Paliperidone, Oral/Injection

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KEY POINTS

• This medicine is taken by mouth or given by injection to treat symptoms of schizophrenia or schizoaffective disorder. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antipsychotic

Generic and brand names: paliperidone, oral; Invega; paliperidone, injection; Invega Sustenna; Invega Trinza

What is this medicine used for?

This medicine is taken by mouth or given by injection to treat symptoms of schizophrenia or schizoaffective disorder.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis
• A stroke or transient ischemic attack (TIA)
• Alzheimer's disease or dementia
• Breast cancer
• Diabetes
• Heart disease, irregular heartbeat, or a heart attack
• High cholesterol or triglyceride levels in the blood
• Kidney or liver disease
• Long QT syndrome (problems with electrical activity in your heart muscle)
• Low blood pressure
• Low white blood cell counts
• Parkinson's disease
• Problems with low levels of potassium or magnesium in your blood
• Seizures
• Thoughts of suicide
• Trouble swallowing

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval. Taking this medicine during the last 3 months of pregnancy may cause problems for the baby. Symptoms the baby may have include agitation, tight muscles, floppy muscles, shaking, trouble breathing, or trouble feeding. Talk with your provider about this.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Your healthcare provider may adjust your dosage depending on your response. If you do not understand how or when to take this medicine, ask your healthcare provider or pharmacist to explain.

Check with your healthcare provider before using this medicine in children under age 12.

You may take tablets with or without food. Do not break, crush, or chew the tablets. Swallow them whole. You may see partially digested tablets in your bowel movement. This is not harmful.

Injections of this medicine are given by your healthcare provider. It is very important to keep all your appointments and get your injections on time. If you miss an injection, contact your healthcare provider right away to reschedule.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

If you miss an injection, contact your healthcare provider right away to reschedule.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, fast or irregular heartbeat, lightheadedness, dizziness, fainting, uncontrolled movement in tongue, jaw, or neck.

What should I watch out for?

Older adults with dementia are at greater risk for severe side effects or death if they take this medicine. Talk with your provider about this.

You may need to have tests regularly. Keep all appointments.

Newborn babies may have trouble breathing or feeding, or other symptoms, if the mother takes this medicine in the last 3 months of pregnancy. This medicine should be used during pregnancy only if the benefit is greater than the possible risk to your baby. Talk with your provider about this.

This medicine may affect your ability to be alert and think clearly. Do not drive or operate machinery unless you are fully alert.

When you first start taking this medicine, you may get dizzy or lightheaded or feel faint when you get up quickly from sitting or lying down. Try getting up slowly. If this reaction continues, contact your healthcare provider.

Using this medicine for a long time may cause muscle spasms, twitching in the face and body, and uncontrolled tongue or jaw movement. Talk to your healthcare provider about this.

This medicine may increase the total cholesterol and triglyceride levels in your blood. You will need tests to check these levels regularly. Keep all appointments for tests.

This medicine may also cause you to gain weight. Talk with your provider about this.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

While taking this medicine, be careful when you exercise, especially when it is hot. This medicine affects your body's ability to cool down, and you may get too hot. If you get too hot, you might vomit, feel dizzy, have a fast heartbeat, get very stiff muscles, or be confused. Contact your provider right away if you have these symptoms.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may increase the risk of developing diabetes, especially if you are overweight or have a family history of diabetes. If you have diabetes, this medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Seizures; depression or thoughts of suicide; uncontrolled muscle movements; lightheadedness when you stand or sit up; irregular or pounding heartbeat; fainting; increased sweating or confusion; high fever and muscle stiffness; painful erection that will not go away; chest pain; extreme weakness or tiredness; muscle or joint pain; increased urination; increased thirst; unexplained fever, cough, or sore throat; trouble swallowing; unusual bruising or bleeding; severe stomach pain.

Other: Trouble sleeping, restlessness, anxiety, tremors, headache, dizziness, constipation, nausea, heartburn, runny nose, vomiting, sleepiness, dry mouth, blurred vision, trouble urinating, nightmares, weight gain; changes in menstrual periods, breast swelling; injection site pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as captopril, enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), and prazosin (Minipress)
• Angiotensin receptor blockers (ARBs) such as candesartan (Atacand), irbesartan (Avapro), losartan (Cozaar), valsartan (Diovan), and others
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), moxifloxacin (Avelox), rifampin (Rifadin), and others
• Antidepressants such as amitriptyline, fluoxetine (Prozac), imipramine (Tofranil), sertraline (Zoloft), and others
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend), and others
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and others
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), thioridazine, ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), valproic acid (Depacon, Depakene, Depakote), and others
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), sotalol (Betapace, Sorine), and others
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), verapamil (Calan, Covera, Verelan), and others
• Cancer medicines such as arsenic trioxide (Trisenox), enzalutamide (Xtandi), imatinib (Gleevec), nilotinib (Tasigna), and others
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glipizide (Glucotrol), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), and others
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and others
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), quinidine, ranolazine (Ranexa), and others
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Lithium (Lithobid)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, primaquine, quinine, and others
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), salmeterol (Serevent), and others
• Mifepristone (Korlym, Mifeprex)
• Milnacipran (Savella)
• Muscle relaxants such as carisoprodol (Soma), cyclobenzaprine (Amrix), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as dolasetron (Anzemet), droperidol (Inapsine), metoclopramide (Metozolv, Reglan), ondansetron (Zofran), and others
• Octreotide (Sandostatin)
• Pain medicines such as codeine, hydrocodone (Hysingla, Zohydro), oxycodone (OxyContin, Roxicodone), tramadol (ConZip, Ultram), and others
• Parkinson’s disease medicines such as apomorphine (Apokyn), bromocriptine (Cycloset, Parlodel), levodopa/carbidopa (Duopa, Rytary, Sinemet), ropinirole (Requip), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Solifenacin (VESIcare)
• Tetrabenazine (Xenazine)
• Vardenafil (Levitra, Staxyn)

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Tablets should be stored at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.