CITALOPRAM HYDROBROMIDE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Glenmark Therapeutics Inc., USA

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] . Citalopram tablets are contraindicated in patients: 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 https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.4) and Clinical Considerations] . Available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects

Produktu pārskats:

Citalopram Tablets, USP are supplied as follows: Strength Color/Shape Engraved Descriptors Package Configuration NDC Number 10 mg Beige, oval Bottle of 100 NDC # 72657-109-01 Bottle of 500 NDC # 72657-109-05 20 mg Pink, oval Bottle of 100 NDC # 72657-110-01 Bottle of 500 NDC # 72657-110-05 40 mg White, oval Bottle of 100 NDC # 72657-112-01 Bottle of 500 NDC # 72657-112-05 Storage and Handling Citalopram Tablets, USP should be stored at 20ºC 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]. Protect from light and moisture.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Glenmark Therapeutics Inc., USA
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MEDICATION GUIDE
Dispense with Medication Guide available at
www.glenmarkpharma-us.com/medguides
MEDICATION GUIDE
Citalopram (sye tal' oh pram)
Tablets, 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.
o
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?
o
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.
o
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
o
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:
What are citalopram tablets?
Citalopram tablets are a prescription medicine used to treat a certain
type of depression called Major
Depressive Disorder (MDD) in adults.
It is not known if citalopram tablets are safe and effective for use
in children.
Who should not take citalopram tablets?
Do not take citalopram tablets if you:
•
take a Monoamine Oxidase Inhibitor (MAOI)
•
have stopped taking an MAOI in the last 14 days
•
are being

Produkta apraksts

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET, FILM COATED
GLENMARK THERAPEUTICS INC., USA
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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._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.3, 5.4) 8/2023
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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg; 20 mg; and 40 mg (_3_)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
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_).
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)_.
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use
within14 days of discontinuing a
MAOI (_4_).
Concomitant use of pimozide (_4_).
Known hypersensitivity to citalopram or any of the inactive
ingredients of citalopram tablets (_4_).
_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 pa