Patient Medication Information: uses, side effects, how to take - M-Tranylcypromine
What is M-TRANYLCYPROMINE used for?
M-TRANYLCYPROMINE is used for the treatment of major depressive disorder (MDD). It is only for use in adults who have not responded well to other antidepressants. M-TRANYLCYPROMINE is not for the initial treatment of MDD.
How does M-TRANYLCYPROMINE work?
M-TRANYLCYPROMINE belongs to the family of medicines called monoamine oxidase inhibitors (MAOIs). M-TRANYLCYPROMINE helps with the symptoms of depression.
What are the ingredients in M-TRANYLCYPROMINE?
Medicinal ingredient: tranylcypromine (as tranylcypromine sulfate)
Non-medicinal ingredients: Carmine, colloidal silicon dioxide, FD&C Red No. 40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide.
M-TRANYLCYPROMINE comes in the following dosage forms:
Tablet, 10 mg tranylcypromine (as tranylcypromine sulfate)
Do not use M-TRANYLCYPROMINE if you:
Serious Warnings and Precautions
- Suicidal Thoughts and Behaviors: In studies, antidepressants were shown to increase the risk of suicidal thoughts and behaviors in young adults and patients under 18 years of age. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your healthcare professional immediately. You will need to be closely monitored by a healthcare professional during treatment with M-TRANYLCYPROMINE.
Dangerous Increase in Blood Pressure: Certain foods and drinks must be avoided during treatment with M-TRANYLCYPROMINE and for 2 weeks after stopping treatment. If you do not avoid certain foods and drinks, you may have a dangerous increase in blood pressure that can lead to death. A complete list of those foods and drinks are included in the section called “Foods and Beverages to avoid while taking M-TRANYLCYPROMINE”.
- are allergic to the active ingredient, tranylcypromine or any of the components of its formulation or packaging
- have high blood pressure or heart disease
- have ever had a stroke, or any other kind of disorder related to the brain and its blood vessels
- have liver disease
- have a blood disorder
- have a history of severe or frequent headaches
- have a tumor of the adrenal gland (pheochromocytoma) or a type of tumor called a paraganglioma
- were recently or are taking any other medicine for depression or anxiety
were or are taking any of the following:
- carbamazepine, used to treat seizures
- cyclobenzaprine, used as a muscle relaxant
- sumatriptan, rizatriptan and other triptans, used to treat migraines and cluster headaches
- non-prescription medications to treat colds or hay fever, including drops or sprays
- natural health products that are for increased energy or weight loss
- street drugs including MDMA and ecstasy
- amphetamines, used to treat attention deficit disorder
- products containing ephedrine, used to treat nasal congestion
- methyldopa, used to treat high blood pressure
- dopamine, used in hospital to treat certain medical emergencies
- levodopa, used to treat Parkinson’s disease
- dextromethorphan, used as a cough suppressant
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-TRANYLCYPROMINE. Talk about any health conditions or problems you may have, including if you:
- have a history of kidney or heart problems
- have diabetes
- have epilepsy
- have an overactive thyroid gland
- have mania or bipolar disorder
- have or have ever had recurrent or frequent headaches
are pregnant, plan to become pregnant, or are breastfeeding
- are beyond the age of sixty
- drink alcohol and /or use street drugs
- recently had a surgery or are planning to have surgery
- are allergic to a red dye called FD&C Red No. 40 aluminum lake.
Other warnings you should know about:
In the first few weeks of taking M-TRANYLCYPROMINE or when your dose changes, you may feel worse instead of better. You may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your healthcare professional immediately.
M-TRANYLCYPROMINE may cause an acute attack of glaucoma. Having your eyes examined before you take this drug could help identify if you are at risk of having angle-closure glaucoma.
M-TRANYLCYPROMINE may affect your ability to drive or operate machinery. Wait until you know how you feel after taking M-TRANYLCYPROMINE before driving or using heavy machines.
M-TRANYLCYPROMINE may cause insomnia. To help you sleep better, take your afternoon dose no later than 3pm.
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 M-TRANYLCYPROMINE. Your healthcare professional will help you know if it is safe for you to take M-TRANYLCYPROMINE with the drugs listed below:
- opioids, morphine, meperidine, used for treatment of pain
- barbiturates, used as sedatives
- guanethidine, reserpine, alpha-methyldopa, used to treat high blood pressure
- insulin or other oral drugs to treat low blood sugar
- trifluoperazine, used to treat schizophrenia and anxiety
- chlorpromazine, used to treat schizophrenia and depression
- disulfiram, used to treat chronic alcoholism
- treatments for Parkinson’s disease
- St. John’s Wort, a natural health product used to treat depression
Foods and Beverages to avoid while taking M-TRANYLCYPROMINE:
A process of aging or breakdown is used to improve the flavor certain foods. It is important to avoid foods that contain high amounts of tyramine while you are taking M-TRANYLCYPROMINE. Tyramine can interact with M-TRANYLCYPROMINE to cause dangerously high blood pressure. It is very important that you buy and eat only fresh foods or those that have been properly frozen. Fresh foods can age naturally over time, so make sure to eat them when they are fresh.
