SERTANEX-50/100 (SERTRALINE TABLETS)
DESCRIPTION
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.
DOSAGE
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.
CLINICAL PHARMACOLOGY
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.
INDICATIONS
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
CONTRA INDICATIONS
Serotonin Syndrome – Adverse Drug Interaction, Closed Angle Glaucoma, Narrow Iridocorneal Angle, Liver Problems, Bleeding from Stomach, Esophagus or Duodenum, Seizures, Weight Loss, Syndrome of Inappropriate Antidiuretic Hormone Secretion, Low Amount of Sodium in the Blood, Increased Risk of Bleeding, Behaving with Excessive Cheerfulness and Activity, Mild Degree of Mania, Manic-Depression, Having Thoughts of Suicide
SIDE EFFECTS
During its premarketing assessment, multiple doses of ZOLOFT were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to ZOLOFT varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications.
DRUG INTERACTIONS
Because sertraline is tightly bound to plasma protein, the administration of ZOLOFT (sertraline hydrochloride) to a patient taking another drug which is tightly bound to protein (e.g., warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely, adverse effects may result from displacement of protein bound ZOLOFT by other tightly bound drugs.
AVAILABILITY
SERTANEX-50/100 is available in strips of ten capsules containing SERTRALINE TABLETS.
