Tranylcypromine 10 mg Tablet, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Monoamine Oxidase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Tranylcypromine is used to treat depression in people who have not been helped by other medications. Tranylcypromine is in a class of medications called monoamine oxidase inhibitors (MAOIs). It works by increasing the amounts of certain natural substances that are needed to maintain mental balance.
Read the full MedlinePlus article ↗- Tranylcypromine is specifically designed for situations where other antidepressants haven't worked well enough. It works through a completely different mechanism than SSRIs or SNRI...
- Why has my doctor prescribed tranylcypromine when I've already tried other antidepressants?
- This is one of the most important things to get right. You need to avoid foods and drinks high in tyramine — including aged cheeses, cured or air-dried meats like salami, pickled h...
- What foods do I absolutely need to avoid while taking this medication?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tranylcypromine — tap one for details:
Tranylcypromine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 4846Q921YM
Calcium sulfate dihydrate is a white, crystalline mineral salt. It works as a filler and binder in tablets and capsules, helping give them structure and hold ingredients together.
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UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.575 | $57.52 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.7771 | $77.71 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $1.05 | $104.72 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tranylcypromine Sulfate 10 mg 00591-5590-01 | Actavis | 100 tablets | $0.575 | AB | Availability likely | — |
| Tranylcypromine 10 mg 43547-0655-10 | Solco | 100 tablets | $0.575 | AB | Availability likely | — |
| Tranylcypromine Sulfate 10 mg 64380-0176-01 | Strides | 100 tablets | $0.575 | AB | Availability likely | — |
| Tranylcypromine 10 mgthis 70954-0538-10 | Novitium | 100 tablets | $0.575 | AB | Availability likely | — |
| Parnate 10 mg 59212-0447-10 | Advanz | 100 tablets | — | AB | FDA listed | — |
| Tranylcypromine 10 mg 70518-4708-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70954-0538-10 You're viewing this | 100 TABLET in 1 BOTTLE (70954-538-10) | 2021-06-06 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE Suicidal Thoughts and Behaviors A ntidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] . Tranylcypromine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)] .
Hypertensive Crisis with Significant Tyramine Use Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with tranylcypromine tablets or after tranylcypromine tablets discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of tranylcypromine tablets and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content [ see Warnings and Precautions (5.2) and Drug Interactions (7.1, 7.2)].
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE See full prescribing information for complete boxed warning . Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.
Tranylcypromine tablets are not approved for use in pediatric patients. (5.1, 8.4) Excessive consumption of foods or beverages with significant tyramine content or certain drugs can precipitate hypertensive crisis. Monitor blood pressure, allow for medication free intervals, and advise patients to avoid foods and beverages with high tyramine content.
(5.2, 7.1, 7.2)
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine tablets are not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7)] . Tranylcypromine tablets are a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants (1) Tranylcypromine tablets are not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions (1,4, 5, 7)
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Recommended daily dosage is 30 mg in divided doses (2.1) If no adequate response, increase dosage in increments of 10 mg per day every 1 to 3 weeks to a maximum dosage of 30 mg twice daily (60 mg per day). Consider more gradual dosage increases in patients at risk for hypotension (2.1) Consider discontinuing tranylcypromine tablets therapy gradually because of the risk for withdrawal effects (2.3, 5.8, 9.3) Switching from or to other MAOIs or other antidepressants: See full prescribing information for instructions (2.2, 7.1)
2.1Recommended Dosage Tranylcypromine tablets are for oral use. The recommended dosage is 30 mg per day (in divided doses). If patients do not have an adequate response, increase the dosage in increments of 10 mg per day every 1 to 3 weeks to a maximum 30 mg twice daily (60 mg per day). Dosage increases should be made more gradually in patients at risk for hypotension (e.g., geriatric patients) [see Warnings and Precautions (5.5)].
2.2Switching to or from Other Antidepressants Switching from Contraindicated Antidepressants to Tranylcypromine Tablets After stopping treatment with contraindicated antidepressants, a time period of 4 to 5 half-lives of the other antidepressant or any active metabolite should elapse before starting treatment with tranylcypromine tablets. After stopping treatment with an MAO inhibitor antidepressant, a time period of at least one week or 4 to 5 half-lives of the other MAO inhibitor (whichever is longer) should elapse before starting treatment with tranylcypromine tablets to reduce the risk of additive effects [see Contraindications (4.1) and Drug Interactions (7.1)].
