CITALOPRAM HYDROBROMIDE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Dr. Reddy's Laboratories Limited

INN (Mezinárodní Name):

Citalopram hydrobromide

Složení:

Citalopram 10 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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. Healhcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/resea

Přehled produktů:

Citalopram tablets USP, 10 mg are brown, round, biconvex, film-coated tablets embossed “RDY” on one side and “342” on other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-342-30 Bottles of 60 NDC 55111-342-60 Bottles of 100 NDC 55111-342-01 Bottles of 500 NDC 55111-342-05 Unit dose package of 100 (10 x 10) NDC 55111-342-78 Citalopram tablets USP, 20 mg are pink, round, biconvex, film-coated tablets embossed ‘RDY’/343on one side and scored on other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-343-30 Bottles of 60 NDC 55111-343-60 Bottles of 100 NDC 55111-343-01 Bottles of 500 NDC 55111-343-05 Unit dose package of 100 (10 x 10) NDC 55111-343-78 Citalopram tablets USP, 40 mg are white, round, biconvex, film-coated tablets embossed ‘RDY’/344 on one side and scored on other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-344-30 Bottles of 60 NDC 55111-344-60 Bottles of 100 NDC 55111-344-01 Bottles of 500 NDC 55111-344-05 Unit dose package of 100 (10 x 10) NDC 55111-344-78 Storage and HandlingStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Dr. Reddy's Laboratories Limited
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MEDICATION GUIDE
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
•
new or worse depression
•
feeling very agitated or restless
•
trouble sleeping (insomnia)
•
acting aggressive, being angry, or violent
•
an extreme increase in activity or talking (mania)
•
attempts to commit suicide
•
new or worse anxiety
•
acting on dangerous impulses
•
panic attacks
•
new or worse irritability
•
other unusual changes in behavior or mood
What are citalopram tablets?
Citalopram tablets are a prescription medicine used to treat a certain
type of

Charakteristika produktu

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
DR. REDDY'S LABORATORIES LIMITED
----------
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 TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS
(8.4).
INDICATIONS AND USAGE
Citalopram tablets is 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).
Concomiant use of pimozide (4).
Known hypersensitivity to citalopram or any of the inactive
ingredients of citalopram tablets (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 tablets in patients
with congenital long QT syndrome, bradycardia, hypokalemia or
hypomagnesemia, recent
acute myocardia