CITALOPRAM HYDROBROMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

CITALOPRAM HYDROBROMIDE

Composition:

CITALOPRAM 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Citalopram HBr, USP is indicated for the treatment of depression. The efficacy of Citalopram tablets, USP in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-lll and DSM-lll-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 stud

Product summary:

Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows: Bottle of 100 NDC 57664-507-88 Bottle of 500 NDC 57664-507-13 Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows: Bottle of 100 NDC 57664-508-88 Bottle of 500 NDC 57664-508-13 Bottle of 1000 NDC 57664-508-18 Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows: Bottle of 100 NDC 57664-509-88 Bottle of 500 NDC 57664-509-13 Bottle of 1000 NDC 57664-509-18 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET
DIRECT RX
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SPL MEDGUIDE SECTION
Citalopram Tablets, USP
Read the Medication Guide that comes with Citalopram Tablets, USP
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, USP?
Citalopram Tablets, USP and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
Citalopram Tablets, USP 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, USP
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
followin

Summary of Product characteristics

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET
DIRECT RX
----------
CITALOPRAM HYDROBROMIDE
BOXED WARNING SECTION
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 SECTION
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 C20H22BrFN2O and its molecular weight is
405.35.
Citalopram HBr occurs as a fine, white to off-white powder. Citalopram
HBr is sparingly soluble in
water and soluble in ethanol.
Citalopram 10