Consumer Information for: HALOPERIDOL INJECTION, USP

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

This medication is used for the management of manifestations of chronic schizophrenia.

What it does

Haloperidol Injection, USP is an antipsychotic medication which affects chemicals in the brain that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how Haloperidol Injection, USP works is unknown. However, it seems to readjust the balance of dopamine and serotonin.

When it should not be used

You should not use Haloperidol Injection, USP if you have:

  • An allergy to haloperidol, to any of its ingredients or to phenothiazines
  • A medical condition known as
  • pheochromocytoma (a tumor of the adrenal gland)
  • A severe heart or blood vessel disorder
  • Severe kidney problems
  • Had brain damage
  • Liver disease
  • A blood cell disorder such as anemia, low white blood cell counts, or low platelets
  • Drowsiness, slow breathing, weak pulse
  • Decreased alertness caused by taking certain medications or drinking alcohol
  • You are going to receive anesthesia in the spine
  • or for a region (such as an arm, leg or the lower part of your body)
  • Severe depression
  • Any type of spastic disease
  • Parkinson’s syndrome
What the medicinal ingredient is

Haloperidol

What the non-medicinal ingredients are

Haloperidol Injection, USP contains the following non- medicinal ingredients: methylparaben (as preservative), propylparaben (as preservative), lactic acid to adjust the pH and water for injection USP.

What dosage form it comes in

Haloperidol Injection, USP 5 mg/mL (intramuscular) is available in 1 mL multiple-dose vials packaged in boxes of 25 x 1 mL and 10 mL multiple-dose vials packaged in boxes of 1 x 10 mL.

Warnings and precautions

Serious Warnings and Precautions

Studies with various medicines of the group to which Haloperidol Injection, USP belongs, when used in the elderly patients with dementia, have been associated with an increased rate of death. Haloperidol Injection, USP is not indicated in elderly patients with dementia.

BEFORE you use Haloperidol Injection, USP talk to your doctor or pharmacist if you:

  • have heart disease, glaucoma or prostatic
  • hypertrophy
  • have problems with your thyroid
  • are addicted to alcohol. You should not take Haloperidol Injection, USP I if you are under the effects of alcohol.
  • are pregnant. Haloperidol Injection, USP should
  • not be used during pregnancy unless your doctor considers the benefits to you markedly outweigh the potential risks to the fetus
  • are taking barbiturates, painkillers, narcotics or,
  • antihistamines or other drugs that make you drowsy.
  • are taking blood thinners (anticoagulants)
  • have an electrolyte imbalance
  • have a condition called Familial Long QT Syndrome
  • have any allergies to this drug or its ingredients
  • have or ever had a blackout or seizure
  • are breast feeding.
  • You have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives ("The Pill").

Haloperidol Injection, USP may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, especially during the first few days of therapy. You should be cautious when performing potentially hazardous tasks.

Effects on Newborns:
In some cases, babies born to a mother who used Haloperidol Injection, USP during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking or are having difficulty feeding.

People who use Haloperidol Injection, USP are cautioned:

  • Against exposure to extreme heat
  • That drugs such as Haloperidol Injection, USP increase the toxicity of certain types of insecticides ("organophosphorous" insecticides) including insecticides for agriculture (farming), treating animals (flea and tick control) and for treating pests around the house and garden. Be cautious if you must use these products while using Haloperidol Injection, USP.
Interactions with this medication

Haloperidol Injection, USP can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on Haloperidol Injection, USP therapy.

Tell your doctor about all your prescription and over-the- counter medications, vitamins, minerals, herbal products (such as St. John’s Wort), and drugs prescribed by other doctors. Do not start a new This medication should be administered by deep intramuscular injection, preferably in the gluteus maximus, as prescribed. During the first few days your doctor may gradually increase your dose to allow your body to adjust to the medication. Do not increase the dosage or injection frequency without consulting your doctor. Your condition will not improve any faster but the risk of serious side effects will be increased. Do not stop using this drug suddenly without your doctor's approval.

Before using Haloperidol Injection, USP, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxants, and medicine for seizures, depression, or anxiety). You should not use Haloperidol Injection, USP if you have drowsiness caused by other medications.

