AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

RedPharm Drug, Inc.

INN (International Nazwa):

AMITRIPTYLINE HYDROCHLORIDE

Skład:

AMITRIPTYLINE HYDROCHLORIDE 10 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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: Bottles of 30: NDC 0603-2212-16 Bottles of 90: NDC 0603-2212-02 Bottles of 100: NDC 0603-2212-21 Bottles of 1000: NDC 0603-2212-32 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: Bottles of 90: NDC 0603-2213-02 Bottles of 100: NDC 0603-2213-21 Bottles of 1000: NDC 0603-2213-32 Bottles of 2500: NDC 0603-2213-30 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: Bottles of 100: NDC 0603-2214-21 Bottles of 1000: NDC 0603-2214-32 75 mg tablets are orange, round, unscored, film coated tablets, debossed “2104” and “V”. They are supplied as follows: Bottles of 100: NDC 0603-2215-21 Bottles of 300: NDC 0603-2215-25 100 mg tablets are mauve, round, unscored, film coated tablets, debossed “2105” and “V”. They are supplied as follows: Bottles of 100: NDC 0603-2216-21 Bottles of 300: NDC 0603-2216-25 150 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: Bottles of 100: NDC 0603-2217-21 Bottles of 300: NDC 0603-2217-25

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

RedPharm Drug, Inc.
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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?
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

Charakterystyka produktu

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
REDPHARM DRUG, INC.
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BOXED WARNING
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 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:
[This is an image of the sturctural formula of Amitriptyline HCl.]
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