Paliperidone (Intramuscular route)
- Invega Sustenna
- Suspension, Extended Release
Warnings:Intramuscular route(Suspension, Extended Release)
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death; paliperidone palmitate is not approved for use in patients with dementia-related psychosis .
Uses of This Medicine:
Paliperidone injection is used to treat the symptoms of schizophrenia. This medicine should not be used to treat behavioral problems in elderly patients who have dementia.
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 paliperidone 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 paliperidone injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving paliperidone 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.
- Arsenic Trioxide
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
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:
- Alzheimer's disease or dementia or
- Dehydration or
- Heart attack, recent or history of or
- Heart failure or
- Heart or blood vessel disease or
- Heart rhythm problems (e.g., arrhythmia, QT prolongation), or a history of or
- Hypotension (low blood pressure) or
- Hypovolemia (low amount of blood) or
- Parkinson's disease or
- Stroke, history of or
- Trouble with swallowing—May cause side effects to become worse.
- Blood or bone marrow problems (e.g., 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 or
- Stomach or bowel problems (e.g., slow or blocked bowels)—Use with caution. May make these conditions worse.
- 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. This medicine is given as a shot into one of your muscles.
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 any unwanted effects.
Stop using 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 using 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.
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. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
For diabetic patients: This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
Paliperidone injection 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, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements. 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.
Paliperidone 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 or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines, including narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
This medicine 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 cannot cool down.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. 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
- bladder pain
- bloody or cloudy urine
- body aches or pain
- difficult, burning, or painful urination
- difficulty with breathing
- difficulty with swallowing
- dry mouth
- ear congestion
- frequent urge to urinate
- inability to sit still
- irregular heartbeats
- loss of balance control
- loss of voice
- lower back or side pain
- mask-like face
- nasal congestion
- need to keep moving
- runny nose
- shortness of breath
- shuffling walk
- slowed movements
- slurred speech
- sore throat
- stiffness of the arms and legs
- tic-like (jerky) movements of the head, face, mouth, and neck
- trembling and shaking of the fingers and hands
- trouble with sleeping
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- unusual tiredness or weakness
- Less common
- Blurred vision
- difficulty with speaking
- inability to move the eyes
- increase in body movements
- increased blinking or spasms of the eyelid
- loss of balance control
- muscle trembling, jerking, or stiffness
- pounding in the ears
- slow or fast heartbeat
- sticking out of the tongue
- stiffness of the limbs
- trouble with breathing, speaking, or swallowing
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
- More common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- unable to sleep
- Less common
- Back pain
- difficulty with moving
- dry mouth
- increased weight
- joint pain
- lack or loss of strength
- muscle aching or cramping
- muscle pains or stiffness
- pain in the arms or legs
- stuffy or runny nose
- swollen joints
- tearing of the skin
- upper abdominal or stomach pain
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: 11/4/2014