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:

Advagen Pharma Ltd

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: Light brown to brown colored, round, film coated tablets, debossed Λ on one side and plain on other side, and supplied as:                                                                                                                          34 NDC 72888-067-01 bottles of 100 NDC 72888-067-00 bottles of 1000   25 mg: Light brown to brown colored, round, film coated tablets, debossed Λ on one side and plain on other side, and supplied as:                                                                                                                          35 NDC 72888-068-01 bottles of 100 NDC 72888-068-00 bottles of 1000   50 mg: Light brown to brown colored, round, film coated tablets, debossed Λ on one side and plain on other side, and supplied as:                                                                                                                          36 NDC 72888-069-01 bottles of 100 NDC 72888-069-00 bottles of 1000   75 mg: Light brown to brown colored, round, film coated tablets, debossed Λ on one side and plain on other side, and supplied as:                                                                                                                         037 NDC 72888-070-01 bottles of 100   100 mg: Light brown to brown colored, round, film coated tablets, debossed Λ on one side and plain on other side, and supplied as:                                                                                                                          038 NDC 72888-071-01 bottles of 100 NDC 72888-071-03 bottles of 300   150 mg: Light brown to brown colored, oval shaped, film coated tablets, debossed Λ one side and plain on other side, and supplied as:                                                                                                                                     039 NDC 72888-072-01 bottles of 100 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
Advagen Pharma Ltd
----------
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 h

Summary of Product characteristics

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
ADVAGEN PHARMA LTD
----------
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP
RX ONLY
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
Amitriptyline hydrochloride, USP, 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:
5
Each tablet for oral administration contains 10, 25, 50, 75, 100, or
150 mg amitriptyline
hydrochloride, USP. Inactive ingredients include colloidal silicon
dioxide, hydroxypropyl
cellulose, low substituted hydroxy