AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)

Available from:

DIRECT RX

INN (International Name):

AMITRIPTYLINE HYDROCHLORIDE

Composition:

AMITRIPTYLINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states. Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with a gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with Cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute recovery phase following myocardial infa

Product summary:

10 mg tablets are blue, round, unscored, film coated tablets, debossed “2101” on one side and debossed “V” on the reverse side. They are supplied as follows: 25 mg tablets are yellow, round, unscored, film coated tablets, debossed “2102” on one side and debossed “V” on the reverse side. They are supplied as follows: 50 mg tablets are beige, round, unscored, film coated tablets, debossed “2103” on one side and debossed “V” on the reverse side. They are supplied as follows: 75 mg tablets are orange, round, unscored, film coated tablets, debossed “2104” and “V”. They are supplied as follows: 100 mg tablets are mauve, round, unscored, film coated tablets, debossed “2105” and “V”. They are supplied as follows: 150 mg tablets are blue, capsule shaped, unscored, film coated tablets, debossed “2106” on one side and debossed “V” on the reverse side. They are supplied as follows: Storage: Store in a well-closed container. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. In addition, amitriptyline tablets must be protected from light and stored in a well-closed, light-resistant container. METABOLISM Studies in man following oral administration of 14C-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, pp 170–175. 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 out-patients 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, pp 5–56. *Based on a maximum recommended amitriptyline dose of 150 mg/day or 3 mg/kg/day for a 50 kg patient. **Hollister LE: Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241(23):2530–2533. Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8180153 Rev. 5/13 R14 A SUPPLY OF MEDICATION GUIDES AS PRINTED AT THE END OF THIS INSERT IS AVAILABLE, FREE OF CHARGE, BY CALLING (800) 444–4011.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
DIRECT RX
----------
SPL MEDGUIDE SECTION
Medication Guide
Antidepressant Medicines, Depression and Other Serious Mental
lllnesses, 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

Summary of Product characteristics

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
DIRECT RX
----------
AMITRIPTYLINE HYDROCHLORIDE
BOXED WARNING SECTION
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS 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 WITH 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 COMMUNICATION
WITH THE PRESCRIBER.
AMITRIPTYLINE HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR USE IN
PEDIATRIC PATIENTS (SEE
WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS:
INFORMATION FOR PATIENTS, AND
PRECAUTIONS: PEDIATRIC USE.)
DESCRIPTION SECTION
Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d]
cycloheptene-5-ylidene)-N,N-dimethyl-1-
propanamine hydrochloride. Its empirical formula is C20H23N•HCl, and
its structural formula is:
Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a
molecular weight of 313.87. It is a white,
odorless, crystalline compound which is freely soluble in water.
Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or
150 mg tablets. Each tablet
contains the following inactive ingredients: colloidal silicon
dioxide, hypromellose, lactose
monohydra