Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors
VA Class: CN601
CAS Number: 549-18-8
Brands: Limbitrol
- Suicidality
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.i j Amitriptyline is not approved for use in pediatric patients <12 years of age.d 103 (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reducedin adults ≥65 years of age with antidepressant therapy compared with placebo.i j
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.i j k
Appropriately monitor and closely observe all patients who are started on amitriptyline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.i j k (See Worsening of Depression and Suicidality Risk under Cautions.)
Introduction
Tricyclic antidepressant (TCA).c
Uses for Amitriptyline Hydrochloride
Major Depressive Disorder
Management of major depressive disorder.c
Anxiety and Depressive Disorders
Has been used in fixed combination with chlordiazepoxide in the management of depression associated with moderate to severe anxiety.e g
Management of moderate to severe anxiety and/or agitation (in fixed combination with perphenazine) in patients with depressed mood.n
Management of severe anxiety and/or agitation (in fixed combination with perphenazine) in patients with depression.n
Management of depression and anxiety (in fixed combination with perphenazine) in association with chronic physical disease.n
Psychotic Disorders
Management of acute depressive episodes (in fixed combination with perphenazine) in patients with schizophrenia.n
Attention Deficit Hyperactivity Disorder
Second-line agent in attention deficit hyperactivity disorder† (ADHD) patients unable to tolerate or unresponsive to stimulants; should be used only under close supervision.a
Associated with a narrower margin of safety than some other therapeutic agents; use only if clearly indicated and with careful monitoring, including baseline and subsequent determinations of ECG and other parameters.
Migraine
Medium to high efficacy for prophylaxis of migraine headache†.
Eating Disorders
Equivocal efficacy for management of eating disorders† (e.g., bulimia†, anorexia nervosa†); avoid use in underweight individuals and in those exhibiting suicidal ideation.a
Bipolar Disorder
Has been used for the short-term management of acute depressive episodes in bipolar disorder†.a b
TCAs associated with a greater risk of precipitating hypomania or manic episodes than other classes of antidepressants;a should always be used in combination with a mood stabilizer (e.g., lithium).b
Postherpetic Neuralgia
Among the drugs of choice for the symptomatic treatment of postherpetic neuralgia†.a
Insomnia
Less effective for insomnia† and associated with more serious adverse reactions than conventional hypnotics.a
Amitriptyline Hydrochloride Dosage and Administration
General
Fixed-ratio combination preparations generally should not be used as initial therapy.d e First administer each drug separately.d e If the optimum maintenance dosage corresponds to the ratio in a commercial combination preparation, a fixed-combination preparation may be used.d e If dosage adjustment is necessary, administer the drugs separately.d e Fixed-ratio combination preparations do not permit individual titration of dosages.m
Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of amitriptyline and vice versa.c Also allow at least 5 weeks to elapse when switching from fluoxetine.c
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.c i j k (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required; monitor periodically for need for continued therapy.c
Avoid abrupt discontinuance in patients receiving high dosages for prolonged periods.d To avoid withdrawal reactions, taper dosage gradually.d
Administration
Oral Administration
Administer in up to 4 divided doses or as a single daily dose at bedtime to avoid daytime sedation.c d
Dosage
Available as amitriptyline hydrochloride (alone and in fixed combination with perphenazine or chlordiazepoxide); dosage is expressed in terms of the salt.103 g n
Pediatric Patients
Major Depressive Disorder
Oral
Adolescents ≥12 years of age: 10 mg 3 times daily plus 20 mg at bedtime.c
Psychotic Disorders
Perphenazine/Amitriptyline Combination Therapy
Oral
Adolescents: Initially, 10 mg (in fixed combination with 4 mg perphenazine) 3 or 4 times daily; adjust as required.n
Maximum daily dosages of perphenazine and amitriptyline hydrochloride not to exceed 16 and 200 mg, respectively.n
Adults
Major Depressive Disorder
Outpatients
Oral
Initially, 75 mg daily in divided doses or 50–100 mg once daily at bedtime.c Increase dosages in 25- or 50-mg increments until maximal therapeutic effect with minimal toxicity is achieved or up to a maximum dosage of 150 mg daily.c
