Haldol

The active ingredient in Haldol is haloperidol. It works by blocking dopamine receptors in the brain. Dopamine is a neurotransmitter that plays a crucial role in regulating mood, behavior, and cognition. In conditions like schizophrenia, there is an excess of dopamine activity, leading to the characteristic symptoms. By blocking dopamine receptors, Haldol helps restore the balance of neurotransmitters in the brain, reducing the severity of symptoms and improving overall mental well-being.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Haldol. However, the following is a synopsis of the general guidelines for the use of Haldol:

• Haldol can be taken orally in the form of tablets or liquid, or it can be given by injection (haloperidol decanoate) in a healthcare setting.
• If taking Haldol orally, you can take it with or without food, but it should be taken consistently in the same way each time.
• If you are prescribed Haldol liquid, carefully measure each dose using a medication spoon or syringe provided by your pharmacist.
• If receiving Haldol injections, they will typically be administered by a healthcare professional in a hospital or clinic setting.
• Do not stop taking Haldol suddenly without consulting your doctor, as this can cause withdrawal symptoms or a return of your symptoms.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

The most common side effects of haloperidol seen in clinical trials as compared to placebo include:

• Stomach pain
• Headache
• Constipation
• Weight gain
• Restlessness
• Dry mouth
• Drowsiness
• Abnormal muscle movement
• Muscle spasms

Some individuals may experience serious side effects while using Haldol. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Neuroleptic malignant syndrome (NMS)
• Symptoms include fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat
• Elevated prolactin levels
• Pneumonia
• Abnormal or changes in heart rhythm (QT prolongation)
• Risk of hypotension and falls
• Symptoms of low white blood cell count
• Tardive dyskinesia
• Serious allergic reaction. Symptoms could include:
• Trouble breathing
• Hives
• Swelling in your face, lips, or tongue

There is a boxed warning that states an increased risk of mortality in elderly patients with dementia-related psychosis. Seek medical attention immediately if symptoms occur.

These are not all of the possible side effects of Haldol. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Haldol, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Parkinson’s disease
• Conditions that affect your central nervous system
• Including certain severe nervous system problems such as severe CNS depression
• Angina (chest pain) or heart problems
• Long QT syndrome
• A seizure
• Low blood pressure
• A thyroid disorder
• Breast cancer
• An electrolyte imbalance

Boxed Warning

Haldol carries a boxed warning. The warning includes the increased incidence of mortality in elderly patients (older adults) who have dementia-related psychosis.

These patients who are taking antipsychotic drugs are at an increased risk of death at a rate of 1.6 to 1.7 times the risk of death in placebo-treated patients.

In the trials that took place, the cause of death varied; however, most appeared to be cardiovascular (sudden death, heart failure) or infections (pneumonia). Similar to atypical antipsychotic drugs, treatment with conventional antipsychotic medications also increases the chance of mortality.

Severe central nervous system depression or comatose states of any cause.

Known hypersensitivity to the drug, including anaphylactic reactions and angioedema.

Parkinson’s disease, as it may lead to neurological adverse effects.

Dementia with Lewy bodies, due to the risk of neurological complications.

Haldol can begin to show effects within a few hours when used for acute symptoms, but full therapeutic benefits may take several days to weeks, depending on the condition being treated. Long-acting injectable forms may take longer to reach full effectiveness, as they are designed for gradual release. Regular follow-up with your healthcare provider is important to monitor progress and adjust the treatment plan if needed.

When Haldol is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Sedatives
• Epinephrine
• Opioid pain medications, including:
• Oxycodone/acetaminophen
• Morphine
• Hydrocodone
• Antihistamines
• Ketoconazole
• Methyldopa
• Lithium
• CYP2D6 inhibitors – chlorpromazine; quinidine; fluoxetine; paroxetine; venlafaxine
• Haloperidol plasma concentrations have been shown to increase with co-administration of these medications
• Carbamazepine
• Rifampin
• Erythromycin
• Amiodarone
• Sotalol
• Aripiprazole
• Antiparkison medication
• This might create extrapyramidal symptoms
• Example includes levodopa

In its tablet form, Haldol comes in the following dosage strengths:

• 0.5 mg
• 1 mg
• 2 mg
• 5 mg
• 10 mg
• 20 mg

In its liquid form, Haldol is available as:

• 2 mg per mL
• 5 mg per mL

As an injection (only in a healthcare setting), Haldol is available as:

Short-acting injection

-5 mg/mL

Long-acting depot injection

• 50 mg/mL
• 100 mg/mL

Store Haldol at room temperature, typically between 68°F to 77°F (20°C to 25°C). Protect from light and moisture. Do not store it in the bathroom or near a sink and keep it out of the reach of children.

Haldol is manufactured by Janssen Pharmaceuticals.

Currently, there is no lower-cost generic available for the brand name Haldol.

Some related medications include Thorazine (chlorpromazine), Prolixin (fluphenazine), and Risperdal (risperidone).

To stop taking Haldol, consult your healthcare provider, as discontinuing it abruptly can lead to withdrawal symptoms or a return of your original symptoms. Your doctor may recommend gradually tapering the dose to ensure a safe transition and minimize side effects. Always follow your provider’s instructions to manage the process effectively.

There is limited data on the safety of using Haldol during pregnancy. Animal studies have shown some adverse effects on fetal development, but there are no well-controlled studies in pregnant women. If a pregnant woman requires treatment with Haldol, the healthcare provider will carefully consider the potential risks to the fetus versus the benefits of treatment. There is a chance Haldol will affect your newborn baby after delivery. In some cases, the benefits of treating a severe mental health condition during pregnancy may outweigh the potential risks.

Currently, there is evidence that Haldol is excreted into breast milk during lactation, so there is a risk that it could affect a nursing infant. However, the extent of this risk is not well-established. Your healthcare provider may consider alternatives or adjust the dosage to minimize the potential exposure of the infant to Haldol.