Parnate
Tranylcypromine sulfate · Tablet, Film Coated · Oral
Uses
1 INDICATIONS AND USAGE PARNATE is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE is 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) ] . PARNATE is 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) PARNATE is 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
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 PARNATE 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 ) 2.1 Recommended Dosage PARNATE 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) ]. 2.2 Switching to or from Other Antidepressants Switching from Contraindicated Antidepressants to PARNATE 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 PARNATE. 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 PARNATE to reduce the risk of additive effects [ see Contraindications (4.1) and Drug Interactions (7.1) ]. Switching from PARNATE to Other MAOIs or Contraindicated Antidepressants After stopping PARNATE 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) ]. 2.3 Discontinuing Treatment Withdrawal effects, including delirium, have been reported with abrupt discontinuation of PARNATE therapy. Higher daily doses and longer duration of use appear to be associated with a higher risk of withdrawal effects. Consider discontinuing PARNATE therapy by slow, gradual dosage reduction [ see Warnings and Precautions (5.8) and Drug Abuse and Dependence (9.3) ]. 2.4 Screen for Bipolar Disorder and Elevated Blood Pressure Prior to Starting PARNATE Prior to initiating treatment with PARNATE: 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
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 (3)
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 ) 4.1 Combination with Certain Drugs Concomitant use of PARNATE 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 PARNATE and contraindicated agents are recommended [ see Dosage and Administration (2.2) and Drug Interactions (7.1) ]. Table 1: Products Contraindicated with the Use of PARNATE 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 4.2 Pheochromocytoma and Catecholamine-Releasing Paragangliomas PARNATE is 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 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 PARNATE dosage or concomitant medication as necessary ( 5.5) Hypotension and Hypertension during Anesthesia and Perioperative Care : If possible, discontinue PARNATE prior to elective surgery ( 5.6 ) Hepatitis and Elevated Liver Enzymes : Monitor accordingly ( 5.10 ) 5.1 Suicidal 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 PARNATE, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. 5.2 Hypertensive Crisis and Hypertension Hypertensive Crisis MAOIs, including PARNATE, 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 may be associated with constricting chest pain. Seizures may also occur. Intracranial bleeding, sometimes fatal, has been reported in association with the increase in blood pressure. Strategies to Reduce the Risk of Hypertensive Crisis: Instruct patients to avoid foods and beverages with high tyramine content while being treated with PARNATE and for 2 weeks after stopping PARNATE [ see Drug Interactions (7.2)] . Careful evaluation of the benefits and risks of PARNATE therapy is necessary in patients with: Hypertension or confirmed or suspected cerebrovascular or cardiovascular disorders that constitute an increased risk for complications from severe hypertension, and A history of headaches that can mask the occurrence of headaches as prodromal of a hypertensive crisis. In all patients taking PARNATE, monitor blood pressure closely to detect evidence of increased blood pressure. Full reliance should not be placed on blood pressure readings. The patient should also be observed for other signs and symptoms of hypertensive crisis. Treatment of Hypertensive Crisis: Therapy should be interrupted with symptoms that may be prodromal or a manifestation of a hypertensive crisis, such as palpitations or headaches, and patients should be evaluated immediately. Discontinue PARNATE, other drugs, foods or beverages suspected to contribute to the hypertensive crisis immediately [see Drug Interactions (7.1, 7.2)]. Patients with severe elevations in blood pressure (e.g., more than 180/120 mm Hg) with evidence of organ dysfunction require immediate blood pressure reduction. Fever should be managed by means of external cooling. However, additional measures to control the causes of hyperthermia (psychomotor agitation, increased neuromuscular activity, persistent seizures) may be required. Hypertension Clinically significant increases in blood pressure have also been reported after the administration of MAOIs, including PARNATE, in patients not ingesting tyramine-rich foods or beverages.
