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

Doxepin Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

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 doxepin 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 beyone 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. Doxepin is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk,PRECAUTIONS: Information for PatientsandPRECAUTIONS: Pediatric Use.)


DESCRIPTION


DESCRIPTION





CLINICAL PHARMACOLOGY





INDICATIONS & USAGE









CONTRAINDICATIONS




WARNINGS


Clinical Worsening and Suicide Risk






All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.


Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.

Screening Patients for Bipolar Disorder


Geriatric Use
PRECAUTIONS: Geriatric Use

Pregnancy


Pediatric Use


PRECAUTIONS

Information for Patients



Clinical Worsening and Suicide Risk


DRUG INTERACTIONS

Drugs Metabolized by P450 2D6





MAO Inhibitors


Cimetidine


Alcohol


Tolazamide


Drowsiness

PRECAUTIONS: Geriatric Use

Suicide


Psychosis


PEDIATRIC USE

BOX WARNINGWARNINGS: Clinical Worsening and Suicide Risk


GERIATRIC USE



WARNINGS

ADVERSE REACTIONS

NOTE:
Anticholinergic Effects:
Central Nervous System Effects:
Cardiovascular:
Allergic:
Hematologic:
Gastrointestinal:
Endocrine:
Other:

Withdrawal Symptoms


OVERDOSAGE



Manifestations

ADVERSE REACTIONS


General Recommendations

General


Gastrointestinal Decontamination


Cardiovascular



CNS


Psychiatric Follow-up


Pediatric Management


DOSAGE & ADMINISTRATION







HOW SUPPLIED




























STORAGE AND HANDLING






SPL MEDGUIDE

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions
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.
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:

What else do I need to know about antidepressant medicines?
  •      Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
  •      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














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Doxepin Hydrochloride

Doxepin Hydrochloride CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-865(NDC:0378-1049)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE Doxepin 10 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
STARCH, CORN
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
GELATIN
titanium dioxide
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
propylene glycol
SHELLAC

Product Characteristics

Color Size Imprint Code Shape
white 14 mm MYLAN;1049 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-865-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070789 2012-01-17


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Be sure to consult your doctor before taking any medication!
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