Olanzapine and fluoxetine (Oral route)

Pronunciation:

floo-OX-e-teen hye-droe-KLOR-ide, oh-LAN-za-peen

Brand Names:

Symbyax

Dosage Forms:

Capsule

Warnings:

Oral route(Capsule)

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. 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 healthcare provider. Fluoxetine hydrochloride/olanzapine is not approved for use in children less than 10 years of age. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Fluoxetine hydrochloride/olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Fluoxetine

Chemical—

Thienobenzodiazepine

Uses of This Medicine:

Olanzapine and fluoxetine combination is used to treat depression that is a part of bipolar disorder, and depression in patients who received other antidepressants that did not work well. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.

Olanzapine and fluoxetine work by increasing the activity of certain chemicals called serotonin, norepinephrine, and dopamine in the brain. These chemicals help relieve the symptoms of depression. Olanzapine is an antipsychotic agent. Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine and fluoxetine combination to treat bipolar I depression in children younger than 10 years of age, and in children with treatment resistant depression. Safety and efficacy have not been established in these groups.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olanzapine and fluoxetine combination in the elderly. However, elderly patients are more likely to have dementia or age-related liver, kidney, or heart problems, which may require caution or an adjustment in the dose for patients receiving olanzapine and fluoxetine combination.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Bromopride
Cisapride
Clorgyline
Dronedarone
Eliglustat
Isocarboxazid
Levoketoconazole
Levomethadyl
Linezolid
Mavacamten
Mesoridazine
Methylene Blue
Metoclopramide
Nialamide
Ozanimod
Phenelzine
Pimozide
Piperaquine
Potassium Citrate
Procarbazine
Rasagiline
Safinamide
Saquinavir
Selegiline
Sparfloxacin
Terfenadine
Thioridazine
Toloxatone
Tranylcypromine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Abciximab
Abiraterone Acetate
Aceclofenac
Acemetacin
Acenocoumarol
Acepromazine
Adagrasib
Alfentanil
Alfuzosin
Almotriptan
Alprazolam
Amantadine
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amtolmetin Guacil
Anagrelide
Anileridine
Apalutamide
Apixaban
Apomorphine
Apomorphine Hydrochloride
Aprindine
Ardeparin
Argatroban
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Aspirin
Astemizole
Atazanavir
Atomoxetine
Azithromycin
Baclofen
Bedaquiline
Belzutifan
Bemiparin
Benperidol
Benzhydrocodone
Benzphetamine
Betrixaban
Bivalirudin
Brexpiprazole
Bromazepam
Bromfenac
Bromocriptine Mesylate
Brompheniramine
Bufexamac
Buprenorphine
Bupropion
Buserelin
Buspirone
Butabarbital
Butorphanol
Cabergoline
Calcium Oxybate
Cangrelor
Cannabidiol
Cannabis
Capmatinib
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Carvedilol
Celecoxib
Ceritinib
Certoparin
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chloroquine
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Choline Salicylate
Cilostazol
Cimetidine
Cinacalcet
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clonixin
Clopidogrel
Clorazepate
Clothiapine
Clozapine
Cobicistat
Cocaine
Codeine
Crizotinib
Cyclobenzaprine
Dabigatran Etexilate
Dabrafenib
Dacomitinib
Dalteparin
Danaparoid
Daridorexant
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Desirudin
Deslorelin
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Deutetrabenazine
Dexfenfluramine
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Dextroamphetamine
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Diazepam
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Diclofenac
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Diflunisal
Digoxin
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Dolasetron
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Doxorubicin
Doxorubicin Hydrochloride Liposome
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Droxicam
Duloxetine
Ebastine
Edoxaban
Efavirenz
Eletriptan
Encainide
Enclomiphene
Encorafenib
Enflurane
Enoxacin
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Entrectinib
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Ethchlorvynol
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Etodolac
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Etoricoxib
Famotidine
Fedratinib
