AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Direct_Rx

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Amitriptyline hydrochloride tablets, USP for oral administration are available as: 10 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I1” on one side and plain on other side, and supplied as: NDC 16729-171-10 bottles of 30 NDC 16729-171-01 bottles of 100 NDC 16729-171-17 bottles of 1,000 25 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I2” on one side and plain on other side, and supplied as: NDC 16729-172-10 bottles of 30 NDC 16729-172-01 bottles of 100 NDC 16729-172-17 bottles of 1,000 50 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I3” on one side and plain on other side, and supplied as: bottles of 30 bottles of 100 bottles of 1,000 75 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I4” on one side and plain on other side, and supplied as: bottles of 30 bottles of 100 bottles of 1,000 100 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I5” on one side and plain on other side, and supplied as: bottles of 30 bottles of 100 bottles of 1,000 150 mg: Brown coloured, capsule shaped, biconvex, film coated tablet debossed with “I6” on one side and plain on other side, and supplied as: bottles of 30 bottles of 100 bottles of 1,000 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Direct_Rx
----------
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?
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, and young
adults within the first few months of treatment.
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.
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
feelin

Fachinformation

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
DIRECT_RX
----------
AMITRIPTYLINE HYDROCHLORIDE
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)
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 5, γ-propylamine hydrochloride. It has the following
structural formula:
[amitriptyline HCl chemical structure]
Each tablet for oral administration contains 10, 25, 50, 75, 100, or
150 mg amitriptyline
hydrochloride. Inactive ingredients include colloidal anhydrous
silica, croscarmellose
sodium, lactose (monohydrate), lecithin, magnesium stearate,
microc