Olanzapine (Intramuscular route)
- ZyPREXA IntraMuscular
- ZyPREXA Relprevv
- Powder for Solution
- Powder for Suspension, Extended Release
Warnings:Intramuscular route(Powder for Solution)
Risk of death is increased in elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs. 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. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .Intramuscular route(Powder for Suspension, Extended Release)
Patients are at risk for severe sedation (including coma) or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency response services. Because of this risk, olanzapine pamoate is available only through a restricted distribution program called olanzapine pamoate Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine pamoate is not approved for the treatment of patients with dementia-related psychosis .
Uses of This Medicine:
Olanzapine injection is used to treat agitation that occurs with schizophrenia and bipolar mania. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.
This medicine is available only with your doctor's prescription.
Zyprexa® Relprevv™ is available only under a special restricted distribution program called Zyprexa® Relprevv™ patient care program.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of olanzapine injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olanzapine injection in the elderly. However, elderly patients are more likely to have dementia or age-related liver, kidney, or heart problems, which may require caution or an adjustment in the dose for patients receiving olanzapine injection.
|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.|
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Inotuzumab Ozogamicin
- Morphine Sulfate Liposome
- Secretin Human
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Betel Nut
- Valproic Acid
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of 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 disease 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
- Glaucoma, narrow-angle or
- Hyperlipidemia (high cholesterol or fat in the blood) or
- Hyperprolactinemia (high prolactin in the blood) or
- Liver disease 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 levels.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine in a clinic, community health center, or hospital. This medicine is given as a shot into a muscle.
Your doctor may give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Tell your doctor if you smoke tobacco. You might need a different amount of this medicine if you smoke.
Precautions While Using This Medicine:
It is very important that your doctor check your progress while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.
Olanzapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.
This medicine may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). Call your doctor right away if you have a rash, red, swollen skin, fever, chills, cough, trouble breathing, swollen glands, or unusual bleeding, bruising, or weakness after receiving this medicine.
This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.
This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.
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.
Check with your doctor right away if you have any of the following symptoms while receiving 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 receiving 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.
Olanzapine injection may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, which may lead to falls, fractures, or other injuries. 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.
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.
This medicine may cause post-injection delirium/sedation syndrome. Tell your doctor right away if you have the following symptoms: convulsions (seizures), dizziness, drowsiness, sleepiness, or confusion as to time, place, or person after receiving the injection.
This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
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.
Avoid drinking alcohol while you are receiving this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.
Side Effects of This Medicine:
- 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
- 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
- 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
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- difficult or labored breathing
- difficult, burning, or painful urination
- excessive muscle tone
- frequent urge to urinate
- inability to move the 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
- pain, redness, and swelling at the injection site
- pounding in the ears
- problems with memory
- rhythmic movement of the muscles
- 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
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual or incomplete body or facial movements
- weakness of the arms and legs
- More common
- Acid or sour stomach
- back pain
- change in personality
- difficulty having a bowel movement (stool)
- feeling sad or empty
- increased appetite
- increased cough
- lack of appetite
- lack or loss of strength
- loss of interest or pleasure
- runny nose
- stomach discomfort, upset, or pain
- stuffy nose
- trouble sleeping
- trouble with concentrating
- watering of the mouth
- weight gain
- Less common
- Body aches or pain
- cold sweats
- dry skin
- dryness or soreness of the throat
- false or unusual sense of well-being
- heavy menstrual bleeding
- joint pain
- lack of feeling or emotion
- leg cramps
- pain in the arms or legs
- tender, swollen glands in the neck
- uncaring feelings
- voice change
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 or nurse immediately if any of the following side effects occur:
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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017