SERTRALINE HYDROCHLORIDE TABLETS
Sertraline Information
Company Name Genpharm
Sertraline (Sertraline hydrochloride) Description
Sertraline (Sertraline hydrochloride) hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline (Sertraline hydrochloride) hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula CHNCl•HCl is represented by the following structural formula:
Sertraline (Sertraline hydrochloride) hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.
Sertraline (Sertraline hydrochloride) hydrochloride tablets are supplied for oral administration as scored tablets containing Sertraline (Sertraline hydrochloride) hydrochloride equivalent to 25, 50 and 100 mg of Sertraline (Sertraline hydrochloride) and the following inactive ingredients: dibasic calcium phosphate, hypromellose 2910 (3cp and 6cp, USP), macrogel, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin.
Sertraline (Sertraline hydrochloride) Indications And Usage
The efficacy of Sertraline (Sertraline hydrochloride) 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 under ).
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 (Sertraline hydrochloride) in hospitalized depressed patients has not been adequately studied.
The efficacy of Sertraline (Sertraline hydrochloride) 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 (Sertraline hydrochloride) for extended periods should be reevaluated periodically (see under ).
Sertraline (Sertraline hydrochloride) Contraindications
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see ). Concomitant use in patients taking pimozide is contraindicated (see ).
Sertraline (Sertraline hydrochloride) is contraindicated in patients with a hypersensitivity to Sertraline (Sertraline hydrochloride) or any of the inactive ingredients in Sertraline (Sertraline hydrochloride) .
Sertraline (Sertraline hydrochloride) Warnings
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 behaviour (suicidality) in children, adolescents, and young adults (ages 18-24) 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 difference 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.
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 nonpsychiatric. 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 (see and – Discontinuation of Treatment with Sertraline (Sertraline hydrochloride) , for a description of the risks of discontinuation of Sertraline (Sertraline hydrochloride) ).
Sertraline (Sertraline hydrochloride) Precautions
During marketing of sertaline and other SSRIs and SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.
Patients should be monitored for these symptoms when discontinuing treatment with Sertraline (Sertraline hydrochloride) . A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see ).
Published case reports have documented the occurrence of bleeding episodes in patients treated with psychotropic drugs that interfere with serotonin reuptake. Subsequent epidemiological studies, both of the case-control and cohort design, have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. In two studies, concurrent use of a non-selective nonsteroidal anti-inflammatory drug (i.e., NSAIDs that inhibit both cyclooxygenase isoenzymes, COX 1 and 2) or aspirin potentiated the risk of bleeding (see ). Although these studies focused on upper gastrointestinal bleeding, there is reason to believe that bleeding at other sites may be similarly potentiated. Patients should be cautioned regarding the risk of bleeding associated with the concomitant use of Sertraline (Sertraline hydrochloride) with non-selective NSAIDs (i.e., NSAIDs that inhibit both cyclooxygenase isoenzymes, COX 1 and 2), aspirin, or other drugs that affect coagulation.
Patients with a recent history of myocardial infarction or unstable heart disease were excluded from clinical studies during the product’s premarket testing. However, the electrocardiograms of 774 patients who received Sertraline (Sertraline hydrochloride) in double-blind trials were evaluated and the data indicate that Sertraline (Sertraline hydrochloride) is not associated with the development of significant ECG abnormalities.
Sertraline (Sertraline hydrochloride) administered in a flexible dose range of 50 to 200 mg/day (mean dose of 89 mg/day) was evaluated in a post-marketing, placebo-controlled trial of 372 randomized subjects with a DSM-IV diagnosis of major depressive disorder and recent history of myocardial infarction or unstable angina requiring hospitalization. Exclusions from this trial included, among others, patients with uncontrolled hypertension, need for cardiac surgery, history of CABG within 3 months of index event, severe or symptomatic bradycardia, non-atherosclerotic cause of angina, clinically significant renal impairment (creatinine > 2.5mg/dl), and clinically significant hepatic dysfunction. Sertraline (Sertraline hydrochloride) treatment initiated during the acute phase of recovery (within 30 days post-MI or post-hospitalization for unstable angina) was indistinguishable from placebo in this study on the following week 16 treatment endpoints: left ventricular ejection fraction, total cardiovascular events (angina, chest pain, edema, palpitations, syncope, postural dizziness, CHF, MI, tachycardia, bradycardia, and changes in BP), and major cardiovascular events involving death or requiring hospitalization (for MI, CHF, stroke, or angina).
