CITALOPRAM tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Direct Rx

INN（国際名）:

CITALOPRAM HYDROBROMIDE

構図:

CITALOPRAM 40 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr 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 mainta

製品概要:

Citalopram Tablets, USP contain citalopram hydrobromide USP, equivalent to 10, 20 or 40 mg citalopram base. Citalopram Tablets USP 10 mg Bottle of 30 NDC 13668-009-30 Bottle of 100 NDC 13668-009-01 Bottle of 500 NDC 13668-009-05 Bottle of 9990 NDC 13668-009-09 10 x 10 Unit Dose NDC 13668-009-74 Tan coloured, round shaped, biconvex film coated tablets with '10' debossed on one side and plain on the other side. Citalopram Tablets, USP 20 mg Bottle of 30 NDC 13668-010-30 Bottle of 100 NDC 13668-010-01 Bottle of 500 NDC 13668-010-05 Bottle of 5600 NDC 13668-010-06 10 x 10 Unit Dose NDC 13668-010-74 Tan coloured, oval shaped, biconvex film coated tablets with '2|0' debossed ('2' on left side and '0' on right side of the break line) on one side and '1010' on the other side. Citalopram Tablets, USP 40 mg Bottle of 30 NDC 13668-011-30 Bottle of 100 NDC 13668-011-01 Bottle of 500 NDC 13668-011-05 Bottle of 2800 NDC 13668-011-08 10 x 10 Unit Dose NDC 13668-011-74 Tan coloured, oval shaped, biconvex film coated tablets with '4|0' debossed ('4' on left side and '0' on right side of the break line) on one side and '1011' on the other side. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

CITALOPRAM- CITALOPRAM TABLET
Direct Rx
----------
SPL MEDGUIDE SECTION
Medication Guide
Citalopram (si TAL o pram) Tablets, USP
Rx Only
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 changes in behavior or mood
Call your healthcare provider right away if you have any of the
following

製品の特徴

CITALOPRAM- CITALOPRAM TABLET
DIRECT RX
----------
CITALOPRAM
BOXED WARNING SECTION
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.)
SPL UNCLASSIFIED SECTION
Rx Only
DESCRIPTION SECTION
Citalopram HBr, 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 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:
Citalopram HBr, USP occurs as a fine, white to off-white
powder.Citalopram HBr is
sparingly soluble in water and soluble in ethanol.
Citalopram hydrobromide is available only in tablet dosage form.
Citalopram hydrobromi