Country: United States
Language: English
Source: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
STAT Rx USA LLC
ESCITALOPRAM OXALATE
ESCITALOPRAM 20 mg
ORAL
PRESCRIPTION DRUG
Escitalopram tablets USP is indicated for the acute and maintenance treatment of major depressive disorder in adults [see Clinical Studies (14.1) ]. Information related to usage of e scitalopram in adolescents is approved for Forest Laboratories, Inc.'s Escitalopram Oxalate Tablets and Oral Solution. However, due to Forest Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that adolescent usage information. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. Escitalopram is i
Escitalopram Tablets USP, 20 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed “5852” on one side and “”, a score, and “20” on the other side, packaged in: bottles of 28 NDC 42549-672-28 bottles of 30 NDC 42549-672-30 bottles of 60 NDC 42549-672-60 bottles of 90 NDC 42549-672-90 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure as required. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA 30501
Abbreviated New Drug Application
ESCITALOPRAM - ESCITALOPRAM TABLET, FILM COATED STAT Rx USA LLC ---------- MEDGUIDE Escitalopram (ES-sye-TAL-oh-pram) Tablets USP Read the Medication Guide that comes with escitalopram before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about escitalopram? Escitalopram and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Escitalopram and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when escitalopram is started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual changes in behavior or mood Call your healthcare provider right away if you have any of Read the complete document
ESCITALOPRAM - ESCITALOPRAM TABLET, FILM COATED STAT RX USA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESCITALOPRAM TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM TABLETS USP. INITIAL U.S. APPROVAL: 2002 INDICATIONS AND USAGE Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for: Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults (1.1) Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) DOSAGE AND ADMINISTRATION Escitalopram tablets USP should generally be administered once daily, morning or evening with or without food (2.1, 2.2). Indication Recommended Dose MDD (2.1) Adults (2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD (2.2) Adults (2.2) Initial: 10 mg once daily Recommended: 10 mg once daily No additional benefits seen at 20 mg/day dose (2.1). 10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment (2.3). No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal impairment (2.3). Discontinuing Escitalopram: A gradual dose reduction is recommended (2.4). DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3.1) CONTRAINDICATIONS Monoamine Oxidase Inhibitors: Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 14 days after stopping escitalopram before starting an MAOI (4.1, 5.10). Pimozide: Do not use concomitantly (4.2, 7.10). Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients (4.3). WARNINGS AND PRECAUTIONS Clinical Worsening/Suicide Risk: Monitor for clinical worsening, suicidality and unusual change in behavior, especially during the initial few months of therapy or at times of dose changes (5.1). Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: Manage with immediate discontinuation Read the complete document