DESIPRAMINE HYDROCHLORIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

DESIPRAMINE HYDROCHLORIDE (UNII: 1Y58DO4MY1) (DESIPRAMINE - UNII:TG537D343B)

Доступна з:

Ingenus Pharmaceuticals, LLC

ІПН (Міжнародна Ім'я):

DESIPRAMINE HYDROCHLORIDE

Склад:

DESIPRAMINE HYDROCHLORIDE 10 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Desipramine hydrochloride tablets, USP is indicated for the treatment of depression. The use of MAOIs intended to treat psychiatric disorders with desipramine hydrochloride or within 14 days of stopping treatment with desipramine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of desipramine hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting desipramine hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION). Desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.

Огляд продуктів:

10 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '112' on the other side. 25 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '113' on the other side. 50 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '114' on the other side. 75 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '115' on the other side. 100 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '116' on the other side. 150 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '117' on the other side. Store at 20o C to 25o C (68o F to 77o F) [See USP Controlled Room Temperature]. Protect from excessive heat. Dispense in a tight container. Rx Only 553403 Revised: 01/2023 Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811 Dispense with Medication Guide available at: www.ingenus.com/medguide/desipramine-hydrochloride-tablets.pdf

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET
Ingenus Pharmaceuticals, LLC
----------
Dispense with Medication Guide available at:
www.ingenus.com/medguide/desipramine-hydrochloride-
tablets.pdf
Medication Guide
Desipramine Hydrochloride (des-IP-ra-meen HYE-droe-KLOR-ide) Tablets,
USP
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, espe

Характеристики продукта

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET
INGENUS PHARMACEUTICALS, LLC
----------
DESIPRAMINE HYDROCHLORIDE 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 DESIPRAMINE
HYDROCHLORIDE 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. DESIPRAMINE HYDROCHLORIDE IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS _(SEE WARNINGS: CLINICAL_
_WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS,_
_AND PRECAUTIONS: PEDIATRIC USE.)_
DESCRIPTION
Desipramine hydrochloride, USP is an antidepressant drug of the
tricyclic type, and is
chemically:
5_H_-Dibenz[_bƒ_]azepine-5-propanamine,10,11-dihydro-_N_-methyl-,
monohydrochloride.
INACTIVE INGREDIENT
The following inactive ingredients are contained in all dosage
strengths: lactose
monohydrate, croscarmellose sodium, povidone K-30, opadry Y-1R-7000
white powder
(hypromellose 2910, titanium dioxide, polyethylene glycol
400/macrogol), and
magnesium stearate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Available evidence suggests that many depressions have a biochemical
basis in the form
of