* Disclaimer: The Harmonized System (HS) code provided on this webpage are for information purposes only and are subject to change without notice. USP is not responsible for the accuracy or completeness of the information furnished. The exporter and/or importer of record is responsible for determining the accuracy of items at the time of export/import per U. Sertraline is used for a number of conditions, including major depressive disorder (MDD), obsessive–compulsive disorder (OCD), body dysmorphic disorder (BDD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), panic disorder, and social anxiety disorder (SAD). The comparative efficacy of sertraline and TCAs for melancholic depression has not been studied. A 1998 review suggested that, due to its pharmacology, sertraline may be more efficacious than other SSRIs and equal to TCAs for the treatment of melancholic depression. A meta-analysis of 12 new-generation antidepressants showed that sertraline and escitalopram are the best in terms of efficacy and acceptability in the acute-phase treatment of adults with unipolar MDD. Sertraline used for the treatment of depression in elderly (older than 60) patients was superior to placebo and comparable to another SSRI fluoxetine, and TCAs amitriptyline, nortriptyline (Pamelor) and imipramine. Sertraline had much lower rates of adverse effects than these TCAs, with the exception of nausea, which occurred more frequently with sertraline. In addition, sertraline appeared to be more effective than fluoxetine or nortriptyline in the older-than-70 subgroup. placebo in elderly patients showed a statistically significant (that is, unlikely to occur by chance), but clinically very modest improvement in depression and no improvement in quality of life. A meta-analysis on SSRIs and SNRIs that look at partial response (defined as at least a 50% reduction in depression score from baseline) found that sertraline, paroxetine and duloxetine were better than placebo.
This website contains 106190 drug listings as submitted to the Food and Drug Administration (FDA). At the present time, this Web site does not contain a complete listing of labels for approved prescription drugs. Posted: December 19, 2017 Drug Listing Certification The U. Food and Drug Administration is reminding the pharmaceutical industry of the December 31, 2017, deadline to update or certify their drug listings with FDA. This applies to drug listings that were not initially listed or updated during the current calendar year. This is the first deadline of the annual certification requirement under Part 207 of Title 21 of the Code of Federal Regulations. Companies must submit this information to FDA in electronic format. They may make a blanket "no changes" certification to indicate that their listing information is up to date in FDA's database. Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-Nmethyl- 1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2•HCl is represented by the following structural formula: Sertraline Hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline Tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3c P, hypromellose 6c P, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3c P, hypromellose 6c P, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3c P, hypromellose 6c P, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate. 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. 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 downregulate brain norepinephrine receptors, as has been observed with other drugs effective in the treatment of major depressive disorder. ) of sertraline occurred between 4.5 to 8.4 hours post-dosing.
Please note that pre-registration is required to buy Reference Standards. If you're not able to "Select" an item from this list, it means the item is restricted and cannot be ordered online as we first need to ensure that DEA requirements are fulfilled. Please call USP Customer Service at 1-800-227-8772 or 301-881-0666 to order. USP provides Safety Data Sheets (SDS) for all Reference Standards and USP Certificates for some Reference Standards. Click on any product description to access the SDS and the USP Certificate, if available. Animal, Plant, Fish) may require special country importation requirements. USP recommends you contact your country competent authorities to determine if any certifications, permits or licenses may be required prior to ordering. Material Origins are found within the Product under Origin Information. These highlights do not include all the information needed to use ZOLOFT safely and effectively. ZOLOFT (sertraline hydrochloride) tablets, for oral use ZOLOFT (sertraline hydrochloride) oral solution Initial U. Approval: 1991Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (6.1) Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors The recommended initial dosage and maximum ZOLOFT dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage. For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of ZOLOFT, the recommended interval between dose changes is one week. The recommended starting ZOLOFT dosage in adult women with PMDD is 50 mg per day. ZOLOFT may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses).
Sertraline Hydrochloride 100 mg. USP Certificate for Current Lot, View. CAS#, 79559-97-0. USP Certificates and Valid Use Dates for Previous Lots, View. Sertraline Hydrochlorde and Alprazolam in pharmaceutical dosage form by RP-HPLC. USP tailing. USP plate count USP resolution. 1. Sertraline HCL. 2.344.