Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
Macleods Pharmaceuticals Limited
ESCITALOPRAM OXALATE
ESCITALOPRAM 5 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Escitalopram oral solution is 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. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram is contraindicated in patients: • taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. The use of escitalopram 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 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 se
How Supplied Escitalopram Oral Solution 5 mg/5 mL, peppermint flavor (240 mL) NDC 33342- 053-28 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
ESCITALOPRAM - ESCITALOPRAM SOLUTION Macleods Pharmaceuticals Limited ---------- MEDICATION GUIDE Escitalopram Oral Solution (ES-sye-TAL-oh-pram) What is the most important information I should know about Escitalopram Oral Solution? Escitalopram Oral Solution may cause serious side effects, including: • Increased risk of suicidal thoughts or actions. Escitalopram Oral Solution 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 Oral Solution? Escitalopram Oral Solution is a prescription medicine used to treat: • a certain type of d Baca dokumen lengkapnya
ESCITALOPRAM - ESCITALOPRAM SOLUTION MACLEODS PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESCITALOPRAM ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM ORAL SOLUTION. ESCITALOPRAM ORAL SOLUTION, USP 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 ORAL SOLUTION IS 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 5/2023 with Other MAOIs such as Linezolid or Methylene Blue (2.7) - Removed Warnings and Precautions (5.2, 5.7) 8/2023 INDICATIONS AND USAGE Escitalopram oral solution 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 (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 • No additional benefits were seen at 20 mg once daily (2.1) • Administer once daily, morning or evening, with or without food (2.3) • Elderly patients: recommended dosage is 10 mg once daily (2.4) • Hepatic impairment: recommended dosage is 10 mg once daily (2.4, Baca dokumen lengkapnya