Side effects
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 PARNATE: 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 Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
See Full Prescribing Information for a list of products, foods and beverages that can interact with PARNATE. (7) 7.1 Clinically Significant Drug Interactions Tables 3 and 4 lists drug classes and individual products, respectively, with a potential for interaction with PARNATE, 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 PARNATE after Discontinuation of a Contraindicated Drug For products that are contraindicated with PARNATE, a time period of 4 to 5 half-lives of the other product or any active metabolite should elapse before starting treatment with PARNATE. 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 PARNATE 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 PARNATE The potential for interactions persists after discontinuation of PARNATE 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 PARNATE, 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 PARNATE 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 for all antidepressants For MAOIs, increased MAO inhibition and risk of adverse reactions, SS, and HR g Amphetamines and methylphenidates and derivatives Contraindicated a HR Sympathomimetic drugs** Contraindicated a HR; Including risk of intracerebral hemorrhage Triptans Contraindicated a SS * Some drugs in these groups may also be listed in Table 4 below. ** Sympathomimetic drugs include amphetamines as well as cold, hay fever or weight-reducing products that contain vasoconstrictors such as pseudoephedrine, phenylephrine, and ephedrine) a [See Contraindications (4.1)] ; b [See Warnings and Precautions (5.2)] ; c [See Warnings and Precautions (5.3)] d If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals, use agent at the lowest appropriate dosage, monitor for effects of the interaction, advise the patient to report potential effects).
Use in specific populations
8.1 Pregnancy Risk Summary There are limited published reports of placental infarction and congenital anomalies in association with use of PARNATE during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of PARNATE 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 PARNATE and drugs or procedures (e.g., epidural anesthesia) should be taken into account in women who have received PARNATE [ see Warnings and Precautions (5.6) and Drug Interactions (7.1)]. 8.2 Lactation 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 PARNATE 8.4 Pediatric Use Safety and effectiveness of PARNATE in the pediatric population have not been established. All risks associated with the use of PARNATE, including the risk of suicidal thoughts and behavior, apply to adults and pediatric patients [ see Boxed Warning and Warnings and Precautions (5) ]. 8.5 Geriatric 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
8.1 Pregnancy Risk Summary There are limited published reports of placental infarction and congenital anomalies in association with use of PARNATE during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of PARNATE 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 PARNATE and drugs or procedures (e.g., epidural anesthesia) should be taken into account in women who have received PARNATE [ see Warnings and Precautions (5.6) and Drug Interactions (7.1)].
Pediatric use
8.4 Pediatric Use Safety and effectiveness of PARNATE in the pediatric population have not been established. All risks associated with the use of PARNATE, including the risk of suicidal thoughts and behavior, apply to adults and pediatric patients [ see Boxed Warning and Warnings and Precautions (5) ].
Geriatric use
8.5 Geriatric 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
10.1 Overdosage Symptoms, Signs, and Laboratory Abnormalities Overdose of PARNATE can cause the adverse reactions generally associated with PARNATE 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 PARNATE 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 10.2 Overdosage Management There are no specific antidotes for PARNATE. For current information on the management of poisoning or overdosage, contact a poison control center at 1-800-222-1222. Abrupt withdrawal of PARNATE 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 PARNATE 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.
Description
Tranylcypromine sulfate, the active ingredient of PARNATE, 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: PARNATE 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. Structural Formula
Mechanism of action
12.1 Mechanism of Action The mechanism of action of PARNATE 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
(tranylcypromine) 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 59212-447-10 Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light resistant container.
Patient 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 PARNATE. Advise the patient to inform other physicians, pharmacists, and dentists about the treatment with PARNATE. 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 PARNATE treatment abruptly, as withdrawal symptoms may occur and that the effect of PARNATE may continue even after discontinuation [ see Warnings and Precautions (5.8, 5.9)]. Aggravation of Coexisting Symptoms of Depression Inform the patient that PARNATE 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. PARNATE ® is a registered trademark of Mercury Pharma Group Limited. Distributed by Advanz Pharma (US) Corp. under license. Manufactured for: Advanz Pharma (US) Corp. Bannockburn, IL 60015
Label text from the FDA structured product label by Advanz Pharma (US) Corp. (revised Jul 2, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Tranylcypromine Sulfate in 1 product
Parnate NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59212-447 | Tranylcypromine Sulfate 10 mg/1 Tablet, Film Coated | Advanz Pharma (US) Corp. | NDA |
Frequently asked questions
What is Parnate used for?
1 INDICATIONS AND USAGE PARNATE is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE is 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…
What are the side effects of Parnate?
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)]… See the full label for the complete list.
Who makes Parnate?
Parnate is listed by 1 labeler in the FDA NDC directory, including Advanz Pharma (US) Corp..