Description
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.
This product is available in the following dosage forms:
- Capsule
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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
- Isocarboxazid
- Levoketoconazole
- Levomethadyl
- Linezolid
- Mavacamten
- Mavorixafor
- 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
- Abiraterone Acetate, Micronized
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Acepromazine
- Aclidinium
- 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
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
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.
- For treatment of bipolar I depression:
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
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
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.
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