Tranylcypromine Sulfate 10 mg Tablet, Film Coated, 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
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.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
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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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A synthetic red dye used to color tablets and capsules. It helps make medicines visually distinctive so patients can easily identify their medication.
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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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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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Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
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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 B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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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.
15 inactive ingredients listed in the exact product block matched to this NDC.
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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 | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.05 | $104.72 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tranylcypromine Sulfate 10 mgthis 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 mg 70954-0538-10 | Novitium | 100 tablets | $0.575 | AB | Availability likely | — |
| Parnate 10 mg 59212-0447-10 | Advanz | 100 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00591-5590-01 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (0591-5590-01) | 2016-02-05 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING:SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE Suicidal Thoughts and Behaviors Antidepressants 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 sulfate 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 sulfate tablets or after tranylcypromine sulfate tablets discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of tranylcypromine sulfate 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 sulfate 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 )
MEDICATION GUIDE TRANYLCYPROMINE SULFATE (tran-ill-SIP-row-meen SULL-fate) TABLETS What is the most important information I should know about tranylcypromine sulfate tablets? Tranylcypromine sulfate tabletscan 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 sulfate tablet 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 sulfate 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 attempts to commit suicide new or worse depression new or worse anxiety feeling agitated, restless, angry or irritable panic attacks trouble sleeping new or worse irritability acting aggressive, being angry or violent acting on dangerous impulses an extreme increase in activity or talking (mania) 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 s…
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Tranylcypromine sulfate tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine sulfate 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 sulfate 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 sulfate 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 sulfate 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 sulfate 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 Sulfate 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 sulfate 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 sulfate tablets to reduce the risk of additive effects [see Contraindications (4.1) and Drug Interactions (7.1)].
Switching from Tranylcypromine Sulfate Tablets to Other MAOIs or Contraindicated Antidepressants After stopping tranylcypromine sulfate 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 sulfate tablets therapy. Higher daily doses and longer duration of use appear to be associated with a higher risk of withdrawal effects. Consider discontinuing tranylcypromine sulfate 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 Sulfate Tablets Prior to initiating treatment with tranylcypromine sulfate 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, rose-red, film-coated, and debossed on one side with "PARNATE" and "SB." Tablets: 10 mg
⛔ 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 sulfate 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 sulfate 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 Sulfate Tablets Drug 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 sulfate 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 sulfate tablets dosage or concomitant medication as necessary (5.5) Hypotension and Hypertension during Anesthesia and Perioperative Care: If possible, discontinue tranylcypromine sulfate 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 sulfate tablets , in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
5.2Hypertensive Crisis and Hypertension Hypertensive Crisis MAOIs, including tranylcypromine sulfate 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 brady…
🤒 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 post approval use of tranylcypromine sulfate tablets: Blood and lymphatic system disorders: agranulocytosis, leukopenia, thrombocytopenia, anemia Endocrine disorders: impaired water excretion compatible with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) Metabolism and nutrition disorders: significant anorexia, weight gain Psychiatric 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) Eye disorders: blurred vision, nystagmus Ear and labyrinth disorders: tinnitus Cardiac disorders: tachycardia, palpitations Vascular disorders: hypertensive crisis, hypertension, hypotension (including postural hypotension with syncope) Gastrointestinal disorders: diarrhea, constipation, nausea, abdominal pain, dry mouth, fissuring in corner of mouth Hepatobiliary disorders: hepatitis, elevated aminotransferases Skin and subcutaneous tissue disorders: localized scleroderma, flare-up of cystic acne, urticaria, rash, alopecia, sweating Renal and urinary disorders : urinary retention, urinary incontinence, urinary frequency Reproductive 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 Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 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 sulfate 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 sulfate 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.
