CITALOPRAM HYDROBROMIDE- citalopram tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Aphena Pharma Solutions - Tennessee, LLC

INN (nemzetközi neve):

CITALOPRAM HYDROBROMIDE

Összetétel:

CITALOPRAM 20 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Citalopram Tablets, USP 10 mg. They are supplied in Bottle of 30 NDC # 76282-206-30, Bottle of 90 NDC # 76282-206-90, Bottle of 500 NDC # 76282-206-05 and 1,000 NDC # 76282-206-10 Beige, film coated round, bi-convex tablets de-bossed with IG on one side and “206” on the other. 20 mg. They are supplied in Bottle of 30 NDC # 76282-207-30, Bottle of 90 NDC # 76282-207-90, Bottle of 500 NDC # 76282-207-05 and 1,000 NDC # 76282-207-10 Pink, film coated, round, bi-convex tablets de-bossed with I on the left side of bisect and G on right side of bisect on one side and “207” on the other. 40 mg. They are supplied in Bottle of 30 NDC # 76282-208-30, Bottle of 90 NDC # 76282-208-90, Bottle of 500 NDC # 76282-208-05 and 1,000 NDC # 76282-208-10 White, film coated, round, bi-convex tablets de-bossed with I on the left side of bisect and G on right side of bisect on one side and “208” on the other. Store at 20°C to 25° C (68° F to 77° F) [see USP Controlled Room Temperature]

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

CITALOPRAM HYDROBROMIDE - CITALOPRAM TABLET
Aphena Pharma Solutions - Tennessee, LLC
---------- MEDICAT
ION GUIDE CITALOPRAM
TABLETS, USP (SIH-
TAL-OH-PRAM)
Read the Medication Guide that comes with citalopram 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 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 changes in behavior or mood
Call your healthcar

Termékjellemzők

CITALOPRAM HYDROBROMIDE - CITALOPRAM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 TABLETS 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 TABLETS
ARE 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-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 405.35.
Citalopram hydrobromide, USP occurs as a fine, white to off-white
powder. Citalopram HBr is
sparingly soluble in water and soluble in