Paliperidone (Oral)

Paliperidone is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. It may also be used on its own or 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.

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

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

This medicine may raise your risk of having a stroke. This is more likely in people who already have heart or blood vessel disease. Check with your doctor right away if you are having confusion, difficulty speaking, slow speech, inability to speak or move the arms, legs, or facial muscles, double vision, or headache.

Check with your doctor right away if you or your child have difficulty breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, 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 or your child 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.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you or your child have blurred vision, dry mouth, flushed, dry skin, increased hunger, increased thirst or urination, nausea, sweating, trouble breathing, unexplained weight loss, unusual tiredness or weakness, or vomiting. 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.

Dizziness, lightheadedness, or fainting may occur, especially when you suddenly get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine can cause changes in heart rhythm, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you or your child have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.

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 right away if you 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 drowsiness, trouble with thinking, or trouble controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with paliperidone may worsen the side effects of this medicine, including dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are using paliperidone. If you become too cold, you may feel drowsy, confused, or clumsy.

This medicine may increase your or your child's weight. Your doctor may need to check your or your child's weight on a regular basis while you are using this medicine.

This medicine may increase prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how paliperidone affects children with schizophrenia younger than 12 years old and children with schizoaffective disorder. Safety and effectiveness in these age groups have not been established.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the usefulness of paliperidone. However, older patients are more likely to have kidney issues related to aging, which may require caution and a dose adjustment for those taking paliperidone.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might occur. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the following medicines. The following interactions have been chosen based on their possible 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.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be necessary 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
• Adagrasib
• Ajmaline
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Atazanavir
• Azimilide
• Azithromycin
• Bedaquiline
• Bretylium
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Erythromycin
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxymorphone
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Ribociclib
• Rifampin
• Selpercatinib
• Sematilide
• Sertraline
• Sevoflurane
• Simeprevir
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Tipranavir
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., leukopenia, neutropenia) 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
• Priapism (painful or prolonged erection of the penis) or
• Seizures, history of or
• Stomach or bowel problems (e.g., blockage)—Use with caution. May worsen these conditions.

• Bradycardia (slow heartbeat) or
• Heart rhythm problems (e.g., arrhythmia, QT prolongation), or history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. May increase the risk of more serious side effects.

• Dehydration or
• Recent heart attack or history of or
• Heart failure or
• Heart or blood vessel disease or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood) or
• Ischemic heart disease, history of or
• Stroke, history of or
• Trouble swallowing—Use with caution. May cause side effects to worsen.

• Kidney disease—Use with caution. The effects may be greater due to slower removal of the medicine from the body.

• Lewy body dementia or
• Parkinson's disease—Use with caution. Patients with these conditions may be more sensitive to the effects of this medicine.

Along with its needed effects, Paliperidone (Oral) may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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
• 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
• mask-like face
• muscle tension or tightness
• pain in the arms or legs
• slow heartbeat
• slowed movements
• slurred speech
• sticking out of the 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

Incidence not known

• Black, tarry stools
• blood in the urine
• bloody nose
• decrease in the frequency of urination
• decrease in urine volume
• decreased awareness or responsiveness
• difficulty in passing urine (dribbling)
• heavier menstrual periods
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lip smacking or puckering
• loss of bladder control
• mimicry of speech or movements
• peculiar postures or movements, mannerisms, or grimacing
• painful or prolonged erection of the penis
• painful urination
• pinpoint red spots on the skin
• puffing of cheeks
• rapid or worm-like movements of the tongue
• severe constipation
• severe sleepiness
• severe vomiting
• skin rash
• stomach pain
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs

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 Paliperidone (Oral). 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
• 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

• Back pain
• belching
• blurred vision
• changes in appetite
• dry mouth
• fever
• heartburn
• indigestion
• lack or loss of strength
• muscle aches
• sore throat
• stomach discomfort or upset
• stuffy or runny nose
• swelling or soreness of the breasts in both females and males
• swollen tongue
• unexpected or excess milk flow from breasts
• upper stomach pain

Incidence not known

• Sleepwalking

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.

In the U.S.

• Invega

In Canada

• Mar-Paliperidone
• Mylan-Paliperidone

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

You may take this medicine 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—At first, 6 milligrams (mg) once a day, every morning. Some patients may need 3 mg per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 mg per day. Children 12 to 17 years of age and weighs 51 kg (112 lbs) or more—At first, 3 mg once a day, every morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 12 mg per day. Children 12 to 17 years of age and weighs less than 51 kg (112 lbs)—At first, 3 mg once a day, every morning. Your doctor may increase your dose as 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—At first, 6 milligrams (mg) once a day, every morning. Some patients may need 3 mg per day. Your doctor may adjust your dose as 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

Call your doctor or pharmacist for instructions.

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.

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