Usual maintenance dosage: 50–100 mg daily, administered as a single daily dose, preferably at bedtime.c For some patients, 25–40 mg daily may be sufficient.d Continue therapy for at least 3 months to prevent relapse.c
Hospitalized Patients
Oral
Initially, 100 mg daily; dosage may be increased gradually to 200–300 mg daily as needed.c
Anxiety and Depressive Disorders
Chlordiazepoxide/Amitriptyline Combination Therapy
Oral
Initially, amitriptyline hydrochloride 75 or 100 mg daily (in fixed combination with chlordiazepoxide 30 or 40 mg daily, respectively) in divided doses.g If needed, increase dosage to amitriptyline hydrochloride 150 mg daily (in fixed combination with chlordiazepoxide 60 mg daily) in divided doses.g
Alternatively, in patients who do not tolerate larger dosages, initial dosage of amitriptyline hydrochloride 37.5 or 50 mg daily (in fixed combination with chlordiazepoxide 15 or 20 mg daily, respectively) in divided doses.g
For some patients, amitriptyline hydrochloride 50 mg daily (in fixed combination with chlordiazepoxide 20 mg daily) in divided doses may be adequate.g
Perphenazine/Amitriptyline Combination Therapy
Oral
Initially, amitriptyline hydrochloride 25 mg (in fixed combination with perphenazine 2 or 4 mg) 3 or 4 times daily.n Alternatively, amitriptyline hydrochloride 50 mg (in fixed combination with perphenazine 4 mg) twice daily.n
Carefully adjust subsequent dosage according to patient’s tolerance and therapeutic response.n During maintenance therapy, keep dosage at the lowest effective level.n Amitriptyline hydrochloride maintenance dosages usually range from 50–100 mg daily and perphenazine maintenance dosages usually range from 4–16 mg daily.n
Maximum daily dosage of perphenazine and amitriptyline hydrochloride not to exceed 16 and 200 mg, respectively.n
Psychotic Disorders
Perphenazine/Amitriptyline Combination Therapy
Oral
Initially, 2 tablets of amitriptyline hydrochloride 25 mg (in fixed combination with perphenazine 4 mg) 3 times daily.n If needed, a fourth dose may be given at bedtime.n
Carefully adjust subsequent dosage according to patient’s tolerance and therapeutic response.n During maintenance therapy, keep dosage at the lowest effective level.n Amitriptyline hydrochloride maintenance dosages usually range from 50–100 mg daily and perphenazine maintenance dosages usually range from 4–16 mg daily.n
Maximum daily dosage of perphenazine and amitriptyline hydrochloride not to exceed 16 and 200 mg, respectively.n
Prescribing Limits
Pediatric Patients
Psychotic Disorders
Perphenazine/Amitriptyline Combination Therapy
Oral
Adolescents: Maximum 16 and 200 mg daily of perphenazine and amitriptyline hydrochloride, respectively.n
Adults
Major Depressive Disorder
Outpatients
Oral
Maximum 150 mg daily.c
Hospitalized Patients
Oral
Maximum 300 mg daily.c
Anxiety and Depressive Disorders
Perphenazine/Amitriptyline Combination Therapy
Oral
Maximum 16 and 200 mg daily of perphenazine and amitriptyline hydrochloride, respectively.n
Psychotic Disorders
Perphenazine/Amitriptyline Combination Therapy
Oral
Maximum 16 and 200 mg daily of perphenazine and amitriptyline hydrochloride, respectively.n
Special Populations
Geriatric Patients
10 mg 3 times daily plus 20 mg at bedtime.c
Anxiety and Depressive Disorders
When used in fixed combination with chlordiazepoxide, select initial dosages at the lower end of the usual ranges and gradually increase dosages if needed and tolerated.g
Psychotic Disorders
When used in fixed combination with perphenazine, an oral dosage of 10 mg of amitriptyline hydrochloride and 4 mg of perphenazine 3 or 4 times daily is recommended initially.n Subsequent dosage adjustments may be made as necessary.n
Cautions for Amitriptyline Hydrochloride
Contraindications
Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.c (See Specific Drugs under Interactions.)
Concurrent therapy with cisapride.c (See Specific Drugs under Interactions.)
During the acute recovery phase following MI.c
Known hypersensitivity to amitriptyline or any component in the formulations.c g n
Warnings/Precautions
Warnings
Shares the toxic potentials of other tricyclic antidepressants; observe the usual precautions of tricyclic antidepressant therapy.a d g n
Worsening of Depression and Suicidality Risk
Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.i j k l However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.i j k
Appropriately monitor and closely observe patients receiving amitriptyline for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.i j k (See Boxed Warning and also see Pediatric Use under Cautions.)
Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.j k Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.i j k (See General under Dosage and Administration.)
Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.j
Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.j
Bipolar Disorder
May unmask bipolar disorder.j (See Activation of Mania or Hypomania under Cautions.) Amitriptyline is not approved for use in treating bipolar depression.d
Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.j
Interactions
May block hypotensive actions of guanethidine and similar agents.c n
May enhance effects of alcohol, barbiturates, and other CNS depressants.c n Use with caution in patients with a history of excessive alcohol consumption.c
Delirium reported when used concomitantly with disulfiram.c
Anticholinergic Effects
Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased intraocular pressure, angle-closure glaucoma).c Usual dosages may precipitate an attack of angle-closure glaucoma.c
Seizures
Risk of seizures; use with caution in patients with a history of seizures.c
Cardiovascular Effects
Possible arrhythmias, sinus tachycardia, and prolongation of the conduction time, MI, and stroke, particularly at higher dosages.c
Patients with preexisting cardiac disease and patients with disturbed eating behaviors (e.g., purging) that result in inadequate hydration and/or compromised cardiac status most at risk;a monitor closely.c
Hyperthyroidism
Use with caution and under close supervision in hyperthyroid patients or patients receiving thyroid agents.c
General Precautions
Activation of Mania or Hypomania
Possible activation of mania or hypomania, particularly in patients with bipolar disorder; decrease dosage and/or administer an antipsychotic agent concomitantly.c (See Bipolar Disorder under Cautions.)
Psychosis
Risk of manifestations of psychosis in patients with schizophrenia, particularly in patients with paranoid symptoms.c
CNS Effects
Performance of activities requiring mental alertness and physical coordination may be impaired.c
Electroconvulsive Therapy (ECT)
Possible increased ECT risks; limit to patients for whom concomitant use is essential.c
Elective Surgery
Discontinue therapy several days prior to surgery whenever possible.c
Blood Glucose Effects
Possible alterations in blood glucose concentrations.c
Use of Fixed Combinations
When used in fixed combination with perphenazine or chlordiazepoxide, consider the cautions, precautions, and contraindications associated with the concomitant agent.g n
Specific Populations
Pregnancy
Category C.c
Lactation
Distributes into milk;c discontinue nursing or the drug.c
Pediatric Use
Amitriptyline hydrochloride not shown to be effective in management of depression in children† or adolescents in clinical studies; not recommended by the manufacturers for use in children <12 years of age.103 c
Safety and efficacy of the chlordiazepoxide-amitriptyline hydrochloride and perphenazine-amitriptyline hydrochloride fixed combinations not established in pediatric patients.e g n
FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).105 However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.l No suicides occurred in these pediatric trials.105 l j
Carefully consider these findings when assessing potential benefits and risks of amitriptyline in a child or adolescent for any clinical use.i j k l (See Worsening of Depression and Suicidality Risk under Cautions.)
Geriatric Use
No substantial differences in efficacy relative to younger adults.c
In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.i j (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)
Possible increased sensitivity to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, orthostatic hypotension, and sedative effects of TCAs and increased risk for falls.c
No overall differences in safety and efficacy of amitriptyline hydrochloride in fixed combination with chlordiazepoxide in geriatric patients relative to younger adults; however, increased sensitivity cannot be ruled out.g
Titrate dosage carefully.c (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Use with caution.c
Common Adverse Effects
Anticholinergic effects (e.g., dry mouth,a constipation,a vision disturbance),a orthostatic hypotension,a sedation, weakness, lethargy, fatigue.a
Interactions for Amitriptyline Hydrochloride
Metabolized in the liver by various CYP isoenzymes (e.g., CYP1A2, CYP2C, CYP2D6, CYP3A4).a
Drugs Affecting Hepatic Microsomal Enzymes
Inhibitors of CYP2D6: potential pharmacokinetic interaction (increased amitriptyline concentrations).a Adjust amitriptyline dosage whenever a CYP2D6 inhibitor is added or discontinued.a
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Alcohol | Potentiates the effects of alcoholc | Increased risks if overdose or suicide attempt occursc |
