Pronunciation:

pal-ee-PER-i-done

Brand Names:

• Invega

Dosage Forms:

• Tablet, Extended Release

Warnings:

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) in these subjects revealed a risk of death in the drug-treated subjects of between 1.6 to 1.7 times that seen in placebo-treated subjects. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated subjects 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. 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. Paliperidone is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Benzisoxazole

Uses of This Medicine:

Paliperidone is used to treat the symptoms of psychotic disorders, such as schizophrenia. This medicine should NOT be used to treat behavioral problems in older adult 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:

Allergies—

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.

Children—

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 .

Older adults—

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.

Other medicines—

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.

• Mesoridazine
• Ranolazine
• Thioridazine

Other interactions—

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:

• Aspiration pneumonia risk, or history of, or
• Blood vessel problems (e.g., history of stroke or heart attack) or
• Dehydration or
• Dementia or
• Kidney disease—These conditions may increase the chance of side effects .

• Breast cancer or
• Diabetes or
• Heart disease or
• Heart rhythm problems (e.g., QT prolongation) or
• Hypotension or
• Neuroleptic malignant syndrome, or history of, or
• Parkinson's disease or
• Seizures, or history of—May make these conditions worse .

• Stomach or intestinal problems (e.g., blocked bowels) or
• Trouble with swallowing—Should not use in patients with these conditions .

Proper Use of This Medicine:

This medicine 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 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 (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 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.

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 This Medicine:

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 this medicine .

For diabetic patients: This medicine 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 .

This medicine 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 .

This medicine 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 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 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 this medicine 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 .

Side Effects of This Medicine:

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.