PARNATE- tranylcypromine sulfate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRANYLCYPROMINE SULFATE (UNII: 7ZAT6ES870) (TRANYLCYPROMINE - UNII:3E3V44J4Z9)

Available from:

Concordia Pharmaceuticals Inc.

INN (International Name):

TRANYLCYPROMINE SULFATE

Composition:

TRANYLCYPROMINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . 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 - Other monoamine oxidase inhibitors (MAOIs) - Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inh

Product summary:

PARNATE (tranylcypromine) tablets are available as:  Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light resistant container.

Authorization status:

New Drug Application

Patient Information leaflet

PARNATE - tranylcypromine sulfate tablet, film coated
Concordia Pharmaceuticals Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
PARNATE® (PAR-nate)
(tranylcypromine)
Tablets
What is the most important information I should know about PARNATE?
PARNATE can 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 PARNATE 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. PARNATE is 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

Summary of Product characteristics

PARNATE - TRANYLCYPROMINE SULFATE TABLET, FILM COATED
CONCORDIA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PARNATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PARNATE.
PARNATE
(TRANYLCYPROMINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1961
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. PARNATE
IS 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)
INDICATIONS AND USAGE
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)
DOSAGE FORMS AN