CITALOPRAM tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

International Laboratories, LLC

INN (שם בינלאומי):

CITALOPRAM HYDROBROMIDE

הרכב:

CITALOPRAM 40 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Citalopram tablets USP are indicated for the treatment of depression. The efficacy of citalopram in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-lII and DSM-llI-R category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-lV) 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 in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in

leaflet_short:

Citalopram tablets USP, 10 mg are brown, round, biconvex, film coated tablets embossed “RDY” on one side and “342” on other side and are supplied in adherence packages of 30. Bottles of 30                                NDC 54458-981-16 Citalopram tablets USP, 20 mg are pink, round, biconvex, film coated tablets embossed ‘RDY’                                                                                                                                               343 on one side and scored on other side and are                                                                                                                                     supplied in adherence packages of 30.             Bottles of 30                                NDC 54458-980-16 Citalopram tablets USP, 40 mg are white, round, biconvex, film coated tablets embossed ‘RDY’                                                                                                                                                344 on one side and scored on other side                                                                                                                                                                                                              and are supplied in adherence packages of 30.                                                                                                                Bottles of 30                                NDC 54458-889-16 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

CITALOPRAM- CITALOPRAM TABLET, FILM COATED
International Laboratories, LLC
----------
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.
What is the most important information I should know about Citalopram
Tablets?
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
are 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 rig

מאפייני מוצר

CITALOPRAM- CITALOPRAM TABLET, FILM COATED
INTERNATIONAL LABORATORIES, LLC
----------
CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
CITALOPRAM TABLETS USP
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 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 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 hydrobromide 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 hydrobromide USP is a racemic
bicyclic phthalane derivative
designated
(±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran
-5-
carbonitrile, hydrobromide with the following structural formula:
CITALOPRAM
The molecular formula is C
H BrFN O and its molecular weight is 405.35.
Citalopram hydrobromide USP occurs as a whit