SERTRALINE HYDROCHLORIDE (Page 14 of 16)

Social Anxiety Disorder

Social anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of sertraline hydrochloride has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.

Obsessive-Compulsive Disorder and Panic Disorder

It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing sertraline hydrochloride for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking sertraline hydrochloride during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50–200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.

Premenstrual Dysphoric Disorder

The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. However, as women commonly report that symptoms worsen with age until relieved by the onset of menopause, it is reasonable to consider continuation of a responding patient. Dosage adjustments, which may include changes between dosage regimens (e.g., daily throughout the menstrual cycle versus during the luteal phase of the menstrual cycle), may be needed to maintain the patient on the lowest effective dosage and patients should be periodically reassessed to determine the need for continued treatment.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with sertraline hydrochloride. Conversely, at least 14 days should be allowed after stopping sertraline hydrochloride before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of Sertraline Hydrochloride With Other MAOIs Such as Linezolid or Methylene Blue

Do not start sertraline hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving sertraline hydrochloride therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, sertraline hydrochloride should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with sertraline hydrochloride may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with sertraline hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

Special Populations

Dosage for Hepatically Impaired Patients

The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Treatment of Pregnant Women During the Third Trimester

Neonates exposed to sertraline hydrochloride and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with sertraline hydrochloride during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

Discontinuation of Treatment with Sertraline Hydrochloride

Symptoms associated with discontinuation of 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 Hydrochloride Oral Concentrate

Sertraline hydrochloride oral concentrate contains 20 mg/mL of sertraline (as the hydrochloride) as the active ingredient and 12% alcohol. Sertraline hydrochloride oral concentrate must be diluted before use. Just before taking, use the dropper provided to remove the required amount of sertraline hydrochloride oral concentrate and mix with 4 oz (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. Do not mix sertraline hydrochloride oral concentrate with anything other than the liquids listed. The dose should be taken immediately after mixing. Do not mix in advance. At times, a slight haze may appear after mixing; this is normal. Note that caution should be exercised for patients with latex sensitivity, as the dropper dispenser contains dry natural rubber.

Sertraline hydrochloride oral concentrate is contraindicated with ANTABUSE (disulfiram) due to the alcohol content of the concentrate.

HOW SUPPLIED

Sertraline hydrochloride capsular-shaped scored tablets, equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles.

Sertraline hydrochloride 25 mg tablets: light green capsular-shaped scored tablets engraved on one side with G 4960 and on the other side engraved with 25 mg.

NDC 54868-5658-0 Bottles of 30
NDC 54868-5658-1 Bottles of 60
NDC 54868-5658-2 Bottles of 90

Sertraline hydrochloride 50 mg tablets: light blue capsular-shaped scored tablets engraved on one side with G 4900 and on the other side engraved with 50 mg.

NDC 54868-5639-2 Bottles of 10
NDC 54868-5639-0 Bottles of 30
NDC 54868-5639-1 Bottles of 45
NDC 54868-5639-6 Bottles of 60
NDC 54868-5639-5 Bottles of 90

Sertraline hydrochloride 100 mg tablets: light yellow capsular-shaped scored tablets engraved on one side with G 4910 and on the side engraved with 100 mg.

NDC 54868-5638-1 Bottles of 30
NDC 54868-5638-0 Bottles of 60
NDC 54868-5638-6 Bottles of 90
NDC 54868-5638-5 Bottles of 100
NDC 54868-5638-7 Bottles of 180

Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F)[see USP Controlled Room Temperature].

Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature].

Rx only

Logo

LAB-0340-20.0

February 2013

Distributed by:
Physicians Total Care, Inc.
Tulsa, OK 74146

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.