Tranylcypromine (Page 3 of 7)

5.5 Hypotension

Hypotension, including postural hypotension, has been observed during therapy with tranylcypromine tablets. At doses above 30 mg daily, postural hypotension is a major adverse reaction and may result in syncope. Symptoms of postural hypotension are seen most commonly, but not exclusively, in patients with pre-existing hypertension. Blood pressure usually returns rapidly to pretreatment levels upon discontinuation of tranylcypromine tablets.

Dosage increases should be made more gradually in patients with a tendency toward hypotension and/or postural hypotension (e.g., elderly patients) [see Dosage and Administration (2.2) and Use in Specific Populations (8.5)]. Such patients should be closely observed for postural changes in blood pressure throughout treatment. Also, when tranylcypromine tablets are used concomitantly with other agents known to cause hypotension, the possibility of additive hypotensive effects should be considered [see Drug Interactions (7.1)]. Postural hypotension may be relieved by having patients lie down until blood pressure returns to normal.

5.6 Hypotension and Hypertension during Anesthesia and Perioperative Care

It is recommended that tranylcypromine tablets be discontinued at least 10 days prior to elective surgery. If this is not possible, for general anesthesia, regional and local anesthesia, and perioperative care avoid the use of agents that are contraindicated for concomitant use with tranylcypromine tablets. Carefully consider the risk of agents and techniques that increase the risk for hypotension (e.g., epidural or spinal anesthesia) or other adverse reactions to tranylcypromine tablets (e.g., hypertension associated with the use of vasoconstrictors in local anesthetics).

5.7 Need for Emergency Treatment with Contraindicated Drugs

If in the absence of therapeutic alternatives emergency treatment with a contraindicated product (e.g., linezolid, intravenous methylene blue, direct-acting sympathomimetic drugs such as epinephrine) becomes necessary and cannot be delayed, discontinue tranylcypromine tablets as soon as possible before initiating treatment with the other product and monitor closely for adverse reactions [see Drug Interactions (7.1)].

5.8 Discontinuation Syndrome

Abrupt discontinuation or dosage reduction of tranylcypromine tablets has been associated with the appearance of new symptoms that include dizziness, nausea, headache, irritability, insomnia, diarrhea, anxiety, fatigue, abnormal dreams, and hyperhidrosis. In general, discontinuation events occurred more frequently with longer duration of therapy.

There have been spontaneous reports of adverse reactions occurring upon discontinuation of MAOIs, particularly when abrupt, including dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesia, such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. While these reactions are generally self-limiting, there have been reports of prolonged discontinuation symptoms.

Patients should be monitored for these symptoms when discontinuing treatment with tranylcypromine tablets. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible [see Dosage and Administration (2.3) and Adverse Reactions (6)].

5.9 Risk of Clinically Significant Adverse Reactions due to Persistence of MAO Inhibition after Discontinuation

Although excretion of tranylcypromine tablets is rapid, inhibition of MAO may persist up to 10 days following discontinuation. This should be taken into account when considering the use of potentially interacting substances or the consumption of tyramine-rich food or beverages [see Drug Interactions (7.4)] , or when interpreting adverse reactions observed after discontinuation of tranylcypromine tablets. Care should be taken to differentiate symptoms of persistent MAO inhibition from withdrawal symptoms [see Drug Abuse and Dependence (9.3)].

5.10 Hepatotoxicity

Hepatitis and elevated aminotransferases have been reported in association with tranylcypromine tablets administration. Patients should be monitored accordingly. tranylcypromine tablets should be discontinued in patients who develop signs and symptoms of hepatotoxicity.

Sedation has occurred in tranylcypromine tablet-treated patients with cirrhosis. Patients with cirrhosis receiving tranylcypromine tablets should be monitored for possible increased risks of central nervous system adverse reactions, such as excessive drowsiness.

5.11 Seizures

Seizures have been reported with tranylcypromine tablets withdrawal after abuse, and with overdose. Patients at risk for seizures should be monitored accordingly.

5.12 Hypoglycemia in Diabetic Patients

Some MAOIs have contributed to hypoglycemic episodes in diabetic patients receiving insulin or other blood-glucose-lowering agents. Monitor blood glucose in patients receiving both tranylcypromine tablets and blood-glucose-lowering agents. A reduction of the dosage of such agents may be necessary [see Drug Interactions (7.1)].

5.13 Aggravation of Coexisting Symptoms of Depression

Tranylcypromine tablets may aggravate coexisting symptoms in depression, such as anxiety and agitation.

5.14 Adverse Effects on the Ability to Drive and Operate Machinery

Some tranylcypromine tablets adverse reactions (e.g., hypotension, faintness, drowsiness, confusion, disorientation) can impair a patient’s ability to operate machinery or use an automobile. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that tranylcypromine tablets therapy does not impair their ability to engage in such activities.

6 ADVERSE REACTIONS

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

  • Suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]
  • Hypertensive crisis and hypertension [see Warnings and Precautions (5.2)]
  • Serotonin syndrome [see Warnings and Precautions (5.3)]
  • Activation of mania/hypomania [see Warnings and Precautions (5.4)]
  • Hypotension [see Warnings and Precautions (5.5)]
  • Hypotension and hypertension during anesthesia and perioperative care [see Warnings and Precautions (5.6)]
  • Discontinuation syndrome [see Warnings and Precautions (5.8)]
  • Persistence of MAO inhibition after discontinuation [see Warnings and Precautions (5.9)]
  • Hepatotoxicity [see Warnings and Precautions (5.10)]
  • Seizures [see Warnings and Precautions (5.11)]
  • Hypoglycemia in diabetic patients [see Warnings and Precautions (5.12)]
  • Aggravation of coexisting symptoms of depression [see Warnings and Precautions (5.13)]
  • Adverse effects on the ability to drive and operate machinery [see Warnings and Precautions (5.14)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Based on clinical trial data, the most common adverse reactions to tranylcypromine were dry mouth, dizziness, insomnia, sedation, and headache (>30%) and overexcitement, constipation, blurred vision, and tremor (>10%).

The following adverse reactions have been identified in clinical trials or during postapproval use of tranylcypromine tablets:

B lood and lymphatic system disorders: agranulocytosis, leukopenia, thrombocytopenia, anemia

E ndocrine disorders: impaired water excretion compatible with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH)

Me tabolism and nutrition disorders: significant anorexia, weight gain

P sychiatric disorders: excessive stimulation/overexcitement, manic symptoms/hypomania, agitation, insomnia, anxiety, confusion, disorientation, loss of libido

Nervous system disorders: dizziness, restlessness/akathisia, akinesia, ataxia, myoclonic jerks, tremor, hyper-reflexia, muscle spasm, paresthesia, numbness, memory loss, sedation, drowsiness, dysgeusia, headaches (without blood pressure elevation)

Ey e disorders: blurred vision, nystagmus

E ar and labyrinth disorders: tinnitus

Cardiac disorders: tachycardia, palpitations

V ascular disorders: hypertensive crisis, hypertension, hypotension (including postural hypotension with syncope)

G astrointestinal disorders: diarrhea, constipation, nausea, abdominal pain, dry mouth, fissuring in corner of mouth

He patobiliary disorders: hepatitis, elevated aminotransferases

Skin and subcutaneous tissue disorders: localized scleroderma, flare-up of cystic acne, urticaria, rash, alopecia, sweating

Re nal and urinary disorders: urinary retention, urinary incontinence, urinary frequency

Re productive system and breast disorders: impotence, delayed ejaculation

General disorders and administration site conditions: edema, chills, weakness, fatigue/lethargy

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.