Clozapine oral suspension

What is this medicine?

CLOZAPINE (KLOE za peen) is used to treat schizophrenia. This medicine is only used when others have not worked. It has a risk of serious side effects and is only available through a monitoring and dispensing system that includes special doctors, pharmacists, and laboratories. For the first few months of treatment, you will be required to have routine blood testing before your prescription can be refilled.

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Also follow the Instructions for Use sheet which provides detailed steps for preparing and taking your dose, and disposing of empty bottles. This medicine may be taken with or without food. Shake the bottle well for 10 seconds before each use. Use the oral syringe that comes with your medicine to measure each dose. Household spoons are not accurate. Take your medicine as soon as you draw it into the syringe. Do not store the medicine in the syringe for later use. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• constipation

• fast, irregular heartbeat

• fever or chills, sore throat

• inability to keep still

• males: prolonged or painful erection

• problems with balance, talking, walking

• rash, fever, and swollen lymph nodes

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• shortness of breath, chest pain, swelling in a leg

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• signs and symptoms of neuroleptic malignant syndrome like confusion; fast or irregular heartbeat; high fever; increased sweating; stiff muscles

• stomach pain or swelling

• sudden numbness or weakness of the face, arm, or leg

• trouble passing urine

• trouble swallowing

• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• drooling

• drowsiness

• dry mouth

• headache

• weight gain

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cisapride

• dronedarone

• mesoridazine

• metoclopramide

• pimozide

• quinidine

• thioridazine

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• atropine

• birth control pills

• caffeine

• certain antibiotics like ciprofloxacin, erythromycin, mefloquine, moxifloxacin, pentamidine, rifabutin, rifampin

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for blood pressure

• certain medicines for cancer

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for irregular heart beat like amiodarone, encainide, flecainide, propafenone, sotalol

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for seizures

• certain medicines for sleep

• certain medicines for stomach problems like cimetidine, dicyclomine, dolasetron, hyoscyamine

• certain medicines for travel sickness like scopolamine

• dofetilide

• ipratropium

• lithium

• medicines that lower your chance of fighting infection

• methadone

• nicotine

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• skeletal muscle relaxants

• St. John's Wort

• tacrolimus

• terbinafine

• ziprasidone

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you miss a dose for more than 2 days, check with your healthcare provider before starting to take it again to make sure you take the correct dose.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20-25 degrees C (68-77 degrees F). Do not refrigerate or freeze. Protect from light. The opened bottle expires 100 days after the initial opening. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• being treated for cancer

• blood disease or disorder, like leukemia

• cigarette smoker

• constipation, fecal impaction, or a history of an obstruction of the intestine

• dementia

• diabetes

• heart disease

• history of irregular heartbeat

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• low levels of potassium or magnesium in the blood

• lung or breathing disease, like asthma

• Parkinson's disease

• seizures

• an unusual or allergic reaction to clozapine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care provider for regular checks on your progress. It may be several weeks before you see the full effects of this medicine. Contact your doctor or health care provider if your symptoms get worse or if you have new symptoms.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

You must have a weekly blood test when you first begin this medicine. If your blood counts stay in the right range for the first 6 months, the frequency of your test may then be reduced. Your name will go on a national registry of patients who take this medicine, to make sure that you have never had a serious reaction to it.

This medicine can cause constipation. Talk to your health care provider if you have bowel movements less often than usual or if you have less than 3 bowel movements per week. Call if stool is hard or dry, or if you have trouble passing gas. Contact your provider right away if you have nausea, vomiting, or stomach swelling or pain. Drink plenty of water.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Do not treat yourself for colds, fever, diarrhea, or allergies. Ask your doctor or health care provider for advice since some nonprescription medicines may increase possible side effects.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

If you smoke, tell your doctor if you notice this medicine is not working well for you. Talk to your doctor if you are a smoker or if you decide to stop smoking.

If you are going to have surgery tell your doctor or health care provider that you are taking this medicine.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.