The table below lists foods to avoid while taking M-TRANYLCYPROMINE and for 2 weeks after stopping it. There are also suggestions of acceptable foods and drinks to help guide you.
| Class of Food or Beverage | Tyramine-Rich Foods and Beverages to Avoid | Acceptable Foods and Drinks, Containing No or Little Tyramine |
|---|---|---|
| Meat, Poultry, and Fish | Air dried, aged and fermented meats, sausages and salamis (including cacciatore, hard salami and mortadella); pickled herring; and any spoiled or improperly stored meat, poultry, and fish (e.g., foods that have undergone changes in coloration, odor, or become moldy); spoiled or improperly stored animal livers | Fresh meat, poultry, and fish, including fresh processed meats (e.g., lunch meats, hot dogs, breakfast sausage, and cooked sliced ham) |
| Vegetables | Broad bean pods (fava bean pods) | All other vegetables |
| Dairy | Aged cheeses | Processed cheeses, mozzarella, ricotta cheese, cottage cheese, and yogurt |
| Beverages | All varieties of tap beer and beers that have not been pasteurized so as to allow for ongoing fermentation and excessive amounts of caffeine. | Use of alcohol with M-TRANYLCYPROMINE is not recommended. (Bottled and canned beers and wines contain little or no tyramine.) |
| Other | Concentrated yeast extract (e.g., Marmite), sauerkraut, most soybean products (including soy sauce and tofu), non-prescription drugs and natural health products containing tyramine, and chocolate | Brewer’s yeast, baker’s yeast, soy milk, commercial chain restaurant pizzas prepared with cheeses low in tyramine |
Check the ingredients of foods or drinks that you have not prepared yourself, including pre-prepared foods and restaurant foods. Speak with your healthcare professional if you have any questions.
How to take M-TRANYLCYPROMINE:
- Take the tablets in the morning and again mid-afternoon. It is better if you take your tablets at the same time every day.
- You should continue to take your medicine even if you do not feel better, as it may take a few weeks for your medicine to work.
- It is important that you take M-TRANYLCYPROMINE exactly as your healthcare professional has instructed. Do not stop taking your medication on your own.
- When it is time to stop taking M-TRANYLCYPROMINE, your healthcare professional will guide you about how to stop taking it slowly to help avoid side effects.
Usual dose:
The usual starting dose of M-TRANYLCYPROMINE is one 10 mg tablet taken 2 times a day (morning and afternoon).
Remember: This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.
Overdose:
| If you think you, or a person you are caring for, have taken too much M-TRANYLCYPROMINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
What are possible side effects from using M-TRANYLCYPROMINE?
These are not all the possible side effects, you may have when taking M-TRANYLCYPROMINE. If you experience any side effects not listed here, tell your healthcare professional.
Possible side effects of M-TRANYLCYPROMINE include the following:
- trouble sleeping
- feeling sick (nausea)
- dry mouth
- feeling tired or sleepy
- weakness
- dizziness
- loss of appetite
- diarrhea
- constipation
- headache
- muscle spasms, twitches or shakiness
- restlessness
- tingling or prickling feeling
- ringing or buzzing in the ears
- abdominal pain
- swelling
- chills
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
| Allergic reactions including but not limited to red and lumpy skin rash, hives, swelling in the mouth, tongue, face and throat, itching, rash, trouble breathing | ✓ | ||
| VERY RARE | |||
| Unusual hair loss or thinning | ✓ | ||
| UNKNOWN | |||
| New or Worsened Emotional or Behavioral Problems: unusual feelings of agitation, hostility or anxiety, impulsive or disturbing thoughts such as thoughts of self-harm or harm to others | ✓ | ||
| Dangerous Increase in Blood Pressure (Hypertensive crisis): severe or frequent headaches, chest pain, fast or slow heartbeat, neck stiffness or soreness, sweating with initial paleness followed by flushing of the skin, enlarged pupils, nausea, vomiting and unusual bleeding or bruising | ✓ | ||
| Drug Dependence and Discontinuation Symptoms: withdrawal symptoms may include sleep disturbances, depression, confusion, delirium, tremor, agitation, convulsion, anxiety, nervousness, hallucinations, headache | ✓ | ||
| Glaucoma: blurred vision, eye pain, changes in vision, swelling or redness in or around the eye | ✓ | ||
| Urinary retention: difficulty passing urine | ✓ | ||
| Low Blood Pressure: severe dizziness or fainting on standing | ✓ | ||
| Overstimulation: symptoms may include feeling excessive happiness or irritability, | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| agitation, anxiety, greatly increased energy, racing thoughts, talking more or faster than usual, reckless behavior | |||
| Low red blood cells (Anemia): being short of breath, feeling very tired, having pale skin, fast heartbeat, loss of energy, or weakness | ✓ | ||
| Low white blood cells - neutrophils and leukocytes (Agranulocytosis and Leukopenia): fever or infection, fatigue, aches and pains, and flu-like symptoms | ✓ | ||
| Low blood platelets (Thrombocytopenia): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | ✓ | ||
| Inflammation of the liver (Hepatitis): yellow discoloration of the skin and whites of the eyes, dark urine, vomiting, and abdominal pain | ✓ | ||
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:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store between 15 and 30°C. Keep out of reach and sight of children.
If you want more information about M-TRANYLCYPROMINE:
- 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); or by contacting the manufacturer at medinfo@mantrapharma.ca, or by calling 1-833-248-7326.
1000 rue du Lux, Suite 201
Brossard, Quebec
J4Y 0E3
Last Authorized: OCT 06, 2023