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(olanzapine) For Extended Release Injectable Suspension
POST-INJECTION DELIRIUM/SEDATION SYNDROME AND INCREASED MORTALITY INELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Post-Injection Delirium/Sedation Syndrome
Adverse events with signs and symptoms consistent with olanzapineoverdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of ZYPREXARELPREVV. ZYPREXA RELPREVV must be administered in a registered healthcare facility with ready access toemergency response services. After each injection, patients must be observed at the healthcare facility by a healthcareprofessional for at least 3 hours. Because of this risk, ZYPREXA RELPREVV is available only through a restricteddistribution program called ZYPREXA RELPREVV Patient Care Program and requires prescriber, healthcare facility,patient, and pharmacy enrollment [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, OVERDOSAGE, and PATIENT INFORMATION].
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-relatedpsychosis 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 theplacebo 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 RELPREVV is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].
ZYPREXA RELPREVV is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 10H-thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-,4,4-methylenebis[3-hydroxy-2- naphthalenecarboxylate] (1:1), monohydrate. The formula is C17H22N4S•C23H14O6•H2O, which corresponds to a molecular weight of 718.8. The chemical structure is:
ZYPREXA RELPREVV is a long-acting form of olanzapine and is intended for deep intramuscular gluteal injection only.
ZYPREXA RELPREVV includes a vial of the drug product and a vial of the sterile diluent for ZYPREXA RELPREVV.
The drug product is olanzapine pamoate monohydrate, present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine base per vial. The diluent for ZYPREXA RELPREVV is a clear, colorless to slightly yellow solution in a glass vial and is composed of carboxymethylcellulose sodium, mannitol, polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. The drug product is suspended in the diluent for ZYPREXA RELPREVV to a target concentration of 150 mg olanzapine per mL prior to intramuscular injection.
What are the possible side effects of olanzapine injection (Zyprexa, ZyPREXA Relprevv)?
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.
Tell your caregivers at once if you have a serious side effect such as:
- fast or slow heart rate;
- feeling like you might pass out;
- twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs; or
- being unable to sit still.
Less serious side effects may include:
What are the precautions when taking olanzapine extended release injectable suspension (Zyprexa Relprevv)?
Before using 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, dementia, seizures, prostate problems, glaucoma (narrow angle type), intestinal disease (such as bowel obstruction, paralytic ileus), difficulty swallowing, low white blood cell count.
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 blood pressure, obesity.
This drug may...
Last reviewed on RxList: 8/31/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Zyprexa Relprevv Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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