Prochlorazine: Uses, Side Effects and Dosage

Serious warnings and precautions box

What PROCHLORAZINE is used for:

PROCHLORAZINE is used in adults and children (over 2 years of age and weighing over 9 kg) to:

• manage the symptoms of psychotic disorders such as:

  • agitation
  • confusion
  • delusion
  • tension and
  • anxiety
• control nausea and vomiting that is triggered by certain drugs or substances

How PROCHLORAZINE works:

PROCHLORAZINE is an antipsychotic medication which affects chemicals in the brain that allow communications between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin.

Exactly how PROCHLORAZINE works is unknown. However, it seems to readjust the balance of dopamine and serotonin.

The ingredients in PROCHLORAZINE are:

Medicinal ingredient: Prochlorperazine maleate

Risk of death in elderly patients with dementia:

• PROCHLORAZINE belongs to a group of medicines called antipsychotics. These medicines have been linked to a higher rate of death when used in elderly patients with dementia (loss of memory and other mental abilities).
• PROCHLORAZINE is not to be used if you are elderly and have dementia.

Neuroleptic Malignant Syndrome (NMS): NMS is a rare but potentially life-threatening condition that has been reported with the use of antipsychotic medications like PROCHLORAZINE. Symptoms include:

• severe muscle stiffness or inflexibility with high fever,
• rapid or irregular heartbeat,
• sweating,
• state of confusion or reduced consciousness.

Non-medicinal ingredients: Carnauba wax, croscarmellose sodium, dextrates and magnesium stearate; the film coating contains D&C yellow #10 aluminum lake 14-18%, hydroxypropyl methylcellulose, polyethylene glycol, sunset yellow aluminum lake 40%, and titanium dioxide.

PROCHLORAZINE comes in the following dosage form:

Tablets 5 mg and 10 mg

Do not use PROCHLORAZINE if:

• You are allergic to phenothiazine, phenothiazine derivatives or to any of the other ingredients in PROCHLORAZINE
• You have a medical condition known as pheochromocytoma (a tumor of the adrenal gland)
• You have a severe heart or blood vessel problem
• You have kidney problems
• You have or had brain damage
• You have liver disease
• You have a blood cell disorder such as anemia, low white blood cell counts, or low platelets
• You have drowsiness, slow breathing, weak pulse

• You have decreased alertness or are in a deep state of prolonged unconsciousness (coma) caused by taking certain medications or drinking alcohol

• You are under 18 years of age and are going to have surgery
• You are taking hypnotics (medicines used to help with sleep)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PROCHLORAZINE. Talk about any health conditions or problems you may have, including if you:

• have heart or blood vessel problems.
• suffer from an increased pressure within the eye(s) (glaucoma).
• have a condition that affects blood flow to your brain.
• have prostate problems (enlarged prostate gland in men).
• are addicted to alcohol. You should not take PROCHLORAZINE if you are under the effects of alcohol.
• are pregnant, think you might be pregnant or are planning to become pregnant. PROCHLORAZINE should not be used during pregnancy unless your healthcare professional considers the benefits to you markedly outweighs the potential risks to the fetus.
• have or have a family history of seizures (including those caused by fever). PROCHLORAZINE may make you more prone to seizures.
• are breastfeeding or planning to breast-feed. It is not known if PROCHLORAZINE can pass into your breast milk.
• are aged 55 years or above
• have liver problems.
• have or have ever had a low number of white blood cells (agranulocytosis).
• are dehydrated, or are exposed or will be exposed to extreme heat. PROCHLORAZINE may interfere with your body’s ability to adjust to heat. Avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking PROCHLORAZINE.

Other warnings you should know about:

Driving and using machines: PROCHLORAZINE may affect your mental and physical abilities. This may be more likely to occur when you start your treatment and when your dose is increased. Before you drive or do tasks that require special attention, wait until you know how you respond to PROCHLORAZINE. You should be cautious when driving a car or operating machinery.

