Methoprazine: Uses, Side Effects and Dosage

What is METHOPRAZINE used for?

METHOPRAZINE is used to treat:

• mental illnesses such as schizophrenia, disorders in the elderly, manic-depressive syndromes,
• pain due to cancer, shingles, trigeminal neuralgia, neurocostal neuralgia, phantom limb pains and muscular discomforts,
• nausea and vomiting,
• insomnia.

How does METHOPRAZINE work?

METHOPRAZINE 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 METHOPRAZINE works is unknown, but it seems to readjust the balance of dopamine and serotonin in your body.

Serious Warnings and Precautions

Elderly Patients with Dementia: Medicines like METHOPRAZINE can raise the risk of death in elderly people who have dementia. METHOPRAZINE is not for use in patients with dementia.

Neuroleptic Malignant Syndrome (NMS): Rare, sometimes fatal cases of NMS (a type of disorder that affects the brain) have been reported in patients taking METHOPRAZINE. Symptoms may include muscle stiffness with a high fever, rapid or irregular heartbeat, sweating and confusion. If you think you are experiencing NMS, seek immediate medical help.

What are the ingredients in METHOPRAZINE?

Medicinal ingredients: Methotrimeprazine Maleate

Non-medicinal ingredients: Carnauba wax, colloidal silicon dioxide, corn starch, d & c yellow #10 aluminum lake 14-18%, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sunset yellow aluminum lake 40% and titanium dioxide.

METHOPRAZINE comes in the following dosage forms:

Tablets: 2 mg, 5 mg, 25 mg and 50 mg

Do not use METHOPRAZINE if:

• you/your child are allergic to methotrimeprazine, phenothiazines (a type of antipsychotic) or to any of the other ingredients in METHOPRAZINE

• you/your child are in an altered state of consciousness or coma, due to alcohol, drugs that make you sleepy (hypnotic drugs), or pain medications

• you/your child are taking other drugs used to treat psychotic disorders including dopaminergics.
• you/your child have a blood disorder
• you/your child have a condition called bone marrow depression
• you/your child have liver problems
• you/your child have brain damage
• you/your child have a medical condition known as pheochromocytoma (a tumor of the adrenal gland)
• you/your child have a severe heart or blood vessel disorder
• you/your child have severely low blood pressure
• you/your child have a medical condition called myasthenia gravis (muscle weakness and fatigue)
• you/your child are going to receive anesthesia in the spine or for a large area of the body (such as an arm, leg or the lower part of your body)
• you/your child have urethra or prostate problems that may impact your/their ability to completely empty your/their bladder (urinary retention)
• you/your child are at risk for having glaucoma (increased pressure in the eye)

METHOPRAZINE is not for use in children less than 1 year of age.

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

• have heart or blood vessel disease.
• have a history of having strokes.
• suffer from an increase pressure within the eyes (glaucoma).
• suffer from an enlarged prostate (Benign Prostatic Hyperplasia) or prostatic hypertrophy.
• are addicted to alcohol. You should not take METHOPRAZINE if you are under the effects of alcohol.

• are pregnant, think you are pregnant or are of child-bearing potential and are not using effective birth control.

• have or have had seizure disorders (epilepsy).
• have kidney problems.
• have Parkinson’s disease.
• have hypothyroidism (underactive thyroid gland).
• have heart failure (heart does not pump blood as well as it should).
• have heart problems or problems with your heart beat.
• have low levels of potassium in the blood.
• are taking any medications that affect how your heart beats.
• plan to have surgery.
• are breast feeding or are planning to breast feed.

• are at risk for developing blood clots or having a stroke; risk factors include:

  • a family history of blood clots or strokes
  • being over the age of 65,
  • smoking,
  • diabetes,
  • high cholesterol,
  • obesity,
  • recent major surgery (such as hip or knee replacement),
  • not being able to move due to air travel or other reason,
  • taking oral birth control (such as "The Pill").

Other warnings you should know about:

Do NOT stop taking METHOPRAZINE without talking to your healthcare professional first, as it may cause unwanted side effects such as headache, insomnia, numbness, tingling, burning, or prickling, nervousness, anxiety, nausea, sweating, dizziness, jitteriness and weakness.

