Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies. No increased risk of suicidality with antidepressants compared to placebo was seen in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. 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 nor for children younger than 10 years of age .
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. 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.
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.
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 12 mg of olanzapine and 50 mg of fluoxetine per day.
- Children—Use and dose must be determined by your doctor.
- For treatment of bipolar I depression:
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.
Use & StorageTOP
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.
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:
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.
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.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
- Methylene Blue
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.
- Amtolmetin Guacil
- Antithrombin III Human
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Chloral Hydrate
- Choline Salicylate
- Dabigatran Etexilate
- Dermatan Sulfate
- Doxorubicin Hydrochloride Liposome
- Drotrecogin Alfa
- Flufenamic Acid
- Iobenguane I 123
- Mefenamic Acid
- Morphine Sulfate Liposome
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Pentosan Polysulfate Sodium
- Protein C
- Salicylic Acid
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Sodium Salicylate
- St John's Wort
- Tiaprofenic Acid
- Tolfenamic Acid
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.
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.
Other Medical ProblemsTOP
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
- Enlarged prostate 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 in the blood) or
- Mania, history of or
- Paralytic ileus (bowels stop moving), history of or
- Seizures, history of or
- Trouble swallowing—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.
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 convulsions.
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, rizatriptan, sumatriptan, tramadol, 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 the following symptoms: a rash, swollen, red skin, a fever, swollen, painful, or tender lymph glands in neck, armpit, or groin, trouble breathing, or yellow skin or eyes.
Check with your doctor right away if you are having convulsions, difficulty with breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, 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 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 any of the following symptoms while taking this medicine: 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, such as aspirin, nonsteroidal antiinflammatory agents, also called 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, such as 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 such as 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.
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 or vitamin supplements.