Drug Name

Zyprexa (Olanzapine)

Generic Name

Olanzapine Tablets (oh-LAN-za-peen)

Looks like

Olanzapine is available with a prescription under the brand name Zyprexa. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Zyprexa 2.5 mg tablets
• Zyprexa 5 mg tablets
• Zyprexa 7.5 mg tablets
• Zyprexa 10 mg tablets
• Zyprexa 15 mg tablets
• Zyprexa 20 mg tablets

Dosage Form

Tablets

Route Of Administration

ORAL

Imprint Code

LILLY 4112 / LILLY 4115 / LILLY 4116 / LILLY 4117

Alternatives

Bipolar Disorder
Seroquel (Quetiapine), Lamictal (Lamotrigine), Abilify (Aripiprazole)
Schizophrenia
Seroquel (Quetiapine), Abilify (Aripiprazole), Risperdal (Risperidone), Geodon (Ziprasidone)

Drug Uses

Zyprexa is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression).

Zyprexa may also be used for other purposes not listed in this medication guide.

Drug class

Zyprexa is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

How Taken

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Zyprexa can be taken with or without food.

Zyprexa is usually taken once a day. Follow your doctor's instructions.

To take olanzapine orally disintegrating tablets (Zyprexa Zydis):

• Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
• Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
• Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Dosage and Administration

Schizophrenia
Adults
PO Start with 5 to 10 mg/day and adjust dosage at 5 mg increments or decrements in intervals of no less than 1 wk (safety of doses above 20 mg/day not evaluated).

Bipolar Mania
Adults
PO Start with 10 to 15 mg/day and adjust at 5 mg increments or decrements in intervals no less than 24 h (safety of doses more than 20 mg/day not evaluated). When administered in combination with lithium or valproate, oral olanzapine dosing should generally begin with 10 mg daily without regard to meals.

Agitation Associated With Schizophrenia and Bipolar I Mania
Adults
IM Recommended dose is 10 mg; a lower dose of 5 to 7.5 mg may be considered. If agitation persists, subsequent doses up to 10 mg may be given. Safety of total daily doses greater than 30 mg, or 10 mg given more frequently than 2 h after initial dose and 4 h after second dose, has not been evaluated.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Overdose

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include drowsiness, agitation, aggression, slurred speech, confusion, increased heart rate, jerky or uncontrolled muscle movements, trouble breathing, or fainting.

Storage

Store Zyprexa at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Zyprexa out of the reach of children and away from pets.

What is the most important information I should know about Zyprexa (Olanzapine)?

Zyprexa is not for use in psychotic conditions that are related to dementia. Zyprexa has caused fatal heart attack and stroke in older adults with dementia-related conditions.

Zyprexa may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. If you are diabetic, check your blood sugar levels on a regular basis while you are taking Zyprexa.

It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Zyprexa can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol, which can increase some of the side effects of Zyprexa. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Zyprexa. Tell your doctor if you regularly use any of these other medicines. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Zyprexa.

What should I discuss with my doctor before taking Zyprexa (Olanzapine)?

Zyprexa is not for use in psychotic conditions that are related to dementia. Zyprexa has caused fatal heart attack and stroke in older adults with dementia-related conditions.

Before taking Zyprexa, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• kidney disease;
• heart disease, high blood pressure, heart rhythm problems;
• high cholesterol or triglycerides;
• a history of heart attack or stroke;
• a history of breast cancer;
• seizures or epilepsy;
• a personal or family history of diabetes;
• an enlarged prostate or difficulty urinating;
• glaucoma; or
• trouble swallowing.

If you have any of these conditions, you may not be able to use Zyprexa, or you may need a dose adjustment or special tests during treatment.

Zyprexa may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. If you are diabetic, check your blood sugar levels on a regular basis while you are taking Zyprexa.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Zyprexa can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
The olanzapine orally disintegrating tablet (Zyprexa Zydis) may contain phenylalanine. Talk to your doctor before using this form of olanzapine if you have phenylketonuria (PKU).

Absorption

Readily absorbed orally and IM. C max is approximately 6 h (oral) and 15 to 45 min (IM). Steady state is approximately 1 wk.

Distribution

Extensively distributed throughout the body. Vd is approximately 1,000 L; 93% is protein bound.

Metabolism

In liver by glucuronidation and CYP-450–mediated oxidation; major circulating metabolites are inactive.

Elimination

Elimination is 57% in urine (7% unchanged); 30% eliminated in feces. The t 1/2 is 21 to 54 h. Plasma Cl is 12 to 47 L/h.

Special Populations

Elderly

The t 1/2 increases 1.5 times. Use caution when dosing.

Gender

Cl is approximately 30% lower in women.

Smoking

Cl is approximately 40% higher in patients who smoke.

Possible side effects

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 Zyprexa and call your doctor at once if you have any of these serious side effects:

• fever, stiff muscles, sweating, fast or uneven heartbeats;
• jerky muscle movements you cannot control;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• increased thirst, frequent urination, excessive hunger, or weakness;
• feeling light-headed, fainting;
• unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• dizziness, drowsiness, or weakness;
• constipation;
• dry mouth;
• swelling in your hands or feet;
• back pain;
• weight gain, increased appetite; or
• upset stomach.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Zyprexa (Olanzapine)?

Before taking Zyprexa, tell your doctor if you are taking any of the following medicines:

• a medication to treat high blood pressure or a heart condition;
• carbamazepine (Tegretol);
• fluvoxamine (Luvox); or
• a medication to treat Parkinson's disease including levodopa (Sinemet, Larodopa, Atamet), selegiline (Eldepryl, Emsam), pramipexole (Mirapex), ropinirole (Requip), and others.

