MARPLAN- isocarboxazid tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ISOCARBOXAZID (UNII: 34237V843T) (ISOCARBOXAZID - UNII:34237V843T)

から入手可能:

Validus Pharmaceuticals LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Marplan is indicated for the treatment of depression. Because of its potentially serious side effects, Marplan is not an antidepressant of first choice in the treatment of newly diagnosed depressed patients. The efficacy of Marplan in the treatment of depression was established in 6-week controlled trials of depressed outpatients.  These patients had symptoms that corresponded to the DSM-IV category of major depressive disorder; however, they often also had signs and symptoms of anxiety (anxious mood, panic, and/or phobic symptoms) ( see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of gui

製品概要:

Marplan tablets 10 mg are peach colored, round and scored with "MARPLAN 10" imprinted on one side and scored on the other.  Supplied in bottles of 100 (NDC 30698-032-01). Storage: Store at 77ºF (25ºC); excursions permitted to 59º to 86ºF (15º to 30ºC) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in USP. R x   O nly Manufactured for and Distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054 [e-mail] www.validuspharma.com 1-866-982-5438 © 2023 Validus Pharmaceuticals LLC    All rights reserved 60009-09        April 2023

認証ステータス:

New Drug Application

情報リーフレット

MARPLAN- ISOCARBOXAZID TABLET
Validus Pharmaceuticals LLC
----------
Medication Guide
Marplan® Tablets
(isocarboxazid)
Antidepressant Medicines, Depression and other Serious Mental
Illnesses,
and Suicidal Thoughts or Actions
Read the Medication Guide that comes with your 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, wor

製品の特徴

MARPLAN- ISOCARBOXAZID TABLET
VALIDUS PHARMACEUTICALS LLC
----------
MARPLAN
BRAND OF ISOCARBOXAZID TABLETS
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 WITH MAJOR DEPRESSIVE DISORDER (MDD) AND
OTHER PSYCHIATRIC DISORDERS. ANYONE CONSIDERING THE USE OF MARPLAN 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. MARPLAN IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS
_(SEE_
_WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS:
INFORMATION_
_FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE)_.
POOLED ANALYSES OF SHORT-TERM (4 TO 16 WEEKS) PLACEBO-CONTROLLED
TRIALS
OF 9 ANTIDEPRESSANT DRUGS (SSRIS AND OTHERS) IN CHILDREN AND
ADOLESCENTS WITH MAJOR DEPRESSIVE DISORDER (MDD), OBSESSIVE
COMPULSIVE DISORDER (OCD), OR OTHER PSYCHIATRIC DISORDERS (A TOTAL OF
24
TRIALS INVOLVING OVER 4400 PATIENTS) HAVE REVEALED A GREATER RISK OF
ADVERSE EVENTS REPRESENTING SUICIDAL THINKING OR BEHAVIOR
(SUICIDALITY)
DURING THE FIRST FEW MONTHS OF TREATMENT IN THOSE RECEIVING
ANTIDEPRESSANTS. THE AVERAGE RISK OF SUCH EVENTS IN PATIENTS RECEIVING
ANTIDEPRESSANTS WAS 4%, TWICE THE PLACEBO RISK OF 2%. NO SUICIDES
OCCURRED IN THESE TRIALS.
DESCRIPTION
Marplan (isocarboxazid), a monoam