Tranylcypromine Sulfate
Generic Name: tranylcypromine sulfate
Brand Names:
Tranylcypromine Sulfate
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.
Overview
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.
Uses
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)].
Dosage
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 ) 2.1 Recommended Dosage Tranylcypromine sulfate tablets are for oral use. The recommended dosage is 30 mg per day (in divided doses).
Side Effects
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 diabe...
Interactions
7 DRUG INTERACTIONS See Full Prescribing Information for a list of products, foods and beverages that can interact with tranylcypromine sulfate tablets (7) 7.1 Clinically 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.
Warnings
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)] . 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) 5.1 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 pediatr... 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.
Pregnancy
8.1 Pregnancy 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.
Storage
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).
Frequently Asked Questions
What is Tranylcypromine Sulfate used for?▼
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)].
What are the side effects of Tranylcypromine Sulfate?▼
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 diabe...
Can I take Tranylcypromine Sulfate during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Tranylcypromine Sulfate?▼
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)] . 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) 5.1 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 pediatr... 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.