Symbyax (Page 15 of 15)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

SYMBYAX capsules are supplied in 3/25 mg, 6/25 mg (mg olanzapine/mg equivalent fluoxetinea) strengths.

a Fluoxetine base equivalent.

SYMBYAX CAPSULE STRENGTH
3 mg/25 mg 6 mg/25 mg
Color Peach &Light Yellow Mustard Yellow& Light Yellow
Capsule No. PU3230 PU3231
Identification Lilly 3230 Lilly 3231
3/25 6/25
NDC Codes
Bottles 30 0002-3230-30 0002-3231-30

16.2 Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Keep tightly closed and protect from moisture.

17 PATIENT COUNSELING INFORMATION

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 healthcare provider if these occur while taking SYMBYAX.

Information on Medication Guide

Healthcare providers should inform patients, their families, and their caregivers about the potential benefits and potential risks associated with treatment with SYMBYAX and should counsel them in its appropriate use. A patient Medication Guide is available for SYMBYAX. The healthcare providers should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s healthcare provider, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Boxed Warning and Warnings and Precautions (5.1)].

Elderly Patients with Dementia-Related Psychosis: Increased Mortality and Cerebrovascular Adverse Events (CVAE), Including Stroke

Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with olanzapine had a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) compared with placebo. SYMBYAX is not approved for elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.2)].

Neuroleptic Malignant Syndrome (NMS)

Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including olanzapine, a component of SYMBYAX. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions (5.3)].

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Patients should be advised to report to their health care provider at the earliest onset of any signs and symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.4)].

Hyperglycemia and Diabetes Mellitus

Patients should be advised of the potential risk of hyperglycemia-related adverse reactions. Patients should be monitored regularly for worsening of glucose control. Patients and caregivers should be counseled that metabolic changes have occurred during treatment with SYMBYAX. Patients who have diabetes should follow their doctor’s instructions about how often to check their blood sugar while taking SYMBYAX [see Warnings and Precautions (5.5)].

Dyslipidemia

Patients should be counseled that dyslipidemia has occurred during treatment with SYMBYAX. Patients should have their lipid profile monitored regularly [see Warnings and Precautions (5.5)].

Weight Gain

Patients should be counseled that weight gain has occurred during treatment with SYMBYAX. Patients should have their weight monitored regularly [see Warnings and Precautions (5.5)].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of SYMBYAX and other serotonergic agents including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort [see Contraindications (4.1) and Warnings and Precautions (5.6), and Drug Interactions (7.3)]. Patients should be advised of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be cautioned to seek medical care immediately if they experience these symptoms.

Angle-Closure Glaucoma

Patients should be advised that taking SYMBYAX can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.7)].

Allergic Reactions and Rash

Patients should be advised to notify their healthcare provider if they develop a rash or hives [see Warnings and Precautions (5.8)]. Patients should also be advised of the signs and symptoms associated with a severe allergic reaction, including swelling of the face, eyes, or mouth, or have trouble breathing. Patients should be cautioned to seek medical care immediately if they experience these symptoms.

Orthostatic Hypotension

Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration and in association with the use of concomitant drugs that may potentiate the orthostatic effect of olanzapine, e.g., diazepam or alcohol [see Warnings and Precautions (5.11) and Drug Interactions (7.6, 7.7)]. Patients should be advised to change positions carefully to help prevent orthostatic hypotension, and to lie down if they feel dizzy or faint, until they feel better. Patients should be advised to call their doctor if they experience any of the following signs and symptoms associated with orthostatic hypotension: dizziness, fast or slow heart beat, or fainting.

Increased Risk of Bleeding

Patients should be cautioned about the concomitant use of SYMBYAX and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since the combined use of psychotropic drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of bleeding [see Warnings and Precautions (5.16)]. Patients should be advised to call their doctor if they experience any increased or unusual bruising or bleeding while taking SYMBYAX.

