DESIPRAMINE HYDROCHLORIDE- desipramine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals NY LLC

INN (International Name):

DESIPRAMINE HYDROCHLORIDE

Composition:

DESIPRAMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desipramine hydrochloride tablets 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.

Product summary:

Desipramine Hydrochloride Tablets USP, 10 mg are supplied as light blue to blue colored, round, biconvex, film-coated tablets, debossed “AA” and “11” on one side and plain on the other side. Bottles of 30:                          NDC 69238-1053-3 Bottles of 100:                        NDC 69238-1053-1 Desipramine Hydrochloride Tablets USP, 25 mg are supplied as light yellow to yellow colored, round, biconvex, film-coated tablets, debossed “AA” and “12” on one side and plain on the other side. Bottles of 30:                          NDC 69238-1055-3 Bottles of 100:                        NDC 69238-1055-1 Desipramine Hydrochloride Tablets USP, 50 mg are supplied as light green to green colored, round, biconvex, film-coated tablets, debossed “AA” and “13” on one side and plain on the other side. Bottles of 30:                          NDC 69238-1057-3 Bottles of 100:                        NDC 69238-1057-1 Desipramine Hydrochloride Tablets USP, 75 mg are supplied as light red to red colored, round, biconvex, film-coated tablets, debossed “AA” and “14” on one side and plain on the other side. Bottles of 30:                          NDC 69238-1059-3 Bottles of 100:                        NDC 69238-1059-1 Desipramine Hydrochloride Tablets USP, 100 mg are supplied as peach colored, round, biconvex, film-coated tablets, debossed “AA” and “15” on one side and plain on the other side. Bottles of 30:                          NDC 69238-1061-3 Bottles of 100:                        NDC 69238-1061-1 Desipramine Hydrochloride Tablets USP, 150 mg are supplied as white to off-white, round, biconvex, film-coated tablets, debossed “AA” and “16” on one side and plain on the other side. Bottles of 50:                          NDC 69238-1063-2 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from excessive heat. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2023-05

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE TABLET, FILM COATED
Amneal Pharmaceuticals NY LLC
----------
MEDICATION GUIDE
Desipramine (des-IP-ra-meen) 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 tablets?
•
You should not take

Summary of Product characteristics

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS NY LLC
----------
DESIPRAMINE HYDROCHLORIDE TABLETS, USP
(10 MG, 25 MG, 50 MG, 75 MG, 100 MG & 150 MG)
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 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 is an antidepressant drug of the tricyclic
type, and is
chemically:
5_H_-Dibenz[_b_ƒ]azepine-5-propanamine,10,11-dihydro-_N_-methyl-,
monohydrochloride.
Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50
mg, 75 mg, 100
mg, or 150 mg of desipramine hydrochloride, USP for oral
administration.
INACTIVE INGREDIENTS
Desipramine hydrochloride tablets, USP contain the following inactive
ingredients: corn
starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum
lake (in 10 mg
and 50 mg), FD&C Blu