Sertraline (Sertraline hydrochloride) is extensively metabolized by the liver. In patients with chronic mild liver impairment, Sertraline (Sertraline hydrochloride) clearance was reduced, resulting in increased AUC, Cmax and elimination half-life. The effects of Sertraline (Sertraline hydrochloride) in patients with moderate and severe hepatic impairment have not been studied. The use of Sertraline (Sertraline hydrochloride) in patients with liver disease must be approached with caution. If Sertraline (Sertraline hydrochloride) is administered to patients with liver impairment, a lower or less frequent dose should be used (see and ).
Since Sertraline (Sertraline hydrochloride) is extensively metabolized, excretion of unchanged drug in urine is a minor route of elimination. A clinical study comparing Sertraline (Sertraline hydrochloride) pharmacokinetics in healthy volunteers to that in patients with renal impairment ranging from mild to severe (requiring dialysis) indicated that the pharmacokinetics and protein binding are unaffected by renal disease. Based on the pharmacokinetic results, there is no need for dosage adjustment in patients with renal impairment (see ).
Hyponatremia:
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Sertraline (Sertraline hydrochloride) and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Sertraline (Sertraline hydrochloride) . The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Sertraline (Sertraline hydrochloride) .
Patients should be told that although Sertraline (Sertraline hydrochloride) has not been shown to impair the ability of normal subjects to perform tasks requiring complex motor and mental skills in laboratory experiments, drugs that act upon the central nervous system may affect some individuals adversely. Therefore, patients should be told that until they learn how they respond to Sertraline (Sertraline hydrochloride) they should be careful doing activities when they need to be alert, such as driving a car or operating machinery.
Patients should be cautioned about the concomitant use of Sertraline (Sertraline hydrochloride) and non-selective NAIDs (i.e., NSAIDs that inhibit both cyclooxygenase isoenzymes, COX 1 and 2), aspirin, or other drugs that affect coagulation since the combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding.
Patients should be told that although Sertraline (Sertraline hydrochloride) has not been shown in experiments with normal subjects to increase the mental and motor skill impairments caused by alcohol, the concomitant use of Sertraline (Sertraline hydrochloride) and alcohol is not advised.
Patients should be told that while no adverse interaction of Sertraline (Sertraline hydrochloride) with over-the-counter (OTC) drug products is known to occur, the potential for interaction exists. Thus, the use of any OTC product should be initiated cautiously according to the directions of use given for the OTC product.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.
Patients should be advised to notify their physician if they are breast feeding an infant.
In a study comparing prothrombin time AUC (0 to 120 hr) following dosing with warfarin (0.75 mg/kg) before and after 21 days of dosing with either Sertraline (Sertraline hydrochloride) (50 to 200 mg/day) or placebo, there was a mean increase in prothrombin time of 8% relative to baseline for Sertraline (Sertraline hydrochloride) compared to a 1% decrease for placebo (p
In a placebo-controlled trial in normal volunteers, the administration of two doses of Sertraline (Sertraline hydrochloride) did not significantly alter steady-state lithium levels or the renal clearance of lithium.
Nonetheless, at this time, it is recommended that plasma lithium levels be monitored following initiation of Sertraline (Sertraline hydrochloride) therapy with the appropriate adjustments to the lithium dose.
In a controlled study of a single dose (2 mg) of pimozide, 200 mg Sertraline (Sertraline hydrochloride) (q.d.) coadministration to steady state was associated with a mean increase in pimozide AUC and Cmax of about 40%, but was not associated with any changes in EKG. Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with Sertraline (Sertraline hydrochloride) , the effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of Sertraline (Sertraline hydrochloride) and pimozide should be contraindicated (see ).
Results of a placebo-controlled trial in normal volunteers suggest that chronic administration of Sertraline (Sertraline hydrochloride) 200 mg/day does not produce clinically important inhibition of phenytoin metabolism.
Nonetheless, at this time, it is recommended that plasma phenytoin concentrations be monitored following initiation of Sertraline (Sertraline hydrochloride) therapy with appropriate adjustments to the phenytoin dose, particularly in patients with multiple underlying medical conditions and/or those receiving multiple comcomitant medications.
The effect of Sertraline (Sertraline hydrochloride) on valproate levels has not been evaluated in clinical trials. In the absence of such data, it is recommended that plasma valproate levels be monitored following initiation of Sertraline (Sertraline hydrochloride) therapy with appropriate adjustments to the valproate dose.
The risk of using Sertraline (Sertraline hydrochloride) in combination with other CNS active drugs has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of Sertraline (Sertraline hydrochloride) and such drugs is required.
There is limited controlled experience regarding the optimal timing of switching from other drugs effective in the treatment of major depressive disorder to Sertraline (Sertraline hydrochloride) . Care and prudent medical judgement should be exercised when switching, particularly from long-acting agents. The duration of an appropriate washout period which should intervene before switching from one selective serotonin reuptake inhibitor (SSRI) to another has not been established.
Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 337 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk of developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20 week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. There is currently no corroborative evidence regarding the risk for PPHN following exposure to SSRIs in pregnancy, this is the first study that has investigated the potential risk. The study did not include enough cases with exposure to individual SSRIs to determine if all SSRIs posed similar levels of PPHN risk.
When treating a pregnant woman with Sertraline (Sertraline hydrochloride) during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment (see ). Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic in the context of antidepressant therapy at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.
Sertraline (Sertraline hydrochloride) pharmacokinetics were evaluated in 61 pediatric patients between 6 and 17 years of age and revealed similar drug exposures to those of adults when plasma concentration was adjusted for weight (see under ).
Approximately 600 pediatric patients between 6 and 17 years of age have received Sertraline (Sertraline hydrochloride) in clinical trials, both controlled and uncontrolled. The adverse event profile observed in these patients was generally similar to that observed in adult studies with Sertraline (Sertraline hydrochloride) (see ). As with other SSRIs, decreased appetite and weight loss have been observed in association with the use of Sertraline (Sertraline hydrochloride) . In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50 to 200 mg) outpatient trials for major depressive disorder (N=373), there was a difference in weight change between Sertraline (Sertraline hydrochloride) and placebo of roughly 1 kilogram, for both children (ages 6 to 11) and adolescents (ages 12 to 17), in both cases representing a slight weight loss for Sertraline (Sertraline hydrochloride) compared to a slight gain for placebo. At baseline the mean weight for children was 39 kg for Sertraline (Sertraline hydrochloride) and 38.5 kg for placebo. At baseline the mean weight for adolescents was 61.4 kg for Sertraline (Sertraline hydrochloride) and 62.5 kg for placebo. There was a bigger difference between Sertraline (Sertraline hydrochloride) and placebo in the proportion of outliers for clinically important weight loss in children than in adolescents. For children, about 7% had a weight loss > 7% of body weight compared to none of the placebo patients; for adolescents, about 2% had a weight loss > 7% of body weight compared to about 1% of placebo patients. A subset of these patients who completed the randomized controlled trials (Sertraline (Sertraline hydrochloride) N=100, placebo N=121) were continued into a 24 week, flexible-dose, open-label, extension study. A mean weight loss of approximately 0.5 kg was seen during the first eight weeks of treatment for subjects with first exposure to Sertraline (Sertraline hydrochloride) during the open–label extension study, similar to the mean weight loss observed among Sertraline (Sertraline hydrochloride) treated subjects during the first eight weeks of the randomized controlled trials. The subjects continuing in the open label study began gaining weight compared to baseline by week 12 of Sertraline (Sertraline hydrochloride) treatment. Those subjects who completed 34 weeks of Sertraline (Sertraline hydrochloride) treatment (10 weeks in a placebo controlled trial + 24 weeks open label, N=68), had a weight gain that was similar to that expected using data from age-adjusted peers. Regular monitoring of weight and growth is recommended if treatment of a pediatric patient with an SSRI is to be continued long term. Safety and effectiveness in pediatric patients with major depressive disorder have not been established.
The risks, if any, that may be associated with Sertraline (Sertraline hydrochloride) ’s use beyond 1 year in children and adolescents have not been systematically assessed. The prescriber should be mindful that the evidence relied upon to conclude that Sertraline (Sertraline hydrochloride) is safe for use in children and adolescents derives from clinical studies that were 10 to 52 weeks in duration and from extrapolation of experience gained with adult patients. In particular, there are no studies that directly evaluate the effects of long term Sertraline (Sertraline hydrochloride) use on the growth, and maturation of children and adolescents. Although there is no affirmative finding to suggest that Sertraline (Sertraline hydrochloride) possesses a capacity to adversely affect growth, development or maturation, the absence of such findings is not compelling evidence of the absence of the potential of Sertraline (Sertraline hydrochloride) to have adverse effects in chronic use.
Other Adverse Events in Geriatric Patients. In 354 geriatric subjects treated with Sertraline (Sertraline hydrochloride) in placebo-controlled trials, the overall profile of adverse events was generally similar to that shown in Table 1. Urinary tract infection was the only adverse event not appearing in Tables 1 and reported at an incidence of at least 2% and at a rate greater than in placebo-controlled trials.
SSRIs and SNRIs, including Sertraline (Sertraline hydrochloride) , have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see PRECAUTIONS, Hyponatremia).
Sertraline (Sertraline hydrochloride) Adverse Reactions
During its premarketing assessment, multiple doses of Sertraline (Sertraline hydrochloride) were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to Sertraline (Sertraline hydrochloride) 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.
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 (Sertraline hydrochloride) who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving Sertraline (Sertraline hydrochloride) . 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.
