AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Zydus Pharmaceuticals USA Inc.

INN (Alþjóðlegt nafn):

AMITRIPTYLINE HYDROCHLORIDE

Samsetning:

AMITRIPTYLINE HYDROCHLORIDE 10 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Amitriptyline Hydrochloride Tablets USP, 10 mg are white to off white colored, round shaped, biconvex, film-coated tablets debossed with "ZA" over "1" on one side and plain on other side and are supplied as follows: NDC 70710-1225-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1225-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 25 mg are light green colored, round shaped, biconvex, film-coated tablets debossed with "ZA" over "2" on one side and plain on other side and are supplied as follows: NDC 70710-1226-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1226-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 50 mg are brown colored, round shaped, biconvex, film-coated tablets debossed with "ZA" over "3" on one side and plain on other side and are supplied as follows: NDC 70710-1227-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1227-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 75 mg are light blue colored, round shaped, biconvex, film-coated tablets debossed with "12" over "28" on one side and plain on other side and are supplied as follows: NDC 70710-1228-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1228-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 100 mg are orange colored, round shaped, biconvex, film-coated tablets debossed with "12" over "29" on one side and plain on other side and are supplied as follows: NDC 70710-1229-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1229-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 150 mg are cream to beige colored, modified capsule shaped, biconvex, film-coated tablets debossed with "1230" on one side and plain on other side and are supplied as follows: NDC 70710-1230-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1230-0 in bottle of 1,000 tablets Store at 20ºC to 25ºC (68ºF to 77ºF) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

AMITRIPTYLINE HYDROCHLORIDE - AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
Zydus Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Amitriptyline Hydrochloride Tablets, USP
(am'' i trip' tileen hye'' droe klor' ide)
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

Vara einkenni

AMITRIPTYLINE HYDROCHLORIDE - AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP
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 practically odorless, crystalline
powder or small crystals
and freely soluble in water, alcohol, chloroform and methanol and
insoluble in ether.
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 amitriptyline hydrochloride tablet, USP for oral administration
contains 10 mg, 25
mg, 50 mg, 75 mg, 100 mg, or 150 mg amitriptyline hy