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Olanzapine Oral tablet

It is used to treat schizophrenia, psychotic disorders, and bipolar disorder

Generic Name: olanzapine

Brand Names: Zyprexa Zydis, Zyprexa

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: [Web] and [Web].

[Posted 01/29/2010] Lilly and FDA notified healthcare professionals of changes to the Prescribing Information for olanzapine (Zyprexa) related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder [manic or mixed episodes]. The revised labeling states that:

  • Section 1, Indications and Usage: When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.
  • Section 17.14, Need for comprehensive Treatment Program in Pediatric Patients: Olanzapine is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures (psychological, educational, social) for patients with the disorder. Effectiveness and safety of olanzapine have not been established in pediatric patients less than 13 years of age.
  • For more information visit the FDA website at: [Web] and [Web].

    [Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: [Web], [Web] and [Web].

    [Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.

    One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.

    The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.

    Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.

    Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. For more information visit the FDA website at: [Web] and [Web].

    [Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

    Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.

    Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.

    Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together. For more information visit the FDA website at: [Web] and [Web].

    REMS:

    FDA approved a REMS for olanzapine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of olanzapine and consists of the following: medication guide, elements to assure safe use, communication plan, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

    What is this medicine?

    OLANZAPINE (oh LAN za peen) is used to treat schizophrenia, psychotic disorders, and bipolar disorder. Bipolar disorder is also known as manic-depression.

    What should I tell my health care provider before I take this medicine?

    They need to know if you have any of these conditions:
    • breast cancer or history of breast cancer
    • dementia
    • diabetes mellitus, high blood sugar or a family history of diabetes
    • difficulty swallowing
    • glaucoma
    • heart disease, irregular heartbeat, or previous heart attack
    • history of brain tumor or head injury
    • kidney or liver disease
    • low blood pressure or dizziness when standing up
    • Parkinson's disease
    • prostate trouble
    • seizures (convulsions)
    • suicidal thoughts, plans, or attempt by you or a family member
    • an unusual or allergic reaction to olanzapine, other medicines, foods, dyes, or preservatives
    • pregnant or trying to get pregnant
    • breast-feeding

    How should I use this medicine?

    Take this medicine by mouth. Swallow it with a drink of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

    A special MedGuide will be given to you by the pharmacist with each new prescription and refill. Be sure to read this information carefully each time.

    Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 13 years for selected conditions, precautions do apply.

    What if I miss a dose?

    If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

    What may interact with this medicine?

    Do not take this medicine with any of the following medications:
    • certain antibiotics like grepafloxacin and sparfloxacin
    • certain phenothiazines like chlorpromazine, mesoridazine, and thioridazine
    • cisapride
    • clozapine
    • droperidol
    • halofantrine
    • levomethadyl
    • pimozide

    This medicine may also interact with the following medications:

    • carbamazepine
    • charcoal
    • fluvoxamine
    • levodopa and other medicines for Parkinson's disease
    • medicines for diabetes
    • medicines for high blood pressure
    • medicines for mental depression, anxiety, other mood disorders, or sleeping problems
    • omeprazole
    • rifampin
    • ritonavir
    • tobacco from cigarettes

    What should I watch for while using this medicine?

    Visit your doctor or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of this medicine. Notify your doctor or health care professional if your symptoms get worse, if you have new symptoms, if you are having an unusual effect from this medicine, or if you feel out of control, very discouraged or think you might harm yourself or others.

    Do not suddenly stop taking this medicine. You may need to gradually reduce the dose. Ask your doctor or health care professional for advice.

    You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

    Avoid alcoholic drinks. Alcohol can increase dizziness and drowsiness with olanzapine.

    Do not treat yourself for colds, diarrhea or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

    Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

    This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.


    Last Updated: May 07, 2013
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