Table 3 lists the adverse events associated with discontinuation of Sertraline (Sertraline hydrochloride) hydrochloride treatment (incidence at least twice that for placebo and at least 1% for Sertraline (Sertraline hydrochloride) in clinical trials) in major depressive disorder/other*.
Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacological treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.
Table 4 below displays the incidence of sexual side effects reported by at least 2% of patients taking Sertraline (Sertraline hydrochloride) in placebo-controlled trials.
There are no adequate and well-controlled studies examining sexual dysfunction with Sertraline (Sertraline hydrochloride) treatment.
Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.
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 (Sertraline hydrochloride) who experienced an event of the type cited on at least one occasion while receiving Sertraline (Sertraline hydrochloride) . All events are included except those already listed in the previous tables or elsewhere in labeling and those reported in terms so general as to be uninformative and those for which a causal relationship to Sertraline (Sertraline hydrochloride) treatment seemed remote. It is important to emphasize that although the events reported occurred during treatment with Sertraline (Sertraline hydrochloride) , they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients. Events of major clinical importance are also described in the section.
Sertraline (Sertraline hydrochloride) Overdosage
Among 634 overdoses in which Sertraline (Sertraline hydrochloride) hydrochloride was the only drug ingested, 8 resulted in fatal outcome, 75 completely recovered, and 27 patients experienced sequelae after overdosage to include alopecia, decreased libido, diarrhea, ejaculation disorder, fatigue, insomnia, somnolence and serotonin syndrome. The remaining 524 cases had an unknown outcome. The most common signs and symptoms associated with non-fatal Sertraline (Sertraline hydrochloride) hydrochloride overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor.
The largest known ingestion was 13.5 grams in a patient who took Sertraline (Sertraline hydrochloride) hydrochloride alone and subsequently recovered. However, another patient who took 2.5 grams of Sertraline (Sertraline hydrochloride) hydrochloride alone experienced a fatal outcome.
Other important adverse events reported with Sertraline (Sertraline hydrochloride) hydrochloride overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, serotonin syndrome, stupor and syncope.
Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients.
Activated charcoal should be administered. Due to large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for Sertraline (Sertraline hydrochloride) are known.
In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the (PDR®).
Sertraline (Sertraline hydrochloride) Dosage And Administration
While a relationship between dose and effect has not been established for major depressive disorder, patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of Sertraline (Sertraline hydrochloride) for the treatment of this indication. Consequently, a dose of 50 mg administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of Sertraline (Sertraline hydrochloride) , dose changes should not occur at intervals of less than 1 week.
The use of Sertraline (Sertraline hydrochloride) in patients with liver disease should be approached with caution. The effects of Sertraline (Sertraline hydrochloride) in patients with moderate and severe hepatic impairment have not been studied. If Sertraline (Sertraline hydrochloride) is administered to patients with liver impairment, a lower or less frequent dose should be used (see and ).
Symptoms associated with discontinuation of Sertraline (Sertraline hydrochloride) and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Sertraline (Sertraline hydrochloride) Arrayhow Supplied
Sertraline (Sertraline hydrochloride) Hydrochloride Tablets are capsule-shaped scored tablets, containing Sertraline (Sertraline hydrochloride) hydrochloride equivalent to 25, 50 and 100 mg of Sertraline (Sertraline hydrochloride) .
Sertraline (Sertraline hydrochloride) Hydrochloride Tablets, 25 mg: white to off-white capsule-shaped, film coated tablets, embossed with “ST” scoreline “25” on one side and “G” on the other side.
NDC 55567-170-13 Bottles of 30
NDC 55567-170-35 Bottles of 1000
NDC 55567-170-37 Bottles of 5000
Sertraline (Sertraline hydrochloride) Hydrochloride Tablets, 50 mg: white to off-white capsule-shaped, film coated tablets embossed with “ST” scoreline “50” on one side and “G” on the other side.
NDC 55567-171-13 Bottles of 30
NDC 55567-171-35 Bottles of 1000
NDC 55567-171-36 Bottles of 4500
Sertraline (Sertraline hydrochloride) Hydrochloride Tablets, 100 mg: white to off-white capsule-shaped, film coated tablets embossed with “ST” scoreline “100” on one side and “G” on the other side.
NDC 55567-172-13 Bottles of 30
NDC 55567-172-35 Bottles of 1000
NDC 55567-172-34 Bottles of 2400
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
Manufactured by:
Toronto, ON M8Z 2S6
Canada
Printed in Canada
009-588 REV. #09 (P1)
Issued March 2008
Sertraline (Sertraline hydrochloride) Medication Guide
Read the Medication Guide that comes with you or your family member’s antidepressant medicine.
This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.
• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness
• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
• It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
