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BIO-SERTRALINE is a brand name for Sertraline, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bio-SERTRALINE (sertraline hydrochloride capsules) is indicated for: Adults Depression Bio-SERTRALINE is indicated for the symptomatic relief of depressive illness. However, the antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. A placebo-controlled…
Verbatim from this product's HC label. Tap a section to expand.
). 4 Geriatrics). 2 CONTRAINDICATIONS Bio-SERTRALINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient inthe formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see
; 4 DOSAGE AND ADMINISTRATION). 4 Geriatrics). 2 CONTRAINDICATIONS Bio-SERTRALINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient inthe formulation, including any non-medicinal ingredient, or component of the container.
Monoamine Oxidase Inhibitors Cases of serious, sometimes fatal, reactions have been reported in patients receiving sertraline hydrochloride in combination with a monoamine oxidase inhibitor (MAOI), including the selective MAOI, selegiline and the reversible MAOI (reversible inhibitor of monoamine oxidase -RIMA), moclobemide and linezolid, an antibiotic which is a reversible non-selective MAOI and methylthioninium chloride (methylene blue), which is a MAOI.
Some cases presented with features resembling the serotonin syndrome. Similar cases have been reported with other antidepressants during combined treatment with an MAOI and in patients who have recently discontinued an antidepressant and have been started on an MAOI.
Symptoms of a drug interaction between an SSRI and an MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma.
Therefore, Bio-SERTRALINE should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should elapse after discontinuing Bio-SERTRALINE treatment before starting an MAOI.
Pimozide The concomitant use of Bio-SERTRALINE and pimozide is contraindicated as sertraline hydrochloride has been shown to increase plasma pimozide levels. Elevation of pimozide blood concentration may result in QT interval prolongation and severe arrhythmias including Torsade de Pointes (see 7 WARNINGS AND PRECAUTIONS).
). 1 Pediatrics; 7 WARNINGSAND PRECAUTIONS, POTENTIAL ASSOCIATION WITH BEHAVIORAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM). 2 Recommended Dose and Dosage Adjustment Depression and Obsessive-Compulsive Disorder As no clear dose-response relationship has been demonstrated over a range of 50-200 mg/day, a dose of 50 mg/day is recommended as the initial dose.
Panic Disorder Bio-SERTRALINE treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily depending on tolerability and clinical response. No clear dose-response relationship has been demonstrated over a range of 50-200 mg/day.
Bio-SERTRALINE – Product Monograph Page 6 of 56 Titration In depression, OCD and panic disorder, a gradual increase in dosage may be considered if no clinical improvement is observed. Based on pharmacokinetic parameters, steady-state sertraline plasma levels are achieved after approximately 1 week of once daily dosing; accordingly, dose changes, if necessary, should be made at intervals of at least one week.
Doses should not exceed a maximum of 200 mg/day. The full therapeutic response may be delayed until 4 weeks of treatment or longer. Increasing the dosage rapidly does not normally shorten this latent period and may increase the incidence of side effects.
Maintenance During long-term therapy for any indication, the dosage should be maintained at the lowest effective dose and patients should be periodically reassessed to determine the need for continued treatment.
Special Populations Hepatic Impairment:
As with many other medications, Bio-SERTRALINE should be used with caution inpatients with hepatic impairment (see 7 WARNINGS AND PRECAUTIONS). The effects of sertraline hydrochloride in patients with moderate and severe hepatic impairment have not been studied.
Bio-SERTRALINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient inthe formulation, including any non-medicinal ingredient, or component of the container. Monoamine Oxidase Inhibitors Cases of serious, sometimes fatal, reactions have been reported in patients receiving sertraline hydrochloride in combination with a monoamine oxidase inhibitor (MAOI), including the selective MAOI, selegiline and the reversible MAOI (reversible inhibitor of monoamine oxidase -RIMA), moclobemide and linezolid, an antibiotic which is a reversible non-selective MAOI and methylthioninium chloride (methylene blue), which is a MAOI.
