Amitriptyline Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- AMITRIPTYLINE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- AMITRIPTYLINE HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- GERIATRIC USE
- PEDIATRIC USE
- AMITRIPTYLINE HYDROCHLORIDE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- REFERENCES
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
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
CLINICAL PHARMACOLOGY
INDICATIONS & USAGE
AMITRIPTYLINE HYDROCHLORIDE CONTRAINDICATIONS
WARNINGS
Clinical Worsening and Suicide RiskAll 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 2D6CONTRAINDICATIONSseeWARNINGSsection.
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 RiskAMITRIPTYLINE 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 DosageInitial 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 ActionsTalk to your, or your family member's, healthcare provider about:
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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
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?
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● 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.
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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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● thoughts about suicide or dying
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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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● Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
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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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Amitriptyline HydrochlorideAmitriptyline Hydrochloride TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
