Advanced Consumer Information

paliperidone (Oral route)

pal-ee-PER-i-done

Oral routeTablet, Extended Release

Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death 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. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Paliperidone 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. 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. Paliperidone is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s):

In the U.S.

Invega

Available Dosage Forms:

Tablet, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Uses For paliperidone

Paliperidone is used to treat the symptoms of psychotic disorders, such as schizophrenia. paliperidone should NOT be used to treat behavioral problems in older adult patients who have dementia .

paliperidone is available only with your doctor's prescription .

Before Using paliperidone

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 paliperidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to paliperidone 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of paliperidone in children below 18 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of paliperidone in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving paliperidone .

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.

Interactions with Medicines

Using paliperidone 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.

Dronedarone
Mesoridazine
Thioridazine

Using paliperidone 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.

Acecainide
Ajmaline
Amiodarone
Arsenic Trioxide
Azimilide
Bretylium
Chlorpromazine
Disopyramide
Dofetilide
Gatifloxacin
Hydroquinidine
Ibutilide
Iloperidone
Lapatinib
Methadone
Moxifloxacin
Nilotinib
Pirmenol
Prajmaline
Procainamide
Prochlorperazine
Ranolazine
Sematilide
Sotalol
Tedisamil
Tetrabenazine
Trifluoperazine

Using paliperidone 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.

Paroxetine

Interactions with Food/Tobacco/Alcohol

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.

Proper Use of paliperidone

paliperidone may be taken with or without food .

Swallow the extended-release tablet whole with a liquid (water or juice). Do not crush, break, or chew it .

Part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and is nothing to worry about .

Dosing

The dose of paliperidone 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 paliperidone. 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 (extended-release tablets):
- For schizophrenia:
  - Adults—6 milligrams (mg) once a day, every morning. Your doctor may increase your dose if needed. However, the dose is usually not more than 12 mg per day.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of paliperidone, 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.

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

Do not keep outdated medicine or medicine no longer needed.

Keep out of the reach of children.

Precautions While Using paliperidone

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any problems or unwanted effects that may be caused by paliperidone .

For diabetic patients: paliperidone may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor .

paliperidone may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when getting up suddenly from a sitting or lying position, so get up slowly .

paliperidone will add to the effects of alcohol and other medicines that make you drowsy or less alert. Some examples are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping pills; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of these while you are taking paliperidone.

paliperidone 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 .

paliperidone might cause a condition called tardive dyskinesia, which is a movement disorder. If you have muscle spasms, twitching in your face or body, or uncontrolled tongue or jaw movements, stop taking paliperidone and call your doctor right away. Talk to your doctor about the risk of this side effect .

If your symptoms do not improve or if they become worse, check with your doctor .

paliperidone Side Effects

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

Difficulty with speaking
drooling
fast, pounding, or irregular heartbeat or pulse
loss of balance control
muscle trembling, jerking, or stiffness
restlessness
shuffling walk
stiffness of limbs
twisting movements of body
uncontrolled movements, especially of face, neck, and back

Less common

Chest pain
cold sweats
confusion
cough
difficulty with swallowing
dizziness
excessive muscle tone
fainting
inability to move eyes
increased blinking or spasms of eyelid
increased blood pressure
loss of balance control
mask-like face
muscle tension or tightness
pain in arms or legs
slow heartbeat
slowed movements
slurred speech
sticking out tongue when not meaning to
tic-like (jerky) movements of head, face, mouth, and neck
trembling and shaking of fingers and hands
tremors
trouble with breathing, speaking, or swallowing
uncontrolled twisting movements of neck, trunk, arms, or legs
unusual facial expressions
unusual tiredness or weakness

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

Fear or nervousness
headache
inability to sit still
nausea
need to keep moving
sleepiness or unusual drowsiness
weight gain

Less common

Acid or sour stomach
back pain
belching
blurred vision
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
dry mouth
fever
heartburn
indigestion
lack or loss of strength
stomach discomfort, upset, or pain
upper abdominal pain

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

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