Desipramine Hydrochloride Tablets USP Rx only

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI 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 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 white to off-white, round film coated tablets debossed ‘ANI’ on one side and ‘710’ on the other side Bottles of 100           NDC 62559-710-01 25 mg white to off-white, round film coated tablets debossed ‘ANI’ over ‘711’ on one side and plain on the other side Bottles of 100           NDC 62559-711-01 50 mg white to off-white, round film coated tablets debossed ‘ANI’ over ‘712’ on one side and plain on the other side Bottles of 100           NDC 62559-712-01 75 mg white to off-white, round film coated tablets debossed ‘ANI’ over ‘713’ on one side and plain on the other side Bottles of 100           NDC 62559-713-01 100 mg white to off-white, round film coated tablets debossed ‘ANI’ over ‘714’ on one side and plain on the other side Bottles of 100           NDC 62559-714-01 150 mg white to off-white, round film coated tablets debossed ‘ANI’ over ‘715’ on one side and plain on the other side Bottles of 50            NDC 62559-715-50 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container. Protect from excessive heat. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 1586-01 Rev 05/19

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET, FILM
COATED
ANI 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 desipramine hydrochloride?
•
Yo

Summary of Product characteristics

DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET, FILM
COATED
ANI PHARMACEUTICALS, INC.
----------
DESIPRAMINE HYDROCHLORIDE TABLETS USP
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 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.
Each Desipramine Hydrochloride Tablet USP 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: microcrystalline cellulose,
colloidal silicon dioxide, lactose monohydrate, povidone,
croscarmellose sodium, magnesium stearate,
titanium dioxide, hy