Olanzapine + Fluoxetine

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Generic Name: Olanzapine + Fluoxetine Brand Name(s): Generics only. No brands available.

Uses

What is Olanzapine + Fluoxetine used for?

This medication is a combination of 2 drugs, olanzapine (an antipsychotic drug) and fluoxetine (a selective serotonin reuptake inhibitor-SSRI). It is used to treat a certain type of mental/mood disorder (depression associated with bipolar disorder). It is also used to treat depression that has not responded to other medications. This medication may help you sleep, improve your mood, improve your concentration, and decrease nervousness. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

Talk to the doctor about the risks and benefits of treatment (especially when used in teenagers).

How should I take Olanzapine + Fluoxetine?

Take this medication by mouth, with or without food, usually once daily in the evening or as directed by your doctor.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

It may take up to several weeks before the full benefit of this drug takes effect. It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

If your condition persists or worsens, contact your doctor or pharmacist.

How do I store Olanzapine + Fluoxetine?

Olanzapine + Fluoxetine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Olanzapine + Fluoxetine in the bathroom or the freezer. There may be different brands of Olanzapine + Fluoxetine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Olanzapine + Fluoxetine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Olanzapine + Fluoxetine?

Before taking olanzapine/fluoxetine, tell your doctor or pharmacist if you are allergic to olanzapine or fluoxetine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of suicide attempts, breast cancer, intestinal problems (e.g., paralytic ileus, chronic constipation), kidney disease, liver problems, low blood pressure, neuroleptic malignant syndrome, personal or family history of glaucoma (angle-closure type), prostate problems, seizures, stomach/intestinal ulcers, brain problems (e.g., dementia, stroke), severe loss of body water (dehydration), low white blood cell count, personal or family history of diabetes, heart disease, high cholesterol/triglyceride levels, breathing trouble during sleep (sleep apnea).

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.

Fluoxetine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using olanzapine/fluoxetine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.

This medication can make it harder to control your body temperature. Avoid activities that might cause you to overheat (e.g., doing strenuous work, exercising in hot weather, or using hot tubs). Drink plenty of fluids to avoid becoming dehydrated.

Teenagers may be more sensitive to the side effects of this drug, especially weight gain, and also increased amounts of cholesterol, triglycerides and prolactin.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above), drowsiness, constipation, trouble urinating, confusion, dizziness, and lightheadedness. Older adults may also be more likely to develop low sodium in the blood, especially if they are taking “water pills” (diuretics). Drowsiness, confusion, dizziness, and lightheadedness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as depression, bipolar disorder) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Olanzapine + Fluoxetine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Olanzapine + Fluoxetine. Olanzapine + Fluoxetine is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Olanzapine + Fluoxetine?

Dizziness, lightheadedness, drowsiness, diarrhea, dry mouth, constipation, increased appetite, weight gain, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual or severe mental/mood changes (e.g., confusion, nervousness, trouble concentrating, rare thoughts of suicide), swelling hands/ankles/feet, restlessness, shaking (tremor), inability to keep still, decreased interest in sex, changes in sexual ability, trouble urinating, black stools, vomit that looks like coffee grounds, easy bruising/bleeding, muscle spasm, yellowing eyes/skin, severe stomach/abdominal pain, slow heartbeat, interrupted breathing during sleep.

Get medical help right away if any of these rare but seriousfainting, severe headache, seizures, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).

This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet when you start or stop this medication.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels, especially in teenagers. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face/lips/tongue).

In rare cases, this medication may increase your blood level of a certain hormone (prolactin). For females, this rare increase in prolactin levels may result in unwanted breast milk, irregular/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Olanzapine + Fluoxetine?

Fluoxetine (one of the drugs in this medication) can stay in your body for many weeks after your last dose and may interact with many other medications. If you have taken this medication in the previous 5 weeks, consult your doctor or pharmacist before using any other medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs removed from your body by certain liver enzymes (e.g., cimetidine, phenytoin, vinblastine, antipsychotics such as aripiprazole/clozapine/haloperidol/perphenazine, antiarrhythmics such as propafenone/flecainide, TCA antidepressants such as desipramine/imipramine), fosamprenavir/ritonavir, metoprolol, “water pills” (diuretics such as furosemide), drugs that can cause bleeding/bruising (e.g., aspirin, antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, “blood thinners” such as heparin, warfarin), drugs for high blood pressure, medicines for Parkinson’s disease (e.g., cabergoline).