Hyponatremia

Patients should be advised that hyponatremia has been reported during treatment with SNRIs and SSRIs, including SYMBYAX. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death [see Warnings and Precautions (5.17)].

Potential for Cognitive and Motor Impairment

SYMBYAX has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that SYMBYAX therapy does not affect them adversely [see Warnings and Precautions (5.18)].

Body Temperature Dysregulation

Patients should be advised regarding appropriate care in avoiding overheating and dehydration. Patients should be advised to call their doctor right away if they become severely ill and have some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine [see Warnings and Precautions (5.19)].

Concomitant Medication

Patients should be advised to inform their healthcare provider if they are taking Prozac, Sarafem, fluoxetine, Zyprexa, Zyprexa Zydis, or Zyprexa Relprevv. Patients should be advised to inform their healthcare providers if they are taking, plan to take, or have stopped taking any prescription or over-the-counter drugs, including herbal supplements, since there is a potential for interactions. Patients should also be advised to inform their healthcare providers if they plan to discontinue any medications they are taking while taking SYMBYAX, as stopping a medication may also impact the overall blood level of SYMBYAX [see Warnings and Precautions (5.23)].

Discontinuation of Treatment with SYMBYAX

Patients should be advised to take SYMBYAX exactly as prescribed, and to continue taking SYMBYAX as prescribed even after their mood symptoms improve. Patients should be advised that they should not alter their dosing regimen, or stop taking SYMBYAX, without consulting their healthcare provider [see Warnings and Precautions (5.25)].

Alcohol

Patients should be advised to avoid alcohol while taking SYMBYAX [see Drug Interactions (7.6, 7.7)].

Use in Specific Populations

Pregnancy — Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with SYMBYAX. Advise patients that SYMBYAX use later in pregnancy may lead to extrapyramidal symptoms (tremors, abnormal muscle movements), an increased risk for neonatal complications requiring prolonged hospitalization, respiratory distress, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SYMBYAX during pregnancy [see Use in Specific Populations (8.1)].
Lactation — Advise breastfeeding women using SYMBYAX to monitor infants for agitation, irritability, poor weight gain, poor feeding, excess sedation, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs. [see Use in Specific Populations (8.2)].
Infertility
Advise females of reproductive potential that SYMBYAX may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3)].
Pediatric Use — Safety and efficacy of SYMBYAX in patients 10 to 17 years of age have been established for the acute treatment of Depressive Episodes Associated with Bipolar I Disorder. The types of adverse reactions observed with SYMBYAX in children and adolescents were generally similar to those observed in adults. However, the magnitude and frequency of some changes were greater in children and adolescents than adults. These included increases in lipids, hepatic enzymes, and prolactin, as well as increases in the QT interval. Educate patients, families, and caregivers about these risks [see Warnings and Precautions (5.5, 5.18, 5.20), Adverse Reactions (6.1), and Use in Specific Populations (8.4)].
The frequency of weight gain ≥7%, and the magnitude and frequency of increases in lipids, hepatic analytes, and prolactin in children and adolescents treated with SYMBYAX were similar to those observed in adolescents treated with olanzapine monotherapy [see Warnings and Precautions (5.5, 5.20), Adverse Reactions (6.1), and Use in Specific Populations (8.4)].
The safety and effectiveness of SYMBYAX for the treatment of bipolar I depression in patients under 10 years of age have not been established. The safety and effectiveness of SYMBYAX for treatment resistant depression in patients under 18 years of age have not been established.

QT Prolongation

Patients should be advised that QT interval prolongation and ventricular arrhythmia including Torsade de Pointes have been reported in patients treated with fluoxetine. Signs and symptoms of ventricular arrhythmia include fast, slow, or irregular heart rate, dyspnea, syncope, or dizziness, which may indicate serious cardiac arrhythmia [see Warnings and Precautions (5.20)].

Sexual Dysfunction

Advise patients that use of SYMBYAX may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.26)].