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Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fexinidazole
Fingolimod
Flecainide
Flibanserin
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Fluconazole
Flufenamic Acid
Flunitrazepam
Fluoxetine
Fluphenazine
Flurazepam
Flurbiprofen
Fluspirilene
Fluvoxamine
Fondaparinux
Formoterol
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Iloperidone
Iloprost
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Inotuzumab Ozogamicin
Iobenguane I 123
Iobenguane I 131
Isoflurane
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Macimorelin
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Metaxalone
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Methamphetamine
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Methylene Blue
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Mirtazapine
Mitotane
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Mobocertinib
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Morphine Sulfate Liposome
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Naproxen
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Nilotinib
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Nitrazepam
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Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
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Opipramol
Opium
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Osilodrostat
Osimertinib
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Proglumetacin
Promazine
Promethazine
Propafenone
Propofol
Propranolol
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Protein C
Protriptyline
Quazepam
Quetiapine
Quinidine
Quinine
Quizartinib
Ramelteon
Ranolazine
Relugolix
Remifentanil
Remimazolam
Remoxipride
Revefenacin
Reviparin
Ribociclib
Rifampin
Risperidone
Ritonavir
Rivaroxaban
Rizatriptan
Rofecoxib
Rolapitant
Ropeginterferon Alfa-2b-njft
Ropinirole Hydrochloride
Rotigotine
Salicylic Acid
Salsalate
Scopolamine
Secobarbital
Secretin Human
Selexipag
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Sibutramine
Siponimod
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Sodium Salicylate
Solifenacin
Sorafenib
Sotalol
Spiramycin
St John's Wort
Sufentanil
Sulfamethoxazole
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Sulindac
Sulodexide
Sulpiride
Sultopride
Sumatriptan
Sunitinib
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Tacrolimus
Tamoxifen
Tapentadol
Telaprevir
Telavancin
Telithromycin
Temazepam
Tenoxicam
Terbinafine
Tetrabenazine
Thiethylperazine
Thiopental
Thiopropazate
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tilidine
Timolol
Tinzaparin
Tiotropium
Tirofiban
Tizanidine
Tolfenamic Acid
Tolmetin
Tolonium Chloride
Tolperisone
Tolterodine
Topiramate
Toremifene
Tramadol
Trazodone
Treprostinil
Triazolam
Triclabendazole
Trifluoperazine
Trifluperidol
Triflupromazine
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Trimethoprim
Trimipramine
Triptorelin
Tropisetron
Tryptophan
Valbenazine
Valdecoxib
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vernakalant
Vilanterol
Vilazodone
Vinblastine
Vinflunine
Voclosporin
Vorapaxar
Voriconazole
Vorinostat
Vortioxetine
Warfarin
Yohimbine
Zaleplon
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuclopenthixol
Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alprazolam
Amprenavir
Betel Nut
Cyproheptadine
Delavirdine
Diazepam
Fosamprenavir
Ginkgo
Metoprolol
Valproic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Bipolar disorder (mood disorder with mania and depression), or risk of or
Bleeding problems or
Breast cancer, prolactin-dependent or
Diabetes or
Glaucoma, angle-closure type or
Hyperglycemia (high blood sugar) or
Hyperlipidemia (increased blood cholesterol or fats) or
Hyperprolactinemia (increased prolactin in the blood) or
Hyponatremia (low sodium levels in the blood) or
Mania, history of or
Paralytic ileus (bowels stop moving), or history of or
Prostatic hypertrophy (enlarged prostate), or history of or
Seizures, history of or
Trouble swallowing or
Urinary retention (problems with passing urine), or history of—Use with caution. May make these conditions worse.

Blood vessel or circulation problems or
Dehydration or
Heart attack or stroke, history of or
Heart disease or
Heart failure or
Heart rhythm problems (eg, QT prolongation), or history of or
Hypokalemia (low potassium in the blood) or
Hypomagnesemia (low magnesium in the blood) or
Hypovolemia (low blood volume)—May cause side effects to become worse.