Taking MAO inhibitors with his medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for 2 weeks before and at least 5 weeks after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Many drugs besides fluoxetine may affect the heart rhythm (QT prolongation), including pimozide and thioridazine, among others.

Aspirin can increase the risk of bleeding when used with this medication (see above). If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Discuss the risks and benefits with your doctor.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy” St. John’s wort, certain antidepressants (including other SSRIs such as citalopram/paroxetine, SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because it may cause undesirable interactions when used with fluoxetine, ask your pharmacist about other products to treat stomach acid.

Cigarette smoking may decrease blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson’s disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Olanzapine + Fluoxetine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Olanzapine + Fluoxetine?

Olanzapine + Fluoxetine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Olanzapine + Fluoxetine?

Olanzapine + Fluoxetine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Olanzapine + Fluoxetine.

What is the dose of Olanzapine + Fluoxetine for an adult?

Usual Adult Dose for Depression

Initial Dose: Fluoxetine 25 mg-olanzapine 6 mg orally once a day

Maintenance dose: Adjust as clinically necessary to within a range of:

-Fluoxetine: 25 to 50 mg orally once a day

-Olanzapine: 3 to 12 mg orally once a day

Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally once a day

Duration: It is generally accepted that treatment-resistant depression and Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, are chronic illnesses requiring chronic treatment.

Comments:

-Dose adjustments may be made according to efficacy and tolerability.

-The safety of doses above fluoxetine 75 mg and olanzapine 18 mg per day has not been evaluated in clinical studies.

Use: Acute treatment of treatment-resistant depression and depressive episodes associated with Bipolar I Disorder

Usual Adult Dose for Bipolar Disorder

Initial Dose: Fluoxetine 25 mg-olanzapine 6 mg orally once a day

Maintenance dose: Adjust as clinically necessary to within a range of:

-Fluoxetine: 25 to 50 mg orally once a day

-Olanzapine: 3 to 12 mg orally once a day

Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally once a day

Duration: It is generally accepted that treatment-resistant depression and Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, are chronic illnesses requiring chronic treatment.

Comments:

-Dose adjustments may be made according to efficacy and tolerability.

-The safety of doses above fluoxetine 75 mg and olanzapine 18 mg per day has not been evaluated in clinical studies.

Use: Acute treatment of treatment-resistant depression and depressive episodes associated with Bipolar I Disorder

Usual Geriatric Dose for Depression

Initial Dose: Fluoxetine 25 mg-olanzapine 3 mg to fluoxetine 25 mg-olanzapine 6 mg orally once a day

Maintenance dose: Adjust with caution as clinically necessary to within a range of:

-Fluoxetine: 25 to 50 mg orally once a day

-Olanzapine: 6 to 12 mg orally once a day

Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally once a day

Duration: It is generally accepted that treatment-resistant depression and Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, are chronic illnesses requiring chronic treatment.

Comments:

-Dose adjustments may be made according to efficacy and tolerability.

-This drug combination has not been systematically studied in patients over 65 years of age.

Use: Acute treatment of treatment-resistant depression and depressive episodes associated with Bipolar I Disorder

Usual Geriatric Dose for Bipolar Disorder

Initial Dose: Fluoxetine 25 mg-olanzapine 3 mg to fluoxetine 25 mg-olanzapine 6 mg orally once a day

Maintenance dose: Adjust with caution as clinically necessary to within a range of:

-Fluoxetine: 25 to 50 mg orally once a day

-Olanzapine: 6 to 12 mg orally once a day

Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally once a day

Duration: It is generally accepted that treatment-resistant depression and Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, are chronic illnesses requiring chronic treatment.

Comments:

-Dose adjustments may be made according to efficacy and tolerability.

-This drug combination has not been systematically studied in patients over 65 years of age.