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

Copyright © 2003, 2023, Eli Lilly and Company. All rights reserved.

SYM-0021-USPI-20230818

Medication Guide

SYMBYAX® (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:

  1. Suicidal thoughts or actions.
  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).
  4. High fat levels in your blood (increased cholesterol and triglycerides), especially in children and adolescents age 10 to 17.
  5. Weight gain, especially in children and adolescents age 10 to 17.

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:
    • all risks and benefits of treatment with antidepressant medicines.
    • all treatment choices for depression or other serious mental illness.
    • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
    • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
    • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
      • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
      • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
      • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

    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:

    • thoughts about suicide or dying
    • attempts to commit suicide
    • new or worse depression
    • new or worse anxiety
    • feeling very agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
    • new or worse irritability
    • acting aggressive, being angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking (mania)
    • or other unusual changes in behavior or mood.

    What else do I need to know about antidepressant medicines?

    • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
    • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
    • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
    • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
    • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.
  2. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). SYMBYAX is not approved for treating psychosis in elderly people with dementia.
  3. High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:
    • build up of acid in your blood due to ketones (ketoacidosis)
    • coma
    • death

    Your doctor should do tests to check your blood sugar before you start taking SYMBYAX and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when SYMBYAX is stopped. People with diabetes and some people who did not have diabetes before taking SYMBYAX need to take medicine for high blood sugar even after they stop taking SYMBYAX.

    If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking SYMBYAX.

    Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking SYMBYAX:

    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused, or your breath smells fruity.
  4. High fat levels in your blood (increased cholesterol and triglycerides). High fat levels may happen in people treated with SYMBYAX, especially in children and adolescents (10 to 17 years old). You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking SYMBYAX and during treatment.
  5. Increase in weight (weight gain): Weight gain is common in people who take SYMBYAX. Children and adolescents (10 to 17 years old) who received SYMBYAX, were more likely to gain weight and to gain more weight than adults. Some people may gain a lot of weight while taking SYMBYAX, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

What is SYMBYAX?

SYMBYAX is a prescription medicine used for:

  • short-term treatment of episodes of depression that happen with Bipolar I Disorder in people age 10 or older.
  • treatment of episodes of depression that do not respond to 2 other medicines, also called treatment resistant depression, in adults.

SYMBYAX contains two medicines, olanzapine and fluoxetine hydrochloride.

It is not known if SYMBYAX is 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 SYMBYAX?

  • Do not take SYMBYAX if you take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
    • Do not take an MAOI within 5 weeks of stopping SYMBYAX unless directed to do so by your physician.
    • Do not start SYMBYAX if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take SYMBYAX close in time to an MAOI can have serious and life-threatening side effects, with symptoms including:

  • high fever
  • continued muscle spasms that you cannot control
  • rigid muscles
  • changes in heart rate and blood pressure that happen fast
  • confusion
  • unconsciousness.
  • Do not take SYMBYAX if you take Mellaril® (thioridazine). Do not take Mellaril® within 5 weeks of stopping SYMBYAX. Mellaril can cause serious heart rhythm problems and you could die suddenly.
  • Do not take SYMBYAX if you take the antipsychotic medicine pimozide (Orap®). Do not take pimozide (Orap®) within 5 weeks of stopping SYMBYAX.

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:

  • heart problems
  • seizures (convulsions)
  • diabetes or high blood sugar levels (hyperglycemia)
  • high cholesterol or triglyceride levels in your blood
  • liver problems
  • low or high blood pressure
  • strokes or “mini-strokes” also called transient ischemic attacks (TIAs)
  • bleeding problems
  • Alzheimer’s disease
  • angle-closure glaucoma
  • enlarged prostate in men
  • bowel obstruction
  • breast cancer
  • are pregnant or plan to become pregnant. It is not known if SYMBYAX will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
    • If you become pregnant while taking SYMBYAX, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry.
  • are breast-feeding or plan to breast-feed. SYMBYAX can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take SYMBYAX.

