TRANYLCYPROMINE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Solco Healthcare US, LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine 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)] . Concomitant use of tranylcypromine tablets 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 tranylcypromine tablets and contraindicated agents are recommended [see Dosage and Administration (2.2) and

Podsumowanie produktu:

Tranylcypromine Tablets, USP are available as round, red, film-coated tablets debossed with "10" on one side and plain on the other side, containing tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. They are supplied in bottles of 100 tablets with a desiccant. Store between 15° and 30°C (59° and 86°F).  [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

Solco Healthcare US, LLC
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MEDICATION GUIDE
Tranylcypromine Tablets, USP
(tran"-ill-sip'-roe-meen)
What is the most important information I should know about
tranylcypromine tablets?
Tranylcypromine tablets 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 tranylcypromine tablets 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 . Tranylcypromine tablets are 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
•
new or worse depression
•
feeling agitated, restless,
angry or irritable
•
trouble sleeping
•
acting aggressive, being
angry or violent
•
an extreme increase in
activity or talking (mania)
•
attempts to commit suicide
•
new or worse anxiety
•
panic attacks
•
new or worse irritability
•
acting on dangerous impulses
•
other unusual changes in behavior or mood
•
A sudden, severe increase in blood pressure (hypertensive crisis). A
hypertensive

Charakterystyka produktu

TRANYLCYPROMINE- TRANYLCYPROMINE TABLET
SOLCO HEALTHCARE US, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRANYLCYPROMINE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRANYLCYPROMINE
TABLETS.
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.
TRANYLCYPROMINE TABLETS ARE 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)
RECENT MAJOR CHANGES
Boxed Warning
1/2018
Dosage and Administration ( 2)
1/2018
Contraindications ( 4)
1/2018
Warnings and Precautions ( 5)
1/2018
INDICATIONS AND USAGE
Tranylcypromine tablets are 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)
Tranylcypromine 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 ( 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 tranylcyp