CITALOPRAM HYDROBROMIDE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Citalopram hydrobromide (UNII: I1E9D14F36) (Citalopram - UNII:0DHU5B8D6V)

Dostupné s:

MedVantx, Inc.

INN (Mezinárodní Name):

Citalopram hydrobromide

Složení:

Citalopram 40 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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 bottles of 30, 60,100, 500 and unit dose package of 100 (10 × 10). Bottles of 30                                         NDC 55111-342-30 Bottles of 60                                         NDC 55111-342-60 Bottles of 100                                       NDC 55111-342-01 Bottles of 500                                       NDC 55111-342-05 Unit dose package of 100 (10 x 10)        NDC 55111-342-78 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 bottles of 30, 60,100, 500 and unit dose package of 100 (10 x 10). Bottles of 30                                                      NDC 55111-343-30 Bottles of 60                                                      NDC 55111-343-60 Bottles of 100                                                    NDC 55111-343-01 Bottles of 500                                                    NDC 55111-343-05 Unit dose package of 100 (10 x 10)                      NDC 55111-343-78 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 bottles of 30, 60,100, 500 and unit dose package of 100 (10 x 10). Bottles of 30                                                       NDC 55111-344-30 Bottles of 60                                                       NDC 55111-344-60 Bottles of 100                                                     NDC 55111-344-01 Bottles of 500                                                     NDC 55111-344-05 Unit dose package of 100 (10 x 10)                     NDC 55111-344-78 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
MedVantx, 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.
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
somechildren, teenagers, or young adultswithin 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. C

Charakteristika produktu

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
MEDVANTX, INC.
----------
CITALOPRAM 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
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:
The molecular formula is C
H BrFN O and its molecular weight is 405.35.
Citalopram hydrobromide USP occurs as a fine, white to off-white
powder. Citalopram hydrobromide
USP is sparingly soluble i