Use: Acute treatment of treatment-resistant depression and depressive episodes associated with Bipolar I Disorder

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Liver dysfunction:

Initial dose: Fluoxetine 25 mg-olanzapine 3 mg to fluoxetine 25 mg-olanzapine 6 mg orally once a day

-A lower or less frequent dose of the fluoxetine component should be used in patients with cirrhosis; dose adjustments, if clinically indicated, should be done with caution.

Dose Adjustments

An initial dose of fluoxetine 25 mg-olanzapine 3 mg to fluoxetine 25 mg-olanzapine 6 mg orally once a day should be considered in patients:

-With a predisposition to hypotensive reactions

-Who exhibit a combination of factors that may slow the metabolism of fluoxetine-olanzapine (e.g., female gender, geriatric age, nonsmokers)

-Who may be pharmacodynamically sensitive to olanzapine

Comments:

-Dose increases, if clinically indicated, should be performed with caution in these patients.

-Caution is advised when using fluoxetine-olanzapine in patients with diseases or conditions that could affect its metabolism

Switching from:

MAOI to fluoxetine-olanzapine therapy: At least 14 days should elapse

Fluoxetine-olanzapine to MAOI therapy: At least 5 weeks should elapse

Treatment withdrawal:

-A gradual dose reduction is recommended instead of abrupt cessation where possible.

-If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.

Dialysis

Hemodialysis: No adjustment recommended

Peritoneal dialysis: Data not available

Other Comments

Administration advice:

-Doses should be taken in the evening without regard to meals.

General:

-Changes in dose will not be fully reflected in plasma for several weeks due to the long elimination half-lives of fluoxetine and its major active metabolite.

-The need for ongoing treatment should be regularly reviewed.

-Antidepressant efficacy was seen in a daily dose range of fluoxetine 25 to 50 mg and olanzapine 6 mg to 12 mg.

Monitoring:

-Cardiovascular: ECG monitoring (in patients with risk factors for QT-interval prolongation)

-Hepatic: Liver function

-Metabolic: Hyponatremia, hyperglycemia, hyperlipidemia, weight gain

-Nervous system: Serotonin syndrome

-Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior

Patient advice:

-Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.

-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.

-This medicine may cause drowsiness and dizziness; do not drive a car or operate dangerous machinery until you know how this drug affects you.

-Patients should be advised to speak to a healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.

-Do not drink alcohol or take other medicines that may cause sleepiness or dizziness while taking this medicine until you talk to your healthcare provider.

What is the dose of Olanzapine + Fluoxetine for a child?

Usual Pediatric Dose for Depression

10 to 17 years of age:

Initial Dose: Fluoxetine 25 mg-olanzapine 3 mg orally once a day

Maintenance dose: Adjust as clinically necessary to within a range of:

-Fluoxetine: 25 to 50 mg orally per day

-Olanzapine: 6 to 12 mg orally per day

Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally per day

Duration: It is generally accepted that Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, is a chronic illness requiring chronic treatment.

Comment: The safety of doses above fluoxetine 50 mg and olanzapine 12 mg per day has not been evaluated in pediatric clinical studies

Use: Acute treatment of depressive episodes associated with Bipolar I Disorder

Usual Pediatric Dose for Bipolar Disorder

10 to 17 years of age:

Initial Dose: Fluoxetine 25 mg-olanzapine 3 mg orally once a day

Maintenance dose: Adjust as clinically necessary to within a range of:

-Fluoxetine: 25 to 50 mg orally per day

-Olanzapine: 6 to 12 mg orally per day

Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally per day

Duration: It is generally accepted that Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, is a chronic illness requiring chronic treatment.

Comment: The safety of doses above fluoxetine 50 mg and olanzapine 12 mg per day has not been evaluated in pediatric clinical studies

Use: Acute treatment of depressive episodes associated with Bipolar I Disorder

Precautions

Safety and efficacy have not been established in patients younger than 10 years for the treatment of Bipolar I depression.

How is Olanzapine + Fluoxetine available?

Olanzapine + Fluoxetine is available in the following dosage forms and strengths:

  • Oral capsule.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Olanzapine + Fluoxetine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: April 5, 2018 | Last Modified: April 5, 2018

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