Rx Item-Escitalopram 5MG/5ML 240 ML Sol by Camber Pharma USA Gen Lexapro

LEXAPRO- escitalopram oxalate tablet, film coated
PD-Rx Pharmaceuticals, Inc.

WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients less than 12 years of age. [See Warnings and Precautions: Clinical Worsening and Suicide Risk ( 5.1), Patient Counseling Information: Information for Patients ( 17.1), and Use in Specific Populations: Pediatric Use ( 8.4)].

1 INDICATIONS AND USAGE

1.1 Major Depressive Disorder


Lexapro (escitalopram) is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies ( 14.1) ].

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.
2 DOSAGE AND ADMINISTRATION

Lexapro should be administered once daily, in the morning or evening, with or without food.
3 DOSAGE FORMS AND STRENGTHS

3.1 Tablets
Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. Imprinted with "FL" on one side and either "5?, "10", or "20" on the other side according to their respective strengths.

Rx Item-Escitalopram 5MG/5ML 240 ML Sol
Item No. RX232316, 232316, NDC No.: 31722-0569-24, 31722-569-24, 3172256924, 31722056924, 0569-24, 056924 UPC No. 3-31722-56924-8, 331722-569248, 331722569248

Rx Item-Escitalopram 5MG/5ML 240 ML Sol
Item No. RX232316, 232316, NDC No.: 31722-0569-24, 31722-569-24, 3172256924, 31722056924, 0569-24, 056924 UPC No. 3-31722-56924-8, 331722-569248, 331722569248

Rx Item-Escitalopram 5MG/5ML 240 ML Sol
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Camber Pharmaceuticals
Item No. RX232316, 232316, NDC No.: 31722-0569-24, 31722-569-24, 3172256924, 31722056924, 0569-24, 056924 UPC No. 3-31722-56924-8, 331722-569248, 331722569248

Escitalopram 5MG/5ML Solco
Item No. RX232316, 232316, NDC No.: 31722-0569-24, 31722-569-24, 3172256924, 31722056924, 0569-24, 056924 UPC No. 3-31722-56924-8, 331722-569248, 331722569248