Ziprasidone (Oral route)
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 hydrochloride is not approved for the treatment of elderly patients with dementia-related psychosis .
Uses of This Medicine:
Ziprasidone is used to treat symptoms of psychotic (mental) disorders, such as schizophrenia, mania, or bipolar disorder. 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 psychotic disorders.
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:
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 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 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 taking 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 or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor even if you feel well. Do not take more of it and do not take it more often than your doctor ordered.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule whole. Do not split, crush, or chew it.
You should take this medicine with food at the same time every day.
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 (capsules):
- For bipolar disorder:
- Adults—At first, 40 milligrams (mg) two times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg two times per day.
- Children—Use and dose must be determined by your doctor.
- For schizophrenia:
- Adults—At first, 20 milligrams (mg) two times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg two times per day.
- Children—Use and dose must be determined by your doctor.
- For bipolar disorder:
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.
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 that this medicine 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. Call 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.
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 if 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 to have trouble with thinking or controlling body movements, or to have 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.
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.
Ziprasidone 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 unwanted effects, tell your doctor right away.
Avoid drinking alcohol while you are using this medicine.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis. Talk to your doctor about ways to prevent weight gain.
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
- difficulty with speaking
- fear or nervousness
- inability to sit still
- loss of balance control
- muscle trembling, jerking, or stiffness
- need to keep moving
- shuffling walk
- sore throat
- stiffness of the limbs
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
- Less common
- Blurred vision
- body aches or pain
- chest pain
- fast, pounding, or irregular heartbeat or pulse
- pounding in the ears
- runny nose
- slow or fast heartbeat
- swelling of the tongue
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
- Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- persistent, painful erection
- Incidence not known
- Inability to move the eyes
- increased blinking or spasms of the eyelid
- sticking out of tongue
- trouble with breathing
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
- More common
- Acid or sour stomach
- lack or loss of strength
- stomach discomfort, upset, or pain
- weight gain
- Less common
- Blistering, crusting, irritation, itching, or reddening of the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in vision
- cracked, dry, or scaly skin
- difficulty with moving
- dry mouth
- increase in salivation
- itching or reddening of the skin
- joint pain
- loss of appetite
- muscle ache
- muscle pains or stiffness
- muscle tightness
- stuffy nose
- swollen joints
- weakness of the arms and legs
- 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 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