DESIPRAMINE HYDROCHLORIDE 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:

Alembic Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desipramine hydrochloride tablets, USP are indicated for the treatment of depression. The use of MAOIs intended to treat psychiatric disorders with desipramine hydrochloride tablet or within 14 days of stopping treatment with desipramine hydrochloride tablet is contraindicated because of an increased risk of serotonin syndrome. The use of desipramine hydrochloride tablet within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting desipramine hydrochloride tablets 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 tablets are 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 dibenzaze

Product summary:

Desipramine hydrochloride tablets USP, 10 mg are blue, round, biconvex film-coated tablets debossed with “L” on one side and “01”on other side. They are supplied as follows: NDC 62332-315-30                bottle of 30 tablets NDC 62332-315-31                bottle of 100 tablets NDC 62332-315-91                bottle of 1000 tablets Desipramine hydrochloride tablets USP, 25 mg are yellow, round, biconvex film-coated tablets debossed with “L” on one side and “02” on other side. They are supplied as follows: NDC 62332-316-30                bottle of 30 tablets NDC 62332-316-31                bottle of 100 tablets NDC 62332-316-91                bottle of 1000 tablets Desipramine hydrochloride tablets USP, 50 mg are green, round, biconvex film-coated tablets debossed with “L” on one side and “03”on other side. They are supplied as follows: NDC 62332-317-30                bottle of 30 tablets NDC 62332-317-31                bottle of 100 tablets NDC 62332-317-91                bottle of 1000 tablets Desipramine hydrochloride tablets USP, 75 mg are orange, round, biconvex film-coated tablets debossed with “566” on one side plain on other side. They are supplied as follows: NDC 62332-318-30                bottle of 30 tablets NDC 62332-318-31                bottle of 100 tablets NDC 62332-318-91                bottle of 1000 tablets Desipramine hydrochloride tablets USP, 100 mg are peach, round, biconvex film-coated tablets debossed with “567” on one side and plain on other side. They are supplied as follows: NDC 62332-319-30                bottle of 30 tablets NDC 62332-319-31                bottle of 100 tablets NDC 62332-319-91                bottle of 1000 tablets Desipramine hydrochloride tablets USP, 150 mg are white, round, biconvex film-coated tablets debossed with “568” on one side and plain on other side. They are supplied as follows: NDC 62332-320-30                bottle of 30 tablets NDC 62332-320-50                bottle of 50 tablets NDC 62332-320-31                bottle of 100 tablets NDC 62332-320-91                bottle of 1000 tablets  Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight container. Protect from excessive heat. Rx Only Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 09/2021

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DESIPRAMINE HYDROCHLORIDE - desipramine hydrochloride tablet, film
coated
Alembic Pharmaceuticals Inc.
----------
Medication Guide
Desipramine Hydrochloride
(des-IP-ra-meen HYE-droe-KLOR-ide)
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 tablet

Summary of Product characteristics

DESIPRAMINE HYDROCHLORIDE - DESIPRAMINE HYDROCHLORIDE TABLET, FILM
COATED
ALEMBIC 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 TABLETS ARE 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 [bƒ] 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
The following inactive ingredients are contained in all dosage
strengths: croscarmellose
sodium, microcrystalline cellulose, hydroxypropyl cellulose, citric
acid monohydrate,
magnesium stearate, hypromello