CITALOPRAM- citalopram tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals, Inc.

INN (International Name):

CITALOPRAM HYDROBROMIDE

Sammensetning:

CITALOPRAM 40 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Citalopram tablets, USP are indicated for the treatment of depression. The efficacy of citalopram 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 efficacy

Produkt oppsummering:

40 mg. They are supplied in bottles of 15 NDC 68071-1970-1 bottles of 30 NDC 68071-1970-3 bottles of 40 NDC 68071-1970-4 bottles of 45 NDC 68071-1970-5 bottles of 60 NDC 68071-1970-6 bottles of 90 NDC 68071-1970-9 White, film coated, round, bi-convex tablets de-bossed with I on the left side of bisect and G on right side of bisect on one side and " 208 " on the other. Store at 20°C to 25° C (68° F to 77° F) [see USP Controlled Room Temperature] ANIMAL TOXICOLOGY Retinal Changes in Rats Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2-year carcinogenicity study with citalopram. There was an increase in both incidence and severity of retinal pathology in both male and female rats receiving 80 mg/kg/day (13 times the maximum recommended daily human dose of 60 mg on a mg/m 2 basis). Similar findings were not present in rats receiving 24 mg/kg/day for two years, in mice treated for 18 months at doses up to 240 mg/kg/day, or in dogs treated for one year at doses up to 20 mg/kg/day (4, 20, and 10 times, respectively, the maximum recommended daily human dose on a mg/m 2 basis). Additional studies to investigate the mechanism for this pathology have not been performed, and the potential significance of this effect in humans has not been established. Cardiovascular Changes in Dogs In a one-year toxicology study, 5 of 10 beagle dogs receiving oral doses of 8 mg/kg/day (4 times the maximum recommended daily human dose of 60 mg on a mg/m 2 basis) died suddenly between weeks 17 and 31 following initiation of treatment. Although appropriate data from that study are not available to directly compare plasma levels of citalopram (CT) and its metabolites, demethylcitalopram (DCT) and didemethylcitalopram (DDCT), to levels that have been achieved in humans, pharmacokinetic data indicate that the relative dog-to-human exposure was greater for the metabolites than for citalopram. Sudden deaths were not observed in rats at doses up to 120 mg/kg/day, which produced plasma levels of CT, DCT, and DDCT similar to those observed in dogs at doses of 8 mg/kg/day. A subsequent intravenous dosing study demonstrated that in beagle dogs, DDCT caused QT prolongation, a known risk factor for the observed outcome in dogs. This effect occurred in dogs at doses producing peak DDCT plasma levels of 810 to 3,250 nM (39 to 155 times the mean steady state DDCT plasma level measured at the maximum recommended human daily dose of 60 mg). In dogs, peak DDCT plasma concentrations are approximately equal to peak CT plasma concentrations, whereas in humans, steady state DDCT plasma concentrations are less than 10% of steady state CT plasma concentrations. Assays of DDCT plasma concentrations in 2,020 citalopram-treated individuals demonstrated that DDCT levels rarely exceeded 70 nM; the highest measured level of DDCT in human overdose was 138 nM. While DDCT is ordinarily present in humans at lower levels than in dogs, it is unknown whether there are individuals who may achieve higher DDCT levels. The possibility that DCT, a principal metabolite in humans, may prolong the QT interval in dogs has not been directly examined because DCT is rapidly converted to DDCT in that species. Revised: 07/2016

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

CITALOPRAM- CITALOPRAM TABLET
NuCare Pharmaceuticals, Inc.
----------
Medication Guide
Citalopram Tablets, USP
(sih-TAL-oh-pram)
Read the Medication Guide that comes with citalopram 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 tabletsand 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 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

Preparatomtale

CITALOPRAM- CITALOPRAM TABLET
NUCARE PHARMACEUTICALS, INC.
----------
CITALOPRAM TABLETS, USP
RX ONLY
BOXED WARNING
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 HBr 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
O and its molecular weight is 405.35.
20
22
2
Citalopram hydrobromide, USP occurs as a fine, white to off-white
powder. Citalopram HBr is
sparingly soluble in water and soluble in eth