Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
PD-Rx Pharmaceuticals, Inc.
ESCITALOPRAM OXALATE
ESCITALOPRAM 10 mg
ORAL
PRESCRIPTION DRUG
Escitalopram tablets are indicated for the treatment of: • major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. • generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older. Escitalopram tablets are contraindicated in patients: • taking MAOIs with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets because of an increased risk of serotonin syndrome. The use of escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration ( 2.7) and Warnings and Precautions ( 5.2)] . Starting escitalopram tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.6) and Warnings and Precautions ( 5.2)] . • taking
How Supplied Escitalopram tablets, USP 10 mg are white to off-white, round, biconvex, film coated tablets debossed with break line on one side, separating '11' and '36' on one side, and '10' on other side. Bottles of 30 NDC 43063-761-30 Bottles of 90 NDC 43063-761-90 Bottles of 100 NDC 43063-761-01 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
PD-Rx Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Escitalopram (EE sye TAL o pram) Tablets, USP What is the most important information I should know about escitalopram tablets? Escitalopram tablets may cause serious side effects, including: • Increased risk of suicidal thoughts or actions.Escitalopram tablets and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. o Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? o Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you or your child 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 or if you or your child develop suicidal thoughts or actions. o Keep all follow-up visits with your healthcare provider as scheduled and call your healthcare provider between visits if you are worried about symptoms. Call your healthcare provider or get emergency medical help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you: o attempts to commit suicide o acting on dangerous impulses o acting aggressive, being angry or violent o thoughts about suicide or dying o new or worse depression o new or worsening anxiety o panic attacks o feeling very agitated or restless o new or worse irritability o trouble sleeping o an extreme increase in activity or talking (mania) o other unusual changes in behavior or mood What is escitalopram tablets? Escitalopram tablets are prescription medicine used to treat: • a certain type of depression called Major Depressive Disorder (MDD) in adults and children 12 y Прочетете целия документ
ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESCITALOPRAM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM TABLETS. ESCITALOPRAM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2002 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). ESCITALOPRAM TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 7 YEARS OF AGE ( 8.4). RECENT MAJOR CHANGES Indications ( 1) 5/2023 Dosage and Administration ( 2.2, 2.3, 2.5) 5/2023 Dosage and Administration, Use of Escitalopram with Other MAOIs such as Linezolid or Methylene Blue ( 2.7) - Removed 5/2023 Warnings and Precautions ( 5.2, 5.7) 5/2023 INDICATIONS AND USAGE Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: • treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1) • treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years and older ( 1) DOSAGE AND ADMINISTRATION Indication and Population Recommended Dosage MDD in Adults ( 2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Pediatric Patients 12 years and older ( 2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults ( 2.2) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Pediatric Patients 7 years and older ( 2.2) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily • No additional benefits were seen at 20 mg once daily ( 2.1) • Administer once daily, morning or eveni Прочетете целия документ