Tranylcypromine Glenmark

What Is Tranylcypromine Glenmark and What Is It Used For?

Tranylcypromine Glenmark is a monoamine oxidase inhibitor (MAOI) antidepressant containing the active substance tranylcypromine. It is prescribed for severe depressive episodes in adults with major depressive disorder (MDD) who have not responded adequately to standard antidepressant treatment.

Tranylcypromine belongs to the oldest class of antidepressant medications, the monoamine oxidase inhibitors. It works by irreversibly blocking the monoamine oxidase enzymes (both MAO-A and MAO-B) in the brain. These enzymes are responsible for breaking down key neurotransmitters – serotonin, norepinephrine, and dopamine – which play critical roles in regulating mood, motivation, and emotional well-being. By inhibiting their breakdown, tranylcypromine increases the concentration of these neurotransmitters in the brain, thereby alleviating depressive symptoms.

This medication is not a first-line treatment. It is specifically indicated for adults with severe depressive episodes who have failed to achieve an adequate response from at least two standard antidepressant treatments, including a tricyclic antidepressant, plus an augmentation strategy such as lithium. This positioning reflects both the drug's established efficacy in treatment-resistant depression and the significant safety precautions required during its use.

Despite its age, tranylcypromine remains an important option in the psychiatric pharmacological toolkit. Clinical evidence, including data reviewed by the European Medicines Agency (EMA), supports its effectiveness in patients who have not responded to newer antidepressants. Some psychiatrists consider MAOIs to be particularly effective for atypical depression, characterized by mood reactivity, increased appetite, excessive sleepiness, a heavy feeling in the limbs, and sensitivity to rejection.

Tranylcypromine is available as film-coated tablets in two strengths: 10 mg and 20 mg. It is marketed under the brand names Tranylcypromine Glenmark and Abbonate, manufactured by Glenmark Arzneimittel GmbH in Germany, with production at Glenmark Pharmaceuticals s.r.o. in the Czech Republic.

What Should You Know Before Taking Tranylcypromine Glenmark?

Tranylcypromine has numerous contraindications and warnings. It must not be taken with many other medications, by patients with certain cardiovascular conditions, pheochromocytoma, liver or kidney impairment, or porphyria. Strict dietary restrictions are mandatory. Always inform your doctor about all medications and supplements you are taking.

Before starting tranylcypromine, it is essential that your prescribing psychiatrist has a complete picture of your medical history, current medications, dietary habits, and any planned surgical procedures. The safety profile of MAOIs demands thorough screening to prevent potentially life-threatening complications.

Contraindications – Do Not Take Tranylcypromine If:

• You are allergic to tranylcypromine or any other ingredient in this medicine
• You are taking or have taken other MAO inhibitors within the past two weeks
• You have pheochromocytoma (a tumor of the adrenal glands that causes high blood pressure)
• You have severe cardiovascular disease or any cerebrovascular disease
• You have high blood pressure or vascular disease (aneurysms)
• You have known liver damage or impaired kidney function
• You suffer from porphyria (a hereditary condition affecting the nervous system and skin)
• You have diabetes insipidus (a pituitary disorder causing excessive thirst and urination)
• You are taking any of the medications listed as contraindicated drug interactions below

Warnings and Precautions

Talk to your doctor or pharmacist before taking tranylcypromine if any of the following apply to you:

You should also inform your doctor if you:

• Are elderly (lower doses are typically required)
• Have a mild heart condition that limits your activity
• Suffer from seizures or epilepsy
• Are scheduled for surgery in the coming weeks (tranylcypromine must be stopped well before general anesthesia)
• Have a history of drug or alcohol dependence
• Consume foods, stimulants, or beverages containing high levels of tyramine
• Use other antidepressants, particularly SSRIs (risk of serotonin syndrome with symptoms including high blood pressure, irritability, and rising body temperature)

Tranylcypromine is not recommended for children and adolescents under 18 years of age due to insufficient safety data in this population. Clinical trials in young people with psychiatric conditions treated with antidepressants have shown an increased risk of suicidal behavior.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Tranylcypromine should not be used during pregnancy or breastfeeding unless your doctor considers it absolutely necessary. The medicine may pass into breast milk, and the potential effects on the infant have not been adequately studied. Your doctor will weigh the risk-benefit balance and may decide to gradually reduce or discontinue your treatment.

