CITALOPRAM tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

MedVantx, Inc.

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 tablets in the treatment of depression was established in 4 to 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 not been adequately studied. The ef

leaflet_short:

Citalopram Tablets USP are available as follows: 10 mg: light-beige, convex capsule-shaped, unscored tablets, debossed “4740” on one side and “93” on the other side containing citalopram hydrobromide USP equivalent to 10 mg citalopram, packaged in bottles of 100 and 1000 tablets and unit-dose boxes of 100 tablets. 20 mg: light-pink, convex capsule-shaped, scored tablets, debossed “4741” on one side and “9” score “3” on the other side containing citalopram hydrobromide USP equivalent to 20 mg citalopram, packaged in bottles of 100, 500, and 5000 tablets and unit-dose boxes of 100 tablets. 40 mg: white to off-white, convex capsule-shaped, scored tablets, debossed “4742” on one side and “9” score “3” on the other side containing citalopram hydrobromide USP equivalent to 40 mg citalopram, packaged in bottles of 100, 500, and 5000 tablets and unit-dose boxes of 100 tablets. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

CITALOPRAM- CITALOPRAM TABLET
MedVantx, Inc.
----------
MEDICATION GUIDE
Citalopram (sye tal' oh pram) Tablets USP
Read the Medication Guide that comes with citalopram tablets before
you start taking them 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.
∘
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 right away if you have any of the
following symptoms, or call 911 if an
emergency. Citalopram tablet

מאפייני מוצר

CITALOPRAM- CITALOPRAM TABLET
MEDVANTX, INC.
----------
CITALOPRAM TABLETS USP
4740
4741
4742
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
ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (SEE WARNINGS, CLINICAL
WORSENING AND
SUICIDE RISK; PRECAUTIONS, INFORMATION FOR PATIENTS; AND PRECAUTIONS,
PEDIATRIC
US E).
DESCRIPTION
Citalopram Tablets USP are 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,
HBr with the following structural formula:
C
H BrFN O M.W. 405.35
Citalopram hydrobromide, USP occurs as a fine, white to off-white
powder. Citalopram hydrobromide,
USP is sparingly soluble in water and soluble in ethanol.
Each Citalopram Tablet USP,