Prescription Drug Information: Olanzapine (Page 9 of 10)

14.3 Agitation Associated with Schizophrenia and Bipolar I Mania

The efficacy of intramuscular olanzapine for injection for the treatment of agitation was established in 3 short-term (24 hours of intramuscular treatment) placebo-controlled trials in agitated adult inpatients from 2 diagnostic groups: schizophrenia and bipolar I disorder (manic or mixed episodes). Each of the trials included a single active comparator treatment arm of either haloperidol injection (schizophrenia studies) or lorazepam injection (bipolar I mania study). Patients enrolled in the trials needed to be: (1) judged by the clinical investigators as clinically agitated and clinically appropriate candidates for treatment with intramuscular medication, and (2) exhibiting a level of agitation that met or exceeded a threshold score of ≥14 on the 5 items comprising the Positive and Negative Syndrome Scale (PANSS) Excited Component (i.e., poor impulse control, tension, hostility, uncooperativeness and excitement items) with at least 1 individual item score ≥4 using a 1 to 7 scoring system (1=absent, 4=moderate, 7=extreme). In the studies, the mean baseline PANSS Excited Component score was 18.4, with scores ranging from 13 to 32 (out of a maximum score of 35), thus suggesting predominantly moderate levels of agitation with some patients experiencing mild or severe levels of agitation. The primary efficacy measure used for assessing agitation signs and symptoms in these trials was the change from baseline in the PANSS Excited Component at 2 hours post-injection. Patients could receive up to 3 injections during the 24 hour intramuscular treatment periods; however, patients could not receive the second injection until after the initial 2 hour period when the primary efficacy measure was assessed. The results of the trials follow:

  1. In a placebo-controlled trial in agitated inpatients meeting DSM-IV criteria for schizophrenia (n=270), 4 fixed intramuscular olanzapine for injection doses of 2.5 mg, 5 mg, 7.5 mg and 10 mg were evaluated. All doses were statistically superior to placebo on the PANSS Excited Component at 2 hours post-injection. However, the effect was larger and more consistent for the 3 highest doses. There were no significant pairwise differences for the 7.5 mg and 10 mg doses over the 5 mg dose.
  2. In a second placebo-controlled trial in agitated inpatients meeting DSM-IV criteria for schizophrenia (n=311), 1 fixed intramuscular olanzapine for injection dose of 10 mg was evaluated. Olanzapine for injection was statistically superior to placebo on the PANSS Excited Component at 2 hours post-injection.
  3. In a placebo-controlled trial in agitated inpatients meeting DSM-IV criteria for bipolar I disorder (and currently displaying an acute manic or mixed episode with or without psychotic features) (n=201), 1 fixed intramuscular olanzapine for injection dose of 10 mg was evaluated. Olanzapine for injection was statistically superior to placebo on the PANSS Excited Component at 2 hours post-injection.

Examination of population subsets (age, race, and gender) did not reveal any differential responsiveness on the basis of these subgroupings.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Olanzapine tablets, USP, 2.5 mg, 5 mg and 10 mg tablets are white or off-white, film coated, round, and debossed with tablet numbers on one side. The tablets are available as follows:

TABLET STRENGTH
2.5 mg 5 mg 10 mg
Tablet No. 2.5 5 10
NDC No. Bottle of 30 69807-2011-1 69807-2012-1 69807-2013-1

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 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 olanzapine tablets, USP from light and moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (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 olanzapine 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 olanzapine, call your doctor. When using olanzapine and fluoxetine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.

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 olanzapine had a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) compared with placebo.

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

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 olanzapine. 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)].

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Patients should be advised to report to their health care provider at the earliest onset of any signs and symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.4)] .

Hyperglycemia and Diabetes Mellitus

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 olanzapine [see Warnings and Precautions (5.5) ] .

Dyslipidemia

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

Weight Gain

Patients should be counseled that weight gain has occurred during treatment with olanzapine. Patients should have their weight monitored regularly [see Warnings and Precautions (5.5)].

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 olanzapine, e.g., diazepam or alcohol [see Warnings and Precautions (5.7) 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 heartbeat, or fainting.

Potential for Cognitive and Motor Impairment

Because olanzapine 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 olanzapine therapy does not affect them adversely [see Warnings and Precautions (5.12)].

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)].

Concomitant Medication

Patients should be advised to inform their healthcare providers if they are taking, or plan to take, Symbyax. Patients should also be advised to inform their healthcare providers 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)].

Alcohol

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

Use in Specific Populations

Pregnancy — Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with olanzapine. Advise patients that olanzapine may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to olanzapine during pregnancy [see Use in Specific Populations (8.1)].

Lactation — Advise breastfeeding women using olanzapine to monitor infants for excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs. [see Use in Specific Populations (8.2)].
Infertility — Advise females of reproductive potential that olanzapine may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3)] [see Use in Specific Populations (8.3)].

Pediatric Use — Olanzapine 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 olanzapine 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 olanzapine in patients under 13 years of age have not been established. Safety and efficacy of olanzapine and fluoxetine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with bipolar I disorder. Safety and effectiveness of olanzapine and fluoxetine in combination in patients <10 years of age have not been established [see Warnings and Precautions (5.5) and Use in Specific Populations (8.4) ].

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. 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 healthcare provider’s assessment of the chronicity and severity of the patient’s symptoms [see Indications and Usage ( 1.3)] .

