Fluoxetine and olanzapine

You should not use this medicine if you also take pimozide or thioridazine, or if you take fluoxetine or olanzapine in a non-combination form (Prozac, Zyprexa, and others).

Serious drug interactions can occur when certain medicines are used with fluoxetine and olanzapine. Tell your doctor about all your current medicines and any you start or stop using.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Fluoxetine and olanzapine should not be given to a child younger than 10 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Drinking alcohol can increase certain side effects of fluoxetine and olanzapine.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID), including aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using this medicine with an NSAID may cause you to bruise or bleed easily.

Avoid driving or operating machinery until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Applies to fluoxetine / olanzapine: oral capsule

Along with its needed effects, fluoxetine / olanzapine 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 while taking fluoxetine / olanzapine:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• confusion
• congestion
• cough
• delusions
• dementia
• dryness or soreness of the throat
• fever
• hoarseness
• rapid weight gain
• runny nose
• shakiness in the legs, arms, hands, or feet
• 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

• Blurred vision
• change in personality
• change in vision
• difficult or labored breathing
• difficulty with sleeping
• difficulty with speaking
• dizziness
• ear pain
• headache
• impaired vision
• increase in body movements
• loss of memory
• nervousness
• pounding in the ears
• problems with memory
• slow, fast, pounding, or irregular heartbeat or pulse
• tightness in the chest

• 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

• Bloody or black, tarry stools
• constipation
• severe stomach pain
• vomiting of blood or material that looks like coffee grounds

Some side effects of fluoxetine / olanzapine 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:

• Diarrhea
• dry mouth
• increased appetite
• lack or loss of strength
• weight gain

• 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
• muscle pain or stiffness
• not able to have an orgasm
• pain, swelling, or redness in the joints
• tooth disorder
• twitching

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

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

No adjustment recommended

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.