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:

H.J. Harkins Company, Inc.

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 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 infarc

Product summary:

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 0781-1486-31 bottles of 30 NDC 0781-1486-01 bottles of 100 NDC 0781-1486-10 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 0781-1487-31 bottles of 30 NDC 0781-1487-01 bottles of 100 NDC 0781-1487-10 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 0781-1488-31 bottles of 30 NDC 0781-1488-01 bottles of 100 NDC 0781-1488-10 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 0781-1489-31 bottles of 30 NDC 0781-1489-01 bottles of 100 NDC 0781-1489-10 bottles of 1000 100 mg: Round, film-coated orange tablets, debossed GG 461 on one side and plain on the reverse side, and supplied as: NDC 0781-1490-31 bottles of 30 NDC 0781-1490-01 bottles of 100 NDC 0781-1490-10 bottles of 1000 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 0781-1491-31 bottles of 30 NDC 0781-1491-01 bottles of 100 NDC 0781-1491-10 bottles of 1000 Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMITRIPTYLINE HYDROCHLORIDE - AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
H.J. Harkins Company, Inc.
----------
MEDICATION GUIDE
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 the

Summary of Product characteristics

AMITRIPTYLINE HYDROCHLORIDE - AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
H.J. HARKINS COMPANY, INC.
----------
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP
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 IS NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS. (SEE WARNINGS:
CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR
PATIENTS, AND
PRECAUTIONS: PEDIATRIC USE)
DESCRIPTION
Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or
practically white, odorless,
crystalline compound which is freely soluble in water and alcohol.
It is designated chemically as
10,11-Dihydro-N,N-dimethyl-5_H_-dibenzo[a,d] cycloheptene-Δ , γ-
propylamine hydrochloride. It has the following structural formula:
Each tablet for oral administration contains 10, 25, 50, 75, 100, or
150 mg amitriptyline hydrochloride.
Inactive ingredients include colloidal silicon dioxide, hydroxypropyl
cellulose, hydroxypropyl
methylcellulose, lactose (monohydrate),