Generic Name: paliperidone (Oral route)

pal-ee-PER-i-done

Oral route(Tablet, Extended Release)

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. 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 Invega

Paliperidone is used to treat the symptoms of psychotic disorders, such as schizophrenia. It may be used alone or together with other medicines to treat patients with schizoaffective disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.

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This medicine is available only with your doctor's prescription.

Before Using Invega

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of paliperidone in children with schizophrenia younger than 12 years of age and in children with schizoaffective disorder in children younger than 18 years of age. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-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 caution and 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

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.

  • Amifampridine
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Sparfloxacin
  • Thioridazine

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.

  • Acecainide
  • Ajmaline
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Bretylium
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Erythromycin
  • Escitalopram
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Hydromorphone
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Lomitapide
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Mifepristone
  • Moxifloxacin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Pasireotide
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Posaconazole
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Salmeterol
  • Saquinavir
  • Sematilide
  • Sevoflurane
  • Simeprevir
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Tizanidine
  • Tocophersolan
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Ziprasidone

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.

  • Carbamazepine
  • 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.

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 or
  • Breast cancer, prolactin-dependent or
  • Diabetes or
  • Dyslipidemia (high cholesterol or fats in the blood) or
  • Hyperglycemia (high blood sugar) or
  • Hyperprolactinemia (high prolactin in the blood) or
  • Neuroleptic malignant syndrome (NMS), history of or
  • Parkinson's disease or
  • Priapism (painful or prolonged erection of the penis) or
  • Seizures, history of or
  • Stomach or bowel problems—Use with caution. May make these conditions worse.
  • Bowel blockage or
  • Brain tumor or
  • Reye's syndrome—Paliperidone may prevent vomiting and hide these medical problems from you or your doctor.
  • Bradycardia (slow heartbeat) or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—Use with caution. May increase risk for more serious side effects.
  • 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
  • Ischemic heart disease, history of or
  • Stroke, history of or
  • Trouble with swallowing—Use with caution. May cause side effects to become worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Invega

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

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. Some patients may need 3 mg per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 12 mg per day.
      • Teenagers 12 to 17 years of age weighing 51 kg (112 lbs) or more—3 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.
      • Teenagers 12 to 17 years of age weighing less than 51 kg (112 lbs)—3 mg once a day, every morning. Your doctor may increase your dose if needed. However, the dose is usually not more than 6 mg per day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For schizoaffective disorder:
      • Adults—6 milligrams (mg) once a day, every morning. Some patients may need 3 mg per day. Your doctor may adjust 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.

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 Invega

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Stop taking this medicine and check with your doctor right away if you your child 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 your child have any of the following symptoms while taking 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.

For diabetic patients: This medicine may affect your blood sugar levels. Check with your doctor right away if you your child 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 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 immediately if you your child think you are getting an infection or if you get 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 require you to be alert, well-coordinated, or able to think or see well.

Paliperidone 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, your child, 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 other 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 your child 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 your child 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 your child are using this medicine.

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

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.

Invega 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
  • increase in body movements
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • restlessness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
Less common
  • Chest pain
  • cold sweats
  • confusion
  • cough
  • difficulty with swallowing
  • dizziness
  • excessive muscle tone
  • fainting
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • increased blood pressure
  • loss of balance control
  • mask-like face
  • muscle tension or tightness
  • pain in the arms or legs
  • slow heartbeat
  • slowed movements
  • slurred speech
  • sticking out tongue when not meaning to
  • tic-like (jerky) movements of the head, face, mouth, and neck
  • trembling and shaking of the fingers and hands
  • tremors
  • trouble with breathing, speaking, or swallowing
  • uncontrolled twisting movements of the 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
  • Absent, missed, or irregular menstrual periods
  • difficulty having a bowel movement (stool)
  • fear or nervousness
  • headache
  • inability to sit still
  • nausea
  • need to keep moving
  • sleepiness or unusual drowsiness
  • stopping of menstrual bleeding
  • vomiting
  • weight gain
Less common
  • Acid or sour stomach
  • back pain
  • belching
  • blurred vision
  • changes in appetite
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fever
  • heartburn
  • indigestion
  • lack or loss of strength
  • muscle aches
  • sore throat
  • stomach discomfort, upset, or pain
  • stuffy or runny nose
  • swelling of the breasts or breast soreness in both females and males
  • swollen tongue
  • unexpected or excess milk flow from breasts
  • upper abdominal or stomach pain

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.

See also: Side effects (in more detail)

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