Zyprexa (Page 14 of 14)

16.2 Storage and Handling

Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP] for up to 1 hour if necessary. Discard any unused portion of reconstituted ZYPREXA IntraMuscular. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.

Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide for the oral formulations.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking ZYPREXA as monotherapy or in combination with fluoxetine. If you do not think you are getting better or have any concerns about your condition while taking ZYPREXA, call your doctor. When using ZYPREXA and fluoxetine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.

17.1 Information on Medication Guide

Prescribers or other health professionals should inform patients, their families, and their caregivers about the potential benefits and potential risks associated with treatment with ZYPREXA, and should counsel them in its appropriate use. A patient Medication Guide is available for ZYPREXA. Prescribers or other health professionals should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. When using ZYPREXA and fluoxetine in combination, also refer to the Medication Guide for Symbyax.

17.2 Elderly Patients with Dementia-Related Psychosis: Increased Mortality and Cerebrovascular Adverse Events (CVAE), Including Stroke

Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with ZYPREXA had a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) compared with placebo.

ZYPREXA is not approved for elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1)].

17.3 Neuroleptic Malignant Syndrome (NMS)

Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including ZYPREXA. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions (5.3)].

17.4 Hyperglycemia

Patients should be advised of the potential risk of hyperglycemia-related adverse reactions. Patients should be monitored regularly for worsening of glucose control. Patients who have diabetes should follow their doctor’s instructions about how often to check their blood sugar while taking ZYPREXA [see Warnings and Precautions (5.4)].

17.5 Hyperlipidemia

Patients should be counseled that hyperlipidemia has occurred during treatment with ZYPREXA. Patients should have their lipid profile monitored regularly [see Warnings and Precautions (5.5)].

17.6 Weight Gain

Patients should be counseled that weight gain has occurred during treatment with ZYPREXA. Patients should have their weight monitored regularly [see Warnings and Precautions (5.6)].

17.7 Orthostatic Hypotension

Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration and in association with the use of concomitant drugs that may potentiate the orthostatic effect of ZYPREXA, e.g., diazepam or alcohol [see Warnings and Precautions (5.8) and Drug Interactions (7)]. Patients should be advised to change positions carefully to help prevent orthostatic hypotension, and to lie down if they feel dizzy or faint, until they feel better. Patients should be advised to call their doctor if they experience any of the following signs and symptoms associated with orthostatic hypotension: dizziness, fast or slow heart beat, or fainting.

17.8 Potential for Cognitive and Motor Impairment

Because ZYPREXA has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that ZYPREXA therapy does not affect them adversely [see Warnings and Precautions (5.12)].

17.9 Body Temperature Regulation

Patients should be advised regarding appropriate care in avoiding overheating and dehydration. Patients should be advised to call their doctor right away if they become severely ill and have some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine [see Warnings and Precautions (5.13)].

17.10 Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, Symbyax. Patients should also be advised to inform their physicians if they are taking, plan to take, or have stopped taking any prescription or over-the-counter drugs, including herbal supplements, since there is a potential for interactions [see Drug Interactions (7)].

17.11 Alcohol

Patients should be advised to avoid alcohol while taking ZYPREXA [see Drug Interactions (7)].

17.12 Phenylketonurics

ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) contains phenylalanine (0.34, 0.45, 0.67, or 0.90 mg per 5, 10, 15, or 20 mg tablet, respectively) [see Description (11)].

17.13 Use in Specific Populations

Pregnancy — Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with ZYPREXA [see Use in Specific Populations (8.1)].

Nursing Mothers — Patients should be advised not to breast-feed an infant if they are taking ZYPREXA [see Use in Specific Populations (8.3)].

Pediatric Use — ZYPREXA is indicated for treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents 13 to 17 years of age. Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin, and hepatic aminotransferase levels. Patients should be counseled about the potential long-term risks associated with ZYPREXA and advised that these risks may lead them to consider other drugs first [see Indications and Usage (1.1, 1.2)]. Safety and effectiveness of ZYPREXA in patients under 13 years of age have not been established. Safety and effectiveness of ZYPREXA and fluoxetine in combination in patients <18 years of age have not been established [see Warnings and Precautions (5.5, 5.6) and Use in Specific Populations (8.4)].

17.14 Need for Comprehensive Treatment Program in Pediatric Patients

ZYPREXA 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 ZYPREXA have not been established in pediatric patients less than 13 years of age. Atypical antipsychotics are not intended for use in the pediatric patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders. Appropriate educational placement is essential and psychosocial intervention is often helpful. The decision to prescribe atypical antipsychotic medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms [see Indications and Usage (1.3)].

