CITALOPRAM HYDROBROMIDE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Legacy Pharmaceutical Packaging, LLC

INN (Nome Internazionale):

CITALOPRAM HYDROBROMIDE

Composizione:

CITALOPRAM 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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. Unit of Use Bottles of 30:  10 mg (NDC 68645-569-54) 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. Unit of Use Bottles of 30:  20 mg (NDC 68645-570-54) 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. Unit of Use Bottles of 30:  40 mg (NDC 68645-571-54) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

CITALOPRAM HYDROBROMIDE- citalopram hydrobromide tablet, film coated
Legacy Pharmaceutical Packaging, LLC
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Medication Guide
Citalopram Tablets, USP
(s ye-TAL-oh-pram)
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

Scheda tecnica

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
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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 tablets, USP contains citalopram hydrobromide USP, 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.
20
22
2
Citalopram hydrobromide USP occurs as a white or almost white