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

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Amitriptyline Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Suicidality and Antidepressant Drugs:
Antidpressants 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 amitriptyline hydrochloride tablets 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 wiht antidepressants compared to placebo in adults beyond 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 commnication with the prescriber. Amitritpyline hydrochloride is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk,PRECAUTIONS: Information for Patients, andPRECAUTIONS: Pediatric Use)


AMITRIPTYLINE HYDROCHLORIDE DESCRIPTION



Amitriptyline Hydrochloride



CLINICAL PHARMACOLOGY




INDICATIONS & USAGE



AMITRIPTYLINE HYDROCHLORIDE 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 health care providers. Such monitoring should include daily observation by families and caregivers.

Screening Patients for Bipolar Disorder







Usage in Pregnancy

Pregnancy Category C
1



1

Nursing Mothers



Usage in Pediatric Patients


PRECAUTIONS








INFORMATION FOR PATIENTS




Clinical Worsening and Suicide Risk



DRUG INTERACTIONS

Drugs Metabolized by P450 2D6



CONTRAINDICATIONSseeWARNINGSsection.
When amitriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.
Hyperpyrexia has been reported when amitriptyline is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.
Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs.
Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.
Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 to 150 mg of amitriptyline hydrochloride.

GERIATRIC USE


DOSAGE AND ADMINISTRATION

PEDIATRIC USE

BOX WARNINGWARNINGS: Clinical Worsening and Suicide Risk

AMITRIPTYLINE HYDROCHLORIDE ADVERSE REACTIONS


Cardiovascular:
CNS and Neuromuscular:
Anticholinergic:
Allergic:
Hematologic:
Gastrointestinal:
Endocrine:
Other:

Withdrawal Symptoms



Causal Relationship Unknown

Body as a Whole:
Digestive:

Postmarketing Adverse Events



OVERDOSAGE



Manifestations

ADVERSE REACTIONS

Management

General


Gastrointestinal Decontamination


Cardiovascular



CNS



Psychiatric Follow-up


Pediatric Management


DOSAGE & ADMINISTRATION

Oral Dosage


Initial Dosage for Adults




Adolescent and Elderly Patients


Maintenance


Usage in Pediatric Patients


Plasma Levels
2

2

HOW SUPPLIED



























STORAGE AND HANDLING




METABOLISM



REFERENCES















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.

     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:
  • ●     thoughts about suicide or dying
  • ●     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?
  •      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














Amitriptyline Hydrochloride

Amitriptyline Hydrochloride

Amitriptyline Hydrochloride

Amitriptyline Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-617(NDC:0781-1490)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE 100 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
STARCH, CORN
SILICON DIOXIDE
D&C RED NO. 30
D&C YELLOW NO. 10
hydroxypropyl cellulose
lactose monohydrate
MAGNESIUM STEARATE
polyethylene glycol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
orange 11 mm GG461 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-617-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085967 2011-12-06


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Be sure to consult your doctor before taking any medication!
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