CITALOPRAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Camber Pharmaceuticals

INN (International Name):

CITALOPRAM HYDROBROMIDE

Composition:

CITALOPRAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Citalopram Tablets, USP 10 mg. They are supplied in Bottle of 30 NDC # 31722-206-30, Bottle of 100 NDC # 31722-206-01, Bottle of 500 NDC # 31722-206-05 and 1000 NDC # 31722-206-10 Beige, film coated round, bi-convex tablets de-bossed with IG on one side and “206 ” on the other. 20 mg. They are supplied in Bottle of 30 NDC # 31722-207-30, Bottle of 100 NDC # 31722-207-01, Bottle of 500 NDC # 31722-207-05 and 1000 NDC # 31722-207-10 Pink, 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 “207 ” on the other. 40 mg. They are supplied in Bottle of 30 NDC # 31722-208-30, Bottle of 100 NDC # 31722-208-01, Bottle of 500 NDC # 31722-208-05 and 1000 NDC # 31722-208-10 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/m2 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/m2 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/m2 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. Rev: 12/14

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CITALOPRAM- CITALOPRAM TABLET
Camber Pharmaceuticals
----------
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 and other antidepressant medicines may cause serious side
effects, including:
1.
Suicidal thoughts or actions:
•
Citalopram 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 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 have any of the
follo

Summary of Product characteristics

CITALOPRAM- CITALOPRAM TABLET
CAMBER PHARMACEUTICALS
----------
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
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 Use).
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.
Citalopram hydrobromide, USP occurs as a fine, white to off-white
powder. Citalopram HBr is
sparingly soluble in water and soluble in ethanol.
Citalopram hydrobromide,