Pronunciation:

oh-LAN-za-peen

Brand Names:

• Zyprexa
• Zyprexa Zydis

Dosage Forms:

• Tablet
• Tablet, Disintegrating

Warnings:

• Increased mortality in elderly patients with dementia-related psychosis -
  • Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 times to 1.7 times that seen 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 (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

• Increased mortality in elderly patients with dementia-related psychosis -
  • Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 times to 1.7 times that seen 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 (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Thienobenzodiazepine

Uses of This Medicine:

Olanzapine is used to treat psychiatric (mental) disorders, such as schizophrenia or bipolar disorder (manic-depressive illness) .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of olanzapine in elderly patients who have schizophrenia. This medicine should not be used to treat behavioral problems in older adult patients who have dementia .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Levomethadyl

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel or circulation problems or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume)—May cause side effects to become worse .

• Breast cancer, prolactin dependent or
• Hyperlipidemia (high cholesterol or fat in the blood) or
• Hyperprolactinemia (high prolactin in the blood) or
• Liver disease or
• Narrow-angle glaucoma or
• Paralytic ileus (severe intestinal problem), history of or
• Prostatic hypertrophy (enlarged prostate) or
• Seizures, history of—Use with caution. This medicine may make these conditions worse .

• Diabetes or
• Hyperglycemia (high blood sugar)—This medicine may raise your blood sugar level .

• Phenylketonuria (PKU, a genetic disease of metabolism)—The orally disintegrating tablet (Zyprexa® Zydis®) contains phenylalanine, which can make this condition worse .

Proper Use of This Medicine:

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water .

You may take this medicine with or without food .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (orally disintegrating tablets, regular tablets):
  • For treatment of schizophrenia:
    • Adults—At first, 5 to 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor .
  • For treatment of bipolar disorder:
    • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor .

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine .

Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS) .

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs .

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor .

Olanzapine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well .

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; barbiturates; medicines for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine .

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

change in vision

change in walking and balance

clumsiness or unsteadiness

difficulty with speaking

difficulty with swallowing

drooling

impaired vision

inability to sit still

loss of balance control

mask-like face

muscle trembling, jerking, or stiffness

need to keep moving

rapid weight gain

restlessness

shakiness in the legs, arms, hands, or feet

shuffling walk

slowed movements

slurred speech

stiffness of the arms and legs

tic-like (jerky) movements of the head, face, mouth, and neck

tingling of the hands or feet

trembling or shaking of the fingers, hands, or feet

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

unusual weight gain or loss

Less common

Bladder pain

bloody or cloudy urine

bruising

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

difficult or labored breathing

difficult, burning, or painful urination

dizziness

excessive muscle tone

frequent urge to urinate

headache

inability to move eyes

increased blinking or spasms of the eyelid

itching of the vagina or genital area

lack of coordination

large, flat, blue or purplish patches in the skin

loss of bladder control

loss of memory

lower back or side pain

muscle tension or tightness

nervousness

pain during sexual intercourse

pounding in the ears

problems with memory

rhythmic movement of the muscles

shortness of breath

slow, fast, pounding, or irregular heartbeat or pulse

speaking is less clear than usual

sticking out the tongue

thick, white vaginal discharge with no odor or with a mild odor

tightness in the chest

trouble with breathing, speaking, or swallowing

twitching

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual or incomplete body or facial movements

weakness of the arms and legs

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Anxiety

attacking, assaulting, or using force

change in consciousness

change in patterns and rhythms of speech

confusion as to time, place, or person

convulsions (seizures)

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

drowsiness

dry mouth

fainting

hallucinations

heart stops beating

high fever

high or low blood pressure

holding false beliefs that cannot be changed by fact

increased sweating

irregular, fast or slow, or shallow breathing

irritability

lightheadedness

loss of consciousness

mood or mental changes

no breathing

no pulse or blood pressure

pale or blue lips, fingernails, or skin

rapid breathing

relaxed and calm

severe muscle stiffness

shaking or trembling

sleepiness

trouble sleeping

unconscious

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

unusually pale skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

back pain

belching

change in personality

difficulty having a bowel movement (stool)

discouragement

feeling sad or empty

fever

heartburn

increased appetite

increased cough

indigestion

lack of appetite

lack or loss of strength

loss of interest or pleasure

runny nose

sleeplessness

sneezing

stomach discomfort, upset, or pain

stuffy nose

thirst

trouble concentrating

unable to sleep

watering of mouth

weight gain

Less common

Blemishes on the skin

body aches or pain

chills

cold sweats

congestion

cough

dry skin

dryness or soreness of throat

false or unusual sense of well-being

joint pain

heavy menstrual bleeding (periods)

hoarseness

lack of feeling or emotion

leg cramps

pain in the arms or legs

pimples

sweating

tender, swollen glands in the neck

uncaring feelings

voice change

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.