Switching from Tranylcypromine Tablets to Other MAOIs or Contraindicated Antidepressants After stopping tranylcypromine tablets treatment, at least one week should elapse before starting another MAOI (intended to treat MDD) or other contraindicated antidepressants. Refer to the prescribing information of the subsequently used drug for product-specific advice on a medication-free interval [see Contraindications (4.1) and Drug Interactions (7.1)].
2.3Discontinuing Treatment Withdrawal effects, including delirium, have been reported with abrupt discontinuation of tranylcypromine tablets therapy. Higher daily doses and longer duration of use appear to be associated with a higher risk of withdrawal effects. Consider discontinuing tranylcypromine tablets therapy by slow, gradual dosage reduction [see Warnings and Precautions (5.8) and Drug Abuse and Dependence (9.3)].
2.4Screen for Bipolar Disorder and Elevated Blood Pressure Prior to Starting Tranylcypromine Tablets Prior to initiating treatment with tranylcypromine tablets: Screen patients for a history of mania [see Warnings and Precautions (5.4)]. Measure blood pressure [see Warnings and Precautions (5.2, 5.5)].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Tablets containing tranylcypromine sulfate equivalent to 10 mg tranylcypromine are round, red-rose, film coated tablets, debossed with N538 on one side and plain on other side. Tablets: 10 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Concomitant use or use in rapid succession with other MAOIs; selective serotonin reuptake inhibitors; serotonin and norepinephrine reuptake inhibitors; tricyclic antidepressants; sympathomimetic drugs; and numerous other drugs. See Full Prescribing Information for the full list of contraindicated products (4.1, 7.1) Pheochromocytoma, other catecholamine-releasing paraganglioma (4.2)
4.1Combination with Certain Drugs Concomitant use of tranylcypromine tablets or use in rapid succession with the products in Table 1 is contraindicated. Such use may cause severe or life-threatening reactions such as hypertensive crises or serotonin syndrome [see Drug Interactions (7.1)] . Medication-free periods between administration of tranylcypromine tablets and contraindicated agents are recommended [see Dosage and Administration (2.2) and Drug Interactions (7.1)].
Table 1: Products Contraindicated with the Use of Tranylcypromine Tablets Dr ug Classes Non-selective H1 receptor antagonists Antidepressants including but not limited to: Other monoamine oxidase inhibitors (MAOIs) Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) Tricyclic antidepressants Other antidepressants (e.g., amoxapine, bupropion, maprotiline, nefazodone, trazodone, vilazodone, vortioxetine) Amphetamines and methylphenidates and derivatives Sympathomimetic products (e.g., cold, hay fever or weight-reducing products that contain vasoconstrictors such as pseudoephedrine, phenylephrine, and ephedrine; or dietary supplements that contain sympathomimetics) Triptans Individual Drugs (not included in the above classes) buspirone levodopa s-adenosyl-L-methionine (SAM-e) carbamazepine meperidine tapentadol cyclobenzaprine methyldopa tetrabenazine dextromethorphan milnacipran tryptophan dopamine rasagiline hydroxytryptophan reserpine
4.2Pheochromocytoma and Catecholamine-Releasing Paragangliomas Tranylcypromine tablets are contraindicated in the presence of pheochromocytoma or other catecholamine-releasing paragangliomas because such tumors secrete pressor substances and can lead to hypertensive crisis [see Warnings and Precautions (5.3)].
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Activation of Mania/Hypomania : May be precipitated by antidepressant treatment in patients with bipolar disorder. Screen patients prior to treatment (5.4) Hypotension (including syncope) : Monitor patients and adjust tranylcypromine tablets dosage or concomitant medication as necessary (5.5) Hypotension and Hypertension during Anesthesia and Perioperative Care : If possible, discontinue tranylcypromine tablets prior to elective surgery (5.6) Hepatitis and Elevated Liver Enzymes : Monitor accordingly (5.10)
5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.
There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2. Table 2: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18-24 years old 5 additional patients Decreases Compared to Placebo 25-64 years old 1 fewer patient ≥65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months.
However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.
Consider changing the therapeutic regimen, including possibly discontinuing tranylcypromine tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
5.2Hypertensive Crisis and Hypertension H y p er tensive Crisis MAOIs, including tranylcypromine tablets, have been associated with hypertensive crises caused by the ingestion of foods or beverages with a high concentration of tyramine. In addition, hypertensive reactions and crises may occur with concomitant use of other drugs [see Drug Interactions (7.1)] . Patients with hyperthyroidism may be at greater risk of hypertensive crisis.
