Desipramine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Desipramine Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Suicidality and Antidepressant Drugs
WARNINGS: Clinical Worsening and Suicide RiskPRECAUTIONS: Information for PatientsPRECAUTIONS: Pediatric Use

DESIPRAMINE HYDROCHLORIDE DESCRIPTION


Desipramine Hydrochloride





CLINICAL PHARMACOLOGY





Metabolism





INDICATIONS & USAGE



DESIPRAMINE HYDROCHLORIDE CONTRAINDICATIONS




WARNINGS

Clinical Worsening and Suicide Risk




Age RangeDrug-Placebo Difference in Number of Cases ofof Suicidality per 1000 Patients Treated






Screening Patients for Bipolar Disorder


General










Use in Pregnancy


Geriatric Use
DOSAGE AND ADMINISTRATION


ADVERSE REACTIONS

PRECAUTIONS

Information for Patients



Clinical Worsening and Suicide Risk


Pediatric Use
BOX WARNINGWARNINGSClinical Worsening and Suicide Risk
ADVERSE REACTIONSCardiovascular

General
WARNINGSClinical 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






DESIPRAMINE HYDROCHLORIDE ADVERSE REACTIONS



Cardiovascular


PRECAUTIONSPediatric 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

























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














Desipramine Hydrochloride



Desipramine Hydrochloride



Desipramine Hydrochloride

Desipramine Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-198(NDC:0781-1973)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Desipramine Hydrochloride DESIPRAMINE 50 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 Size Imprint Code Shape
white 9 mm GG65 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-198-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072101 2011-04-21


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Be sure to consult your doctor before taking any medication!
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