SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated
Viwit Pharmaceutical Co., Ltd.
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 [See Warnings and Precautions (5.1)].
Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] :
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Panic disorder (PD)
- Posttraumatic stress disorder (PTSD)
- Social anxiety disorder (SAD)
- Premenstrual dysphoric disorder (PMDD)
The recommended initial dosage and maximum Sertraline Hydrochloride Tablets 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 Sertraline Hydrochloride Tablets, the recommended interval between dose changes is one week.
|Indication||Starting Dose||Therapeutic Range|
|MDD||50 mg||50–200 mg|
|PD, PTSD, SAD||25 mg|
|OCD (ages 6–12 years old)||25 mg||50–200 mg|
|OCD (ages 13–17 years old)||50 mg|
The recommended starting Sertraline Hydrochloride Tablets dosage in adult women with PMDD is 50 mg per day. Sertraline Hydrochloride Tablets 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). Intermittent dosing would be repeated with each new cycle.
- When dosing continuously, patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
- When dosing intermittently, patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first 3 days of dosing followed by 100 mg per day during the remaining days in the dosing cycle.
Prior to initiating treatment with Sertraline Hydrochloride Tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [See Warnings and Precautions (5.4)].
Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage [See Dosage and Administration (2.1, 2.2)] . The use of Sertraline Hydrochloride Tablets in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10–15) is not recommended [See Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of Sertraline Hydrochloride Tablets. In addition, at least 14 days must elapse after stopping Sertraline Hydrochloride Tablets before starting an MAOI antidepressant [See Contraindications (4), Warnings and Precautions (5.2)] .
Adverse reactions may occur upon discontinuation of Sertraline Hydrochloride Tablets [See Warnings and Precautions (5.5)]. Gradually reduce the dosage rather than stopping Sertraline Hydrochloride Tablets abruptly whenever possible.
25 mg tablets: light green, oval shaped, scored, film coated tablets, imprinted “V” on one side, and “SE” bisect “25” on the other side
50 mg tablets: bluish purple, oval shaped, scored, film coated tablets, imprinted “V” on one side, and “SE” bisect “50” on the other side 100 mg tablets: yellow, oval shaped, scored, film coated tablets, imprinted “V” on one side, and “SE” bisect “100” on the other side
Sertraline Hydrochloride Tablets are contraindicated in patients:
- Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)] .
- Taking pimozide [See Drug Interactions (7.1)] .
- With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1, 6.2)].
In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2.
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.
|Age Range (years)||Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated|
|Increases Compared to Placebo|
|<18||14 additional patients|
|18–24||5 additional patients|
|Decreases Compared to Placebo|
|25–64||1 fewer patient|
|≥65||6 fewer patients|
It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Sertraline Hydrochloride Tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including Sertraline Hydrochloride Tablets, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [See Contraindications (4), Drug Interactions (7.1)] . Serotonin syndrome can also occur when these drugs are used alone.
Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
The concomitant use of Sertraline Hydrochloride Tablets with MAOIs is contraindicated. In addition, do not initiate Sertraline Hydrochloride Tablets in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Sertraline Hydrochloride Tablets, discontinue Sertraline Hydrochloride Tablets before initiating treatment with the MAOI [See Contraindications (4), Drug Interactions (7.1)] .
Monitor all patients taking Sertraline Hydrochloride Tablets for the emergence of serotonin syndrome. Discontinue treatment with Sertraline Hydrochloride Tablets and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Sertraline Hydrochloride Tablets with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
Drugs that interfere with serotonin reuptake inhibition, including Sertraline Hydrochloride Tablets, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.
Inform patients of the increased risk of bleeding associated with the concomitant use of Sertraline Hydrochloride Tablets and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.
In patients with bipolar disorder, treating a depressive episode with Sertraline Hydrochloride Tablets or another antidepressant may precipitate a mixed/manic episode. In controlled clinical trials, patients with bipolar disorder were generally excluded; however, symptoms of mania or hypomania were reported in 0.4% of patients treated with Sertraline Hydrochloride Tablets. Prior to initiating treatment with Sertraline Hydrochloride Tablets, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [See Dosage and Administration (2.6)] .
Sertraline Hydrochloride Tablets have not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. Sertraline Hydrochloride Tablets should be prescribed with caution in patients with a seizure disorder.
The pupillary dilation that occurs following use of many antidepressant drugs including Sertraline Hydrochloride Tablets may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including Sertraline Hydrochloride Tablets, in patients with untreated anatomically narrow angles.
Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including Sertraline Hydrochloride Tablets. Cases with serum sodium lower than 110 mmol/L have been reported. 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 or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
In patients with symptomatic hyponatremia, discontinue Sertraline Hydrochloride Tablets and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs [See Use in Specific Populations (8.5)] .
False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking Sertraline Hydrochloride Tablets. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of Sertraline Hydrochloride Tablets. Confirmatory tests, such as gas chromatography/mass spectrometry, will help distinguish Sertraline Hydrochloride Tablets from benzodiazepines [See Drug Interactions (7.3)] .
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