Antiarrhythmics, class 1C (e.g., flecainide, propafenone) | Potential decreased amitriptyline metabolismc | Monitor for TCA toxicityc |
Anticholinergic agents | Hyperthermia, particularly during hot weather, and paralytic ileus.c | Use with caution; dosage adjustment may be neededc |
Anticoagulants (e.g., warfarin) | Possible increased PTa | |
Antipsychotics (e.g., phenothiazines) | Hyperpyrexia, particularly during hot weatherc Potential decreased amitriptyline metabolismc | Use with cautionc |
Cimetidine | Potential decreased amitriptyline metabolismc | |
Cisapride | Increased risk of QT interval prolongation and arrhythmiasc | Concomitant use contraindicatedc |
CNS depressants (e.g., analgesics, antihistamines, barbiturates, general anesthetics, opiates) | Potentiates the effects of CNS depressantsc n | Use with cautionc |
Diazepam | Possible increased plasma amitriptyline concentrationa | |
Disulfiram | Deliriumc | |
Guanethidine and related compounds | Antagonizes the antihypertensive effects of guanethidine and related compoundsc n | |
Levodopa | May interfere with levodopa absorptiona | Monitor levodopa dosage carefullya |
MAO inhibitors | Potentially life-threatening serotonin syndromec | Concomitant use contraindicatedc Allow at least 14 days to elapse when switching to or from these drugsc |
Methylphenidate | Possible increased plasma amitriptyline concentrationsa | |
Quinidine | Possible increased plasma amitriptyline concentrationsc | |
SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) | Possible serotonin syndromec Potential decreased amitriptyline metabolism and increased plasma concentrationsc | Use with caution; monitor for TCA toxicityc Allow at least 5 weeks to elapse when switching from fluoxetinec |
Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine) | Increased vasopressor, cardiac effectsa | Use with caution; dosage adjustment may be requireda |
Thyroid agents | Possible cardiac arrhythmiasa | Use with caution and under close supervisionc |
Amitriptyline Hydrochloride Pharmacokinetics
Absorption
Bioavailability
Rapidly absorbed from the GI tract;c bioavailability of 40–60%.f
Onset
Antidepressant effect may not be evident for up to 4 weeks; sedative effect usually precedes it.c
Distribution
Extent
Distributed into milk;100 101 102 concentrations in milk similar to or slightly greater than those present in maternal serum.101 102
Crosses the placenta.c
Plasma Protein Binding
Approximately 96%.f
Elimination
Metabolism
Extensively metabolized in the liver via demethylation to pharmacologically active metabolite, nortriptyline, by various CYP isoenzymes (e.g., CYP1A2, CYP2D6, CYP3A4, CYP2C).a d f
Elimination Route
Excreted principally in urine (25–50% within 24 hours) as inactive metabolites; small amounts are also excreted in feces via biliary elimination.d
Half-life
10–50 hours.d
Stability
Storage
Oral
Tablets
Tight, light-resistant containers at 15–30°C.c
Fixed-combination (with Chlordiazepoxide) Tablets
Store in a dry place at 25°C (may be exposed to 15–30°C).g
Fixed-combination (with Perphenazine) Tablets
Tight, light-resistant containers at 20–25°C.n
Actions
Mechanism of action in the management of depression unknown but may involve inhibition of reuptake of norepinephrine and/or serotonin.c
Associated with more frequent anticholinergic, sedative, cardiovascular effects, and weight gain than SSRIs.a
Advice to Patients
Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.i j k FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.i j k
Importance of considering possible impaired ability to perform hazardous activities (e.g., operating machinery, driving a motor vehicle).c
Importance of patients understanding that it may take more than 4 weeks before the full effects are apparent.c
Importance of avoiding alcohol-containing beverages or products.c
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.c
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses or planned surgery.c
Importance of informing patients of other important precautionary information.c (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Preparations containing amitriptyline hydrochloride in fixed combination with chlordiazepoxide are subject to control under the Federal Controlled Substances Act of 1970 as schedule IV (C-IV) drugs.e g
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 10 mg* | ||
25 mg* | ||||
50 mg* | ||||
75 mg* | ||||
100 mg* | ||||
150 mg* |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 5 mg Chlordiazepoxide and Amitriptyline Hydrochloride 12.5 mg* | Chlordiazepoxide and Amitriptyline Hydrochloride Tablets ( C-IV) | Mylan, Par |
Limbitrol ( C-IV; with povidone and propylene glycol) | Valeant | |||