The effects of tranylcypromine on human fertility are unknown. Women of childbearing potential should discuss appropriate contraceptive measures with their healthcare provider while taking this medication.

Driving and Using Machines

Tranylcypromine may cause drowsiness, dizziness, or impaired concentration, particularly when treatment is first started. Do not drive or operate machinery until you are certain these side effects do not affect you. You are responsible for assessing your own fitness to drive or perform tasks requiring alertness.

How Does Tranylcypromine Interact with Other Drugs?

Tranylcypromine has some of the most extensive and dangerous drug interactions of any medication. Combining it with SSRIs, sympathomimetics, pethidine, or other MAOIs can cause life-threatening serotonin syndrome or hypertensive crisis. A washout period of at least 2 weeks is required when switching between tranylcypromine and most other antidepressants.

Drug interactions with tranylcypromine are among the most clinically significant in all of pharmacology. The irreversible inhibition of monoamine oxidase means that the body cannot properly metabolize many commonly used medications, leading to dangerous accumulations of neurotransmitters and vasoactive amines. Always tell your doctor or pharmacist about all medications you are taking, including over-the-counter medicines, supplements, and herbal products.

Major Interactions – Absolutely Contraindicated

Interactions Requiring Caution

The following medications may be used with tranylcypromine under careful medical supervision, but dose adjustments and monitoring may be necessary:

What Foods and Drinks Must You Avoid While Taking Tranylcypromine?

Tranylcypromine prevents the breakdown of tyramine, a substance found in many fermented and aged foods. Failure to follow dietary restrictions can cause a potentially fatal hypertensive crisis. You must avoid aged cheeses, yeast extracts, cured meats, broad beans, and alcohol (especially red wine and beer).

The dietary restrictions associated with MAOI therapy are among the most important safety considerations in clinical pharmacology. Tranylcypromine inhibits the enzyme monoamine oxidase in the gut and liver, which normally breaks down tyramine – a naturally occurring amino acid found in many common foods. When tyramine is not metabolized, it causes a massive release of norepinephrine, leading to a sudden and dangerous spike in blood pressure known as hypertensive crisis.

Your doctor and ideally a specialist dietitian with expertise in psychiatric medications should discuss dietary guidelines with you in detail before starting treatment. The following foods and beverages must be strictly avoided:

• Aged cheeses – Cheddar, blue cheese, Stilton, Camembert, Brie, processed cheese made from aged cheese (fresh cottage cheese and cream cheese are generally safe)
• Yeast extracts – Marmite, Bovril, Vegemite, and brewer's yeast supplements
• Fermented or cured meats – Salami, pepperoni, cured sausages, smoked meat or fish, liver that is not fresh, pickled herring
• Broad (fava) beans – These contain dopamine precursors in addition to tyramine
• Banana peel – The peel contains high levels of tyramine (banana flesh is generally safe in moderation)
• Fermented soy products – Soy sauce, miso, tempeh, tofu that has been fermented
• Sauerkraut and kimchi – Fermented vegetables can contain significant tyramine

Alcohol: You should not drink alcohol while taking tranylcypromine, particularly red wine, which contains high levels of tyramine. Non-alcoholic beer and lager should also be avoided, as they can still contain tyramine from the fermentation process. The effects of alcohol are enhanced by tranylcypromine, and even small amounts can cause excessive sedation or dangerous blood pressure changes.

As a general rule, choose fresh foods wherever possible and consume them promptly. Tyramine levels increase as food ages, and even normally safe foods can become problematic if stored for extended periods or not properly refrigerated. Keep a food diary during the first weeks of treatment, and do not hesitate to ask your doctor or dietitian about any specific food.

What Is the Correct Dosage of Tranylcypromine Glenmark?

The starting dose is 10 mg once daily in the morning. The usual therapeutic dose is 20–40 mg per day, divided into 1–3 doses. The maximum dose is 60 mg per day. The last dose should be taken before 3 PM. All dosing must be supervised by a psychiatrist.

Always take this medicine exactly as your doctor has told you. Treatment should only be initiated and monitored by a psychiatrist experienced in managing MAOI therapy. Swallow the tablets whole with a glass of water.

Adults

The 10 mg tablet has a score line to help with swallowing, but it is not intended for dividing into equal doses. The 20 mg tablet can be divided into two equal 10 mg halves along the score line.