Before starting SYMBYAX, tell your doctor about all the medicines that you take, including

  • Prescription and non-prescription medicines
  • Vitamins, and herbal supplements
  • Triptans used to treat migraine headache
  • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs, MAOIs, or antipsychotics
  • Tramadol, fentanyl, meperidine, methadone, or other opioids
  • Amphetamines
  • Over-the-counter supplements such as tryptophan or St. John’s Wort
  • Electroconvulsive therapy (ECT)

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.

If you take SYMBYAX, you should not take any other medicines that contain:

  • olanzapine (the active ingredient in Zyprexa® and Zyprexa® Zydis®) or
  • fluoxetine hydrochloride (the active ingredient in Prozac® , and Sarafem®).

You could take too much medicine (overdose).

How should I take SYMBYAX?

  • Take SYMBYAX exactly as prescribed. Your doctor may need to change (adjust) the dose of SYMBYAX until it is right for you.
  • If you miss a dose of SYMBYAX, take the missed dose as soon as you remember. If 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 SYMBYAX at the same time.
  • To prevent serious side effects, do not stop taking SYMBYAX suddenly. If you need to stop taking SYMBYAX, your doctor can tell you how to safely stop taking it.
  • If you take too much SYMBYAX, call your doctor or poison control center right away, or get emergency treatment.
  • SYMBYAX can be taken with or without food.
  • SYMBYAX is usually taken one time each day, in the evening.
  • If you do not think you are getting better or have any concerns about your condition while taking SYMBYAX, call your doctor.

What should I avoid while taking SYMBYAX?

  • SYMBYAX can cause sleepiness and 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 SYMBYAX affects you.
  • Avoid drinking alcohol while taking SYMBYAX. Drinking alcohol while you take SYMBYAX may make you sleepier than if you take SYMBYAX alone.

What are the possible side effects of SYMBYAX?

Other possible serious risks:

  • Increased risk of death and increased incidence of stroke or “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with psychosis related to dementia (a brain disorder that lessens the ability to remember, think, and reason). SYMBYAX is not approved for these patients.
  • Severe allergic reactions: Tell your doctor right away if you get red itchy welts (hives) or, a rash alone or with fever and joint pain, while taking SYMBYAX. Call your doctor right away if you become severely ill and have some or all of these symptoms:
    • swelling of your face, eyes, or mouth
    • trouble breathing
  • Neuroleptic malignant syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including SYMBYAX. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have some or all of these symptoms:
    • high fever
    • excessive sweating
    • rigid muscles
    • confusion
    • changes in your breathing, heartbeat, and blood pressure
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): DRESS can occur. Features of DRESS may include rash, fever, swollen glands and other internal organ involvement such as liver, kidney, lung and heart. DRESS is sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs.
  • Tardive Dyskinesia: This condition causes body movements that keep happening and that you cannot control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking SYMBYAX. It may also start after you stop taking SYMBYAX. Tell your doctor if you get any body movements that you cannot control.
  • Serotonin Syndrome: This is a condition that can be life threatening. Call your doctor right away if you become severely ill and have some or all of these symptoms:
    • agitation, hallucinations, coma or other changes in mental status
    • coordination problems or muscle twitching (overactive reflexes)
    • racing heartbeat, high or low blood pressure
    • sweating or fever
    • nausea, vomiting, and diarrhea
    • muscle rigidity
    • dizziness
    • flushing
    • tremor
    • seizures
  • Visual problems:
    • eye pain
    • changes in vision
    • swelling or redness in or around the eye
    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.
  • Abnormal bleeding: Tell your doctor if you notice any increased or unusual bruising or bleeding while taking SYMBYAX, especially if you take one of these medicines:
    • the blood thinner warfarin (Coumadin, Jantoven)
    • a non-steroidal anti-inflammatory drug (NSAID)
    • aspirin
  • Low salt (sodium) levels in the blood (hyponatremia): Call your doctor right away if you become severely ill and have some or all of these symptoms:
    • headache
    • feel weak
    • confusion
    • problems concentrating
    • memory problems
    • feel unsteady
  • Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsade de Pointes). This condition can be life threatening. The symptoms may include:
    • fast, slow, or irregular heartbeat
    • shortness of breath
    • dizziness or fainting
  • Decreased blood pressure when you change positions, with symptoms of dizziness, fast or slow heart beat, or fainting
  • Difficulty swallowing
  • Seizures
  • Problems with control of body temperature: You could become very hot, for instance when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have some or all of these symptoms of dehydration:
    • sweating too much or not at all
    • dry mouth
    • feeling very hot
    • feeling thirsty
    • not able to produce urine
  • Sexual problems (dysfunction): Taking selective serotonin reuptake (SSRIs), including fluoxetine, a component of SYMBYAX, may cause sexual problems.
    • Symptoms in males may include:
      • Delayed ejaculation or inability to have an ejaculation
      • Decreased sex drive
      • Problems getting or keeping an erection
    • Symptoms in females may include:
      • Decreased sex drive
      • Delayed orgasm or inability to have an orgasm
    Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with SYMBYAX. There may be treatments your healthcare provider can suggest.

