Majeptil: Uses, Side Effects and Dosage

What dosage forms it comes in:

Tablet, 10 mg

WARNINGS AND PRECAUTIONS

What the medication is used for:

MAJEPTIL is a medication used to treat all types of acute and chronic schizophrenia, including those which did not respond to the usual antischizophrenic medication. It is also used to treat manic episodes.

What it does:

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

When it should not be used:

You should not use Majeptil if you have:

• An allergy to thioproperazine mesylate, 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)
• Parkinson’s Disease
• If you are under three years old

What the medicinal ingredient is:

Thioproperazine mesylate

What the nonmedicinal ingredients are:

Acetic anhydride, calcium phosphate, carnauba wax, cellulose, colloidal silicon dioxide, diethyl phthalate, FD&C Yellow No 6 aluminum lake, magnesium stearate, polacrilin potassium, sodium oleate, titanium oxide and zein.

BEFORE you use Majeptil talk to your doctor or pharmacist if:

• You have heart, liver or kidney disease, glaucoma or prostatic hypertrophy

• You are addicted to alcohol. You should not take

  Majeptil if you are under the effects of alcohol.

• 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”).

• You are pregnant. Majeptil should not be used during pregnancy unless your doctor considers the benefits to you markedly outweigh the potential risks to the fetus

• You are taking barbiturates, painkillers, narcotics, antihistamines or other drugs that make you drowsy.
• You have any allergies to this drug or its ingredients
• You have or ever had a blackout or seizure
• You are breast feeding.

Majeptil 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 taking Majeptil 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 take Majeptil are cautioned:

• Against exposure to extreme heat
• That drugs such as Majeptil 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 taking Majeptil.

ABOUT THIS MEDICATION

Serious Warnings and Precautions

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

INTERACTIONS WITH THIS MEDICATION

Majeptil can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on Majeptil 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 medication without telling your doctor.

Before using Majeptil, 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 take Majeptil if you have drowsiness caused by other medications.

Drugs that may interact with Majeptil include: anti-anxiety agents, antidepressants, muscle relaxants, anti- seizure medicine, high blood pressure medicine, cabergoline, metrizamide, guanethidine, guanadrel, grepafloxacin, sparfloxacin, lithium, cisapride, 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, general anesthetics.

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 Majeptil.

PROPER USE OF THIS MEDICATION

Take this medication by mouth exactly 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 take this more often or increase your dose without consulting your doctor. 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 doctor's approval.

Your doctor will decide which dose is best for you.

Usual dose:

Adults:

Usual Initial dose: 5 mg a day in a single dose or divided doses.

Usual Optimal Dose: 30 to 40 mg per day.

This usual optimal dose can be increased by your physician.

Maintenance Dose: Your doctor will decrease your dose to the lowest effective level. Always follow the doctor’s instructions.

Children (Over 10 years Old):

Usual Initial dose: 1 to 3 mg a day in a single dose or divided doses.

The physician will determine the best dosage for your child. Always follow the doctor’s instructions.

Overdose:

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:

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

Like other medications, Majeptil 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: anxiety, lack of feeling or emotion, depression, difficulty sleeping, cramps, diarrhea or constipation, sweating, reduced amount of urine, urinary incontinence, dizziness, drowsiness, dry mouth or drooling, 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, teary eyes and blurred vision.

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

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

Your doctor should take blood tests before starting Majeptil. 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.

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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.

This is not a complete list of side effects. For any unexpected effects while taking Majeptil, contact your doctor or pharmacist.

Store this medication at room temperature between 15 and 30 °C away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach and sight of children.

MORE INFORMATION

HOW TO STORE IT

REPORTING SUSPECTED 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 3 ways:

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• 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, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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.

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.searchlightpharma.com or by contacting the sponsor, Searchlight Pharma Inc., at: 1-647-945-9762

Last revised: OCT 25, 2022