CITALOPRAM HYDROBROMIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)

제공처:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

CITALOPRAM HYDROBROMIDE

구성:

CITALOPRAM 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Citalopram tablets, USP (citalopram Hbr) is indicated for the treatment of depression. The efficacy of citalopram tablets, USP in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has no

제품 요약:

Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows: Bottle of 100 NDC 57664-507-88 Bottle of 500 NDC 57664-507-13 Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows: Bottle of 100 NDC 57664-508-88 Bottle of 500 NDC 57664-508-13 Bottle of 1000 NDC 57664-508-18 Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows: Bottle of 100 NDC 57664-509-88 Bottle of 500 NDC 57664-509-13 Bottle of 1000 NDC 57664-509-18 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Citalopram Tablets, USP
Read the Medication Guide that comes with citalopram tablets before
you start taking it and each time you
get a refill. There may be new information. This Medication Guide does
not take the place of talking to your
healthcare provider about your medical condition or treatment. Talk
with your healthcare provider if there is
something you do not understand or want to learn more about.
Citalopram tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Citalopram tablets and other antidepressant medicines may increase
suicidal thoughts or actions in
some children, teenagers, or young adults within the first few months
of treatment or when the dose is
changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
•
Pay particular attention to such changes when citalopram tablets is
started or when the dose is
changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the
following symptoms, or call 911

제품 특성 요약

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
CITALOPRAM TABLETS, USP
10 MG, 20 MG AND 40 MG
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 CITALOPRAM
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. CITALOPRAM TABLETS IS NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK,
PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC
USE.)
DESCRIPTION
Citalopram tablets, USP is an orally administered selective serotonin
reuptake inhibitor
(SSRI) with a chemical structure unrelated to that of other SSRIs or
of tricyclic,
tetracyclic, or other available antidepressant agents. Citalopram HBr
is a racemic bicyclic
phthalane derivative designated
(±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-
dihydroisobenzofuran-5- carbonitrile, HBr with the following
structural formula:
The molecular formula is C
H
BrFN
0and its molecular weight is 405.35.
Citalopram HBr occurs as a fine, white to off-white powder. Citalopram
HBr is sparingly
solubl