Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)
QPharma Inc
CITALOPRAM HYDROBROMIDE
CITALOPRAM 20 mg
ORAL
PRESCRIPTION DRUG
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. H
Citalopram tablets, USP are supplied as follows: 20 mg Tablets – Light pink colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘6’ on other side. Bottles of 30 NDC 42708-019-30 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].
Abbreviated New Drug Application
QPharma Inc ---------- 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 depression called M Прочитать полный документ
CITALOPRAM- CITALOPRAM HYDROBROMIDE TABLET, FILM COATED QPHARMA 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 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)._ Concomiant 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 uncompensated Прочитать полный документ