Common possible side effects of SYMBYAX include: dry mouth, tiredness, sleeping for long period of time, increased appetite, swelling of your hands and feet, drowsiness, tremors (shakes), or blurred vision.

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 SYMBYAX. 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 SYMBYAX?

  • Store SYMBYAX at room temperature, between 59°F to 86°F (15°C to 30°C).
  • Keep SYMBYAX away from light.
  • Keep SYMBYAX dry and away from moisture. Keep the bottle closed tightly.

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.

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).

What are the ingredients in SYMBYAX?

Active ingredients: olanzapine and fluoxetine hydrochloride

Inactive ingredients: pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide revised August, 2023

Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA

Copyright © 2009, 2023, Eli Lilly and Company. All rights reserved.

SYM-0007-MG-20230818

PACKAGE LABEL – SYMBYAX 3mg/25mg capsules, bottle of 30

NDC 0002-3230-30

30 CAPSULES

No. 3230

Symbyax®

Olanzapine and Fluoxetine Capsules

3 mg/25 mg

Each capsule contains 3 mg olanzapine and 25 mg fluoxetine*

Rx only

Lilly


PACKAGE LABEL – SYMBYAX 3mg/25mg capsules, bottle of 30
(click image for full-size original)

PACKAGE LABEL – SYMBYAX 6mg/25mg capsules, bottle of 30

NDC 0002-3231-30

30 CAPSULES

No. 3231

Symbyax®

Olanzapine and Fluoxetine Capsules

6 mg/25 mg

Each capsule contains 6 mg olanzapine and 25 mg fluoxetine*

Rx only

Lilly


PACKAGE LABEL – SYMBYAX 6mg/25mg capsules, bottle of 30
(click image for full-size original)
SYMBYAX olanzapine and fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3230
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Olanzapine (Olanzapine) Olanzapine 3 mg
Fluoxetine hydrochloride (Fluoxetine) Fluoxetine 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
Gelatin, Unspecified
Dimethicone
titanium dioxide
sodium lauryl sulfate
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color pink (Peach) , yellow (Light Yellow) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code Lilly;3230;3;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3230-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021520 04/09/2007
SYMBYAX olanzapine and fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3231
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Olanzapine (Olanzapine) Olanzapine 6 mg
Fluoxetine hydrochloride (fluoxetine) fluoxetine 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
Gelatin, Unspecified
Dimethicone
titanium dioxide
sodium lauryl sulfate
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color yellow (Mustard Yellow) , yellow (Light Yellow) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code Lilly;3231;6;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3231-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021520 12/24/2003
Labeler — Eli Lilly and Company (006421325)

Revised: 08/2023 Eli Lilly and Company

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