Signs, Symptoms, and Complications of Hypertensive Crisis: In some patients a hypertensive crisis constitutes a hypertensive emergency, which requires immediate attention to prevent serious complications or fatal outcome. These emergencies are characterized by severe hypertension (e.g., with a blood pressure of more than 180/120 mm Hg) and evidence of organ dysfunction. Symptoms may include occipital headache (which may radiate frontally), palpitations, neck stiffness or soreness, nausea or vomiting, sweating (sometimes with fever or cold, clammy skin), dilated pupils, photophobia, shortness of breath, or confusion.
Either tachycardia or bradycardia may be present and…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] Hypertensive crisis and hypertension [see Warnings and Precautions (5.2)] Serotonin syndrome [see Warnings and Precautions (5.3)] Activation of mania/hypomania [see Warnings and Precautions (5.4)] Hypotension [see Warnings and Precautions (5.5)] Hypotension and hypertension during anesthesia and perioperative care [see Warnings and Precautions (5.6)] Discontinuation syndrome [see Warnings and Precautions (5.8)] Persistence of MAO inhibition after discontinuation [see Warnings and Precautions (5.9)] Hepatotoxicity [see Warnings and Precautions (5.10)] Seizures [see Warnings and Precautions (5.11)] Hypoglycemia in diabetic patients [see Warnings and Precautions (5.12)] Aggravation of coexisting symptoms of depression [see Warnings and Precautions (5.13)] Adverse effects on the ability to drive and operate machinery [see Warnings and Precautions (5.14)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Based on clinical trial data, the most common adverse reactions to tranylcypromine were dry mouth, dizziness, insomnia, sedation, and headache (>30%) and overexcitement, constipation, blurred vision, and tremor (>10%). The following adverse reactions have been identified in clinical trials or during postapproval use of tranylcypromine tablets: B lood and lymphatic system disorders: agranulocytosis, leukopenia, thrombocytopenia, anemia E ndocrine disorders: impaired water excretion compatible with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) Me tabolism and nutrition disorders: significant anorexia, weight gain P sychiatric disorders: excessive stimulation/overexcitement, manic symptoms/hypomania, agitation, insomnia, anxiety, confusion, disorientation, loss of libido Nervous system disorders: dizziness, restlessness/akathisia, akinesia, ataxia, myoclonic jerks, tremor, hyper-reflexia, muscle spasm, paresthesia, numbness, memory loss, sedation, drowsiness, dysgeusia, headaches (without blood pressure elevation) Ey e disorders: blurred vision, nystagmus E ar and labyrinth disorders: tinnitus Cardiac disorders: tachycardia, palpitations V ascular disorders: hypertensive crisis, hypertension, hypotension (including postural hypotension with syncope) G astrointestinal disorders: diarrhea, constipation, nausea, abdominal pain, dry mouth, fissuring in corner of mouth He patobiliary disorders: hepatitis, elevated aminotransferases Skin and subcutaneous tissue disorders: localized scleroderma, flare-up of cystic acne, urticaria, rash, alopecia, sweating Re nal and urinary disorders: urinary retention, urinary incontinence, urinary frequency Re productive system and breast disorders: impotence, delayed ejaculation General disorders and administration site conditions: edema, chills, weakness, fatigue/lethargy Most common adverse reactions (>10%) were dry mouth, dizziness, insomnia, sedation, headache, overexcitement, constipation, blurred vision, and tremor (6) To report SUSPECTED ADVERSE REACTIONS, contact Novitium Pharma LLC at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS See Full Prescribing Information for a list of products, foods and beverages that can interact with tranylcypromine tablets (7)
7.1Clinically-Significant Drug Interactions Tables 3 and 4 lists drug classes and individual products, respectively, with a potential for interaction with tranylcypromine tablets, describes the predominant observed or anticipated risks, and provides advice on concomitant use. Given serious adverse reactions with multiple agents, patients should avoid taking over-the-counter medications or dietary supplements without prior consultation with a healthcare provider able to provide advice on the potential for interactions.
T ime to Start Tranylcypromine Tablets after Discontinuation of a Contraindicated Drug For products that are contraindicated with tranylcypromine tablets, a time period of 4 to 5 half-lives of the other product or any active metabolite should elapse before starting treatment with tranylcypromine tablets. After stopping treatment with an MAO inhibitor antidepressant, a time period of at least 1 week or 4 to 5 half-lives of the other MAO inhibitor (whichever is longer) should elapse before starting treatment with tranylcypromine tablets because of the risk for clinically significant adverse reactions after discontinuation due to persistent MAO inhibition [see Dosage and Administration (2.2), Warnings and Precautions (5.9)] .
