Olanzapine/Fluoxetine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat depression in people with bipolar disorder. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions, or cause other behavior changes in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause glaucoma or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take it with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antipsychotic/antidepressant for bipolar depression

Generic and brand names: olanzapine/fluoxetine, oral; Symbyax

What is this medicine used for?

This medicine is taken by mouth to treat depression in people with bipolar disorder.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis
• A low white blood cell count
• Alzheimer's disease or dementia
• Bleeding problems
• Breast cancer
• Diabetes
• Glaucoma
• Heart disease, a heart attack, stroke, or heart failure
• High cholesterol or high triglycerides
• Liver or kidney disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Low or high blood pressure
• Parkinson's disease
• Problems with low levels of sodium, potassium, or magnesium in the blood
• Seizures
• Thoughts of suicide
• Trouble swallowing
• Trouble urinating or an enlarged prostate gland

Tell your provider if you smoke. Smoking affects the way this medicine works.

Do not take this medicine if you have taken an MAO inhibitor in the last 2 weeks. Also, do not start taking an MAO inhibitor within 5 weeks after stopping this medicine. You may have serious side effects. Talk with your healthcare provider about this.

Do not take this medicine if you also are taking pimozide (Orap) or thioridazine. Also, do not take thioridazine within 5 weeks after stopping this medicine because this can cause serious or life-threatening heart rhythm problems.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval. Taking this medicine during the last 3 months of pregnancy may cause problems for the baby. Symptoms the baby may have include agitation, tight muscles, floppy muscles, shaking, trouble breathing, or trouble feeding. Talk with your provider about this.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take it at night unless specifically instructed otherwise by your healthcare provider. Take this medicine exactly as directed by your healthcare provider. Do not increase the dosage on your own. Do not stop taking this medicine without your healthcare provider's approval. Your dosage needs to be reduced gradually.

Check with your healthcare provider before using this medicine in children under age 10.

You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose one day, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses the next day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: fast or irregular heartbeat, trouble walking, coma, confusion, seizures, drowsiness, tremors, unusual behavior, fainting, dizziness, slurred speech, uncontrolled muscle movements, trouble breathing, nausea, vomiting.

What should I watch out for?

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment or at times of dose changes. Talk with your healthcare provider about this.

Behavior changes may be caused by the medicine or by depression or another mental health problem. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Hallucinations
• Worsening of depression
• Suicidal thoughts

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination or muscle twitching
• Tremor
• Stiff muscles
• Fast heart beat
• Rapid changes in blood pressure
• Dizziness
• Increased body temperature, sweating, or flushing
• Nausea
• Vomiting
• Diarrhea

Newborn babies may have trouble breathing or feeding, or other symptoms, if the mother takes this medicine in the last 3 months of pregnancy. This medicine should be used during pregnancy only if the benefit is greater than the possible risk to your baby. Talk with your provider about this.

This medicine can cause low blood pressure, especially when you start taking it, or if you take it with alcohol or sedatives. Low blood pressure may make you feel lightheaded or dizzy. Getting up slowly when sitting or lying down may help. Take care to avoid falling.

This medicine may trigger angle-closure glaucoma. Contact your provider right away if you have eye pain, vision changes, or redness and swelling in or around your eye.

Older adults with dementia are at greater risk for side effects. Talk with your provider about this.

This medicine can cause drowsiness, dizziness, and problems with judgment. Do not drive or operate machinery until you are fully alert.

You will need blood tests regularly to see how this medicine affects you. Keep all appointments for tests.

Contact your healthcare provider if your condition does not improve or if it gets worse.

While taking this medicine, be careful when you exercise, especially when it is hot. This medicine affects your body's ability to cool down, and you may get too hot. If you get too hot, you might vomit, feel dizzy, have a fast heartbeat, get very stiff muscles, or be confused. Contact your provider right away if you have these symptoms.

Using this medicine for a long time may cause muscle spasms, twitching in the face and body, and uncontrolled tongue or jaw movement. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may increase the risk of developing diabetes, especially if you are overweight or have a family history of diabetes. If you have diabetes, this medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Thoughts of suicide; unusual mood or behavior changes; new or worsening depression; seizures; increased thirst; increased or decreased urination; extreme hunger; uncontrolled muscle movements; tremors, shaking, or muscle twitching; severe or unusual agitation or nervousness; stiff neck; slurred speech; vision problems; sweating; confusion; extreme weakness or tiredness; unusual bruising or bleeding; severe diarrhea; unexplained fever, sore throat, or cough; memory problems or trouble concentrating; severe dizziness or fainting; severe drowsiness; trouble swallowing or breathing problems; slow, fast, or irregular heartbeat; severe or ongoing trouble sleeping; severe nausea or vomiting; blistering, peeling, or severe skin rash.

Other: Drowsiness; trouble sleeping; mild agitation or nervousness; mild headache; mild dizziness; runny nose; constipation; dry mouth; nausea; weight gain; increased appetite; blurred vision; change in sexual ability or desire.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Anticholinergic medicines such as benztropine (Cogentin), dicyclomine (Bentyl), glycopyrrolate (Cuvposa, Robinul), hyoscyamine (HyoMax, Levbid, Levsin), oxybutynin (Ditropan XL, Oxytrol), propantheline, tolterodine (Detrol), and trihexyphenidyl
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine (Anafranil), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), terbinafine (Lamisil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aspirin and other salicylates
• Atomoxetine (Strattera)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), crizotinib (Xalkori), degarelix (Firmagon), nilotinib (Tasigna), procarbazine (Matulane), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cinacalcet (Sensipar)
• Clonidine (Catapres, Kapvay)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and tolbutamide
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), furosemide (Lasix), and hydrochlorothiazide (Microzide)
• Doxepin (Silenor)
• Gemfibrozil (Lopid)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, mexiletine, procainamide, propafenone (Rythmol), quinidine, and ranolazine (Ranexa)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Lithium (Lithobid)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not start taking this medicine if you have taken an MAO inhibitor in the last 14 days; Do not start an MAO inhibitor within 5 weeks after stopping this medicine.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole (Protonix)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana) and formoterol (Perforomist)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• Metoclopramide (Metozolv, Reglan)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as alfalfa, anise, bilberry, cat's claw, Co-Q10, garlic, ginger, ginkgo biloba, ginseng, glucosamine, gotu kola, kava, SAMe, St. John’s wort, tryptophan, and valerian
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Parkinson’s disease medicines such as apomorphine (Apokyn), bromocriptine (Cycloset, Parlodel), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), and ropinirole (Requip)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rasagiline (Azilect)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants and diet pills such as armodafinil (Nuvigil), benzphetamine (Regimex), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), diethylpropion (Tenuate), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), modafinil (Provigil), phendimetrazine, and phentermine (Adipex-P, Suprenza)
• Tacrolimus (Astagraf, Prograf, Protopic)

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.