
  • Olanzapine
  • Fluoxetine
  • see Use in Specific Populations ()
  • Efficacy for olanzapine and fluoxetine capsules was established for the:
  • No data
  • See FDA-approved Medication Guide.
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking olanzapine and fluoxetine capsules.
  • Olanzapine (oh-LAN-zah-peen) and Fluoxetine (floo-OX-eh-teen) Capsules
  • Read the Medication Guide that comes with olanzapine and fluoxetine capsules before you start taking them 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 olanzapine and fluoxetine capsules.
  • What is the most important information I should know about olanzapine and fluoxetine capsules?
  • Olanzapine and fluoxetine capsules may cause serious side effects, including:
  • These serious side effects are described below.
  • 1. Suicidal thoughts or actions.
  • Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:
  • Talk to your, or your family member's, healthcare provider about:
  • Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
  • What else do I need to know about antidepressant medicines?
  • 2. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
  • 3. High blood sugar (hyperglycemia):
  • Your doctor should do tests to check your blood sugar before you start taking olanzapine and fluoxetine capsules and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine and fluoxetine capsules are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine and fluoxetine capsules need to take medicine for high blood sugar even after they stop taking olanzapine and fluoxetine capsules.
  • If you have diabetes, follow your doctor's instructions about how often to check your blood sugar while taking olanzapine and fluoxetine capsules.
  • Call your doctor
  • 4. High fat levels in your blood (increased cholesterol and triglycerides).
  • 5. Increase in weight (weight gain):
  • What are olanzapine and fluoxetine capsules?
  • Olanzapine and fluoxetine capsules are a prescription medicine used for:
  • Olanzapine and fluoxetine capsules contain two medicines, olanzapine and fluoxetine hydrochloride.
  • It is not known if olanzapine and fluoxetine capsules are safe and effective in children under the age of 10.
  • The symptoms of Bipolar I 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 Bipolar I Disorder may improve.
  • 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.
  • If you do not think you are getting better, call your doctor.
  • Who should not take olanzapine and fluoxetine capsules?
  • People who take olanzapine and fluoxetine capsules 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 olanzapine and fluoxetine capsules?
  • Olanzapine and fluoxetine capsules may not be right for you. Before starting olanzapine and fluoxetine capsules, tell your doctor about all your medical conditions, including if you have or had any of the following:
  • Before starting olanzapine and fluoxetine capsules, including
  • Olanzapine and fluoxetine capsules 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 olanzapine and fluoxetine capsules with your other medicines. Do not start or stop any medicine while taking olanzapine and fluoxetine capsules without talking to your doctor first.
  • If you take olanzapine and fluoxetine capsules, you should not take any other medicines that contain:
  • You could take too much medicine (overdose).
  • How should I take olanzapine and fluoxetine capsules?
  • What should I avoid while taking olanzapine and fluoxetine capsules?
  • What are the possible side effects of olanzapine and fluoxetine capsules?
  • Other possible serious risks:
  • Common possible side effects of olanzapine and fluoxetine capsules include:
  • Tell your doctor about any side effect that bothers you or that does not go away.
  • These are not all the possible side effects with olanzapine and fluoxetine capsules. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store olanzapine and fluoxetine capsules?
  • Keep olanzapine and fluoxetine capsules and all medicines out of the reach of children.
  • General information about olanzapine and fluoxetine capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use olanzapine and fluoxetine capsules for a condition for which they were not prescribed. Do not give olanzapine and fluoxetine capsules to other people, even if they have the same condition. They may harm them.
  • This Medication Guide summarizes the most important information about olanzapine and fluoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about olanzapine and fluoxetine capsules that was written for healthcare professionals. For more information about olanzapine and fluoxetine capsules call 1-888-838-2872.
  • What are the ingredients in olanzapine and fluoxetine capsules?
  • Active ingredients:
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Orap is a registered trademark of Teva Pharmaceuticals USA, Inc.
  • Distributed By:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. L 5/2018
  • No data
  • No data
  • No data
  • No data
  • No data

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