Literature revised June 2, 2011

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

Copyright © 1997, 2011, Eli Lilly and Company. All rights reserved.

PV 6249 AMP

Medication Guide

ZYPREXA® (zy-PREX-a)

(olanzapine)

Tablet

ZYPREXA® ZYDIS® (zy-PREX-a ZY-dis)

(olanzapine)

Tablet, Orally Disintegrating

Read the Medication Guide that comes with ZYPREXA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about ZYPREXA.

What is the most important information I should know about ZYPREXA?

ZYPREXA may cause serious side effects, including:

  1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
  2. High blood sugar (hyperglycemia).
  3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17.
  4. Weight gain, especially in teenagers age 13 to 17.

These serious side effects are described below.

  1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). ZYPREXA is not approved for treating psychosis in elderly people with dementia.
  2. High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:
    • a build up of acid in your blood due to ketones (ketoacidosis)
    • coma
    • death

    Your doctor should do tests to check your blood sugar before you start taking ZYPREXA and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when ZYPREXA is stopped. People with diabetes and some people who did not have diabetes before taking ZYPREXA need to take medicine for high blood sugar even after they stop taking ZYPREXA.
    If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking ZYPREXA.
    Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking ZYPREXA:
    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused or your breath smells fruity
  3. High fat levels in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with ZYPREXA, especially in teenagers (13 to 17 years old). You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking ZYPREXA and during treatment.
  4. Weight gain. Weight gain is very common in people who take ZYPREXA. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Some people may gain a lot of weight while taking ZYPREXA, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

What is ZYPREXA?

ZYPREXA is a prescription medicine used to treat:

  • schizophrenia in people age 13 or older.
  • bipolar disorder, including:
    • manic or mixed episodes that happen with bipolar I disorder in people age 13 or older.
    • manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate, in adults.
    • long-term treatment of bipolar I disorder in adults.
  • episodes of depression that happen with bipolar I disorder, when used with the medicine fluoxetine (Prozac®), in adults.
  • episodes of depression that do not get better after 2 other medicines, also called treatment resistant depression, when used with the medicine fluoxetine (Prozac), in adults.

ZYPREXA has not been approved for use in children under 13 years of age.

The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.

The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior.

Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.

What should I tell my doctor before taking ZYPREXA?

ZYPREXA may not be right for you. Before starting ZYPREXA, tell your doctor if you have or had:

  • heart problems
  • seizures
  • diabetes or high blood sugar levels (hyperglycemia)
  • high cholesterol or triglyceride levels in your blood
  • liver problems
  • low or high blood pressure
  • strokes or “mini-strokes” also called transient ischemic attacks (TIAs)
  • Alzheimer’s disease
  • narrow-angle glaucoma
  • enlarged prostate in men
  • bowel obstruction
  • phenylketonuria, because ZYPREXA ZYDIS contains phenylalanine
  • breast cancer
  • thoughts of suicide or hurting yourself
  • any other medical condition
  • are pregnant or plan to become pregnant. It is not known if ZYPREXA will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. ZYPREXA can pass into your breast milk and may harm your baby. You should not breast-feed while taking ZYPREXA. Talk to your doctor about the best way to feed your baby if you take ZYPREXA.

Tell your doctor if you exercise a lot or are in hot places often.

The symptoms of bipolar I disorder, treatment resistant depression, or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.

Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ZYPREXA and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take ZYPREXA with your other medicines. Do not start or stop any medicine while taking ZYPREXA without talking to your doctor first.

How should I take ZYPREXA?

  • Take ZYPREXA exactly as prescribed. Your doctor may need to change (adjust) the dose of ZYPREXA until it is right for you.
  • If you miss a dose of ZYPREXA, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of ZYPREXA at the same time.
  • To prevent serious side effects, do not stop taking ZYPREXA suddenly. If you need to stop taking ZYPREXA, your doctor can tell you how to safely stop taking it.
  • If you take too much ZYPREXA, call your doctor or poison control center at 1-800-222-1222 right away, or get emergency treatment.
  • ZYPREXA can be taken with or without food.
  • ZYPREXA is usually taken one time each day.
  • Take ZYPREXA ZYDIS as follows:
    • Be sure that your hands are dry.
    • Open the sachet and peel back the foil on the blister. Do not push the tablet through the foil.
    • As soon as you open the blister, remove the tablet and put it into your mouth.
    • The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid.
  • Call your doctor if you do not think you are getting better or have any concerns about your condition while taking ZYPREXA.

What should I avoid while taking ZYPREXA?

