Amitriptyline Hydrochloride (Page 5 of 6)


2
Hollister, L.E.; Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241(23):2530-2533.

HOW SUPPLIED

Amitriptyline hydrochloride tablets, USP for oral administration are available as:

10 mg: Round, film-coated pink tablets, debossed GG 40 on one side and plain on the reverse side, and supplied as:

NDC 16714-446-01 bottles of 100

NDC 16714-446-02 bottles of 1000

25 mg: Round, film-coated light green tablets, debossed GG 44 on one side and plain on the reverse side, and supplied as:

NDC 16714-447-01 bottles of 100

NDC 16714-447-02 bottles of 1000

50 mg: Round, film-coated brown tablets, debossed GG 431 on one side and plain on the reverse side, and supplied as:

NDC 16714-448-01 bottles of 100

NDC 16714-448-02 bottles of 1000

75 mg: Round, film-coated purple tablets, debossed GG 451 on one side and plain on the reverse side, and supplied as:

NDC 16714-449-01 bottles of 100

100 mg: Round, film-coated orange tablets, debossed GG 461 on one side and plain on the reverse side, and supplied as:

NDC 16714-450-01 bottles of 100

150 mg: Capsule shaped, film-coated light green tablets, debossed GG 450 on one side and plain on the reverse side, and supplied as:

NDC 16714-451-01 bottles of 100

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

KEEP OUT OF THE REACH OF CHILDREN.

METABOLISM

Studies in man following oral administration of 14 C-labeled drug indicated that amitriptyline is rapidly absorbed and metabolized. Radioactivity of the plasma was practically negligible, although significant amounts of radioactivity appeared in the urine by 4 to 6 hours and one-half to one-third of the drug was excreted within 24 hours.

Amitriptyline is metabolized by N-demethylation and bridge hydroxylation in man, rabbit, and rat. Virtually the entire dose is excreted as glucuronide or sulfate conjugate of metabolites, with little unchanged drug appearing in the urine. Other metabolic pathways may be involved.

REFERENCES

Ayd FJ Jr: Amitriptyline therapy for depressive reactions. Psychosomatics 1960;1:320-325.

Diamond S: Human metabolizer of amitriptyline tagged with carbon 14. Curr Ther Res, Mar 1965, pp170-175.

Dorfman W: Clinical experiences with amitriptyline: A preliminary report. Psychosomatics 1960;1:153-155.

Fallette JM, Stasney CR, Mintz AA: Amitriptyline poisoning treated with physostigmine. South Med J 1970;63:1492-1493.

Hollister LE, Overall JE, Johnson M, et al: Controlled comparison of amitriptyline, imipramine and placebo in hospitalized depressed patients. J Nerv Ment Dis 1964;139:370-375.

Hordern A, Burt CG, Holt NF: Depressive states: A pharmacotherapeutic study, Springfield study. Springfield, Ill, Charles C. Thomas, 1965.

Jenike MA: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy. J Geriatr Psychiatry 1989;22(1):77-112.

Klerman GL, Cole JO: Clinical pharmacology of imipramine and related antidepressant compounds. Int J Psychiatry 1976;3:267-304.

Liu B, Anderson G, Mittman N, et al: Use of selective serotonin-reuptake inhibitors or tricyclic antidepressants and risk of hip fractures in elderly people. Lancet 1998; 351 (9112):1303-1307.

McConaghy N, Joffe AD, Kingston WA, et al: Correlation of clinical features of depressed outpatients with response to amitriptyline and protriptyline. Br J Psychiatry 1968;114:103-106.

McDonald IM, Perkins M, Marjerrison G, et al: A controlled comparison of amitriptyline and electroconvulsive therapy in the treatment of depression. Am J Psychiatry 1966;122:1427-1431.

Slovis T, Ott J, Teitelbaum D, et al: Physostigmine therapy in acute tricyclic antidepressant poisoning. Clin Toxicol 1971;4:451-459.

Symposium on depression with special studies of a new antidepressant, amitriptyline. Dis Nerv Syst, (Sect 2) May 1961, pp5-56.

MEDICATION GUIDE

Amitriptyline Hydrochloride Tablets, USP (a-mee-TRIP-ti-leen)

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. 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:

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
Visual problems: eye pain, changes in vision, swelling or redness in or around the eye

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.
Visual problems. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
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.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Medication guide available at www.northstarrxllc.com/products or call 1-800-206-7821.

Manufactured for

Northstar Rx LLC,

Memphis, TN 38141

Manufactured by

Sandoz Inc.,

Princeton, NJ 08540

Rev. November 2018

MF0446REV11/18

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