Pronunciation:

Fluoxetine Hydrochloride, oh-LAN-za-peen

Brand Names:

• Symbyax

Dosage Forms:

• Capsule

Warnings:

• Suicidality and Antidepressant Drugs -
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine hydrochloride/olanzapine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluoxetine hydrochloride/olanzapine is not approved for use in pediatric patients.
• Increased Mortality in Elderly Patients with Dementia-Related Psychosis - .
  • Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infections (e.g., pneumonia) in nature. Fluoxetine hydrochloride/olanzapine is not approved for the treatment of patients with 30 dementia-related psychosis

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients. Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Fluoxetine

Chemical—

Thienobenzodiazepine

Uses of This Medicine:

Olanzapine and fluoxetine combination is used to treat depression that is a part of bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine and fluoxetine combination in the pediatric population. Safety and efficacy have not been established .

Older adults—

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 of dosage in patients receiving olanzapine and fluoxetine combination .

Pregnancy—

	Pregnancy Category	Explanation
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.

Breast-feeding—

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.

Other medicines—

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
• Clorgyline
• Dihydroergotamine
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Levomethadyl
• Mesoridazine
• Methylergonovine
• Methysergide
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Pimozide
• Procarbazine
• Selegiline
• Terfenadine
• Thioridazine
• Toloxatone
• Tranylcypromine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or 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:

• Alzheimer's disease—Risk of aspiration pneumonia and seizures may be increased .

• Blood vessel or circulation problems or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypovolemia (low blood volume)—Low blood pressure may be worsened or may make these conditions worse .

• Breast cancer or
• Enlarged prostate or
• Hyperlipidemia (increased blood cholesterol or fats) or
• Hyperprolactinemia (increased prolactin in the blood) or
• Liver disease or
• Narrow-angle glaucoma or
• Paralytic ileus (severe intestinal problem), history of or
• Seizures, history of—Use with caution. This medicine may make these conditions worse .

• Diabetes or
• Hyperglycemia (high blood sugar)—This medicine may raise your blood sugar levels .

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. 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. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information .

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 treatment of depression that occurs with bipolar disorder:
  • For oral dosage form (capsules):
    • Adults—One capsule once a day in the evening. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor .

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 While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide .

Do not take this medicine within 2 weeks of taking a monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan®], phenelzine [e.g., Nardil®], selegiline [e.g., Eldepryl®], tranylcypromine [e.g., Parnate®]) and do not take an MAO inhibitor for at least 5 weeks after taking this medicine. If you do, you may develop extremely high blood pressure or seizures .

Do not take thioridazine (e.g., Mellaril®) while you are taking this medicine or less than 5 weeks after you have stopped taking this medicine. You should not use pimozide (e.g., Orap®) while you are taking this medicine. Using these medicines together can cause very serious heart problems .

Do not breastfeed while you are using this medicine .

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. Your doctor may give you insulin or other medicines that can lower the amount of sugar in your blood .

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.

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 .

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible .

Make sure your doctor knows about all the other medicines you are using. This medicine may cause a serious condition called Serotonin Syndrome when taken with certain medicines such as linezolid [e.g., Zyvox®], lithium, tryptophan, St. John’s Wort, or some pain medicines (e.g., tramadol [e.g., Ultram®], sumatriptan [e.g., Imitrex®], zolmitriptan [e.g., Zomig®], or rizatriptan [e.g., Maxalt®]). Check with your doctor first before taking any other medicines .

Check with your doctor right away if you are having convulsions, difficulty in 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 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 cheeks, rapid or worm-like movements of tongue, uncontrolled chewing movements, or uncontrolled movements of arms and legs .

Make sure your doctor knows if you are also using aspirin, NSAIDS (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or a blood thinner such as warfarin or Coumadin®. Olanzapine and fluoxetine combination may increase your risk of having bleeding problems especially when taken together with these medicines .

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 .

This medicine may cause drowsiness, trouble in thinking, trouble in controlling movements, or trouble in seeing clearly. 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. 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 light-headedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting .

Avoid drinking alcohol while you are using this medicine .

Side Effects of This Medicine:

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 face, arms, hands, lower legs, or feet

body aches or pain

confusion

congestion

cough

delusions

dementia

dryness or soreness of throat

fever

hoarseness

rapid weight gain

runny nose

shakiness in legs, arms, hands, or feet

tender, swollen glands in neck

tingling of hands or feet

trembling or shaking of hands or feet

trouble in swallowing

unusual weight gain or loss

voice changes

Less common

Blurred vision

change in personality

change in vision

difficult or labored breathing

difficulty in sleeping

difficulty in speaking

dizziness

ear pain

headache

impaired vision

increase in body movements

loss of memory

nervousness

pounding in the ears

problems with memory

shortness of breath

slow, fast, pounding, or irregular heartbeat or pulse

tightness in chest

wheezing

Rare

Inability to move eyes

increased blinking or spasms of eyelid

sticking out of tongue

uncontrolled twisting movements of neck, trunk, arms, or legs

unusual facial expressions

Incidence not known

Bloody or black, tarry stools

constipation

severe stomach pain

vomiting of blood or material that looks like coffee grounds

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Change in consciousness

changes in patterns and rhythms of speech

fainting

loss of consciousness

seizures

shakiness and unsteady walk

sleepiness

slurred speech

trouble in speaking

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

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 in 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 joints

tooth disorder

twitching

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.