Haldol

GENERIC NAME: HALOPERIDOL (HAL-oh-PER-i-dol)

COMMON USES: This medicine is an antipsychotic agent used to treat certain mental disorders (eg, schizophrenia). It is also used to control certain symptoms associated with Tourette's disorder. It also may be used to treat severe behavior problems in children and for the short-term treatment of hyperactive children. It may also be used to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. Take the remaining doses for the day at evenly spaced intervals. Do not take 2 doses at once.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE without checking with your doctor. Laboratory and/or medical tests may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are taking this medicine. This medicine may cause drowsiness, dizziness, or blurred vision. These effects could be worse if you take it with alcohol or certain medicines. DO NOT DRIVE, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. DO NOT DRINK ALCOHOL while you are taking this medicine. CHECK WITH YOUR DOCTOR before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. THIS MEDICINE MAY CAUSE increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period. DO NOT BECOME OVERHEATED in hot weather or during exercise or other activities since heatstroke may occur. NEUORLEPTIC MALIGNANT SYNDROME (NMS) is a possibly fatal syndrome that can be caused by this medicine. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms. SOME PATIENTS WHO TAKE THIS MEDICINE MAY DEVELOP MUSCLE MOVEMENTS that they cannot control. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking this medicine. THIS MEDICINE MAY LOWER THE ABILITY OF YOUR BODY TO FIGHT INFECTION. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. THIS MEDICINE MAY RARELY CAUSE A PROLONGED, PAINFUL ERECTION. If this is not treated right away, it could lead to permanent sexual problems such as impotence. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of this medicine. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Using this medicine during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; restlessness; stomach upset; or trouble sleeping. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY INCREASE THE AMOUNT OF A CERTAIN HORMONE (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blurred vision or other vision changes; chest pain; confusion; dark urine; decreased urination; dehydration; difficulty speaking or swallowing; drooling; excessive or unusual sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, abnormal thinking, agitation, anxiety, depression); missed menstrual period or other menstrual changes; prolonged, painful erection; rigid or stiff muscles; seizures; severe or persistent dizziness, headache, or vomiting; shuffling walk; uncontrolled muscle movements (eg, of the arms, legs, tongue, jaw, or cheeks; tremors; twitching); or yellowing of skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: WARNING: This medicine is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. This medicine is not approved to treat mental problems caused by dementia. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking astemizole, dofetilide, dronedarone, nilotinib, propafenone, sodium oxybate (GHB), terfenadine, or tetrabenazine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticholinergics (eg, benztropine), anticoagulants, (eg, warfarin), arsenic, azole antifungals (eg, itraconazole), bepridil, antiarrhythmics, (eg, amiodarone, disopyramide, flecainide, procainamide, quinidine, sotalol), antipsychotics (eg, iloperidone, paliperidone, ziprasidone), carbamazepine, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, ketolides (eg, telithromycin), kinase inhibitors (eg, lapatinib), lithium, macrolides (eg, erythromycin), maprotiline, methadone, narcotic pain medicines (eg, oxycodone), phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin, moxifloxacin), rifampin, or tramadol. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including the blood disease porphyria; low white blood cell levels; electrolyte problems (eg, low blood magnesium, low blood potassium); high or low blood pressure; heart problems or irregular heartbeat (eg, QT prolongation, long QT syndrome), or if a member of your family has a history of these conditions; high blood prolactin levels; allergies; pregnancy; or breast-feeding. Tell your doctor if you are dehydrated, drink alcohol, if you are regularly exposed to extreme heat, or if you are at risk for breast cancer. Tell your doctor if you have a history of dementia, Alzheimer disease, seizures, an abnormal electroencephalogram (EEG), thyroid problems, neuroleptic malignant syndrome (NMS), low white blood cell levels caused by a medicine, or certain types of cancer (eg, breast, pancreas, pituitary). USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe central nervous system depression (eg, severe drowsiness, slow or shallow breathing), severely low levels of certain white blood cells (neutrophils), Parkinson disease, or you are in a coma. Use of this medicine in CHILDREN under age 3 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions about taking this medicine.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include agitation, very dry mouth, unusual drowsiness or deep sleep, slow or shallow breathing, rapid or irregular pulse, and muscle weakness, rigidity, or tremor.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.