CITALOPRAM HYDROBROMIDE- citalopram tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Exelan Pharmaceuticals Inc.

INN (International Name):

CITALOPRAM HYDROBROMIDE

Composition:

CITALOPRAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] . Citalopram is 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. 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/research/pregnancyregistry/anti

Product summary:

Citalopram Tablets, USP 10 mg. They are supplied in Bottle of 30 NDC # 76282-628-30, Bottle of 90 NDC # 76282-628-90, Bottle of 500 NDC # 76282-628-05 and 1,000 NDC # 76282-628-10 Beige, film coated round, bi-convex tablets debossed with IG on one side and “206” on the other. 20 mg. They are supplied in Bottle of 30 NDC # 76282-629-30, Bottle of 90 NDC # 76282-629-90, Bottle of 500 NDC # 76282-629-05 and 1,000 NDC # 76282-629-10 Pink, film coated, round, bi-convex tablets debossed 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 debossed with I on the left side of bisect and G on right side of bisect on one side and “208” on the other. Storage and Handling Citalopram tablets should be stored at 20-25°C (68 to 77°F); excursions permitted between 15 and 30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Exelan Pharmaceuticals Inc.
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MEDICATION GUIDE
Citalopram Tablets,USP
(sih-TAL-oh-pram)
What is the most important information I should know about
Citalopram? Citalopram may cause serious side effects,
including:
•
Increased risk of suicidal thoughts and
actions. Citalopram 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 is 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 is Citalopram?
Citalopram is a prescription medicine used to treat a certain type
of depression called Major Depressive Disorder (MDD) in
adults.
It is no

Summary of Product characteristics

CITALOPRAM HYDROBROMIDE - CITALOPRAM TABLET
EXELAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CITALOPRAM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CITALOPRAM .
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).
RECENT MAJOR CHANGES
Warnings and Precautions (5.3, 5.4) 8/2023
INDICATIONS AND USAGE
Citalopram 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, 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 un