CITALOPRAM- citalopram hydrobromide tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

American Health Packaging

INN (International Name):

CITALOPRAM HYDROBROMIDE

Sammensætning:

CITALOPRAM 10 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Citalopram tablets are contraindicated in patients: - taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.3), Drug Interactions (7)]. - taking pimozide because of risk of QT prolongation [see Drug Interactions (7)]. - with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. Reactions have included angioedema and anaphylaxis [see Adverse Reactions (6.2)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at

Produkt oversigt:

Citalopram tablets, USP are supplied as follows: 10 mg Tablets – Peach colored, biconvex, round shaped film coated tablets debossed with ‘A’ on one side and ‘05’ on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-737-01 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

American Health Packaging
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MEDICATION GUIDE
8273701/0722
Citalopram (sye tal' oh pram)
Tablets USP, for oral use
What is the most important information I should know about citalopram
tablets?
citalopram tablets may cause serious side effects, including:
•
Increased risk of suicidal thoughts and actions. Citalopram tablets
and other antidepressant medicines
may increase suicidal thoughts and actions in some children,
adolescents, and young adults especially
within the first few months of treatment or when the dose is changed.
Citalopram tablets are not for
use in children.
•
Depression and other mental illnesses are the most important causes of
suicidal thoughts and
actions.
•
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
•
Pay close attention to any changes, especially sudden changes in mood,
behavior, thoughts, or
feelings, or if you develop suicidal thoughts or actions. This is very
important when an antidepressant
medicine is started or when the dose is changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call your healthcare provider or get emergency medical help right away
if you or your family member have
any of the following symptoms, especially if they are new, worse, or
worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling very agitated or restless
•
acting on dangerous impulses
•
trouble sleeping (insomnia)
•
panic attacks
•
acting aggressive, being angry, or violent
•
new or worse irritability
•
an extreme increase in activity or talking (mania)
•
other unusual changes in behavior or mood
What are citalopram tablets?
Citalopram tablets are a prescription medicine used to treat a cert

Produktets egenskaber

CITALOPRAM- CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CITALOPRAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CITALOPRAM TABLETS.
CITALOPRAM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND
YOUNG ADULT
PATIENTS TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL
ANTIDEPRESSANT-TREATED PATIENTS
FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS _(5.1)._
CITALOPRAM IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS _(8.4)._
INDICATIONS AND USAGE
Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI)
indicated for the treatment of major
depressive disorder (MDD) in adults _(1)._
DOSAGE AND ADMINISTRATION
Administer once daily with or without food _(2)._
Initial dosage is 20 mg once daily; after one week may increase to
maximum dosage of 40 mg once
daily _(2.1)._
Patients greater than 60 years of age, patients with hepatic
impairment, and CYP2C19 poor
metabolizers: maximum recommended dosage is 20 mg once daily _(2.2)._
When discontinuing citalopram tablets, reduce dosage gradually _(2.4,
5.6)._
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg; 20 mg, scored; and 40 mg, scored _(3)_
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within
14 days of discontinuing a
MAOI _(4)._
Concomitant use of pimozide _(4)._
Known hypersensitivity to citalopram or any of the inactive
ingredients of citalopram _(4)._
WARNINGS AND PRECAUTIONS
_QT-Prolongation and Torsade de Pointes:_ Dose-dependent QTc
prolongation, Torsade de pointes,
ventricular tachycardia, and sudden death have occurred. Avoid use of
citalopram in patients with
congenital long QT syndrome, bradycardia, hypokalemia or
hypomagnesemia, recent acute myocardial
infarction, or uncompensate