Parnate

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/27/2022
Parnate Side Effects Center

What Is Parnate?

Parnate (tranylcypromine sulfate) Tablets is a monoamine oxidase inhibitor (MAOI) used the treatment of major depressive episode without melancholia. Parnate should be used in adults who are closely supervised. Parnate is available in generic form.

What Are Side Effects of Parnate?

Common side effects of Parnate include:

  • frequent headaches,
  • vision problems,
  • sensitivity to light,
  • restlessness,
  • weakness,
  • drowsiness,
  • nausea,
  • diarrhea,
  • constipation,
  • loss of appetite,
  • stomach pain,
  • chills,
  • numbness or tingly feeling,
  • dry mouth,
  • decreased urination,
  • problems sleeping,
  • blurred vision,
  • ringing in your ears,
  • impotence, or
  • difficulty having an orgasm.

Tell your doctor if you have unlikely but serious side effects of Parnate including:

A serious side effect of Parnate is the occurrence of hypertensive crises that can be fatal.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Parnate

Parnate dosage (available in 10 mg tablets) should be adjusted to the requirements of the individual patient. If there are no signs of improvement after about 2 weeks, then the dosage may be increased (10 mg per day) at intervals of 1 to 3 weeks and extended to a maximum of 60 mg per day.

What Drugs, Substances, or Supplements Interact with Parnate?

Inform the doctor about all the other prescription and over-the-counter medications used, including vitamins, minerals, and herbal products; Parnate interacts with many other medications.

Parnate During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Parnate; it is unknown if it will harm a fetus. Parnate can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Parnate (tranylcypromine sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Depression is a(n) __________ . See Answer
Parnate Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • dilated pupils, vision problems, sensitivity to light;
  • sudden and severe headache, neck pain or stiffness;
  • numbness or weakness, problems with vision or speech;
  • fast or pounding heartbeats;
  • fever, cold sweat, nausea, vomiting;
  • a light-headed feeling, like you might pass out;
  • a seizure;
  • manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
  • high levels of serotonin in the body--agitation, hallucinations, sweating, shivering, muscle stiffness, twitching, loss of coordination, vomiting, diarrhea; or
  • liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Serious side effects may be more likely in older adults.

Common side effects may include:

  • dizziness, drowsiness;
  • constipation;
  • dry mouth, blurred vision;
  • trouble sleeping;
  • headache; or
  • feeling shaky or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Parnate (Tranylcypromine)

SLIDESHOW

Learn to Spot Depression: Symptoms, Warning Signs, Medication See Slideshow
Parnate Professional Information

SIDE EFFECTS

The following adverse reactions are described in greater detail in other sections:

  • Suicidal thoughts and behaviors [see WARNINGS AND PRECAUTIONS]
  • Hypertensive crisis and hypertension [see WARNINGS AND PRECAUTIONS]
  • Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
  • Activation of mania/hypomania [see WARNINGS AND PRECAUTIONS]
  • Hypotension [see WARNINGS AND PRECAUTIONS]
  • Hypotension and hypertension during anesthesia and perioperative care [see WARNINGS AND PRECAUTIONS]
  • Discontinuation syndrome [ see WARNINGS AND PRECAUTIONS]
  • Persistence of MAO inhibition after discontinuation [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Seizures[see WARNINGS AND PRECAUTIONS]
  • Hypoglycemia in diabetic patients [see WARNINGS AND PRECAUTIONS]
  • Aggravation of coexisting symptoms of depression [see WARNINGS AND PRECAUTIONS]
  • Adverse effects on the ability to drive and operate machinery [see WARNINGS AND PRECAUTIONS]

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, hyperreflexia, 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

DRUG INTERACTIONS

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, WARNINGS AND PRECAUTIONS]. 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]. 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 Usea Predominant Effect/Risk[Hypertensive Reaction (HR)b or Serotonin Syndrome (SS)c]
Agents with blood pressure-reducing effects Use with cautiondd Hypotension,e
Non-selective H1 receptor antagonists Contraindicateda Increased anticholinergic effects
Beta-adrenergic blockers (see also agents or procedures with blood pressure-reducing effects) Use with the cautiondd 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, SS, and HRg
Amphetamines and methylphenidates and derivatives Contraindicateda HR
Sympathomimetic drugs** Contraindicateda HR; Including risk of intracerebral hemorrhage
Triptans Contraindicateda 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];
b[see WARNINGS AND PRECAUTIONS];
c[see WARNINGS AND PRECAUTIONS]
dIf 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).
e[see WARNINGS AND PRECAUTIONS];
f[see WARNINGS AND PRECAUTIONS];
g[See OVERDOSE]

