DESIPRAMINE HYDROCHLORIDE  - desipramine hydrochloride tablet 
REMEDYREPACK INC.

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BOXED WARNING

Suicidality and Antidepressant Drugs
WARNINGS: Clinical Worsening and Suicide Risk
, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

DESCRIPTION


MM1






CLINICAL PHARMACOLOGY

Mechanism of Action




Metabolism





INDICATIONS & USAGE



CONTRAINDICATIONS




WARNINGS

Clinical Worsening and Suicide Risk











Screening Patients for Bipolar Disorder


General










PREGNANCY



GERIATRIC USE

DOSAGE AND ADMINISTRATION


ADVERSE REACTIONS

PRECAUTIONS

Information for Patients



Clinical Worsening and Suicide Risk


PEDIATRIC USE

BOX WARNING WARNINGS Clinical Worsening and Suicide Risk
ADVERSE REACTIONS Cardiovascular

General
WARNINGS Clinical Worsening and Suicide Risk
If serious adverse effects occur, dosage should be reduced or treatment should be altered. Desipramine hydrochloride therapy in patients with manic-depressive illness may induce a hypomanic state after the depressive phase terminates.
The drug may cause exacerbation of psychosis in schizophrenic patients.
Both elevation and lowering of blood sugar levels have been reported.
Clinical experience in the concurrent administration of ECT and antidepressant drugs is limited. Thus, if such treatment is essential, the possibility of increased risk relative to benefits should be considered.
This drug should be discontinued as soon as possible prior to elective surgery because of possible cardiovascular effects. Hypertensive episodes have been observed during surgery in patients taking desipramine hydrochloride.

DRUG INTERACTIONS

Drugs Metabolized by P450 2D6






ADVERSE REACTIONS



Cardiovascular


PRECAUTIONS Pediatric Use

Psychiatric


Neurologic



Anticholinergic


Allergic


Hematologic


Gastrointestinal


Endocrine


Other


Withdrawal Symptoms


OVERDOSAGE



Oral LD50


Manifestations of Overdosage

ADVERSE REACTIONS

Management


General


Gastrointestinal Decontamination


Cardiovascular


CNS


Psychiatric Follow-up


Pediatric Management


DOSAGE & ADMINISTRATION

WARNINGS


Usual Adult Dose







Adolescent and Geriatric Dose





HOW SUPPLIED
























STORAGE AND HANDLING




SPL MEDGUIDE



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?




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.
Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

attempts to commit suicide
new or worse depression
new or worse anxiety
feeling very agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?

Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.







PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














MM2




MM3





DESIPRAMINE HYDROCHLORIDE 
desipramine hydrochloride   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49349-172 (00781-1971)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE) DESIPRAMINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
HYDROXYPROPYL CELLULOSE  
HYPROMELLOSE 2910 (3 MPA.S)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL  
STARCH, CORN  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score no score
Shape ROUND (TABLET) Size 6mm
Flavor Imprint Code GG63
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 49349-172-02 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072104 04/18/2011

Labeler - REMEDYREPACK INC. (829572556)
Revised: 04/2011 REMEDYREPACK INC.