Desipramine Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- DESIPRAMINE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- DESIPRAMINE HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DRUG INTERACTIONS
- DESIPRAMINE HYDROCHLORIDE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
Suicidality and Antidepressant DrugsWARNINGS: Clinical Worsening and Suicide RiskPRECAUTIONS: Information for PatientsPRECAUTIONS: Pediatric Use
DESIPRAMINE HYDROCHLORIDE DESCRIPTION
CLINICAL PHARMACOLOGY
Metabolism
INDICATIONS & USAGE
DESIPRAMINE HYDROCHLORIDE CONTRAINDICATIONS
WARNINGS
Clinical Worsening and Suicide RiskAge 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 PatientsClinical 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 2D6DESIPRAMINE 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
WARNINGSUsual Adult Dose
Adolescent and Geriatric Dose
HOW SUPPLIED
SPL MEDGUIDE
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● all risks and benefits of treatment with antidepressant medicines
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● all treatment choices for depression or other serious mental illness
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● What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
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● Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
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● 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.
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● 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:
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● attempts to commit suicide
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● new or worse depression
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● new or worse anxiety
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● feeling very agitated or restless
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● panic attacks
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● trouble sleeping (insomnia)
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● new or worse irritability
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● acting aggressive, being angry, or violent
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● acting on dangerous impulses
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● an extreme increase in activity and talking (mania)
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● other unusual changes in behavior or mood
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● What else do I need to know about antidepressant medicines?
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● 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.
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● 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.
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● 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.
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● Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.
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● 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 HydrochlorideDesipramine Hydrochloride TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
