PHENELZINE SULFATE tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

PHENELZINE SULFATE (UNII: 2681D7P965) (PHENELZINE - UNII:O408N561GF)

थमां उपलब्ध:

Greenstone LLC

INN (इंटरनेशनल नाम):

PHENELZINE SULFATE

रचना:

PHENELZINE 15 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Phenelzine sulfate has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients with endogenous features. Phenelzine sulfate should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions. Phenelzine sulfate should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function tests. The potentiation of sympathomimetic substances and related compounds by MAO inhibitors may result in hypertensive crises (see WARNINGS). Therefore, patients being treated with phenelzine sulfate should not take sy

उत्पाद समीक्षा:

Each phenelzine sulfate tablet is orange, biconvex, film-coated, and engraved with "P-D 270" and contains phenelzine sulfate equivalent to 15 mg of phenelzine base. NDC 59762-0119-1. Bottle of 60 Store between 15° – 30°C (59° – 86°F).

प्राधिकरण का दर्जा:

New Drug Application Authorized Generic

सूचना पत्रक

PHENELZINE SULFATE- PHENELZINE SULFATE TABLET, FILM COATED
Greenstone LLC
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MEDICATION GUIDE
ANTIDEPRESSANT MEDICINES,
DEPRESSION AND OTHER SERIOUS MENTAL
ILLNESSES, AND SUICIDAL THOUGHTS OR
ACTIONS
Read the Medication Guide that comes with you or your family member's
antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member's, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, and
young adults within the first few months of treatment.
2.
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.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
•
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 the 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 or your family member has
any of the following symptoms,
especially if they are new, worse, or worry you:
•

उत्पाद विशेषताएं

PHENELZINE SULFATE- PHENELZINE SULFATE TABLET, FILM COATED
GREENSTONE LLC
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PHENELZINE SULFATE TABLETS, USP
SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal
thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term
studies of major depressive
disorder (MDD) and other psychiatric disorders. Anyone considering the
use of phenelzine
sulfate or any other antidepressant in a child, adolescent, or young
adult must balance this risk
with the clinical need. Short-term studies did not show an increase in
the risk of suicidality with
antidepressants compared to placebo in adults beyond age 24; there was
a reduction in risk with
antidepressants compared to placebo in adults aged 65 and older.
Depression and certain other
psychiatric disorders are themselves associated with increases in the
risk of suicide. Patients of
all ages who are started on antidepressant therapy should be monitored
appropriately and
observed closely for clinical worsening, suicidality, or unusual
changes in behavior. Families
and caregivers should be advised of the need for close observation and
communication with the
prescriber. Phenelzine sulfate is not approved for use in pediatric
patients. (See Warnings:
Clinical Worsening and Suicide Risk, Precautions: Information for
Patients, and Precautions:
Pediatric Use)
DESCRIPTION
Phenelzine sulfate is a potent inhibitor of monoamine oxidase (MAO).
Phenelzine sulfate is a hydrazine
derivative. It has a molecular weight of 234.27 and is chemically
described as C H N • H SO . Its
chemical structure is shown below:
Each phenelzine sulfate film-coated tablet for oral administration
contains phenelzine sulfate equivalent
to 15 mg of phenelzine base and the following inactive ingredients:
mannitol, USP; croscarmellose
sodium, NF; povidone, USP; edetate disodium, USP; magnesium stearate,
NF; isopropyl alcohol, USP;
purified water, USP; opadry orange Y30-13242A.
CLINICAL PHARMACOLOGY
Monoamine oxidase is a complex