PHENELZINE SULFATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Novel Laboratories, Inc.

INN (Nome Internazionale):

PHENELZINE SULFATE

Composizione:

PHENELZINE 15 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Phenelzine Sulfate Tablets, USP 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 Tablets 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 Tablets 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 Phenelzi

Dettagli prodotto:

Each Phenelzine Sulfate Tablets is orange, biconvex, film-coated tablets, debossed with “NL” on one side and “360” on the other side. Contains phenelzine sulfate equivalent to 15 mg of phenelzine base. NDC 40032-360-21. Bottle of 60 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] . Preserve in tight containers, protected from heat and light. Rx only Manufactured by: Novel Laboratories Inc, Somerset, NJ 08873 NIN-360-02 August 2014

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

PHENELZINE SULFATE - PHENELZINE SULFATE TABLET
Novel Laboratories, Inc.
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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:
�

Scheda tecnica

PHENELZINE SULFATE - PHENELZINE SULFATE TABLET
NOVEL LABORATORIES, INC.
----------
PHENELZINE SULFATE TABLETS, USP
NOVEL LABORATORIES, INC.
RX ONLY
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 Tablets 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 Tablets is not approved for
use in pediatric patients.
(SeeWarnings: ClinicalWorsening and Suicide Risk, Precautions:
Information for Patients, and
Precautions: Pediatric Use)
DESCRIPTION
Phenelzine Sulfate Tablets, USP (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 Tablets film-coated for oral administration
contains phenelzine sulfate
equivalent to 15 mg of phenelzine base and the following inactive
ingredients: mannitol, USP; colloidal
silicon dioxide, NF; povidone, USP; edentate disodium, USP; magnesium
stearate, NF; purified water,
USP; polyvinyl alcohol