NARDIL- phenelzine sulfate tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Parke-Davis Div of Pfizer Inc

INN (Nome Internazionale):

PHENELZINE SULFATE

Composizione:

PHENELZINE 15 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

NARDIL 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. NARDIL 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. NARDIL 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 NARDIL should not take sympathomimetic drugs (including amphetamines, co

Dettagli prodotto:

Each NARDIL tablet is orange, biconvex, film-coated, and engraved with "P-D 270" and contains phenelzine sulfate equivalent to 15 mg of phenelzine base. NDC 0071-0350-60. Bottle of 60 Store between 15° – 30°C (59° – 86°F).

Stato dell'autorizzazione:

New Drug Application

Foglio illustrativo

NARDIL- PHENELZINE SULFATE TABLET, FILM COATED
Parke-Davis Div of Pfizer Inc
----------
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.
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

NARDIL- PHENELZINE SULFATE TABLET, FILM COATED
PARKE-DAVIS DIV OF PFIZER INC
----------
NARDIL
(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 Nardil 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. Nardil is not
approved for use in pediatric patients. (See Warnings: Clinical
Worsening and Suicide Risk,
Precautions: Information for Patients, and Precautions: Pediatric Use)
DESCRIPTION
NARDIL (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 NARDIL 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 enzyme system,