Children and Adolescents

Tranylcypromine Glenmark is not recommended for use in children and adolescents under 18 years of age. There is insufficient safety and efficacy data for this population, and clinical trials have indicated an increased risk of suicidal behavior in young people treated with antidepressants.

Elderly Patients

Elderly patients typically require lower starting doses and more gradual dose increases. The elderly are more susceptible to postural hypotension (dizziness when standing) and other side effects. Your doctor will adjust the dose carefully and monitor you closely, particularly during the initial treatment period.

Missed Dose

If you forget to take a dose, wait until your next scheduled dose. Do not take a double dose to make up for the one you missed. Never take more than one dose at a time. Simply continue with your regular dosing schedule.

Overdose

Stopping Treatment

Do not stop taking tranylcypromine suddenly, as withdrawal symptoms may occur, including anxiety, restlessness, sleep disturbances, and drowsiness. Your doctor will gradually reduce your dose over a period of time. Always consult your doctor before making any changes to your treatment.

After stopping tranylcypromine, you must continue to observe the dietary and medication restrictions for at least 2 weeks, as the inhibition of monoamine oxidase is irreversible and it takes approximately 2 weeks for the body to produce enough new enzyme to safely metabolize tyramine and interacting drugs.

What Are the Side Effects of Tranylcypromine Glenmark?

Common side effects include insomnia, headache, drowsiness, dizziness, dry mouth, rapid heartbeat, restlessness, and low blood pressure on standing. Serious but rare side effects include hypertensive crisis, manic episodes, liver problems, and serotonin syndrome. Seek immediate medical attention for sudden severe headache, chest pain, or signs of mania.

Like all medicines, tranylcypromine can cause side effects, although not everybody gets them. Many side effects are mild and may improve as your body adjusts to the medication. However, some side effects can be serious and require immediate medical attention.

If you experience persistent low blood pressure causing prolonged dizziness when standing, your doctor may choose to discontinue the medication. Anxiety and agitation can sometimes occur; your doctor may reduce your dose if this happens.

Tell your doctor immediately if you develop a sore throat, high fever, become very tired and pale, or notice unusual bruising or nosebleeds, as these may be signs of blood abnormalities requiring urgent investigation.

How Should You Store Tranylcypromine Glenmark?

Store at room temperature, out of sight and reach of children. Do not use after the expiry date on the packaging. No special storage conditions are required. Dispose of unused medicine through your pharmacy – do not flush or place in household waste.

Keep this medicine out of the sight and reach of children at all times. Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.

There are no special storage requirements for Tranylcypromine Glenmark. Store at room temperature, protected from excessive heat and moisture. Keep the tablets in the original packaging until you are ready to take them.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment and prevent accidental ingestion.

What Does Tranylcypromine Glenmark Contain?

Each tablet contains 10 mg or 20 mg of the active substance tranylcypromine. Other ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, and a film coating containing Allura Red AC (E129).

Active Substance

The active substance is tranylcypromine. Each film-coated tablet contains either 10 mg or 20 mg of tranylcypromine.

Other Ingredients (Excipients)

• Tablet core: Lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, anhydrous colloidal silicon dioxide, magnesium stearate
• Film coating: Macrogol, titanium dioxide (E171), talc, Allura Red AC aluminium lake (E129)

Appearance and Pack Sizes

10 mg tablets: Pink to light pink, round (7 mm diameter), biconvex film-coated tablets embossed with ‘Y3’ on one side and a score line on the other. The score line is for ease of swallowing only, not for dividing into equal doses. Each tablet contains 82 mg lactose monohydrate.

20 mg tablets: Pink to light pink, round (9 mm diameter), biconvex film-coated tablets embossed with ‘Y73’ on one side and a score line on the other. The tablet can be divided into two equal 10 mg doses. Each tablet contains 164 mg lactose monohydrate.

Available in white, opaque PVC/PVDC aluminum blister packs containing 10, 20, or 30 tablets, or in HDPE bottles containing 28 tablets (10 mg) or 28 or 90 tablets (20 mg). Not all pack sizes may be marketed in your country.

Manufacturer

Marketing Authorization Holder: Glenmark Arzneimittel GmbH, Industriestr. 31, 82194 Gröbenzell, Germany.

Manufacturer: Glenmark Pharmaceuticals s.r.o., Fibichova 143, 566 17 Vysoké Mýto, Czech Republic.