AMITRIPTYLINE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Graviti Pharmaceuticals Private Limited

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET
Graviti Pharmaceuticals Private Limited
----------
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 visi

Preparatomtale

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET
GRAVITI PHARMACEUTICALS PRIVATE LIMITED
----------
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 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 Hydrochloride, USP a dibenzocycloheptadiene derivative,
is a white or
practically white, odorless or partially odorless, crystalline powder
or small crystals which
is Freely soluble in water, in alcohol, in chloroform and in methanol,
insoluble in ether.
It is designated chemically as
10,11-Dihydro-_N,N_-dimethyl-5_H_-dibenzo[a,d]
cycloheptene-Δ
-propylamine hydrochloride. It has the following structural formula:
5,γ
Each tablet for oral administration contains 10, 25, 50, 75, 100, or
150 mg amitriptyline
hydrochloride USP. Inactive ingredient