This period can be several weeks long (e.g., a minimum of 5 weeks for fluoxetine given fluoxetine’s long half-life). Refer to the prescribing information of the contraindicated product for relevant information. T ime to Start Contraindicated Drug after Discontinuation of Tranylcypromine Tablets The potential for interactions persists after discontinuation of tranylcypromine tablets until MAO activity has sufficiently recovered.
Inhibition of MAO may persist up to 10 days following discontinuation [see Warnings and Precautions (5.9)] . After stopping tranylcypromine tablets, at least 1 week should elapse before starting another MAOI (intended to treat MDD) or other contraindicated antidepressants. Refer to the prescribing information of any agent considered for subsequent use for recommendations on the duration of a waiting period after discontinuation of a MAO inhibitor.
If in the absence of therapeutic alternatives and emergency treatment with a contraindicated drug (e.g., linezolid, intravenous methylene blue, direct-acting sympathomimetic drugs such as epinephrine) becomes necessary and cannot be delayed, discontinue tranylcypromine tablets as soon as possible before initiating treatment with the other agent, and monitor closely for adverse reactions. Table 3: Clinically Significant Drug Interactions with Drug Classes* P r oduct C linical Comment on Concomitant Usea P r e dominant Effect/Risk [Hypertensive Reaction (HR)b or Serotonin Syndrome (SS)c] Agents with blood pressure-reducing effects Use with cautiond Hypotensione Non-selective H1 receptor antagonists Contraindicateda Increased anticholinergic effects Beta-adrenergic blockers (see also agents or procedures with blood pressure-reducing effects) Use with cautiond More pronounced bradycardia, postural hypotensione Blood glucose-lowering agents Dosage reduction of such agents may be necessary.
Monitor blood glucose. Excessive reduction of blood glucose (additive effect)f CNS depressant agents (including opioids, alcohol, sedatives, hypnotics) Use with cautiond Increased CNS depression Dietary supplements containing sympathomimetics Contraindicateda Antidepressants including but not limited to: Other MAOIs (e.g., linezolid, intravenous methylene blue, selective MAOIs) Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) Tricyclic antidepressants Amoxapine, bupropion, maprotiline, nefazodone, trazodone, vilazodone, vortioxetine Contraindicateda SS for all antidepressants For MAOIs, increased MAO inhibition and risk of adverse reactions,…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are limited published reports of placental infarction and congenital anomalies in association with use of tranylcypromine tablets during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of tranylcypromine tablets during pregnancy. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Animal embryo-fetal development studies were not conducted with tranylcypromine; however, published animal reproduction studies report placental transfer of tranylcypromine in rats and a dose-dependent decrease in uterine blood flow in pregnant sheep.
Advise pregnant women of the potential risk to a fetus. Clinical Considerations Labor or Delivery During labor and delivery, the potential for interactions between tranylcypromine tablets and drugs or procedures (e.g., epidural anesthesia) should be taken into account in women who have received tranylcypromine tablets [see Warnings and Precautions (5.6) and Drug Interactions (7.1)].
8.2Lactation Risk Summary Tranylcypromine is present in human milk. There is no available information on the effects of tranylcypromine on milk production. There is no available information on the effects of tranylcypromine on a breastfed child; however, because of the potential for serious adverse reactions in a breastfed infant, advise nursing women to discontinue breastfeeding during treatment with tranylcypromine tablets.
8.4Pediatric Use Safety and effectiveness of tranylcypromine tablets in the pediatric population have not been established. All risks associated with the use of tranylcypromine tablets, including the risk of suicidal thoughts and behavior, apply to adults and pediatric patients [see Boxed Warning and Warnings and Precautions (5)].
8.5Geriatric Use Older patients may be at greater risk of postural hypotension and other serious adverse reactions [see Warnings and Precautions (5)] . In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are limited published reports of placental infarction and congenital anomalies in association with use of tranylcypromine tablets during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of tranylcypromine tablets during pregnancy. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Animal embryo-fetal development studies were not conducted with tranylcypromine; however, published animal reproduction studies report placental transfer of tranylcypromine in rats and a dose-dependent decrease in uterine blood flow in pregnant sheep.
