"The US Food and Drug Administration (FDA) announced today that its review of two patients who died after receiving intramuscular injections of the schizophrenia drug olanzapine pamoate (Zyprexa Relprevv, Eli Lilly) is inconclusive, altho"...
Zyprexa, Zyprexa Zydis
(olanzapine) Tablets and Injection
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. ZYPREXA (olanzapine) is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].
When using ZYPREXA and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.
ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:
Olanzapine is a yellow crystalline solid, which is practically insoluble in water.
ZYPREXA tablets are intended for oral administration only.
Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake.
ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only.
Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben.
ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only.
Each vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.
What are the possible side effects of olanzapine (Zyprexa, Zyprexa Zydis)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using olanzapine and call your doctor at once if you have any of these serious side effects:
- very stiff (rigid) muscles, high fever, tremors, sweating, confusion, fast or uneven heartbeats, slow heart rate, feeling like you might pass out;
- twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
- trouble speaking or swallowing;
- dry mouth,...
What are the precautions when taking olanzapine (Zyprexa, Zyprexa Zydis)?
Before taking olanzapine, tell your doctor or pharmacist if you are allergic to it; 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: liver problems, seizures, difficulty swallowing, low white blood cell count, dementia, difficulty urinating (for example, due to enlarged prostate), glaucoma (narrow angle), stomach/intestinal disease (such as blockage, paralytic ileus), smoking.
Also tell your doctor or pharmacist if either you or a family member has a history of the following: diabetes, heart disease, high blood cholesterol/triglyceride levels, high...
Last reviewed on RxList: 3/20/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Zyprexa, Zyprexa Zydis Information
- Zyprexa, Zyprexa Zydis Drug Interactions Center: olanzapine oral
- Zyprexa, Zyprexa Zydis Side Effects Center
- Zyprexa, Zyprexa Zydis in detail including Side Effects and Drug Images
- Zyprexa, Zyprexa Zydis Overview including Precautions
- Zyprexa, Zyprexa Zydis FDA Approved Prescribing Information including Dosage
Zyprexa, Zyprexa Zydis - User Reviews
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