Amitriptyline Hydrochloride (Page 4 of 5)

HOW SUPPLIED

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

The 10 mg tablets are Pink colored, round tablets, debossed with “1” on one side and plain on the other side. They are supplied as:

Bottles of 30 Tablets with Child-Resistant Closure NDC 69844-058-01

Bottles of 100 Tablets with Child-Resistant Closure NDC 69844-058-02

Bottles of 1,000 Tablets NDC 69844-058-03

The 25 mg tablets are Light green colored, round tablets, debossed with “31” on one side and plain on the other side. They are supplied as:

Bottles of 30 Tablets with Child-Resistant Closure NDC 69844-059-01

Bottles of 100 Tablets with Child-Resistant Closure NDC 69844-059-02

Bottles of 1,000 Tablets NDC 69844-059-03

The 50 mg tablets are Brown colored, round tablets, debossed with “32” on one side and plain on the other side. They are supplied as:

Bottles of 30 Tablets with Child-Resistant Closure NDC 69844-060-01

Bottles of 100 Tablets with Child-Resistant Closure NDC 69844-060-02

Bottles of 1,000 Tablets NDC 69844-060-03

The 75 mg tablets are Purple colored, round tablets, debossed with “45” on one side and plain on the other side. They are supplied as:

Bottles of 30 Tablets with Child-Resistant Closure NDC 69844-061-01

Bottles of 100 Tablets with Child-Resistant Closure NDC 69844-061-02

Bottles of 1,000 Tablets NDC 69844-061-03

The 100 mg tablets are Orange colored, round tablets, debossed with “46” on one side and plain on the other side. They are supplied as:

Bottles of 30 Tablets with Child-Resistant Closure NDC 69844-062-01

Bottles of 100 Tablets with Child-Resistant Closure NDC 69844-062-02

Bottles of 1,000 Tablets NDC 69844-062-03

The 150 mg tablets are Light green colored, capsule shaped tablets, debossed with “47” on one side and plain on the other side. They are supplied as:

Bottles of 30 Tablets with Child-Resistant Closure NDC 69844-063-01

Bottles of 100 Tablets with Child-Resistant Closure NDC 69844-063-02

Bottles of 1,000 Tablets NDC 69844-063-03

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

METABOLISM

Studies in man following oral administration of 14 C-labeled drug indicated that amitriptyline hydrochloride 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 hydrochloride 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, F.J., Jr.: Amitriptyline therapy for depressive reactions, Psychosom. 1: 320-325, Nov.-Dec. 1960.

Diamond, S.: Human metabolization of amitriptyline tagged with carbon 14, Curr. Therap. Res. 7: 170-175, Mar. 1965.

Dorfman, W.: Clinical experiences with amitriptyline (A preliminary report), Psychosom. 1: 153- 155, May-June 1960.

Fallette, J.M.; Stasney, C.R.; Mintz, A.A.: Amitriptyline poisoning treated with physostigmine, S. Med. J. 63: 1492-1493, Dec. 1970 (in Soc. Proc.).

Hollister, L.E.; Overall, J.E.; Johnson, M.; Pennington, V.; Katz, G.; Shelton, J.: Controlled comparison of amitriptyline, imipramine and placebo in hospitalized depressed patients, J. Nerv. and Ment. Dis. 139: 370-375, Oct. 1964.

Hordern, A.; Burt, C.G.; Holt, N.F.: Depressive states. A pharmacotherapeutic study, Springfield, Ill., Charles C. Thomas, 1965.

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

Klerman, G.L.; Cole, J.O.: Clinical pharmacology of imipramine and related antidepressant compounds, Int. J. Psychiat. 3: 267-304, Apr. 1976.

Liu, B.; Anderson, C.; 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, A.D.; Kingston, W.R.; Stevenson, H.G.; Atkinson, I.; Cole, E.; Fennessy, L.A.; Correlation of clinical features of depressed outpatients with response to amitriptyline and protriptyline, Brit. J. Psychiat. 114: 103-106, Jan. 1968.

McDonald, I.M.; Perkins, M.; Marjerrison, G.; Podilsky, M.: A controlled comparison of amitriptyline and electroconvulsive therapy in the treatment of depression, Amer. J. Psychiat. 122: 1427-1431. June 1966 (in Brief Communications).

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

Symposium on depression with special studies of a new antidepressant, amitriptyline, Dis. Nerv. Syst. 22: 5-56, May 1961 (Sect. 2).

Dispense with Medication Guide available at: https://www.gravitipharma.com/medguide/Amitriptyline.pdf

MEDICATION GUIDE

Amitriptyline Hydrochloride

(“am” i trip’ tileen hye” droe klor’ ide”)

Tablets, USP

Dispense with Medication Guide available at: https://www.gravitipharma.com/medguide/Amitriptyline.pdf

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.

For more information, call Graviti Pharmaceuticals Inc., at 1-855-298-4506.

Manufactured for:

Graviti Pharmaceuticals Inc.,

Wilmington, Delaware – 19801, USA.

Manufactured by:

Graviti Pharmaceuticals Pvt. Ltd.

Telangana-502307, INDIA.

Made in India

Revised: March 2023

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