This list is not complete and there may be other drugs that can interact with Zyprexa. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I avoid while taking Zyprexa (Olanzapine)?

Zyprexa can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol, which can increase some of the side effects of Zyprexa. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Zyprexa. Tell your doctor if you regularly use any of these other medicines. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Zyprexa.

Contraindications

Standard considerations.

Warnings

Elderly patients with dementia-related psychosis treated with atypical antipsychotic agents are at an increased risk of death compared with placebo. Although the causes of death are varied, most appear to be either CV (eg, heart failure, sudden death) or infectious (eg, pneumonia). Olanzapine is not approved for treatment of patients with dementia-related psychosis.ease in sildenafil dosage is recommended.

Precautions

Pregnancy

Category C.

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Hepatic Function

Use with caution.

Special Risk Patients

Use with caution in patients with clinically important prostatic hypertrophy, narrow-angle glaucoma, or a history of paralytic ileus.

Body temperature regulation

Antipsychotics disrupt the ability to reduce core body temperature. Use with caution in patients who will experience conditions that may contribute to an elevation in core body temperature (eg, concomitant anticholinergic therapy, exposure to extreme heat, strenuous exercise, subject to dehydration).

Cerebrovascular adverse reactions

Cerebrovascular adverse reactions (eg, stroke, transient ischemic attack), including fatalities, may occur.

Cognitive and motor impairment

Caution patients about operating potentially hazardous machinery (eg, cars) until they know whether the drug impairs their ability. Advise patients to avoid alcohol.

Dysphagia

Use with caution in patients at risk for aspiration pneumonia.

Hyperglycemia and diabetes mellitus

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, may occur.

Hyperprolactinemia

Olanzapine-treated patients often have elevation in prolactin levels; however, there is no evidence of increased breast tumor risk.

Neuroleptic malignant syndrome (NMS)

NMS has occurred and is potentially fatal. Signs and symptoms are altered mental status, diaphoresis, hyperpyrexia, irregular pulse, irregular BP, muscle rigidity, and tachycardia.

Orthostatic hypotension

May occur with associated symptoms of dizziness, syncope, and tachycardia. Most common during titration period and in patients with CV disease, cerebrovascular disease, and conditions that predispose to hypotension (eg, dehydration, hypovolemia, treatment with antihypertensive agents).

Seizures

Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold (eg, Alzheimer dementia).

Suicide

Possible suicide attempts are inherent to schizophrenia and bipolar disorder. Closely supervise high-risk patients.

Tardive dyskinesia

Syndrome of potentially irreversible, involuntary dyskinetic movements may develop. Prevalence is highest in elderly patients, especially women.

Special warnings about Zyprexa

Certain antipsychotic drugs, including Zyprexa, are associated with an increased risk of developing high blood sugar, which on rare occasions has led to coma or death. See your doctor right away if you develop signs of high blood sugar, including dry mouth, unusual thirst, increased urination, and tiredness. If you have diabetes or have a high risk of developing it, see your doctor regularly for blood sugar testing.

Use Zyprexa with caution if you have any of the following conditions: Alzheimer's disease, Parkinson's disease, trouble swallowing, narrow angle glaucoma (high pressure in the eye), an enlarged prostate, heart irregularities, heart disease, heart failure, liver disease, or a history of heart attack, seizures, or intestinal blockage.

Zyprexa should not be used to treat elderly patients who have dementia because the drug could increase the risk of stroke. In addition, antipsychotic drug treatment has been associated with swallowing and breathing problems in older people and those with Alzheimer's disease.

Drugs such as Zyprexa sometimes cause a condition called Neuroleptic Malignant Syndrome (NMS). Symptoms include high fever, muscle rigidity, irregular pulse or blood pressure, rapid heartbeat, excessive sweating, and changes in heart rhythm. If these symptoms appear, contact your doctor right away. You'll have to discontinue using Zyprexa while the condition is under treatment.

There is also a risk of developing tardive dyskinesia, a condition marked by slow, rhythmical, involuntary movements. This problem is more likely to surface in older adults, especially elderly women. When it does, use of Zyprexa is usually stopped.

Animal studies suggest that Zyprexa may increase the risk of breast cancer, although human studies have not confirmed such a risk. If you have a history of breast cancer, see your doctor regularly for checkups.

People at high risk of suicide attempts should be prescribed the lowest dose possible to reduce the risk of intentional overdose.

Zyprexa sometimes causes drowsiness and can impair your judgment, thinking, and motor skills. Use caution while driving and don't operate dangerous machinery until you know how the drug affects you.

Medicines such as Zyprexa can interfere with regulation of the body's temperature. Do not get overheated or become dehydrated while taking Zyprexa. Avoid extreme heat and drink plenty of fluids.

Zyprexa can cause low blood pressure upon standing, resulting in dizziness, rapid heartbeat, and fainting, especially at the start of therapy. Let the doctor know if you develop this problem; your dosage can be adjusted to reduce the symptoms.

If you have phenylketonuria and must avoid the amino acid phenylalanine, you should not take Zyprexa Zydis, which contains this substance.

The safety and effectiveness of Zyprexa have not been studied in children.

Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor immediately. Zyprexa should be used during pregnancy only if absolutely necessary. The drug may appear in breast milk; do not breastfeed while on Zyprexa therapy.

References

References and complaints