Brands listed are the trademarks of their respective owners.

Manufactured by:
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Lianyungang, Jiangsu 222069, China

Distributed by:
eVenus Pharmaceutical Laboratories, Inc.
506 Carnegie Center, Suite 100
Princeton, NJ 08540 USA

Revised January 2020

Rev. 03

Medication Guide

Olanzapine Tablets

(oh lan’ za peen)

Read the Medication Guide that comes with Olanzapine Tablets 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 Olanzapine Tablets.

What is the most important information I should know about Olanzapine Tablets?

Olanzapine Tablets 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 or when used in combination with fluoxetine in children age 10 to 17.

4. Weight gain, especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 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). Olanzapine Tablets 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 Olanzapine Tablets and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when Olanzapine Tablets is stopped. People with diabetes and some people who did not have diabetes before taking Olanzapine Tablets need to take medicine for high blood sugar even after they stop taking Olanzapine Tablets.

If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking Olanzapine Tablets.

Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking Olanzapine Tablets:

• 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 Olanzapine Tablets, especially in teenagers (13 to 17 years old), or when used in combination with fluoxetine in children (10 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 Olanzapine Tablets and during treatment.

4. Weight gain. Weight gain is very common in people who take Olanzapine Tablets. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Children (10 to 17 years old) are also more likely to gain weight and to gain more weight than adults when Olanzapine Tablets is used in combination with fluoxetine. Some people may gain a lot of weight while taking Olanzapine Tablets, 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 Olanzapine Tablets?

Olanzapine Tabletsis 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 people age 10 or older.

• 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.

Olanzapine Tablets has not been approved for use in children under 13 years of age. Olanzapine Tablets in combination with fluoxetine has not been approved for use in children under 10 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 Olanzapine Tablets?

Olanzapine Tablets may not be right for you. Before starting Olanzapine Tablets, 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

• breast cancer

• thoughts of suicide or hurting yourself

• any other medical condition

• are pregnant or plan to become pregnant. It is not known if Olanzapine Tablets will harm your unborn baby.

• If you become pregnant while receiving Olanzapine Tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and- research-programs/pregnancyregistry/.

• are breast-feeding or plan to breast-feed. Olanzapine passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Olanzapine Tablets.

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 non-prescription medicines, vitamins, and herbal supplements. Olanzapine Tablets 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 Olanzapine Tablets with your other medicines. Do not start or stop any medicine while taking Olanzapine Tablets without talking to your doctor first.

How should I take Olanzapine Tablets?

• Take Olanzapine Tablets, exactly as prescribed. Your doctor may need to change (adjust) the dose of Olanzapine Tablets until it is right for you.

• If you miss a dose of Olanzapine Tablets, 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 Olanzapine Tablets at the same time.

To prevent serious side effects, do not stop taking Olanzapine Tablets suddenly. If you need to stop taking Olanzapine Tablets, your doctor can tell you how to safely stop taking it.

If you take too much Olanzapine Tablets, call your doctor or poison control center at 1-800-222-1222 right away, or get emergency treatment.

• Olanzapine Tablets can be taken with or without food.

• Olanzapine Tablets are usually taken one time each day

• Call your doctor if you do not think you are getting better or have any concerns about your condition while taking Olanzapine Tablets.

What should I avoid while taking Olanzapine Tablets?

• Olanzapine Tablets 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 Olanzapine Tablets affects you.

• Avoid drinking alcohol while taking Olanzapine Tablets. Drinking alcohol while you take Olanzapine Tablets may make you sleepier than if you take Olanzapine Tablets alone.

What are the possible side effects of Olanzapine Tablets?

Serious side effects may happen when you take Olanzapine Tablets, including:

• See “What is the most important information I should know about Olanzapine Tablets?”, 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). Olanzapine Tablets 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 Olanzapine Tablets. 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

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): DRESS can occur with Olanzapine Tablets. Features of DRESS may include rash, fever, swollen glands and other internal organ involvement such as liver, kidney, lung and heart. DRESS is sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs.

• 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 Olanzapine Tablets. It may also start after you stop taking Olanzapine Tablets. 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 Olanzapine Tablets.

• 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 Olanzapine Tablets 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 to 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 Olanzapine Tablets. 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 Olanzapine Tablets?

• Store Olanzapine Tablets at room temperature, between 68°F to 77°F (20°C to 25°C).

• Keep Olanzapine Tablets away from light.

• Keep Olanzapine Tablets dry and away from moisture.

Keep Olanzapine Tablets and all medicines out of the reach of children.

General information about Olanzapine Tablets

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

This Medication Guide summarizes the most important information about Olanzapine Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Olanzapine Tablets that was written for healthcare professionals.

For more information about Olanzapine Tablets call 1-609-395-8625.

What are the ingredients in Olanzapine Tablets?

Active ingredient: olanzapine

Inactive ingredients: Tablets — crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The coating contains hypromellose, titanium dioxide and polyethylene glycol.

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

Medication Guide revised January 2020

Rx Only

Brands listed are the trademarks of their respective owners.

Manufactured by:
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Lianyungang, Jiangsu 222069, China

Distributed by:
eVenus Pharmaceutical Laboratories, Inc.
506 Carnegie Center, Suite 100 Princeton, NJ 08540 USA

Revised January 2020

Rev. 03

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Medication Sections

Medication Information by RSS

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.