CITALOPRAM HYDROBROMIDE solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

ATLANTIC BIOLOGICALS CORP.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 not bee

Ringkasan produk:

Citalopram oral solution USP, 10 mg/5 mL is supplied as a peppermint flavored oral solution. Bottles of 240 mL with Induction Sealing Foil seal Wad (NDC 31722-564-24) UD NDC 17856-0564-01 CITALOPRAM ORAL SOL 52MG/10ML CUP 72 Store at 20º to 25º C (68° to 77° F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE SOLUTION
ATLANTIC BIOLOGICALS CORP.
----------
SPL MEDGUIDE
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
�

Karakteristik produk

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE SOLUTION
ATLANTIC BIOLOGICALS CORP.
----------
CITALOPRAM ORAL SOLUTION, 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 ORAL SOLUTION USP 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,
HBr with
the following structural formula:
The molecular formula is C
H BrFN O and its molecular weight is 405.30.
Citalopram hydrobromide, USP occurs as a white to almost white
crystalline powder. Citalopram