DESIPRAMINE HYDROCHLORIDE- desipramine hydrochloride tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

American Health Packaging

DCI (Denominação Comum Internacional):

DESIPRAMINE HYDROCHLORIDE

Composição:

DESIPRAMINE HYDROCHLORIDE 25 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Desipramine hydrochloride tablets, USP are 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.

Resumo do produto:

Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as: 25 mg: debossed GG 64 on one side and plain on the reverse side, and supplied as:      Unit dose packages of 30 (5 x 6) NDC 68084-972-25 Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature). FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET, FILM
COATED
American Health Packaging
----------
8297221/1016OS
MEDICATION GUIDE
Desipramine Hydrochloride Tablets, USP
(des ip' ra meen)
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?
1.
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.
2.
Call the healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
3.
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.
Who should not take desipramine HCl tablets, USP?
•
Y

Características técnicas

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET, FILM
COATED
AMERICAN HEALTH PACKAGING
----------
DESIPRAMINE HYDROCHLORIDE TABLETS, USP
8297221/1016OS
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
DESIPRAMINE HYDROCHLORIDE 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.
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 available as tablets of
10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg for oral administration.
Its chemical name is 5 _H_-
Dibenz[ _bf_]azepine-5-propanamine, 10, 11-dihydro- _N_-methyl-,
monohydrochloride.
Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, starch (corn), and
titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Available evidence suggests that many depressi