DrugBuyers.Com: Zoloft

Zoloft - Sertraline

Sertraline HCl is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It is chemically unrelated to other SSRIs, tricyclic, tetracyclic, or other available antidepressant agents. 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-nanphthalenamine hydrochloride. The empirical formula is C17H17NCl2·HCl.

Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.

Zoloft is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg and the following inactive ingredients: dibasic calcium phosphate dihydrate, Dy & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD&C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.
Zoloft oral concentrate is available in a multidose 60 ml bottle. Each ml of solution contains sertraline HCl equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytolunene (BHT). The oral concentrate must be diluted prior to administration.

INDICATIONS

Depression

Sertraline HCl is indicated for the treatment of depression.

The efficacy of sertraline HCl in the treatment of a major depressive episode was established in six to eight week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL STUDIES).

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.

The antidepressant action of sertraline HCl in hospitalized depressed patients has not been adequately studied.

The efficacy of sertraline HCl in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline HCl for extended periods should be reevaluated periodically.

Obsessive-Compulsive Disorder

Sertraline HCl is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R (i.e., the obsessions and compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.)

The efficacy of sertraline HCl was established in 12-week trials with obsessive-compulsive outpatients having diagnosis of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria
Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

The effectiveness of sertraline HCl in long-term use for OCD (i.e., for more than 12 weeks) has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use sertraline HCl for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient

PATIENT INFORMATION

Sertraline HCl is used for the treatment of Depression, Obsessive Compulsive Disorder, and Panic Disorder.

Do not take this medication if you are taking MAO Inhibitors (e.g., Parnate). Do not drink alcohol while taking this medication.

Inform your doctor if you are pregnant or breast feeding. Sertraline HCl may cause dizziness, use caution while driving or operating hazordous machinery.

This medication may cause stomach upset, nausea, diarrhea, dizziness, tremor, insomnia, sleepiness, sweating, dry mouth, and male sexual dysfunction. Inform your physician or pharmacist if these occur