Olanzapine and fluoxetine

Name: Olanzapine and fluoxetine

Olanzapine and Fluoxetine Precautions

Serious side effects have been reported with olanzapine/fluoxetine including the following:

  • increased risk for suicidal thoughts or behaviors. You should be closely monitored for any changes in mood or behavior by your physician and family members.
  • neuroleptic malignant syndrome. Symptoms of neurolpetic syndrome may include fever, rapid or abnormal heart beat, sweating, confusion, and muscle rigidity. Seek emergency medical attention if you experience any of these symptoms.
  • hyperglycemia (high blood sugar). Prolonged elevated blood sugar over time may lead to diabetes and complications from diabetes. Your doctor should do blood tests to test you for diabetes. Tell your doctor if you are urinating more frequently, have an increased appetite, or experience increased thirst. 
  • hyperlipidemia (high amounts of (fats) lipids). This can lead to increased risk of cardiovascular (heart) problems. Your doctor should do blood tests to check the levels of fats in your blood.
  • serotonin syndrome. This occurs when too much serotonin builds up in your body. Symptoms of serotonin syndrome include increased sweating, rapid heartbeat, skin redness, difficulty breathing, confusion, restlessness, and tremors (shaking). Seek emergency medical attention if you experience any of these symptoms.
  • decreased blood counts. Olanzapine may reduce the amount of white blood cells in your body to fight off infections. Tell your doctor if you have a sore throat, fever, chills, or other signs of infection.
  • sexual dysfunction. Fluoxetine may lead to changes in sexual functioning, including decreased libido, erectile dysfunction, and prolonged erections.
  • QT prolongation. QT prolongation is a condition that may lead to a dangerous type of irregular heartbeat. Call your doctor right away if you experience a rapid heartbeat, an extremely strong heartbeat, or dizziness.
  • dystonia. This refers to spasms of the muscle that do not go away for a prolonged period of time.
  • gastritis. This refers to swelling of the stomach. Symptoms of gastritis may include abdominal pain, nausea, and vomiting.
  • gastrointestinal hemorrhage. In some cases, damage to the intestines can become so severe that bleeding may occur. Seek emergency medical treatment if you notice any severe abdominal pain.
  • pancreatitis. Symptoms of pancreatitis include nausea, vomiting, and abdominal pain that radiates to the back.
  • weight loss. Although olanzapine most commonly leads to weight gain, it may cause weight loss in rare cases.
  • menorrhagia. Symptoms of menorrhagia include very heavy menstrual bleeding or bleeding that lasts longer than normal. Tell your doctor if you experience any changes in your menstrual cycle.
  • angle-closure glaucoma. This is a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision. Your doctor should do an eye exam before starting fluoxetine. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.
  • orthostatic hypotension. This refers to a drop in blood pressure upon standing from a sitting or lying down position. You may feel faint, light-headed, or dizzy upon standing. Get up more slowly until you know how this medication affects you.
  • joint pain. Call your doctor if you have joint pain.
  • rash or hives. Call your doctor if you develop a rash or hives.
  • seizures. Call your doctor if you have a seizure.
  • difficulty breathing or swallowing. Seek emergency medical attention if you have trouble breathing or swallowing.
  • liver problems. Tell your doctor if you have ever had liver disease.
  • hyponatremia (low sodium levels). Symptoms of hyponatremia include headache, difficulty concentrating and remembering, and muscle spasms.
  • difficulty controlling your body temperature. Olanzapine may make it more difficult to cool down during exercise or when you are in hot places. Call your if you are feeling more thirsty, are sweating excessively or not at all, or if you are unable to produce urine.

Olanzapine/fluoxetine can cause drowsiness, dizziness, or blurred vision. Do not drive or operate heavy machinery until you know how olanzapine/fluoxetine affects you.

Do not take olanzapine/fluoxetine if you:

  • are allergic to olanzapine/fluoxetine or any of its ingredients
  • are taking pimozide
  • are taking thioridazine

Olanzapine and Fluoxetine Overdose

If you take too much olanzapine/fluoxetine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If olanzapine/fluoxetine is administered by a healthcare professional in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Olanzapine and Fluoxetine FDA Warning

WARNINGS: SUICIDAL THOUGHTS AND BEHAVIORS; AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Suicidal Thoughts and Behaviors — Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Olanzapine and fluoxetine capsules are not approved for use in children less than 10 years of age.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death 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 infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine and fluoxetine capsules are not approved for the treatment of patients with dementia-related psychosis.

What are some other side effects of Olanzapine and Fluoxetine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dry mouth.
  • Feeling tired or weak.
  • Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Olanzapine and Fluoxetine?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about olanzapine and fluoxetine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about olanzapine and fluoxetine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using olanzapine and fluoxetine.

Review Date: October 4, 2017

Index Terms

  • Fluoxetine and Olanzapine
  • Olanzapine and Fluoxetine Hydrochloride
  • Olanzapine/Fluoxetine
  • Olanzapine/Fluoxetine HCl

Administration

Administer capsules once daily in the evening; may be taken without regard to meals.

Pregnancy Risk Factor C Pregnancy Considerations

Adverse events were observed in animal reproduction studies using this combination. Refer to individual agents for additional information.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry mouth, loss of strength and energy, or fatigue. Have patient report immediately to prescriber signs of infection, signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), signs of high blood sugar (confusion, fatigue, more thirst, hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low sodium (headache, difficulty focusing, memory problems, confusion, weakness, seizures, or change in balance), bruising, bleeding, irritability, panic attacks, agitation, passing out, severe dizziness, swelling of arms or legs, enlarged breasts, nipple discharge, sexual dysfunction, amenorrhea, lack of sweating, difficult urination, swollen glands, signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, severe headache, confusion, change in thinking, tachycardia, abnormal heartbeat, or sweating a lot), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain) signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse), or signs of tardive dyskinesia (unable to control body movements; tongue, face, mouth, or jaw sticking out; mouth puckering; or puffing cheeks) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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