CITALOPRAM HYDROBROMIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

INN (International Name):

CITALOPRAM HYDROBROMIDE

Composition:

CITALOPRAM 10 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Citalopram oral solution, USP is indicated for the treatment of depression. The efficacy of citalopram oral solution, USP 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 oral solution, USP in hospitalized depressed patients has no

Product summary:

Citalopram oral solution, USP:             10 mg/5 mL, peppermint flavor (240 mL)                NDC 65862-074-24 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CITALOPRAM HYDROBROMIDE - CITALOPRAM HYDROBROMIDE SOLUTION
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Citalopram Oral Solution USP
(sye tal' oh pram)
Read the Medication Guide that comes with citalopram oral solution
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
oral solution?
Citalopram oral solution and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Citalopram oral solution 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 oral solution
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 unusua

Summary of Product characteristics

CITALOPRAM HYDROBROMIDE - CITALOPRAM HYDROBROMIDE SOLUTION
AUROBINDO PHARMA LIMITED
----------
CITALOPRAM ORAL SOLUTION, 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
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 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 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 is sparingly soluble