CITALOPRAM HYDROBROMIDE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Preferred Pharmaceuticals, Inc.

INN (International Nazwa):

CITALOPRAM HYDROBROMIDE

Skład:

CITALOPRAM 10 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)] . The maxium recommended dosage of citalopram tablets when used concomitantly with a CYP2C19 inhibitor is 20 mg once daily [see Warnings and Precautions ( 5.2), Drug Interactions ( 7)] . 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

Podsumowanie produktu:

Citalopram Tablets, USP contain citalopram hydrobromide USP, equivalent to 10, 20 or 40 mg citalopram base. Citalopram Tablets, USP 10 mg Bottle of 30 - 68788-9692-3 Bottle of 60 - 68788-9692-6 Bottle of 90 - 68788-9692-9 Bottle of 100 - 68788-9692-1 Bottle of 120 - 68788-9692-8 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 - 68788-0802-3 Bottle of 60 - 68788-0802-6 Bottle of 90 - 68788-0802-9 Bottle of 100 - 68788-0802-1 Bottle of 120 - 68788-0802-8 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° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET
Preferred Pharmaceuticals, Inc.
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MEDICATION GUIDE
CITALOPRAM (SI TAL O PRAM), USP
(CITALOPRAM)
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. ° 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 t

Charakterystyka produktu

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
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 (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 thoughs and behaviors _( 5.1) _.
• Citalopram tablets are not approved for use in pediatric patients
_( 8.4) _.
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 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, bra