Ziprasidone (Intramuscular route)
- Powder for Solution
Warnings:Intramuscular route(Powder for Solution)
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared with 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. 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. Ziprasidone mesylate is not approved for the treatment of patients with dementia-related psychosis .
Uses of This Medicine:
Ziprasidone injection is used to treat agitation that occurs with schizophrenia. It should not be used to treat behavioral problems in elderly patients who have dementia. Ziprasidone works by changing some of the chemicals in the brain that cause schizophrenia.
This medicine is to be given only by or under the direct supervision of your doctor.
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 ziprasidone 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 ziprasidone injection in the elderly. However, this medicine should not be used for behavioral problems in older adults with dementia.
|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.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Inotuzumab Ozogamicin
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
- Methylene Blue
- Morphine Sulfate Liposome
- St John's Wort
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.
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 or bone marrow problems (eg, agranulocytosis, leukopenia, neutropenia) or
- Diabetes or
- Hyperglycemia (high blood sugar) or
- Hyperprolactinemia (high prolactin in the blood) or
- Neuroleptic malignant syndrome (NMS), history of or
- Priapism (painful or prolonged erection of the penis) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Bradycardia (slow heartbeat) or
- Dehydration or
- Heart or blood vessel disease or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Hypotension (low blood pressure) or
- Hypovolemia (low amount of blood) or
- Stroke, history of or
- Trouble with swallowing—May cause side effects to become worse.
- Heart attack, recent acute or
- Heart failure, uncompensated or
- Heart rhythm problems (eg, congenital long QT syndrome, QT prolongation)—Should not be used in patients with these conditions.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine in a clinic or hospital setting. This medicine is given as a shot into one of your muscles.
Your doctor will 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.
Precautions While Using This Medicine:
Your doctor will check your progress after you receive this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with amiodarone (Cordarone®), arsenic trioxide, chlorpromazine (Thorazine®), disopyramide (Norpace®), dofetilide (Tikosyn®), dolasetron mesylate (Anzemet®), droperidol (Inapsine®), gatifloxacin (Tequin®), halofantrine, levomethadyl acetate, mefloquine (Lariam®), mesoridazine (Serentil®), moxifloxacin (Avelox®), pentamidine (Nebupent®), pimozide (Orap®), probucol, procainamide (Pronestyl®), quinidine (Cardioquin®), sotalol (Betapase®), sparfloxacin (Zagam®), tacrolimus (Prograf®), or thioridazine (Mellaril®). Using these medicines together may cause serious unwanted effects.
This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Tell your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
Check with your doctor right away if you have any of the following symptoms: 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).
If you develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.
Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have 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 while you are using 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.
Ziprasidone 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 right away if you think you are getting an infection, or you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may cause some people to become drowsy or dizzy, or may cause trouble with thinking or controlling body movements, 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 anything else that requires you to be alert, well-coordinated, or able to think well.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
Ziprasidone injection 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. If you or your caregiver notice any of these side effects, tell your doctor right away.
You may get overheated more easily while you are using this medicine. Be careful if you exercise often or are exposed to high temperatures or humidity. Drink more water and stay out of the sun.
Avoid drinking alcohol while you are using 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
- cold sweats
- Less common
- bleeding or bloody stools
- blurred vision
- breathing too fast
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in personality
- chest pain or discomfort
- difficulty with speaking
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- feeling of warmth or heat
- feeling, seeing, or hearing things that are not there
- flushing or redness of the skin, especially on the face and neck
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- loss of balance control
- multiple swollen and inflamed skin lesions
- muscle aches and pains
- muscle discomfort
- muscle tension or tightness
- muscle trembling, jerking, or stiffness
- painful or prolonged erection of the penis
- pounding in the ears
- rigid or stiff muscles
- runny nose
- severe mood or mental changes
- shuffling walk
- slow or fast heartbeat
- sore throat
- stiffness of the limbs or muscles
- trouble sleeping
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
- unusual behavior
- unusual tiredness or weakness
- Actions that are out of control
- difficulty with breathing
- high fever
- high or low blood pressure
- hives or itching
- lip smacking or puckering
- loss of bladder control
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid or worm-like movements of the tongue
- talking or acting with excitement you cannot control
- unexpected or excess milk flow from the breasts
- unusually pale skin
- More common
- Pain at the site of injection
- sleepiness or unusual drowsiness
- Less common
- Acid or sour stomach
- back pain
- heavy bleeding
- inability to sit still
- need to keep moving
- stomach discomfort, upset, or pain
- stuffy nose
- tooth disorder
- weight loss
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