Advise pregnant women of the potential risk to a fetus. Clinical Considerations Labor or Delivery During labor and delivery, the potential for interactions between tranylcypromine tablets and drugs or procedures (e.g., epidural anesthesia) should be taken into account in women who have received tranylcypromine tablets [see Warnings and Precautions (5.6) and Drug Interactions (7.1)].
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of tranylcypromine tablets in the pediatric population have not been established. All risks associated with the use of tranylcypromine tablets, including the risk of suicidal thoughts and behavior, apply to adults and pediatric patients [see Boxed Warning and Warnings and Precautions (5)].
🧓 Geriatric Use ▾
8.5Geriatric Use Older patients may be at greater risk of postural hypotension and other serious adverse reactions [see Warnings and Precautions (5)] . In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Overdosage Symptoms, Signs, and Laboratory Abnormalities Overdose of tranylcypromine tablets can cause the adverse reactions generally associated with tranylcypromine tablets administration [see Warnings and Precautions (5), Adverse Reactions (6) and Drug Interactions (7.1)] . However, these reactions may be more severe, including fatal reactions. Effects reported with overdosage of tranylcypromine tablets and/or other MAOIs include: Insomnia, restlessness, and anxiety, progressing in severe cases to agitation, mental confusion, and incoherence; delirium; seizures Hypotension, dizziness, weakness, and drowsiness, progressing in severe cases to extreme dizziness and shock Hypertension with severe headache and other symptoms/complications Twitching or myoclonic fibrillation of skeletal muscles, with hyperpyrexia, sometimes progressing to generalized rigidity and coma
10.2Overdosage Management There are no specific antidotes for tranylcypromine tablets. For current information on the management of poisoning or overdosage, contact a poison control center at 1-800-222-1222. Abrupt withdrawal of tranylcypromine tablets following overdosage can precipitate withdrawal symptoms, including delirium [see Warnings and Precautions (5.9) and Drug Abuse and Dependence (9.3)].
Medical management should normally consist of general supportive measures, close observation of vital signs, and steps to counteract specific manifestations as they occur [see Warnings and Precautions (5)]. The toxic effects of tranylcypromine tablets may be delayed or prolonged following the last dose of the drug [see Clinical Pharmacology (12.2)] . Therefore, the patient should be closely observed for at least 1 week.
Data on the dialyzability of tranylcypromine are lacking.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of tranylcypromine tablets as an antidepressant is not fully understood, but is presumed to be linked to potentiation of monoamine neurotransmitter activity in the central nervous system (CNS) resulting from its irreversible inhibition of the enzyme monoamine oxidase (MAO).
12.2Pharmacodynamics Although tranylcypromine is eliminated in 24 hours, recovery MAO activity takes up to 3 to 5 days [see Warnings and Precautions (5.9)] .
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of tranylcypromine tablets as an antidepressant is not fully understood, but is presumed to be linked to potentiation of monoamine neurotransmitter activity in the central nervous system (CNS) resulting from its irreversible inhibition of the enzyme monoamine oxidase (MAO).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Tranylcypromine Tablets, USP are available as round, red-rose, film coated tablets, debossed with N538 on one side and plain on other side, and contain tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. They are supplied in bottles of 100 with a desiccant. 10 mg, bottles of 100 tablets: NDC 70954-538-10 Store tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Dispense in a tight, light resistant container.
📋 Description ▾
11 DESCRIPTION Tranylcypromine sulfate, the active ingredient of Tranylcypromine Tablets, USP, is a non-hydrazine MAOI. The chemical name is (±)- trans -2-phenylcyclopropylamine sulfate (2:1). The molecular formula is (C9H11N)2•H2SO4 and its molecular weight is 364.46.
The structural formula is: Tranylcypromine film-coated tablets are intended for oral administration. Each round, red-rose, film coated tablet is debossed with N538 on one side and plain on other side, and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of calcium sulfate, carboxymethyl cellulose sodium, croscarmellose sodium, FD&C Blue No.
2 lake, FD&C Red No. 40 lake, FD&C Yellow No. 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, talc and titanium dioxide. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during treatment and when the dosage is adjusted up or down [see Box Warning and Warnings and Precautions (5.1)]. Hypertensive Crisis Advise the patient on possible symptoms and instruct the patient to seek immediate medical attention if related signs or symptoms are present [see Boxed Warning and Warnings and Precautions (5.2)].