Table 4: Clinically Significant Drug Interactions with Individual Products*

Product Clinical Comment on Concomitant Usea Predominant Effect/Risk [Hypertensive Reaction (HR)b or Serotonin Syndrome (SS)c]
Altretamine Use with cautiond Orthostatic hypotensione
Buspirone Contraindicateda HR
Carbamazepine Contraindicateda SS
Chlorpromazine Use with cautiond Hypotensive effectse
Cyclobenzaprine Contraindicateda SS
Dextromethorphan Contraindicateda SS; Psychosis, bizarre behavior
Dopamine Contraindicateda HR
Droperidol Use with cautiond QT interval prolongation
Entacapone Use with cautiond HR
Fentanyl Use with cautiond SS
Hydroxytryptophan Contraindicateda SS
Levodopa Contraindicateda HR
Lithium Use with cautiond SS
Meperidine Contraindicateda SS
Methadone Use with cautiond SS
Methyldopa Contraindicateda HR
Metoclopramide Use with cautiond HR/SS
Mirtazapine Contraindicateda SS
Oxcarbazepine Use with cautiond because of close structural relationship with tricyclic antidepressants SS
Rasagiline Contraindicateda HR
Reserpine Contraindicateda HR
S-adenosyl-Lmethionine (SAMe) Contraindicateda SS
Tapentadol Contraindicateda HR/SS
Tetrabenazine Contraindicateda HR
Tolcapone Use with cautiond HR
Tramadol Use with cautiond SS; Increased seizure risk
Tryptophan Contraindicatea SS
*Some drugs in this table may also belong to groups listed in Table 3 above, and may be associated with additional interactions.
a[see CONTRAINDICATIONS];
b[see WARNINGS AND PRECAUTIONS];
c[see WARNINGS AND PRECAUTIONS]
dIf not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the interaction
e[see WARNINGS AND PRECAUTIONS]

Tyramine-Containing Foods And Beverages

PARNATE inhibits intestinal MAO, which is responsible for the catabolism of tyramine in food and beverages. As a result of this inhibition, large amounts of tyramine may enter the systemic circulation and precipitate a sudden elevation in blood pressure or hypertensive crisis [see WARNINGS AND PRECAUTIONS]. Instruct PARNATE-treated patients to avoid foods and beverages with significant tyramine content during treatment with PARNATE or within 2 weeks of stopping treatment (see Table 5 for a list of food and beverages containing significant amounts of tyramine).

Table 5: Foods and Beverages with and without Significant Amounts of Tyramine

Class of Food or Beverage Tyramine-Rich Foods and Beverages to Avoid Acceptable Foods and Drinks, Containing No or Little Tyramine
Meat, Poultry, and Fish Air dried, aged and fermented meats, sausages and salamis (including cacciatore, hard salami and mortadella); pickled herring; and any spoiled or improperly stored meat, poultry, and fish (e.g., foods that have undergone changes in coloration, odor, or become moldy); spoiled or improperly stored animal livers Fresh meat, poultry, and fish, including fresh processed meats (e.g., lunch meats, hot dogs, breakfast sausage, and cooked sliced ham)
Vegetables Broad bean pods (fava bean pods) All other vegetables
Dairy Aged cheeses Processed cheeses, mozzarella, ricotta cheese, cottage cheese, and yogurt
Beverages All varieties of tap beer and beers that have not been pasteurized so as to allow for ongoing fermentation and excessive amounts of caffeine. Concomitant use of alcohol with PARNATE is not recommended. (Bottled and canned beers and wines contain little or no tyramine.)
Other Concentrated yeast extract (e.g., Marmite), sauerkraut, most soybean products (including soy sauce and tofu), OTC supplements containing tyramine, and chocolate Brewer’s yeast, baker’s yeast, soy milk, commercial chain restaurant pizzas prepared with cheeses low in tyramine

Drug Abuse And Dependence

Abuse

Abuse of PARNATE has been reported. Some of these patients had a history of previous substance abuse.

The potential for abuse and the increased risk of serious adverse reactions with higher doses should be taken into account when considering the use of PARNATE for patients at increased risk for substance abuse.

Dependence

Dependence, evidenced by precipitation of withdrawal effects following abrupt discontinuation of PARNATE has been reported. Reported withdrawal effects included delirium (even with low daily doses), restlessness, anxiety, confusion, hallucinations, headache, weakness, diarrhea, and/or rapid relapse into depression. Thrombocytopenia and liver enzyme increases have also been observed in association with PARNATE withdrawal from high doses [See OVERDOSE]

Withdrawal effects have appeared within 1 to 3 days of discontinuation and have persisted for several weeks after discontinuation. The use of daily doses greater than recommended and longer duration of use appear to be associated with a higher risk of withdrawal effects.

Monitor for withdrawal effects for at least 1 week after discontinuation. Consider discontinuing PARNATE therapy by slow, gradual dose reduction [see DOSAGE AND ADMINISTRATION].

Read the entire FDA prescribing information for Parnate (Tranylcypromine)

© Parnate Patient Information is supplied by Cerner Multum, Inc. and Parnate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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