DESIPRAMINE HYDROCHLORIDE- desipramine hydrochloride tablet, sugar coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

desipramine hydrochloride (UNII: 1Y58DO4MY1) (desipramine - UNII:TG537D343B)

Available from:

Winthrop U.S.

INN (International Name):

desipramine hydrochloride

Composition:

desipramine hydrochloride 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desipramine hydrochloride 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.

Product summary:

10 mg blue coated tablets imprinted W-30 25 mg yellow coated tablets imprinted W 1031 50 mg green coated tablets imprinted W 1032 75 mg orange coated tablets imprinted W 1033 100 mg peach coated tablets imprinted W 1034 150 mg white coated tablets imprinted W 1035 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in tight container.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET, SUGAR
COATED
Winthrop U.S.
----------
MEDICATION GUIDE
Desipramine Hydrochloride 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, especially if you have concerns
about symptoms.
Who should not take Desipramine Hydrochloride?
•
You should not take desipramine hydrochloride if

Summary of Product characteristics

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET, SUGAR
COATED
WINTHROP U.S.
----------
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 INGREDIENTS
The following inactive ingredients are contained in all dosage
strengths: acacia, calcium carbonate,
corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and
150 mg), FD&C Blue No. 1
(except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide,
light mineral oil, magnesium
stearate, mannitol, polyethylene glycol 8000, pregelatinized corn
starch, sodium benzoate (except 150
mg),