DESIPRAMINE HCL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

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:

10 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '112' on the other side. NDC 50742-112-01: bottles of 100 25 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '113' on the other side. NDC 50742-113-01: bottles of 100 50 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '114' on the other side. NDC 50742-114-01: bottles of 100 75 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '115' on the other side. NDC 50742-115-01: bottles of 100 100 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '116' on the other side. NDC 50742-116-01: bottles of 100 150 mg white to off white, round, biconvex, film coated tablet debossed with 'ING' on one side and '117' on the other side. NDC 50742-117-50: bottles of 50 Storage Store at 20oC to 25oC (68oF to 77oF) [See USP Controlled Room Temperature]. Protect from excessive heat. Dispense in a tight container. Rx Only 553401 Revised: 06/2019 Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 [Ingenus Logo]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DESIPRAMINE HCL- DESIPRAMINE HCL TABLET
Direct_Rx
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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?
You should not take desipramine hydrochloride if you take a monoamine
oxidase

Summary of Product characteristics

DESIPRAMINE HCL- DESIPRAMINE HCL TABLET
DIRECT_RX
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DESIPRAMINE HCL
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.
[Structural Formula]
The following inactive ingredients are contained in all dosage
strengths: lactose
monohydrate, croscarmellose sodium, povidone K-30, opadry Y-1R-7000
white powder
(hypromellose 2910, titanium dioxide, polyethylene glycol
400/macrogol), and
magnesium stearate.
MECHANISM OF ACTION
Available evidence suggests that many depressions have a biochemical
basis in the form
of a relative deficiency of neurotransmitters such as norepinephrine
and serotonin.
Norepinephrine deficiency may be associated with relatively low
urinary 3-methoxy-4-
hydroxyphenyl glycol (MHPG) levels, while serotonin deficiencies may
be associated with
low spinal fluid levels of 5-hydroxyindoleacetic acid.
While the precise mechanism of action of the tricyclic antidepressants
is unknown, a
leading theory suggests that they restore normal levels of
neurotransmitters by blocking
the re-uptake of these substances from the synapse in the central
nervous system.
Evidence indicates that the secondary amine tricyclic antidepressants,
including
desipramine hydrochloride may have greater activity in blocking the
re-uptake of
norepinephrine. Tertiary amine tricyclic antidepressants, such as
amitriptyline, may have
greater effect on serotonin re-uptake.
Desipramine hydrochloride is not a monoamine oxidase inhibitor (MAOI)
and does not
act primarily as a central nervous system stimulant. It has been found
in some studies
to have a more rapid onset of action than imipramine. Earliest
therapeutic effects may
occasionally be seen in 2 to 5 days, but full treatment benefit
usually requires 2 to 3
weeks to obtain.
Metabolism
Tricyclic antidepressants, such as desipramine hydrochloride, are
rapidly absorbed from
the gastrointestinal tract. Tricyclic antidepressants or their
metabolites are to so