Amitriptyline Hydrochloride: Package Insert and Label Information (Page 3 of 3)

HOW SUPPLIED

Amitriptyline Hydrochloride Tablets USP, 25 mg are light green colored, round shaped, biconvex, film-coated tablets debossed with “ZA” over “2” on one side and plain on other side and are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-433-01

Amitriptyline Hydrochloride Tablets USP, 50 mg are brown colored, round shaped, biconvex, film-coated tablets debossed with “ZA” over “3” on one side and plain on other side and are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-444-01

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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, 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: 1,492-1,493, 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):1,303-1,307.

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: 1,427-1,431. 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).

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Zydus Pharmaceuticals (USA) Inc.as follows:
(25 mg / 100 UD) NDC 60687-433-01 packaged from NDC 70710-1226
(50 mg / 100 UD) NDC 60687-444-01 packaged from NDC 70710-1227

Distributed by:
American Health Packaging
Columbus, OH 43217

8443301/0720

MEDICATION GUIDE

8443301/0720

Amitriptyline Hydrochloride Tablets, USP
(am” i trip’ tileen hye” droe klor’ ide)

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.

Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Distributed by:
American Health Packaging Columbus, OH 43217

8443301/0720

Package/Label Display Panel – Carton – 25 mg

NDC 60687- 433 -01

Amitriptyline
Hydrochloride
Tablets, USP

25 mg

100 Tablets (10 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Amitriptyline hydrochloride USP………………………………………. 25 mg

Usual Dosage: See package insert for full prescribing information.

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

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 70710-1226, Zydus Pharmaceuticals (USA) Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

743301 0443301/0119

Package/Label Display Panel – Blister – 25 mg

Amitriptyline
Hydrochloride Tablet, USP     25 mg

Package/Label Display Panel – Carton – 50 mg

NDC 60687- 444 -01

Amitriptyline
Hydrochloride
Tablets, USP

50 mg

100 Tablets (10 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Amitriptyline hydrochloride USP……………………………50 mg

Usual Dosage: See package insert for full prescribing
information.

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

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 70710-1227, Zydus Pharmaceuticals (USA) Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

744401 0444401/0119

Package/Label Display Panel – Blister – 50 mg

Amitriptyline
Hydrochloride Tablet, USP    50 mg

AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-433(NDC:70710-1226) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM SILICON DIOXIDE HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 8000 STARCH, CORN TALC TITANIUM DIOXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1

Product Characteristics Color green (LIGHT GREEN) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZA;2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60687-433-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-433-11) 1 NDC:60687-433-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-433-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210086 07/31/2019

AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-444(NDC:70710-1227) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM SILICON DIOXIDE HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 8000 STARCH, CORN TALC TITANIUM DIOXIDE D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW

Product Characteristics Color brown (BROWN) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code ZA;3 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60687-444-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-444-11) 1 NDC:60687-444-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-444-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210086 07/30/2019

Labeler — American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Operations
American Health Packaging		929561009	repack (60687-433), repack (60687-444)

Revised: 08/2020 American Health Packaging