CITALOPRAM- citalopram hydrobromide tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

citalopram hydrobromide (UNII: I1E9D14F36) (citalopram - UNII:0DHU5B8D6V)

Commercializzato da:

Jubilant Cadista Pharmaceuticals Inc.

INN (Nome Internazionale):

citalopram hydrobromide

Composizione:

citalopram 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Citalopram tablets are indicated for the treatment of depression. The efficacy of citalopram 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 in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in mai

Dettagli prodotto:

Citalopram tablets, USP are supplied as: 10 mg Tablets - White, round, film-coated tablets debossed with ‘F7’ on one side and ‘C’ on the other side. Bottle of 30s (Child Resistant )                                   NDC 59746-543-30 Bottle of 100s (Child Resistant)                                  NDC 59746-543-01 Bottle of 500s (Ribbed Stock)                                     NDC 59746-543-05 Bottle of 1,000s (Ribbed Stock)                                  NDC 59746-543-10 20 mg Tablets - White, oval shaped, biconvex, film-coated tablets with scoreline on one side, debossed with ‘F’ on the left side and ‘8’ on the right side of the scoreline and ‘C’ on the other side. Citalopram tablets 20 mg have functional scoring. Bottle of 30s (Child Resistant )                                   NDC 59746-544-30 Bottle of 100s (Child Resistant)                                  NDC 59746-544-01 Bottle of 500s (Ribbed Stock)                                     NDC 59746-544-05 Bottle of 1,000s (Ribbed Stock)                                  NDC 59746-544-10 40 mg Tablets - White, oval shaped, biconvex, film-coated tablets with scoreline on one side, debossed with ‘G’ on left side and ‘1’ on right side of the scoreline and ‘C’ on the other side. Citalopram tablets 40 mg have functional scoring. Bottle of 30s (Child Resistant )                                   NDC 59746-546-30 Bottle of 100s (Child Resistant)                                  NDC 59746-546-01 Bottle of 500s (Ribbed Stock)                                     NDC 59746-546-05 Bottle of 1,000s (Ribbed Stock)                                  NDC 59746-546-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

CITALOPRAM - CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
Jubilant Cadista Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Citalopram Tablets, USP
(sye tal' oh pram hye" droe broe' mide)
Read the Medication Guide that comes with citalopram tablets 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 tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Citalopram tablets 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 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

Scheda tecnica

CITALOPRAM - CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
----------
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 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, USP 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, USP 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 405.30.
Citalopram hydrobromide, USP occurs as a white to almost white
crystalline powder.
Citalopram hydrobrom