CITALOPRAM- 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:

Pharmaceutical Associates, Inc.

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 4-6 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

Ringkasan produk:

Citalopram Oral Solution, USP 10 mg/5 mL, peppermint flavor is supplied as: NDC 0121-0848-05: 5 mL unit dose cup NDC 0121-0848-40: Case contains 40 unit dose cups of 5 mL (0121-0848-05) packaged in 4 trays of 10 unit dose cups each. NDC 0121-1696-10: 10 mL unit dose cup NDC 0121-1696-40: Case contains 40 unit dose cups of 10 mL (0121-1696-10) packaged in 4 trays of 10 unit dose cups each. Store at 20° - 25°C (68° - 77ºF). [see USP Controlled Room Temperature]

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

CITALOPRAM- CITALOPRAM HYDROBROMIDE SOLUTION
Pharmaceutical Associates, Inc.
----------
MEDICATION GUIDE
Citalopram (sye tal' oh pram) Oral Solution, USP
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 unusual chan

Karakteristik produk

CITALOPRAM- CITALOPRAM HYDROBROMIDE SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
----------
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 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-flurophenyl)-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 HBr occurs as a fine, white to off-white powder. Citalopram
HBr is sparingly soluble in
water and soluble in ethanol.
Citalopram hydrobromide