Haloperidol Injection

IMPORTANT WARNING:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as haloperidol have an increased chance of death during treatment.

Haloperidol injection and haloperidol extended-release injection are not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is being treated with haloperidol injection or haloperidol extended-release injection. For more information visit the FDA website: http://www.fda.gov/Drugs

Talk to your doctor about the risk(s) of receiving haloperidol injection or haloperidol extended-release injection.

WHY is this medicine prescribed?

Haloperidol injection and haloperidol extended-release injection are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Haloperidol injection is also used to control motor tics (uncontrollable need to repeat certain body movements) and verbal tics (uncontrollable need to repeat sounds or words) in people who have Tourette's disorder (condition characterized by motor or verbal tics). Haloperidol is in a class of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Haloperidol injection comes as a solution to be injected into a muscle by a healthcare provider. Haloperidol injection is usually given as needed for agitation, motor tics, or verbal tics. If you still have symptoms after you receive your first dose, you may be given one or more additional doses. Haloperidol extended-release injection comes as a solution to be injected into a muscle by a healthcare provider. Haloperidol extended-release injection is usually given once every 4 weeks.

Haloperidol injection and haloperidol extended-release injection may help control your symptoms but will not cure your condition. Continue to keep appointments to receive haloperidol even if you feel well. Talk to your doctor if you do not feel like you are getting better during your treatment with haloperidol injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving haloperidol injection or haloperidol extended-release injection,

• tell your doctor and pharmacist if you are allergic to haloperidol, any other medications, or any of the ingredients in haloperidol injection or haloperidol extended-release injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); amiodarone (Cordarone, Nexterone, Pacerone); anticoagulants (blood thinners); antifungals medications such as itraconazole (Onmel, Sporanox) and ketoconazole (Nizoral); antihistamines (in cough and cold medications); medications for anxiety, depression, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; buspirone; carbamazepine (Carbatrol, Tegretol, Teril, others); chlorpromazine; disopyramide (Norpace); diuretics ('water pills'); epinephrine (Adrenalin, Epipen, Twinject, others); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem, Selfemra); fluvoxamine (Luvox); lithium (Lithobid); moxifloxacin (Avelox); narcotic medications for pain; nefazodone; paroxetine (Brisdelle, Paxil, Pexeva); promethazine (Promethegan); quinidine (in Nuedexta); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sertraline (Zoloft); sleeping pills; tranquilizers; and venlafaxine (Effexor XR). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with haloperidol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Your doctor will probably tell you not to receive haloperidol injection.

• tell your doctor if you have a low number of white blood cells. Also tell your doctor if you have or have ever had QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death); bipolar disorder (condition that causes episodes of depression, episodes of mania, and other abnormal moods); trouble keeping your balance; an abnormal electroencephalogram (EEG; a test that records electrical activity in the brain); seizures; an irregular heartbeat; low levels of potassium or magnesium in your blood; or heart or thyroid disease.

• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while receiving haloperidol, call your doctor. Haloperidol may cause problems in newborns following delivery if it is given during the last months of pregnancy.

• you should know that receiving haloperidol injection or haloperidol extended-release injection may make you drowsy and may affect your ability to think clearly, make decisions, and react quickly. Do not drive a car or operate machinery after you receive haloperidol injection or haloperidol extended-release injection until you know how this medication affects you.

• you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol during your treatment with haloperidol.

• you should know that haloperidol injection may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you forget to keep an appointment to receive haloperidol extended-release injection, call your doctor to schedule another appointment as soon as possible.

What SIDE EFFECTS can this medicine cause?

Haloperidol injection or haloperidol extended-release injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• mood changes
• difficulty falling asleep or staying asleep
• restlessness
• anxiety
• agitation
• dizziness, feeling unsteady, or having trouble keeping your balance
• headache
• dry mouth
• increased saliva
• blurred vision
• loss of appetite
• constipation
• diarrhea
• heartburn
• nausea
• vomiting
• breast enlargement or pain
• breast milk production
• missed menstrual periods
• decreased sexual ability in men
• increased sexual desire
• difficulty urinating

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fever
• muscle stiffness
• falling
• confusion
• fast or irregular heartbeat
• sweating
• decreased thirst
• involuntary movements of tongue, face, mouth or jaw
• uncontrollable eye movements
• unusual, slowed, or uncontrollable movements of any part of the body
• tightness in the throat
• fine, worm-like tongue movements
• neck cramps
• difficulty breathing or swallowing
• tongue that sticks out of the mouth
• uncontrollable, rhythmic face, mouth, or jaw movements
• difficulty walking
• difficulty talking
• seizures
• seeing things or hearing voices that do not exist
• yellowing of the skin or eyes
• erection that lasts for hours

Haloperidol injection or haloperidol extended-release injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• unusual, slowed, or uncontrollable movements of any part of the body
• uncontrollable shaking of a part of the body
• stiff or weak muscles
• sedation

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to haloperidol injection or haloperidol extended-release injection.

Ask your pharmacist any questions you have about haloperidol injection or haloperidol extended-release injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.