SERTRALINE HYDROCHLORIDE — sertraline hydrochloride solution, concentrate
Rising Pharmaceuticals, Inc.
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 oral solution is 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 oral solution 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 oral solution, the recommended interval between dose changes is one week.
|Table 1: Recommended Daily Dosage of Sertraline Hydrochloride Oral Solution in Patients with MDD, OCD, PD, PTSD, and SAD|
|Indication||Starting Dose||Therapeutic Range|
|MDD||50 mg||50 to 200 mg|
|PD, PTSD, SAD||25 mg|
|OCD (ages 6 to 12 years old)||25 mg||50 to 200 mg|
|OCD (ages 13 to 17 years old)||50 mg|
The recommended starting sertraline hydrochloride oral solution dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride oral solution 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 oral solution 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 oral solution in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10 to 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 oral solution. In addition, at least 14 days must elapse after stopping sertraline hydrochloride oral solution before starting an MAOI antidepressant [See Contraindications (4), Warnings and Precautions (5.2)].
Adverse reactions may occur upon discontinuation of sertraline hydrochloride oral solution [See Warnings and Precautions (5.5)]. Gradually reduce the dosage rather than stopping sertraline hydrochloride oral solution abruptly whenever possible.
Sertraline hydrochloride oral solution must be diluted before use.
- Use the supplied calibrated dispensing syringe to measure the amount of sertraline hydrochloride oral solution needed
- Note: The supplied calibrated dispensing syringe has 25 mg and 50 mg graduation marks only
- Mix with 4 ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. After mixing, a slight haze may appear, which is normal.
Instruct patients or caregivers to immediately take the dose after mixing.
Sertraline Hydrochloride Oral Solution USP is a clear, colorless peppermint flavored liquid containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol. It is supplied as a 60 mL amber colored round PET bottle with an accompanying calibrated dispensing syringe that has 25 mg and 50 mg graduation marks.
Sertraline hydrochloride oral solution is 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 addition to the contraindications for all sertraline hydrochloride oral solution formulations listed above, sertraline hydrochloride oral solution is contraindicated in patients:
- Taking disulfiram. Sertraline hydrochloride oral solution contains alcohol, and concomitant use of sertraline hydrochloride oral solution and disulfiram may result in a disulfiram-alcohol reaction.
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.
Table 2: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients
|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 to 24||5 additional patients|
|Decreases Compared to Placebo|
|25 to 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, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
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