Pregnancy: You should not take PROCHLORAZINE while you are pregnant or if you are planning on becoming pregnant unless you have talked to your healthcare professional about it. If you took PROCHLORAZINE at any time while you were pregnant or if you took it before you became pregnant, the following symptoms may happen in your newborn baby:

• shaking,
• stiffness in their muscles and/or weakness,
• sleepiness,
• agitation,
• breathing problems, or
• difficulty feeding.

Get medical help right away if your newborn has any of these symptoms.

Taking PROCHLORAZINE may also affect your pregnancy tests by producing false-positive pregnancy results.

Testing and check-ups: Your healthcare professional will monitor your health throughout your treatment. They may do this by performing certain tests before and periodically during your treatment. This will tell your healthcare professional how PROCHLORAZINE is affecting you. These tests may monitor:

• your blood glucose level;
• your body weight;
• the profile of your blood (e.g., red blood cell, white blood cell, and platelet counts);
• your liver and kidney function; and
• your eyes.

Hyperprolactinemia (increased levels of prolactin): PROCHLORAZINE can raise your levels of a hormone called “prolactin”. This is measured with a blood test. Symptoms may include:

• In men:

  • swelling in the breast,
  • difficulty in getting or maintaining an erection or other sexual dysfunction.

• In women:

  • discomfort in the breasts,
  • leaking of milk from the breasts (even if not pregnant),
  • missing your menstrual period or other problems with your cycle.

If you have high levels of prolactin and a condition called hypogonadism, you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with PROCHLORAZINE:

• alcohol. PROCHLORAZINE can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on PROCHLORAZINE therapy.
• general anesthetics, medicines used during surgery.
• barbiturates, medicines used to relax the body and help with sleeping.
• opiates, medicines used to relieve pain (e.g., codeine, hydromorphone and tramadol).
• muscle relaxants, medicines used to treat muscle spasms and back pain (e.g., suxamethonium, pancuronium and dantrolene).

How to take PROCHLORAZINE:

• Take PROCHLORAZINE exactly as your healthcare professional has told you.
• During the first few days of your treatment, your healthcare professional may gradually increase your dose. This is to allow your body to adjust and minimize side effects.
• Do not take PROCHLORAZINE more often or increase your dose without consulting your healthcare professional. Taking more than you should will not improve your condition any faster. Instead, you will increase your risk of serious side effects.
• Do not stop taking this medicine suddenly without your healthcare professional’s approval.

Usual dose:

Your healthcare professional will decide on the best dose for you depending on the severity of your symptoms; and how you respond to your treatment. Your healthcare professional may change your dose based on how you respond to PROCHLORAZINE.

Adults:

• For symptoms of psychotic disorders: The usual dose is 10 mg three or four times a day.
• For nausea and vomiting: 5 mg to 10 mg three or four times a day.

Children (over 2 years of age and weighing over 9 kg):

• The usual dose is based on how much they weigh and given in divided doses.

Overdose:

Symptoms of an overdose with PROCHLORAZINE may include:

• muscle spasms
• restlessness
• drowsiness
• coma
• agitation
• restlessness
• convulsions
• fever
• low blood pressure
• dry mouth
• problems with your intestine

If you think you, or a person you are caring for, have taken too much PROCHLORAZINE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your next dose at your regularly scheduled time. Do NOT double your dose to make up for the missed dose.

Possible side effects from using PROCHLORAZINE:

These are not all the possible side effects you may have when taking PROCHLORAZINE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with PROCHLORAZINE may include:

• sweating,
• urinary incontinence,
• increased urination,
• dizziness,
• drowsiness,
• dry mouth,
• increased salivation,
• changes in appetite,
• swelling in the extremities,
• skin pigmentation,
• nasal congestion,
• nausea and vomiting,
• headache,
• menstrual changes,
• change in libido,
• trouble getting or keeping an erection,
• swelling of the breasts and milk production in both men and women,
• weight changes,
• lack of energy,
• trouble falling asleep and/or staying asleep,
• abnormal dreams, and
• blurred vision.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature 15°C to 30°C.

Protect from light.

Do not use after the expiry date shown on the bottle.

Keep out of reach and sight of children.

If you want more information about PROCHLORAZINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.aapharma.ca/en/); or by calling 1-877-998-9097.

Date of Authorization: 2025-12-15