Driving and using machines: Until you know how METHOPRAZINE affects you, do not drive or use machinery, especially when you first start treatment. Taking METHOPRAZINE can cause side effects such as:

• drowsiness,
• confusion,
• dizziness, and
• blurred vision.

Constipation: If you experience severe constipation and you are elderly, please consult your healthcare professional as soon as possible.

Monitoring and laboratory tests: Your healthcare professional should do tests before starting treatment with METHOPRAZINE and while you are taking it. These tests will monitor:

• blood sugar,
• body weight,
• blood count,
• liver and kidney,
• blood pressure, and
• if you/your child develop a sore throat, fever and weakness.

Increased levels of prolactin: METHOPRAZINE can raise the levels of a hormone called “prolactin”. 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. High levels of prolactin may also impair fertility in both men and women.

Effects on Newborns: In some cases babies born to a mother taking METHOPRAZINE 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
• have difficulty feeding.

Dehydration and Overheating: It is important to not become too hot or dehydrated while you are taking METHOPRAZINE.

• Do not exercise too much,
• In hot weather, stay inside in a cool place if possible,
• Stay out of the sun,
• Do not wear too much clothing or heavy clothing,
• Drink plenty of water.

Sensitivity to sunlight: METHOPRAZINE may increase sensitivity to sunlight. You/your child should wear sunscreen if you/they will be spending time outside.

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 METHOPRAZINE:

• alcohol. METHOPRAZINE can add to the effects of alcohol. Avoid consuming alcoholic beverages while taking METHOPRAZINE.
• medicines used to treat heart rhythm problems, such as atropine.
• medicines used to treat depression, such as monoamine oxidase inhibitors, amitriptyline.
• medicines that lower the seizure threshold.
• medicines used to treat gastrointestinal problems, such as magnesium, aluminum and calcium salts, oxides and hydroxides.
• medicines used to treat diabetes.
• medicines used to lower blood pressure, such as guanethidine, guanadrel, bepridil, diltiazem, verapamil, beta blockers, clonidine, guanfacine.
• lithium, used in the treatment of mood disorders.
• adrenaline, a medicine used to treat life threatening allergic reactions.
• amphetamine, medicine used to treat Attention Deficit Hyperactivity Disorder (ADHD).

METHOPRAZINE may cause a false reading of some types of pregnancy tests. For more information, talk to your healthcare professional.

How to take METHOPRAZINE:

• Take this medication by mouth.
• Take exactly as your healthcare professional tells you to.
• During the first few days your healthcare professional may gradually increase your dose to allow your body to adjust to the medication.
• Do not take METHOPRAZINE more often than prescribed or increase your dose without consulting your healthcare professional. If you do, your condition will not improve any faster but the risk of serious side effects will be increased.
• Do not stop taking this drug suddenly without your healthcare professional's approval.

Usual dose:

Your healthcare professional will decide your/your child’s dose of METHOPRAZINE and how often you/your child should take it. Take METHOPRAZINE exactly as your healthcare professional tells you to.

If you have any questions or concerns about your treatment, talk to your healthcare professional.

Overdose:

Overdose symptoms may include:

• agitation,
• confusion,
• drowsiness,
• dizziness,
• muscle stiffness or twitching,
• tremors (shaking),
• difficulty breathing,
• increased salivation,
• trouble swallowing,
• weakness,
• loss of balance or coordination,
• fainting,
• coma.

Missed Dose:

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up the missed dose.

What are possible side effects from using METHOPRAZINE?

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

Side effects may include:

• sweating
• leaking of urine due to loss of bladder control (urinary incontinence)
• inability to urinate
• dizziness
• drowsiness
• dry mouth
• nasal congestion
• nausea and vomiting
• headache
• sensitivity of the skin to the sun
• skin rash, hives
• menstrual changes
• change in libido
• impotence,
• swelling of the breasts and milk production in both men and women
• weight changes
• blurred vision
• anxiety or altered mood
• confusion
• insomnia (difficulty sleeping)
• changes in body temperature (feeling very hot and unable to cool down)
• severe constipation – if you become constipated while taking METHOPRAZINE tell your healthcare professional, you may need to take a laxative

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

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

Storage:

Store at room temperature 15˚C to 30˚C. Protect from light.

Keep out of reach and sight of children.

If you want more information about METHOPRAZINE:

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

Last Revised: MAY 17, 2024