Some cases presented with features resembling the serotonin syndrome. Similar cases have been reported with other antidepressants during combined treatment with an MAOI and in patients who have recently discontinued an antidepressant and have been started on an MAOI.
Symptoms of a drug interaction between an SSRI and an MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma.
Therefore, Bio-SERTRALINE should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should elapse after discontinuing Bio-SERTRALINE treatment before starting an MAOI.
Pimozide The concomitant use of Bio-SERTRALINE and pimozide is contraindicated as sertraline hydrochloride has been shown to increase plasma pimozide levels. Elevation of pimozide blood concentration may result in QT interval prolongation and severe arrhythmias including Torsade de Pointes (see 7 WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sertraline in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
1 Pediatrics; 7 WARNINGSAND PRECAUTIONS, POTENTIAL ASSOCIATION WITH BEHAVIORAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM). 2 Recommended Dose and Dosage Adjustment Depression and Obsessive-Compulsive Disorder As no clear dose-response relationship has been demonstrated over a range of 50-200 mg/day, a dose of 50 mg/day is recommended as the initial dose.
Panic Disorder Bio-SERTRALINE treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily depending on tolerability and clinical response. No clear dose-response relationship has been demonstrated over a range of 50-200 mg/day.
Bio-SERTRALINE – Product Monograph Page 6 of 56 Titration In depression, OCD and panic disorder, a gradual increase in dosage may be considered if no clinical improvement is observed. Based on pharmacokinetic parameters, steady-state sertraline plasma levels are achieved after approximately 1 week of once daily dosing; accordingly, dose changes, if necessary, should be made at intervals of at least one week.
Doses should not exceed a maximum of 200 mg/day. The full therapeutic response may be delayed until 4 weeks of treatment or longer. Increasing the dosage rapidly does not normally shorten this latent period and may increase the incidence of side effects.
Maintenance During long-term therapy for any indication, the dosage should be maintained at the lowest effective dose and patients should be periodically reassessed to determine the need for continued treatment.
Special Populations Hepatic Impairment:
As with many other medications, Bio-SERTRALINE should be used with caution inpatients with hepatic impairment (see 7 WARNINGS AND PRECAUTIONS). The effects of sertraline hydrochloride in patients with moderate and severe hepatic impairment have not been studied.
Pediatrics (< 18 years): Health Canada has not authorized an indication for pediatric use. (see 1 INDICATIONS and 7 WARNINGS AND PRECAUTIONS, POTENTIAL ASSOCIATION WITH BEHAVIORAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM). 1 Pregnant Women).
When treating a pregnant woman with Bio-SERTRALINE during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment. The health professional may consider tapering Bio-SERTRALINE in the third trimester.
Switching Patients to or from a Monoamine Oxidase Inhibitor At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Bio- SERTRALINE. In addition, at least 14 days should be allowed after stopping Bio-SERTRALINE before starting an MAOI (see 2 CONTRAINDICATIONS).
Discontinuation of Bio-SERTRALINE Treatment Symptoms associated with the discontinuation or dosage reduction of sertraline hydrochloride have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or duringdosage reduction (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
A gradual reduction in the dose over several weeks rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient’s clinical response (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
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Pediatrics (< 18 years): Health Canada has not authorized an indication for pediatric use. (see 1 INDICATIONS and 7 WARNINGS AND PRECAUTIONS, POTENTIAL ASSOCIATION WITH BEHAVIORAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM). 1 Pregnant Women).
When treating a pregnant woman with Bio-SERTRALINE during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment. The health professional may consider tapering Bio-SERTRALINE in the third trimester.
Switching Patients to or from a Monoamine Oxidase Inhibitor At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Bio- SERTRALINE. In addition, at least 14 days should be allowed after stopping Bio-SERTRALINE before starting an MAOI (see 2 CONTRAINDICATIONS).
Discontinuation of Bio-SERTRALINE Treatment Symptoms associated with the discontinuation or dosage reduction of sertraline hydrochloride have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or duringdosage reduction (see 7 WARNINGS AND PRECAUTIONS and