Clozapine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat schizophrenia or to reduce the risk of suicidal behavior in people with schizophrenia. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause life-threatening heart problems, severe infections, seizures, uncontrollable movements, or other 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: clozapine, oral; Clozaril; FazaClo Orally Disintegrating Tablets; Versacloz Oral Suspension

What is this medicine used for?

This medicine is taken by mouth to treat schizophrenia. This medicine is also used to lower the risk of suicide in people who have schizophrenia or schizoaffective disorder. It is a very powerful medicine that is used when other treatments have not helped.

You must be enrolled in a special program before you can receive this medicine. Talk with your healthcare provider about this.

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, ulcerative colitis, or severe constipation
• A head injury or brain tumor
• A low white blood cell count
• A stroke or transient ischemic attack (TIA)
• Alzheimer's disease or dementia
• Blood clots or bleeding disorders
• Bone marrow disorders
• Diabetes
• Glaucoma
• Heart problems or a heart attack
• High cholesterol or high triglycerides
• Kidney or liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Low levels of magnesium or potassium in your blood
• Low or high blood pressure
• Lung disease
• Myasthenia gravis
• Phenylketonuria (PKU). The dissolving tablet contains phenylalanine.
• Problem with alcohol abuse
• Problems with dehydration
• Seizures
• Trouble urinating or an enlarged prostate gland

Tell your provider if you smoke or plan to stop smoking while taking this medicine. Smoking cigarettes can affect how this medicine works.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. 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?

It is very important to take this medicine exactly as your healthcare provider prescribes. Check the label on the medicine for directions about your specific dose. Do not take more or less of it or take it longer than prescribed. Taking too much may cause very serious side effects. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals or milk may lessen the chance the drug will upset your stomach.

Orally disintegrating tablets: If you are taking the disintegrating tablets, peel the foil from the blister and gently remove the tablet. Do not push the tablet through the foil. Place the tablet in your mouth and let it dissolve before swallowing. You do not need to drink water with this tablet. Keep the tablets in the unopened blister pack until you take your dose. If you take half-tablets, throw the other part of the tablet away. Do not save this half-tablet for later use.

Liquid: Carefully follow the instructions for use included in your medicine package. If you have the liquid form, shake the medicine well before use. Use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct. Ask your pharmacist if you have any questions.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you stop taking this medicine for more than 2 days, DO NOT start taking it again at the same dosage. Ask your healthcare provider what dose you should take. 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.

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, dizziness, fainting, coma, change in behavior, confusion, fast or irregular heartbeat, drooling, slow breathing, seizures.

What should I watch out for?

This medicine can lower the number of white blood cells in your body, which can increase your risk of infection. Tell your healthcare provider if you have any signs of infection such as fever, cough, weakness, mouth sores, or sore throat.

This medicine may cause severe or life-threatening heart problems, seizures, and uncontrollable movements such as twitching of the face, mouth, or jaw. Contact your healthcare provider right away if you have an irregular heartbeat, chest pain, fast or slow heartbeat, fever, shortness of breath, swelling in the arms or legs, severe dizziness or fainting, or seizures.

This medicine may lower your blood pressure, slow your heart rate, or cause fainting. This can be life-threatening. You may feel faint when you get up from sitting or lying down. Getting up slowly may help. This may happen more often when you first start treatment or when your dose is increased. Talk with your healthcare provider about this.

Older adults, especially those with dementia, are at greater risk for side effects. Talk with your provider about this.

You need to have blood tests before you start taking this medicine, regularly while you are taking it, and for several weeks after you stop taking it. Taking this medicine without blood tests regularly can be very dangerous. Keep all your 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.

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.

This medicine may make you drowsy, dizzy, or cause seizures. Do not drive or operate machinery unless you are fully alert.

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.

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; chest pain or tightness in your chest; swelling of 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.): Severe tiredness or weakness; unexplained fever; heavy sweating; sore throat; cough; mouth sores; wounds that do not heal; seizures; severe dizziness; fainting; tremors; muscle twitching, stiffness, or spasms; restlessness; fast, slow, or irregular heartbeat; chest pain; shortness of breath or fast breathing; changes in vision; increased thirst; extreme hunger; uncontrollable eye movements; increased urinating, pain or burning when urinating, or trouble urinating; unusual vaginal itching or discharge; sores or pain in or around the rectal area; severe constipation or diarrhea; yellowing of the skin or eyes; severe nausea or vomiting; severe stomach pain; unusual bruising or bleeding; unexplained swelling in hands, ankles, or feet; confusion or changes in behavior; thoughts of suicide; swelling, redness, or pain in your legs.

Other: Headache, drowsiness, mild dizziness, dry mouth, trouble sleeping, nightmares, nausea, vomiting, constipation, change in sexual ability or desire, sweating, drooling, weight gain.

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 benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), and prazosin (Minipress)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, mexiletine, procainamide, propafenone (Rythmol), and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), belladonna, methscopolamine (Pamine), and scopolamine (Transderm Scop)
• Antidepressants such as amitriptyline, citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), terbinafine (Lamisil), and voriconazole (Vfend)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Atomoxetine (Strattera)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Bosentan (Tracleer)
• Buprenorphine (Buprenex, Butrans)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Buspirone
• Caffeine
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), altretamine (Hexalen), arsenic trioxide (Trisenox), busulfan (Busulfex, Myleran), ceritinib (Zykadia), cisplatin, crizotinib (Xalkori), cytarabine (Cytosar, DepoCyt), doxorubicin (Doxil), enzalutamide (Xtandi), fludarabine (Fludara), gemcitabine (Gemzar), hydroxyurea (Droxia, Hydrea), idelalisib (Zydelig), mitotane (Lysodren), nilotinib (Tasigna), tamoxifen, thioguanine (Tabloid), thiotepa, toremifene (Fareston), vandetanib (Caprelsa), vemurafenib (Zelboraf), vinblastine, and vincristine (Marqibo)
• Conivaptan (Vaprisol)
• Dexamethasone
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fesoterodine (Toviaz)
• Fingolimod (Gilenya)
• Flibanserin (Addyi)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as sirolimus (Rapamune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• 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 block or prevent stomach acid such as cimetidine (Tagamet) and omeprazole (Prilosec)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• Metoclopramide (Metozolv, Reglan)
• Mifepristone (Korlym, Mifeprex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as dolasetron (Anzemet), droperidol (Inapsine), ondansetron (Zofran), and promethazine
• Nicotine replacement products (smoking) and nicotine replacement products such as Habitrol, NicoDerm, Nicorette, Nicotrol
• Other antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), prochlorperazine (Compro), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Parkinson’s disease medicines such as apomorphine (Apokyn), bromocriptine (Cycloset, Parlodel), entacapone (Comtan), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), and ropinirole (Requip)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Peginterferon alfa-2b (Sylatron) or peginterferon alfa-2a (Pegasys)
• Pramlintide (Symlin)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Radiation therapy
• Sleeping pills such as triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)
• Tetrabenazine (Xenazine)
• Tocilizumab (Actemra)

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?

Store this medicine at room temperature. Do not refrigerate or freeze it. For the orally-disintegrating tablets, do not open the blister pack until you are ready to take your dose. Protect 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.