Serotonin Syndrome Advise the patient on possible symptoms, and explain the potentially fatal nature of serotonin syndrome and that it may result from an interaction with other serotonergic drugs. Instruct the patient to seek immediate medical attention if related signs or symptoms are present [see Warnings and Precautions (5.3)]. Interaction with Other Drugs and Dietary Supplements [see Contraindications (4.1) and Drug Interactions (7.1)] Warn the patient not to take concomitant medications, whether prescription or over-the-counter drugs, or dietary supplements without prior consultation with a health care provider able to provide advice on the potential for interactions.
Explain to the patient that some other drugs may require a medication-free interval even after discontinuation of tranylcypromine tablets. Advise the patient to inform other physicians, pharmacists, and dentists about the treatment with tranylcypromine tablets. Interaction with Foods and Beverages [see Contraindications (4.1) and Drug Interactions (7.2)] Warn the patient to avoid tyramine-rich foods and beverages.
Advise the patient to avoid eating foods if storage conditions or freshness is unknown and to be cautious of foods of unknown age or composition even if refrigerated. Hypotension Advise the patient to report any symptoms of hypotension in the initial phase of treatment to the healthcare provider, because occurrence of such symptoms may require discontinuation [see Dosage and Administration (2.1) and Warnings and Precautions (5.5)] . Withdrawal Symptoms Warn the patient not to stop tranylcypromine tablets treatment abruptly, as withdrawal symptoms may occur and that the effect of tranylcypromine tablets may continue even after discontinuation [see Warnings and Precautions (5.8, 5.9)].
Aggravation of Coexisting Symptoms of Depression Inform the patient that tranylcypromine tablets may aggravate coexisting symptoms in depression, such as anxiety and agitation and instruct them to contact their healthcare provider if they experience such symptoms [see Warnings and Precautions (5.13)]. Effects on Ability to Drive or Use Machinery [see Warnings and Precautions (5.14)] Warn the patient about the possible adverse reactions that can impair the performance of potentially hazardous tasks such as driving a car or operating machinery.
Tell the patient not to operate hazardous machinery and automobiles until they are reasonably certain that their ability to engage in such activities is not impaired. All trademarks are the property of their respective owners. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520.
Issued: 05/2021 LB4346-00
💬 Medication Guide ▾
SPL MEDGUIDE SECTION MEDICATION GUIDE Tranylcypromine Tablets, USP (tran-ill-SIP-row-meen) What is the most important information I should know about tranylcypromine tablets? Tranylcypromine tablets can cause serious side effects including: Increase in suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment and when the tranylcypromine tablets dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.
Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have, or have a family history of, bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. Tranylcypromine tablets are not for use in children.
How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling agitated, restless, angry or irritable trouble sleeping acting aggressive, being angry or violent an extreme increase in activity or talking (mania) attempts to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood A sudden, severe increase in blood pressure (hypertensive crisis).
A hypertensive crisis can happen when you eat certain foods and drinks certain beverages during or after tranylcypromine tablets treatment. A hypertensive crisis can lead to stroke and death. People who have thyroid problems (hyperthyroidism) may have a higher chance of having a hypertensive crisis.
Symptoms of a hypertensive crisis may include: sudden, severe headache vomiting a fast heartbeat (palpitations) or a change in the way your heart beats the pupils in your eyes increase in size fast or slow heart beat with chest pain nausea stiff or sore neck excessive sweating, sometimes with fever or cold, clammy skin light bothers your eyes bleeding in your brain A hypertensive crisis can also happen if you take tranylcypromine tablets with certain other medicines. See, “Who should not take tranylcypromine tablets?” Avoid foods and drinks with a lot of tyramine while taking tranylcypromine tablets and for 2 weeks after you stop taking it.
For a list of some of the foods and drinks you should avoid during treatment with tranylcypromine tablets see, “What should I avoid while taking tranylcypromine tablets?” What are tranylcypromine tablets? Tranylcypromine tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD) who have not responded well to treatment with other medicines used to treat depression (antidepressants). Tranylcypromine tablets belong to a class of medicines called monoamine oxidase inhibitors (MAOIs).
It is important to talk with your healthcare provider about the risks of treating depression and the risk of not treating it. Talk with your healthcare provider about all your treatment choices. Tranylcypromine tablets are not for use as the first medicine to treat MDD.
It is not known if tranylcypromine tablets are safe and effective for use in children. Who should not take tranylcypromine tablets? Taking tranylcypromine tablets with certain antidepressants and certain pain, allergy symptom, and cold and cough symptom medicines may cause a…