Haldol Decanoate (injection)

Haldol Decanoate is a medicine that helps treat schizophrenia.

Haldol Decanoate is also used to manage motor and speech tics in individuals with Tourette's syndrome.

Haldol Decanoate may be used for people who cannot take the medicine by mouth.

Haldol Decanoate might also be used for reasons not mentioned in this medication guide.

Haldol Decanoate is not approved for use in older adults with dementia-related psychosis.

You should not receive Haldol Decanoate if you are allergic to Haldol Decanoate, or if you have:

• Parkinson's disease;
• dementia with Lewy bodies;
• a peanut allergy (this medicine contains sesame oil); or
• certain conditions that affect your central nervous system (such as severe drowsiness or slowed thinking caused by taking other medicines or drinking alcohol).

Haldol Decanoate may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems, angina (chest pain);
• long QT syndrome (in you or a family member);
• low blood pressure;
• a seizure;
• low white blood cell (WBC) counts;
• a thyroid disorder; or
• an electrolyte imbalance (such as low blood levels of potassium or magnesium).

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. If you get pregnant, tell your doctor right away. Do not stop the medicine without your doctor's advice.

You should not breastfeed while using Haldol Decanoate.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of haloperidol can lead to a serious movement disorder that may not be reversible. The longer you use Haldol Decanoate, the more likely you are to develop this disorder, especially if you are a diabetic or an older adult.

Haldol Decanoate may cause serious side effects. Call your doctor immediately if you experience:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• rapid changes in mood or behavior;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (feeling like you might pass out);
• cough with mucus, chest pain, feeling short of breath;
• lack of energy, decreased thirst;
• muscle spasms in your neck, tightness in your throat, trouble swallowing;
• low white blood cell counts—fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• severe nervous system reaction—very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Serious side effects may be more likely in older adults.

Common side effects of Haldol Decanoate may include:

• drowsiness;
• neck stiffness;
• tremors; or
• involuntary muscle movements.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may be given oral Haldol Decanoate to take by mouth for a short time before you are treated with this medicine.

Haldol Decanoate is injected into a muscle by a healthcare provider, usually once every 3 to 4 weeks as needed.

If you use this medicine long-term, you may need frequent medical tests.

Do not stop using Haldol Decanoate suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Call your doctor for instructions if you miss an appointment for your Haldol Decanoate.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you have overdose symptoms (extreme drowsiness, severe tremors or muscle stiffness, weak or shallow breathing, fainting). An overdose of haloperidol can be fatal.

Avoid driving or hazardous activity until you know how Haldol Decanoate will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise and in hot weather. You may be more prone to heat stroke while you are using Haldol Decanoate.

Sometimes it is not safe to take certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Haldol Decanoate can cause a serious heart problem. Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using Haldol Decanoate with other drugs that make you sleepy can make this effect worse. Ask your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• lithium;
• rifampin;
• medicine to treat Parkinson's disease;
• seizure medicine; or
• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect Haldol Decanoate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.