Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)
Preferred Pharmaceuticals, Inc.
CITALOPRAM HYDROBROMIDE
CITALOPRAM 10 mg
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET Preferred Pharmaceuticals, Inc. ---------- 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 Izlasiet visu dokumentu
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 Izlasiet visu dokumentu