Drugs that may interact with Haloperidol Injection, USP include:
anti-anxiety agents, antidepressants, antiparkinsonian agents, anticoagulants, muscle relaxants, anti-seizure medicine, high blood pressure medicine, cabergoline, metrizamide, guanethidine, guanadrel, grepafloxacin, sparfloxacin, lithium, cisapride, rifampin, atropine-like drugs, narcotic pain relievers (e.g., codeine), drugs used to aid sleep, drowsiness-causing antihistamines (e.g., diphenhydramine), other drugs that may make you drowsy.

Many cough-and-cold products contain ingredients that may add a drowsiness effect. Before using cough-and-cold medications, ask your doctor or pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

This list is not complete and there may be other drugs that can interact with Haloperidol Injection, USP.

Your doctor will decide which dose is best for you.

Proper use of this medication

Usual Dose

The dose depends on your symptoms, and will be adjusted by your doctor to best treat those symptoms. The medication is delivered by injection in a large muscle, usually the buttocks.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Overdose symptoms may include agitation, and confusion, drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, weakness, loss of balance or coordination, and fainting.

Missed Dose

Get the injection of the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to get the injection of the medicine and skip the missed dose. Do not double your dose to make up the missed dose.

Side effects and what to do about them

Like other medications, Haloperidol Injection, USP may cause some side effects. These side effects may be minor and temporary. However, some may be serious and need medical attention.

Side effects may include: sweating, urinary incontinence, dizziness, drowsiness, dry mouth, nasal congestion, nausea and vomiting, headache, menstrual changes, change in libido, swelling of the breasts and milk production in both men and women, weight changes and blurred vision, confusion, insomnia, restlessness, anxiety, agitation, depression, worsening of psychotic symptoms, skin changes, diarrhea, increased salivation, heartburn and decreased appetite.

If any of these affects you severely, tell your doctor.

Your doctor should check your body weight before starting Haloperidol Injection, USP and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting Haloperidol Injection, USP They will monitor blood sugar, and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and seek immediate emergency medical attention
Unknown
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Neuroleptic Malignant Syndrome: any group of symptoms which may include high fever, sweating, stiff muscles, fast heartbeat, fast breathing and feeling confused, drowsy or agitated     ✔
Extrapyramidal Symptoms: muscle stiffness, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want.     ✔
Fast or irregular heartbeat     ✔
Seizures or fits     ✔
Long-lasting (greater than 4 hours in duration) and painful erection of penis     ✔
Tardive Dyskinesia: uncontrollable movements or twitches of the body, face, eyes or tongue, stretching the neck and body   ✔  
Low Blood Pressure: feeling of Lightheadedness or fainting especially when getting up from a lying or sitting position   ✔  
High Blood Pressure: headaches, vision disorders, nausea and vomiting   ✔  
Decreased sweating   ✔  
Jaundice: yellow colour to skin and eyes, dark urine   ✔  
Respiratory Infection: fever, flu-like symptoms, coughing, difficult or fast breathing   ✔  
New or worsening constipation   ✔  
Akathisia: a feeling of restlessness, inability to remain motionless   ✔  
Vision Changes: blurred vision, glaucoma or other eye disorder   ✔  
Increased Blood Sugar: frequent urination, thirst and hunger ✔    
Uncommon
Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations.   ✔  

This is not a complete list of side effects. For any unexpected effects while using Haloperidol Injection, USP, contact your doctor or pharmacist.

How to store

Haloperidol Injection, USP should be protected from light and stored between 15 °C and 30 °C. Protect from freezing.
Multiple-dose vials. Discard unused portion 28 days after initial puncture.

As with other depot neuroleptics, precipitation may occur if the drug is stored for long periods in the cold. The precipitate should clear on storage at room temperature.

Keep this and all medications out of the reach and sight of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at: 1-877-821-7724.

This leaflet was prepared by:
Fresenius Kabi Canada Ltd.
45 Vogell Rd, Suite 200
Richmond Hill, ON L4B 3P6

Last Revised: September 12, 2016

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