  • ZYPREXA can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZYPREXA affects you.
  • Avoid drinking alcohol while taking ZYPREXA. Drinking alcohol while you take ZYPREXA may make you sleepier than if you take ZYPREXA alone.

What are the possible side effects of ZYPREXA?

Serious side effects may happen when you take ZYPREXA, including:

  • See “What is the most important information I should know about ZYPREXA?”, which describes the increased risk of death in elderly people with dementia-related psychosis and the risks of high blood sugar, high cholesterol and triglyceride levels, and weight gain.
  • Increased incidence of stroke or “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). ZYPREXA is not approved for these patients.
  • Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including ZYPREXA. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have any of these symptoms:
    • high fever
    • excessive sweating
    • rigid muscles
    • confusion
    • changes in your breathing, heartbeat, and blood pressure.
  • Tardive Dyskinesia: This condition causes body movements that keep happening and that you can not control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking ZYPREXA. It may also start after you stop taking ZYPREXA. Tell your doctor if you get any body movements that you can not control.
  • Decreased blood pressure when you change positions, with symptoms of dizziness, fast or slow heartbeat, or fainting.
  • Difficulty swallowing, that can cause food or liquid to get into your lungs.
  • Seizures: Tell your doctor if you have a seizure during treatment with ZYPREXA.
  • Problems with control of body temperature: You could become very hot, for instance when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have any of these symptoms of dehydration:
    • sweating too much or not at all
    • dry mouth
    • feeling very hot
    • feeling thirsty
    • not able to produce urine.

Common side effects of ZYPREXA include: lack of energy, dry mouth, increased appetite, sleepiness, tremor (shakes), having hard or infrequent stools, dizziness, changes in behavior, or restlessness.

Other common side effects in teenagers (13-17 years old) include: headache, stomach-area (abdominal) pain, pain in your arms or legs, or tiredness. Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects with ZYPREXA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZYPREXA?

  • Store ZYPREXA at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep ZYPREXA away from light.
  • Keep ZYPREXA dry and away from moisture.

Keep ZYPREXA and all medicines out of the reach of children.

General information about ZYPREXA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZYPREXA for a condition for which it was not prescribed. Do not give ZYPREXA to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ZYPREXA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZYPREXA that was written for healthcare professionals. For more information about ZYPREXA call 1-800-Lilly-Rx (1-800-545-5979) or visit www.zyprexa.com.

What are the ingredients in ZYPREXA?

Active ingredient: olanzapine

Inactive ingredients:

Tablets — carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains: Titanium Dioxide, FD&C Blue No. 2 Aluminum Lake, or Synthetic Red Iron Oxide.

ZYDIS — gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide revised June 21, 2011

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

Repacked by: H.J. Harkins Company, Inc. Nipomo, CA 93444, USA

www.zyprexa.com

Copyright © 2009, 2011, Eli Lilly and Company. All rights reserved.

PV 6924 AMP

PACKAGE LABEL — ZYPREXA 2.5 mg tablet, bottle of 30

NDC 0002-4112-30

30 Tablets

No. 4112

ZYPREXA

Olanzapine Tablets

2.5 mg

Rx only

Medication Guide is to be dispensed to patients.

zyprexa.com

Lilly

PACKAGE LABEL -- ZYPREXA 2.5 mg tablet, bottle of 30
(click image for full-size original)
ZYPREXA olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-579(NDC:0002-4112)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Olanzapine (Olanzapine) Olanzapine 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba wax
Crospovidone
Hydroxypropyl cellulose
HYPROMELLOSES
Lactose
Magnesium stearate
Cellulose, Microcrystalline
Titanium dioxide
POLYETHYLENE GLYCOL
POLYSORBATE 80
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code LILLY;4112
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-579-30 30 TABLET (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020592 06/23/1997
Labeler — H.J. Harkins Company, Inc. (147681894)
Registrant — Eli Lilly and Company (006421325)
Establishment
Name Address ID/FEI Operations
Eli Lilly S.A. — Irish Branch 986500023 API MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Evonik Degussa Corporation 130890994 ANALYSIS
Establishment
Name Address ID/FEI Operations
Eli Lilly and Company (Indianapolis) 006421325 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Lilly del Caribe, Inc. (PR01) 806917345 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Patheon Italia S.p.A. 338336589 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Catalent UK Swindon ZYDIS LTD 237676320 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions LLC — IL 829672687 PACK, LABEL
Establishment
Name Address ID/FEI Operations
Sharp Corporation-Conshohocken 002346625 REPACK, RELABEL

Revised: 10/2011 H.J. Harkins Company, Inc.

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