Time to Start Tranylcypromine Sulfate Tablets after Discontinuation of a Contraindicated Drug For products that are contraindicated with tranylcypromine sulfate 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 sulfate 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 sulfate 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. Time to Start Contraindicated Drug after Discontinuation of Tranylcypromine Sulfate Tablets The potential for interactions persists after discontinuation of tranylcypromine sulfate 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 sulfate 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 sulfate 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* Product Clinical Comment on Concomitant Use a Predominant Effect/Risk [Hypertensive Reaction (HR) b or Serotonin Syndrome (SS) c ] Agents with blood pressure-reducing effects Use with caution d Hypotension e Non-selective H1 receptor antagonists Contraindicated a Increased anticholinergic effects Beta-adrenergic blockers (see also agents or procedures with blood pressure-reducing effects) Use with the caution d More pronounced bradycardia, postural hypotension e 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 caution d Increased CNS depression Dietary supplements containing sympathomimetics Contraindicated a 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 Contraindicated a SS f…
👥 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 sulfate tablets during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of tranylcypromine sulfate tablets during pregnancy. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, 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 sulfate tablets and drugs or procedures (e.g., epidural anesthesia) should be taken into account in women who have received tranylcypromine sulfate 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 sulfate tablets.
8.4Pediatric Use Safety and effectiveness of tranylcypromine sulfate tablets in the pediatric population have not been established. All risks associated with the use of tranylcypromine sulfate 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 sulfate tablets during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of tranylcypromine sulfate tablets during pregnancy. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, 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 sulfate tablets and drugs or procedures (e.g., epidural anesthesia) should be taken into account in women who have received tranylcypromine sulfate tablets [see Warnings and Precautions (5.6) and Drug Interactions (7.1)].
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of tranylcypromine sulfate tablets in the pediatric population have not been established. All risks associated with the use of tranylcypromine sulfate 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 sulfate tablets can cause the adverse reactions generally associated with tranylcypromine sulfate 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 sulfate 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 sulfate 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 sulfate 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 sulfate 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 sulfate 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 sulfate 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 sulfate tablets are available as: 10 mg: film-coated, round, rose-red and debossed with the product name “PARNATE” and “SB” on one side of the tablet containing tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Bottles of 100 tablets: NDC 0591-5590-01 Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light resistant container.
📋 Description ▾
11 DESCRIPTION Tranylcypromine sulfate, the active ingredient of tranylcypromine sulfate tablets, is a non-hydrazine MAOI. The chemical name is (±)‑ trans ‑2‑phenylcyclopropylamine sulfate (2:1). The molecular formula is (C 9 H 11 N) 2 •H 2 SO 4 and its molecular weight is 364.46.
The structural formula is: Tranylcypromine sulfate tablets film-coated tablets are intended for oral administration. Each round, rose‑red tablet is debossed on one side with the product name “PARNATE” and “SB” and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of microcrystalline cellulose, anhydrous citric acid, croscarmellose sodium, D&C Red No.
7, FD&C Blue No. 2, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, talc, titanium dioxide, carnauba wax, polyethylene glycol 400 and 8000, and hypromellose. 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 sulfate tablets.
Advise the patient to inform other physicians, pharmacists, and dentists about the treatment with tranylcypromine sulfate 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 sulfate tablet treatment abruptly, as withdrawal symptoms may occur and that the effect of tranylcypromine sulfate 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 sulfate 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. Made in Italy Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054
💬 Medication Guide ▾
MEDICATION GUIDE MEDICATION GUIDE TRANYLCYPROMINE SULFATE (tran-ill-SIP-row-meen SULL-fate) TABLETS What is the most important information I should know about tranylcypromine sulfate tablets? Tranylcypromine sulfate tabletscan 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 sulfate tablet 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 sulfate 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 attempts to commit suicide new or worse depression new or worse anxiety feeling agitated, restless, angry or irritable panic attacks trouble sleeping new or worse irritability acting aggressive, being angry or violent acting on dangerous impulses an extreme increase in activity or talking (mania) 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 sulfate 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 nausea vomiting stiff or sore neck a fast heartbeat (palpitations) or a change in the way your heart beats excessive sweating, sometimes with fever or cold, clammy skin the pupils in your eyes increase in size light bothers your eyes fast or slow heart beat with chest pain bleeding in your brain A hypertensive crisis can also happen if you take tranylcypromine sulfate tablets with certain other medicines. See, “Who should not take tranylcypromine sulfate tablets?” Avoid foods and drinks with a lot of tyramine while taking tranylcypromine sulfate tabletsand 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 sulfate tablets see, “What should I avoid while taking tranylcypromine sulfate tablets?” What are tranylcypromine sulfate tablets? Tranylcypromine sulfate 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 sulfate 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 sulfate tablets are not for use as the first medicine to treat MDD. It is not known if tranylcypromine sulfate tablets are safe and effective for use in children.
Who should not take tranylcypromine sulfate tablets? Taking tran…