Sertraline Hydrochloride (Sertraline)

Trade Name : Sertraline

Hikma Pharmaceuticals USA Inc.

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 Hydrochloride (Sertraline) which is also known as Sertraline and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 100 mg/1 per ml. Read more

Sertraline Hydrochloride (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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Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, n- adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric n- disorders. Anyone considering the use of sertraline or any other antidepressant in a child, adolescent, or young n- adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality n- with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants n- compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders n- are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant n- therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or n- unusual changes in behavior. Families and caregivers should be advised of the need for close observation and n- communication with the prescriber. Sertraline is not approved for use in pediatric patients except for patients with n- obsessive compulsive disorder (OCD). (See , n- Array

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-Nmethyl- 1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2u2022HCl 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 3cP, hypromellose 6cP, 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 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.

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All dosage forms of sertraline:n n- Arrayn- Array
Sertraline tablets are contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in sertraline tablets.

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed
closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of
a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (seeu00a0and n , for a description of the risks of discontinuation of sertraline).
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications,
both psychiatric and non-psychiatric, should be alerted about the need to monitor patients for the emergence of agitation,
irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality,
and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by
families and caregivers.
Prescriptions for sertraline should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

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During its premarketing assessment, multiple doses of sertraline were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline 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, including major depressive disorder, OCD, panic disorder, PTSD, PMDD and social anxiety disorder.
Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of sertraline who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving sertraline. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it.
The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.

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Sertraline tablets are modified oval biconvex tablets, containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline, are packaged in bottles.
Sertraline Tablets, USP 25 mg: Light Green film coated, Modified oval, biconvex tablets debossed with u201cIu201d on the left side of bisect and u201cGu201d on the right side of bisect on one side and u201c212u201d on the other side.
Bottles of 30Bottles of 90Bottles of 500
Sertraline Tablets, USP 50 mg: Light Blue film coated, Modified oval, biconvex tablets debossed with u201cIu201d on the left side of bisect and u201cGu201d on the right side of bisect on one side and u201c213u201d on the other side.
Bottles of 30Bottles of 90Bottles of 500
Sertraline Tablets, USP 100 mg: Light Yellow film coated, Modified oval, biconvex tablets debossed with u201cIu201d on the left side of bisect and u201cGu201d on the right side of bisect on one side and u201c214u201d on the other side.
Bottles of 30Bottles of 90Bottles of 500
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by: n Hauppauge, NY 11788
Distributed by:n Eatontown, NJ 07724
Issued September 2012

Sertraline Tablets, USP
Read the Medication Guide that comes with Sertraline Tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
What is the most important information I should know about n- sertraline tablets?n
1. Suicidal thoughts or actions:
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the n- following symptoms, or call 911 if an emergency, especially if they n- are new, worse, or worry you:
Call your healthcare provider right away if you have any of the n- following symptoms, or call 911 if an emergency. Sertraline tablets n- may be associated with these serious side effects:
2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like n- reactions. This condition can be life-threatening and may include:
3. Severe allergic reactions:
4. Abnormal bleeding:
5. Seizures or convulsions
6. Manic episodes:
7. Changes in appetite or weight.
8. Low salt (sodium) levels in the blood.
Do not stop sertraline tablets without first talking to your healthcare provider.
What are SertralineTablets?n
Talk to your healthcare provider if you do not think that your condition is getting better with sertraline tablet treatment.
Who should not take sertraline tablets?n
People who take sertraline tablets close in time to an MAOI may n- have serious or even life-threatening side effects. Get medical help n- right away if you have any of these symptoms:
What should I tell my healthcare provider before taking sertraline n- tablets?
Talk to your healthcare provider about the best way to feed your baby while taking sertraline tablets.
Tell your healthcare provider about all the medicines that you take,
Your healthcare provider or pharmacist can tell you if it is safe to take sertraline tablets with your other medicines. Do not start or stop any medicine while taking sertraline tablets without talking to your healthcare provider first.
How should I take sertraline tablets?
What should I avoid while taking sertraline tablets?n
What are the possible side effects of sertraline tablets?n
Common possible side effects in people who take sertraline tablets include:
Other side effects in children and adolescents 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 tablets. For more information, ask your healthcare provider or pharmacist.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. n- YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.n n- How should I store sertraline tablets?
Keep sertraline tablets and all medicines out of the reach of n- children.
General information about sertraline tabletsn
This Medication Guide summarizes the most important information about sertraline tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline tablets that is written for healthcare professionals.
For more information about sertraline tablets contact West-Ward Pharmaceutical Corp. at 1-877-233-2001 or the FDA at 1-800-FDA-1088 or .
What are the ingredients in Sertraline Tablets, USP?Active ingredient:n- Inactive ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration
Manufactured by:n Hauppauge, NY 11788
Distributed by:n Eatontown, New Jersey 07724Issued September 2012
M-9656
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Sertraline Tablets, USP

Sertraline Tablets, USP

Sertraline Tablets, USP

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Sertraline Hydrochloride (Sertraline)

Trade Name : Sertraline

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Sertraline Hydrochloride (Sertraline)

Trade Name : Sertraline

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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US NDC

Canadian DIN

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