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules):
- For treatment of bipolar I depression:
  - Adults—At first, 1 capsule containing 6 milligrams (mg) of olanzapine and 25 mg of fluoxetine once a day in the evening. Your doctor may adjust your dose as needed. However the dose is usually not more than 18 mg of olanzapine and 75 mg of fluoxetine per day.
  - Children 10 to 17 years of age—At first, 1 capsule containing 3 milligrams (mg) of olanzapine and 25 mg of fluoxetine once a day in the evening. Your doctor may adjust your dose as needed. However the dose is usually not more than 12 mg of olanzapine and 50 mg of fluoxetine per day.
  - Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For treatment resistant depression:
  - Adults—At first, 1 capsule containing 6 milligrams (mg) of olanzapine and 25 mg of fluoxetine once a day in the evening. Your doctor may adjust your dose as needed. However the dose is usually not more than 18 mg of olanzapine and 75 mg of fluoxetine per day.
  - Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take this medicine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking this medicine during the 2 weeks after you stop a MAO inhibitor and wait 5 weeks after stopping this medicine before you start taking a MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.

Do not take thioridazine (Mellaril®) with this medicine, and wait 5 weeks after stopping this medicine before you start taking thioridazine. Do not use pimozide (Orap®) with this medicine. Using these medicines together can cause very serious heart problems.

This medicine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use this medicine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Olanzapine may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). Tell your doctor if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Check with your doctor right away if you have difficulty with breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Tell your doctor right away if you develop a rash or hives, swelling of the face, eyes, or mouth, or trouble breathing after taking this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke.

Contact your doctor right away if you have dizziness, fainting, or a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have ever had a heart rhythm problem, including QT prolongation, or if you or a family member has had a heart attack, heart failure, low blood pressure, or a stroke.

This medicine may cause drowsiness, trouble in thinking, trouble in controlling movements, or trouble in seeing clearly, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Do not suddenly stop taking this medicine without first checking with your doctor. If you have been instructed to stop taking this medicine, ask your doctor how to slowly decrease the dose. This is to decrease the chance of having symptoms including agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble with sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

The use of alcohol is not recommended in patients who are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common: Bloating or swelling of the face, arms, hands, lower legs, or feet; body aches or pain; confusion; cough; delusions; dementia; dryness or soreness of the throat; fever; hoarseness; rapid weight gain; shakiness in the legs, arms, hands, or feet; stuffy or runny nose; tender, swollen glands in the neck; tingling of the hands or feet; trembling or shaking of the hands or feet; trouble with swallowing; unusual weight gain or loss; voice changes

Less common: Blurred vision; change in personality; change in vision; chest tightness; decreased interest in sexual intercourse; difficult or labored breathing; difficulty with sleeping; difficulty with speaking; dizziness; ear pain; headache; impaired vision; inability to have or keep an erection; increase in body movements; loss in sexual ability, desire, drive, or performance; loss of memory; nervousness; pounding in the ears; problems with memory; slow, fast, pounding, or irregular heartbeat or pulse

Rare: Inability to move the eyes; increased blinking or spasms of the eyelid; sticking out of the tongue; uncontrolled twisting movements of the neck, trunk, arms, or legs; unusual facial expressions

Incidence not known: Anxiety; blindness; bloody or black, tarry stools; blue-yellow color blindness; chest pain; chills; constipation; dark-colored urine; delayed or inability to have an orgasm; difficulty swallowing; eye pain; fainting; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; light-colored stools; muscle pain, stiffness, cramps, or spasms; painful or difficult urination; painful or prolonged erection of the penis; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; severe stomach pain; sore throat; sores, ulcers, or white spots on the lips or in the mouth; stomach pain; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness; vomiting of blood or material that looks like coffee grounds; yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Diarrhea; dry mouth; increased appetite; lack or loss of strength; weight gain

Less common: Change or problem with discharge of semen; decreased interest in sexual intercourse; difficulty with moving; inability to have or keep an erection; loss in sexual ability, desire, drive, or performance; not able to have an orgasm; pain, swelling, or redness in the joints; tooth disorder; twitching

Incidence not known: Decrease in smell; loss of sense of smell

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 11/16/2023

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