TRANYLCYPROMINE SULFATE- tranylcypromine sulfate tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Rising Pharmaceuticals, Inc.

INN (Internationale Bezeichnung):

TRANYLCYPROMINE SULFATE

Zusammensetzung:

TRANYLCYPROMINE 10 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

For the treatment of Major Depressive Episode Without Melancholia. Tranylcypromine Sulfate should be used in adult patients who can be closely supervised. It should rarely be the first antidepressant drug given. Rather, the drug is suited for patients who have failed to respond to the drugs more commonly administered for depression. The effectiveness of Tranylcypromine Sulfate has been established in adult outpatients, most of whom had a depressive illness which would correspond to a diagnosis of Major Depressive Episode Without Melancholia. As described in the American Psychiatric Association's Diagnostic and Statistical Manual, third edition (DSM III), Major Depressive Episode 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 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decreas

Produktbesonderheiten:

Tranylcypromine Sulfate is supplied as round, rose-red, film-coated tablets debossed with the product name PARNATE and SB and contains Tranylcypromine Sulfate equivalent to 10 mg of tranylcypromine, in bottles of 100 with a desiccant. 10 mg 100's: NDC 64980-183-01 Store between 15° and 30°C (59° and 86°F). * Amipaque, Nycomed Inc. † Antabuse, TEVA Women’s Health, Inc.

Berechtigungsstatus:

New Drug Application

Gebrauchsinformation

TRANYLCYPROMINE SULFATE - TRANYLCYPROMINE SULFATE TABLET
Rising Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Antidepressant Medicines, Depression and Other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Tranylcypromine Sulfate Tablets
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,
espe

Fachinformation

TRANYLCYPROMINE SULFATE - TRANYLCYPROMINE SULFATE TABLET
RISING PHARMACEUTICALS, INC.
----------
TRANYLCYPROMINE SULFATE 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 OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
TRANYLCYPROMINE 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.
TRANYLCYPROMINE
SULFATE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS
TO PHYSICIANS:
CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR
PATIENTS, AND
PRECAUTIONS: PEDIATRIC USE.)
DESCRIPTION
Chemically, tranylcypromine sulfate is
(±)-_trans_-2-phenylcyclopropylamine sulfate (2:1).
Each round, rose-red, film-coated tablet is debossed with the product
name PARNATE and SB and
contains tranylcypromine sulfate equivalent to 10 mg of
tranylcypromine. Inactive ingredients consist of
cellulose, citric acid, croscarmellose sodium, D&C Red No. 7, FD&C
Blue No. 2, FD&C Red No. 40,
FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, talc,
titanium dioxide, and trace amounts of
other inactive ingredients.
ACTION
Tranylcypromine is a non-hydrazine monoamine oxidase inhibitor with a
rapid on