10 mg Chlordiazepoxide and Amitriptyline Hydrochloride 25 mg* | Chlordiazepoxide and Amitriptyline Hydrochloride Tablets ( C-IV) | Mylan, Par | ||
Limbitrol DS ( C-IV; with povidone and propylene glycol) | Valeant |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 2 mg Perphenazine and Amitriptyline Hydrochloride 10 mg* | Perphenazine and Amitriptyline Hydrochloride Tablets | Mylan, Sandoz, Watson |
2 mg Perphenazine and Amitriptyline Hydrochloride 25 mg* | Perphenazine and Amitriptyline Hydrochloride Tablets | Mylan, Sandoz, Watson | ||
4 mg Perphenazine and Amitriptyline Hydrochloride 10 mg* | Perphenazine and Amitriptyline Hydrochloride Tablets | Mylan, Sandoz, Watson | ||
4 mg Perphenazine and Amitriptyline Hydrochloride 25 mg* | Perphenazine and Amitriptyline Hydrochloride Tablets | Mylan, Sandoz, Watson | ||
4 mg Perphenazine and Amitriptyline Hydrochloride 50 mg* | Perphenazine and Amitriptyline Hydrochloride Tablets | Mylan |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Amitriptyline HCl 10MG Tablets (QUALITEST): 30/$11.99 or 90/$15.97
Amitriptyline HCl 100MG Tablets (QUALITEST): 30/$13.99 or 60/$15.97
Amitriptyline HCl 150MG Tablets (QUALITEST): 90/$20.99 or 180/$38.97
Amitriptyline HCl 25MG Tablets (QUALITEST): 90/$13.99 or 180/$22.97
Amitriptyline HCl 50MG Tablets (QUALITEST): 90/$12.99 or 180/$21.98
Amitriptyline HCl 75MG Tablets (QUALITEST): 100/$15.99 or 300/$39.96
Chlordiazepoxide-Amitriptyline 10-25MG Tablets (MYLAN): 60/$69.99 or 180/$195.96
Chlordiazepoxide-Amitriptyline 5-12.5MG Tablets (MYLAN): 60/$49.99 or 180/$135.97
Limbitrol DS 10-25MG Tablets (VALEANT): 60/$115.99 or 180/$305.98
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 28, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
Only references cited for selected revisions after 1984 are available electronically.
100. Roche Products Inc. Endep prescribing information. In: Huff BB, ed. Physicians’ desk reference. 39th ed. Oradell, NJ: Medical Economics Company Inc; 1985:1711-2.
101. Brixen-Rasmussen L, Halgrener J, Jorgensen A. Amitriptyline and nortriptyline excretion in human breast milk. Psychopharmacology. 1982; 76:94-5. [PubMed 6805016]
102. Bader TF, Newman K. Amitriptyline in human breast milk and the nursing infant’s serum. Am J Psychiatry. 1980; 137:855-6. [IDIS 117830] [PubMed 7386673]
103. AstraZeneca Pharmaceuticals LP. Elavil (amitriptyline hydrochloride tablets and injection) prescribing information. Wilmington, DE; 2003 Feb.
104. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (revision). Am J Psychiatry. 2000; 157(suppl):1-45.
105. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website.
106. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA web site.
107. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA web site.
a. AHFS drug information 2003. McEvoy GK, ed. Tricyclic antidepressants general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2003:2161-9.
b. American Psychiatric Association. Practice guideline for the treatment of patients with bipolar disorder (revised). Am J Psychiatry. 2002; 159(suppl):1-49.
c. Geneva Pharmaceuticals, Inc. Amitriptyline hydrochloride tablets, USP prescribing information. Broomfield, CA; 2001 June.
d. AHFS drug information 2008. McEvoy GK, ed. Amitriptyline hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2415.
e. AHFS drug information 2008. McEvoy GK, ed. Chlordiazepoxide/Chlordiazepoxide hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2582-3.
f. Cohen LJ, DeVane CL. Clinical implications of antidepressant pharmacokinetics and pharmacogenetics. Ann Pharmacother. 1996; 30:1471-80. [PubMed 8968460]
g. Valeant Pharmaceuticals North America. Limbitrol and Limbitrol DS (chlordiazepoxide and amitriptyline hydrochloride) tablets prescribing information. Aliso Viejo, CA; 2007 May.
h. Lotus Biochemical Corp. Triavil (amitriptyline HCl and perphenazine) tablets prescribing information (dated 1998 Oct). In: Physicians’ desk reference. 54th ed. Montvale, NJ: Medical Economics Company Inc; 2000:1656-8.
i. Food and Drug Administration. FDA news: FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. Rockville, MD; 2007 May 2. From the FDA web site.
j. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Rockville, MD; 2007 May 2. From the FDA web site.
k. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site.
l. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007; 297:1683-96. [PubMed 17440145]
m. AHFS drug information 2008. McEvoy GK, ed. Antimuscarinics/antispasmodics general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1293-300.
n. Mylan Pharmaceuticals. Perphenazine and amitriptyline hydrochloride tablets prescribing information. Morgantown, WV; 2007 Aug.
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