DESIPRAMINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

DESIPRAMINE HYDROCHLORIDE

Composition:

DESIPRAMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 23155-578-01: Bottles of 100 25 mg:  white to off white, round biconvex, coated tablets with 'I86' debossed on one side and plain on other side. NDC 23155-579-01: Bottles of 100 50 mg:  white to off white, round biconvex, coated tablets with 'I82' debossed on one side and plain on other side. NDC 23155-580-01: Bottles of 100 75 mg:  white to off white, round biconvex, coated tablets with 'I83' debossed on one side and plain on other side. NDC 23155-581-01: Bottles of 100 100 mg:  white to off white, round biconvex, coated tablets with 'I84' debossed on one side and plain on other side. NDC 23155-582-01: Bottles of 100 150 mg:  white to off white, round biconvex, coated tablets with 'I85' debossed on one side and plain on other side. NDC 23155-583-25: Bottles of 50 Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in tight container with child-resistant closure. Dispense with Medication Guide available at:www.avetpharma.com/product Manufactured by: USV Private Limited Daman - 396210, India Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 06/2023 Dispense with Medication Guide available at:www.avetpharma.com/product

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
----------
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 desipramin

Summary of Product characteristics

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
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: 5H-Dibenz [b,ƒ]
azepine-5-propanamine,10,11-dihydro-_N_-methyl-,
monohydrochloride.
Each desipramine hydrochloride, USP tablet contains 10 mg, 25 mg, 50
mg, 75 mg, 100
mg, or 150 mg of desipramine hydrochloride for oral administration.
INACTIVE INGREDIENTS The following inactive ingredients are contained
in all dosage
strengths: Hypromellose, lactose monohydrate, microcrystalline
cellulose, polyethylene
glycol, sodium starch glycolate type A (potato),