DESIPRAMINE HYDROCHLORIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

INDICUS PHARMA LLC

DCI (Denominação Comum Internacional):

DESIPRAMINE HYDROCHLORIDE

Composição:

DESIPRAMINE HYDROCHLORIDE 10 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 WARNINGSand 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 WARNINGSand 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 available as: 10 mg: white to off white, rounded square shape, biconvex, coated tablets with 'N6' debossed on one side and plain on other side. NDC 24724-067-03: bottles of 30 NDC 24724-067-50: bottles of 500 25 mg: white to off white, round biconvex, coated tablets with 'I86' debossed on one side and plain on other side. NDC 24724-068-03: bottles of 30 NDC 24724-068-50: bottles of 500 50 mg: white to off white, round biconvex, coated tablets with 'I82' debossed on one side and plain on other side. NDC 24724-069-03: bottles of 30 NDC 24724-069-50: bottles of 500 75 mg: white to off white, round biconvex, coated tablets with 'I83' debossed on one side and plain on other side. NDC 24724-070-03: bottles of 30 NDC 24724-070-50: bottles of 500 100 mg: white to off white, round biconvex, coated tablets with 'I84' debossed on one side and plain on other side. NDC 24724-071-03: bottles of 30 NDC 24724-071-50: bottles of 500 150 mg: white to off white, round biconvex, coated tablets with 'I85' debossed on one side and plain on other side. NDC 24724-072-03: bottles of 30 NDC 24724-072-50: bottles of 500 Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in tight container. Rx only Rev. July 2016 Manufactured by: USV Private Limited, H-13,16,16A,17,18,19,20,21,E-22, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396 210, India Manufactured for: Indicus Pharma LLC, 12308 Richmond Run Drive Raleigh, NC 27614

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET
INDICUS PHARMA LLC
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MEDICATION GUIDE
Desipramine Hydrochloride Tablets, USP
(des-IP-ra-meen HYE-droe-KLOR-ide)
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.
Who should not take desipramine hydrochloride tablets, USP?
•
You shoul

Características técnicas

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET
INDICUS PHARMA 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 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, and is chemically: 5 H -
Dibenz [bƒ] azepine - 5 - propanamine, 10, 11 - dihydro - N - methyl
-, monohydrochloride.
INACTIVE INGREDIENTS
The following inactive ingredients are contained in all dosage
strengths:
Lactose monohydrate, microcrystalline cellulose, sodium starch
glycolate type A (potato), stearic acid
and hypromellose, talc, polyethylene glycol and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Available evidence suggests that many depressions have a biochemical
basis in the form of a relative