Rx Item-Sertraline 50MG 30 Tab by Lupin Pharma USA Generic Zoloft

Clinical Information
Gen. Code and Des.
46228 sertraline HCl ORAL TABLET 50 MG
GCN and Des.
16374 sertraline HCl ORAL TABLET 50 MG
Strength
50MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
28160420 SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active Ingredients
3629 sertraline HCl 79559970
Inactive Ingredients
10138 blue dye





ZOLOFT- sertraline hydrochloride tablet, film coated
ZOLOFT- sertraline hydrochloride solution, concentrate
Pfizer


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 ZOLOFT 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. ZOLOFT is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)
ZOLOFT� (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17 H17 NCl2 �HCl


CLINICAL PHARMACOLOGY
Pharmacodynamics
The mechanism of action of sertraline is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT). Studies at clinically relevant doses in man have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha1 , alpha2 , beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A , 5HT1B , 5HT2 ), or benzodiazepine receptors; antagonism of such receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. The chronic administration of sertraline was found in animals to down regulate brain norepinephrine receptors, as has been observed with other drugs effective in the treatment of major depressive disorder. Sertraline does not inhibit monoamine oxidase.
Zoloft Indications and Usage
Major Depressive Disorder
ZOLOFT (sertraline hydrochloride) is indicated for the treatment of major depressive disorder in adults.
The efficacy of ZOLOFT in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
DOSAGE AND ADMINISTRATION
Initial Treatment
Dosage for Adults
Major Depressive Disorder and Obsessive-Compulsive Disorder
ZOLOFT treatment should be administered at a dose of 50 mg once daily.
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder
ZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50�200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for the treatment of these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
Premenstrual Dysphoric Disorder
ZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
While a relationship between dose and effect has not been established for PMDD, patients were dosed in the range of 50�150 mg/day with dose increases at the onset of each new menstrual cycle (see Clinical Trials under CLINICAL PHARMACOLOGY). Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period.
ZOLOFT should be administered once daily, either in the morning or evening.

Rx Item-Sertraline 50MG 30 Tab by Lupin
Item No. RX189030, 189030, NDC No.: 68180-0352-06, 68180-352-06, 6818035206, 68180035206, 0352-06, 035206 UPC No. 3-68180-35206-8, 368180-352068, 368180352068

Rx Item-Sertraline 50MG 30 Tab by Lupin
Item No. RX189030, 189030, NDC No.: 68180-0352-06, 68180-352-06, 6818035206, 68180035206, 0352-06, 035206 UPC No. 3-68180-35206-8, 368180-352068, 368180352068

Rx Item-Sertraline 50MG 30 Tab by Lupin
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

Lupin Pharma
Item No. RX189030, 189030, NDC No.: 68180-0352-06, 68180-352-06, 6818035206, 68180035206, 0352-06, 035206 UPC No. 3-68180-35206-8, 368180-352068, 368180352068

Item No. RX189030, 189030, NDC
Item No. RX189030, 189030, NDC No.: 68180-0352-06, 68180-352-06, 6818035206, 68180035206, 0352-06, 035206 UPC No. 3-68180-35206-8, 368180-352068, 368180352068