AMITRIPTYLINE HYDROCHLORIDE- amitriptyline hydrochloride tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Lake Erie Medical DBA Quality Care Products LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states. CONTRAINDICATIONS 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

Обзор продуктов:

HOW SUPPLIED 10 mg tablets are blue, round, unscored, film coated tablets, debossed “2101” on one side and debossed “V” on the reverse side. 25 mg tablets are yellow, round, unscored, film coated tablets, debossed “2102” on one side and debossed “V” on the reverse side. 50 mg tablets are beige, round, unscored, film coated tablets, debossed “2103” on one side and debossed “V” on the reverse side. 75 mg tablets are orange, round, unscored, film coated tablets, debossed “2104” and “V”. 100 mg tablets are mauve, round, unscored, film coated tablets, debossed “2105” and “V”. 150 mg tablets are blue, capsule shaped, unscored, film coated tablets, debossed “2106” on one side and debossed “V” on the reverse side. Storage: Store in a well-closed container. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. In addition, amitriptyline tablets must be protected from light and stored in a well-closed, light-resistant container.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
Lake Erie Medical DBA Quality Care Products LLC
----------
AMITRIPTYLINE HYDROCHLORIDE - amitriptyline hydrochloride tablet, film
coated
Qualitest Pharmaceuticals
Medication Guide
Antidepressant Medicines, Depression and Other Serious Mental
llnesses, 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.

Характеристики продукта

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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AMITRIPTYLINE HYDROCHLORIDE 50 MG
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 C
H N•HCl, and its structural formula is
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, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate, sodium
starch glycolate and titanium dioxide. The 10 mg tablets also contain
FDandC blue #1 lake. The 25 mg
tablets also contain DandC yellow #10 lake and FDandC blue #2 lake.
The 50 mg tablets also contain
synthetic black iron oxide, synthetic red iron oxide and synthetic
yellow iron oxide. The 75 mg tablets
also contain FDandC yellow #6 lake. The 100 mg tablets also contain
DandC red #33 lake and FDandC
red #40 lake. The 150 mg tablets also contain FDandC blue #2 lake and
FDandC yellow #6 lake
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
Amitriptyline hydrochloride is an antidepressant with sedative
effects. Its mechanism of action in man is
not known. It is not a monoamine oxidase inhibitor, and it does not
act primarily by stimulation of the
central nervous system.
Amitriptyline inhibits the membrane pump mechanism responsible for
uptake of norepinephrine and
serotonin in adrenergic and serotonergic neurons. Pharmacologically
this action may potentiate or
prolong neuronal activity since reuptake of these biogenic amines is
important physiologically in
terminating transmitting activity. This interference with the reuptake
of norepinephrine and/or serotonin
is believed by some to underlie the ant