Sertraline (Sertraline)

Trade Name : Sertraline

Bryant Ranch Prepack

TABLET, FILM COATED

Strength 100 mg/1

SERTRALINE HYDROCHLORIDE Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sertraline (Sertraline) which is also known as Sertraline and Manufactured by Bryant Ranch Prepack. It is available in strength of 100 mg/1 per ml. Read more

Sertraline (Sertraline) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 n
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ()
  • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ()
  • Warnings and Precautions, QTc Prolongation (5.10) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 12/2017
  • Sertraline hydrochloride tablets are indicated for the treatment of the following :
  • Sertraline hydrochloride tablet is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ():
  • Major depressive disorder (MDD)
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder (PD)
  • Post-traumatic stress disorder (PTSD)
  • Social anxiety disorder (SAD)
  • Premenstrual dysphoric disorder (PMDD)
  • No data
  • If inadequate response to starting dosage, titrate in 25 to 50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD ()
  • See Full Prescribing Information for titration in PMDD ()
  • Hepatic impairment:n
  • When discontinuing sertraline hydrochloride tablets, reduce dose gradually (, )
  • 25 mg Tablets
  • Green colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D01' on the other side.
  • 50 mg Tablets
  • Blue colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D02' on the other side.
  • 100 mg Tablets
  • Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L'and 'U' on either side of the breakline on one side and 'D03' on the other side.
  • Tablets: 25 mg, 50 mg and 100 mg ()
  • Sertraline hydrochloride tablets are contraindicated in patients:
  • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (, )
  • Concomitant use of pimozide (, )
  • Known hypersensitivity to sertraline or excipients (, )
  • No data
  • u00a0 Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue sertraline hydrochloride tablets and initiate supportive treatment. ()
  • u00a0 Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti- inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. ()
  • u00a0 Activation of Mania/Hypomania: Screen patients for bipolar disorder. ()
  • u00a0 Seizures: Use with caution in patients with seizure disorders. ()
  • u00a0 Angle Closure Glaucoma: Avoid use of antidepressants, including sertraline hydrochloride tablets, in patients with untreated anatomically narrow angles. ()
  • u00a0 QTc Prolongation: sertraline hydrochloride tablets should be used with caution in patients with risk factors for QTc prolongation. ()
  • The following adverse reactions are described in more detail in other sections of the prescribing information:
  • Most common adverse reactions (u22655% 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 ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Protein-bound drugs: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs (e.g., warfarin) as warranted. (, )
  • CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 (, )
  • No data
  • Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the neonate ()
  • Pediatric use: Safety and effectiveness of sertraline hydrochloride in pediatric patients other than those with OCD have not been established ()
  • No data
  • Human Experience
  • The most common signs and symptoms associated with non-fatal sertraline hydrochloride overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage with only sertraline have been reported.
  • Other important adverse events reported with sertraline hydrochloride overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QTc-interval prolongation, Torsade de Pointes, serotonin syndrome, stupor, and syncope. .
  • Overdose Management
  • No specific antidotes for sertraline hydrochloride are known. Contact Poison Control (1-800-222-1222) for latest recommendations.
  • Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula CHNClu2022HCl is represented by the following structural formula:
  • Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide.
  • Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
  • No data
  • Carcinogenesis
  • Lifetime carcinogenicity studies were carried out in CD-1 mice and Long-Evans rats at doses up to 40 mg/kg/day. These doses correspond to 1 times (mice) and 2 times (rats) the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m basis. There was a dose-related increase of liver adenomas in male mice receiving sertraline at 10 to 40 mg/kg (0.25 to 1.0 times the MRHD on a mg/m basis). No increase was seen in female mice or in rats of either sex receiving the same treatments, nor was there an increase in hepatocellular carcinomas. Liver adenomas have a variable rate of spontaneous occurrence in the CD-1 mouse and are of unknown significance to humans. There was an increase in follicular adenomas of the thyroid in female rats receiving sertraline at 40 mg/kg (2 times the MRHD on a mg/m basis); this was not accompanied by thyroid hyperplasia. While there was an increase in uterine adenocarcinomas in rats receiving sertraline at 10 to 40 mg/kg (0.5 to 2.0 times the MRHD on a mg/m basis) compared to placebo controls, this effect was not clearly drug related.
  • Mutagenesis
  • Sertraline had no genotoxic effects, with or without metabolic activation, based on the following assays: bacterial mutation assay; mouse lymphoma mutation assay; and tests for cytogenetic aberrations in mouse bone marrow and in human lymphocytes.
  • Impairment of Fertility
  • A decrease in fertility was seen in one of two rat studies at a dose of 80 mg/kg (3.1 times the maximum recommended human dose on a mg/m basis in adolescents).
  • Efficacy of sertraline hydrochloride was established in the following trials:
  • Product: 71335-0404
  • NDC: 71335-0404-1 30 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0404-2 60 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0404-3 90 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0404-4 180 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0404-5 28 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0404-6 15 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0404-7 120 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0404-8 100 TABLET, FILM COATED in a BOTTLE
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Suicidal Thoughts and Behaviors
  • Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider n
  • Serotonin Syndrome
  • Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome n
  • Increased Risk of Bleeding
  • Inform patients about the concomitant use of sertraline hydrochloride tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding n
  • Activation of Mania/Hypomania
  • Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider n
  • Discontinuation Syndrome
  • Advise patients not to abruptly discontinue sertraline hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when sertraline hydrochloride tablets are discontinued n
  • Allergic Reactions
  • Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing n
  • Pregnancy
  • Inform pregnant women that sertraline hydrochloride tablets may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) n
  • Manufactured for:
  • Lupin Pharmaceuticals, Inc.
  • Baltimore, Maryland 21202
  • United States
  • MADE IN INDIA
  • Revised: March 2018u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 ID#: 254693
  • Medication Guide
  • Sertraline Hydrochloride (ser' tra leen hye'' droe klor' ide) Tablets
  • What is the most important information I should know about sertraline hydrochloride tablets?
  • Sertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.
  • 1.u00a0u00a0u00a0u00a0u00a0 n- Suicidal thoughts or actions:
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • 2.u00a0u00a0u00a0u00a0u00a0 n- Serotonin Syndrome
  • 3.u00a0u00a0u00a0u00a0u00a0 n- Increased chance of bleeding
  • 4.u00a0u00a0u00a0u00a0u00a0 n- Manic episodes
  • 5.u00a0u00a0u00a0u00a0u00a0 n- Seizures or convulsions.
  • 6.u00a0u00a0u00a0u00a0u00a0 n- Glaucoma (angle-closure glaucoma).
  • 7.u00a0u00a0u00a0u00a0u00a0 n- Changes in appetite or weight
  • 8.u00a0u00a0u00a0u00a0u00a0 n- Low salt (sodium) levels in the blood
  • Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider
  • What are sertraline hydrochloride tablets?
  • Sertraline hydrochloride tablet is a prescription medicine used to treat:
  • It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
  • Sertraline hydrochloride tablets are safe and effective in treating children with OCD age 6 to 17 years.
  • It is not known if sertraline hydrochloride tablets are safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions.
  • Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride tablets treatment.
  • Who should not take sertraline hydrochloride tablets?
  • Do not take sertraline hydrochloride tablets if you:
  • People who take sertraline hydrochloride tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • What should I tell my healthcare provider before taking sertraline hydrochloride tablets?
  • Before starting sertraline hydrochloride tablets, tell your healthcare provider:
  • Tell your healthcare provider about all the medicines that you take,
  • Sertraline hydrochloride tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.
  • Your healthcare provider or pharmacist can tell you if it is safe to take sertraline hydrochloride tablets with your other medicines. start or stop any medicine while taking sertraline hydrochloride tablets without talking to your healthcare provider first.
  • How should I take sertraline hydrochloride tablets?
  • If you take too much sertraline hydrochloride tablets, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.
  • What should I avoid while taking sertraline hydrochloride tablets?
  • Sertraline hydrochloride tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride tablets affect you. drink alcohol while you take sertraline hydrochloride tablets.
  • What are the possible side effects of sertraline hydrochloride tablets?
  • Sertraline hydrochloride tablets may cause serious side effects, including:
  • The most common side effects in children and adolescents who take include
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sertraline hydrochloride tablets. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
  • How should I store sertraline hydrochloride tablets?
  • Keep sertraline hydrochloride tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of sertraline hydrochloride tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride tablets for a condition for which it was not prescribed. Do not give sertraline hydrochloride tablets to other people, even if they have the same condition. It may harm them.
  • This Medication Guide summarizes the most important information about sertraline hydrochloride tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride tablets that is written for healthcare professionals.
  • For more information about sertraline hydrochloride tablets call Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit at www.lupinpharmaceuticals.com.
  • What are the ingredients in sertraline hydrochloride tablets?
  • Active ingredient
  • Inactive ingredients:
  • D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration
  • The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.
  • Manufactured for:
  • Lupin Pharmaceuticals, Inc.
  • Baltimore, Maryland 21202
  • United States
  • MADE IN INDIA
  • Revised: September 2017u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 ID#: 252898
  • No data

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