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PRO-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: PRO-SERTRALINE (sertraline hydrochloride capsules) is indicated for: Adults • Depression PRO-SERTRALINE is indicated for the symptomatic relief of depressive illness. However, the antidepressant action of sertraline in hospitalized depressed patients has not been adequately studied. A placebo-controlled European study…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations 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 PRO-SERTRALINE. In addition, at least 14 days should be allowed after stopping PRO-SERTRALINE before starting an MAOI (see 2 CONTRAINDICATIONS).
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 to 200 mg/day, a dose of 50 mg/ day is recommended as the initial dose.
Panic Disorder PRO-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 to 200 mg/day.
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 PRO-SERTRALINE (Sertraline hydrochloride Capsules) Page 7 of 70 effective dose and patients should be periodically reassessed to determine the need for continued treatment.
Special Populations • Hepatic Impairment:
As with many other medications, PRO-SERTRALINE should be used with caution in patients with hepatic impairment (see 7 WARNINGS AND PRECAUTIONS). The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied.
• Pediatrics (< 18 years of age): Health Canada has not authorized an indication for pediatric use. (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, Including Self-Harm). 1 Pregnant Women).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Depression In clinical development programs, sertraline hydrochloride has been evaluated in 1902 subjects with depression.
The most commonly observed adverse events associated with the use of sertraline were: gastrointestinal complaints; including nausea, diarrhea/loose stools and dyspepsia; male sexual dysfunction (primarily ejaculatory delay) (see 7 WARNINGS AND PRECAUTIONS); insomnia and somnolence; tremor; increased sweating and dry mouth; and dizziness.
In the fixed dose placebo-controlled study, the overall incidence of side effects was dose related with a majority occurring in the patients treated with 200 mg dose. The discontinuation rate due to adverse events was 15% in 2710 subjects who received sertraline in premarketing multiple dose clinical trials.
The more common events (reported by at least 1% of subjects) associated with discontinuation included agitation, insomnia, male sexual dysfunction (primarily ejaculatory delay), somnolence, dizziness, headache, tremor, anorexia, diarrhea/loose stools, nausea and fatigue.
Table 2 enumerates adverse events that occurred at a frequency of 1% or more among sertraline patients who participated in controlled trials comparing titrated sertraline with placebo for depression in adults. 5 *Events reported by at least 1% of patients treated with sertraline are included.
(1) % based on male patients only: 271 sertraline and 271 placebo patients. Male sexual dysfunction can be broken down into the categories of decreased libido, impotence and ejaculatory delay. 9%, respectively. It should be noted that since some sertraline patients reported more than one category of male sexual dysfunction, the incidence of each category of male sexual dysfunction combined is larger than the incidence for the general category of male sexual dysfunction, in which each patient is counted only once.
1 Clinical Trial Adverse Reactions – Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS • PRO-SERTRALINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • 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, PRO-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 PRO-SERTRALINE treatment before starting an MAOI.
• Pimozide The concomitant use of sertraline and pimozide is contraindicated as sertraline 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).
• PRO-SERTRALINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• 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, PRO-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 PRO-SERTRALINE treatment before starting an MAOI.
• Pimozide The concomitant use of sertraline and pimozide is contraindicated as sertraline 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.
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When treating a pregnant woman with PRO-SERTRALINE during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment. The health professional may consider tapering PRO-SERTRALINE in the third trimester.
Discontinuation of Sertraline Treatment Symptoms associated with the discontinuation or dosage reduction of sertraline have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction.
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.
5 Post-Market Adverse Reactions). 4 Administration PRO-SERTRALINE should be administered with food once daily preferably with the evening meal, or, if administration in the morning is desired, with breakfast.
(2) % based on female patient only: 590 sertraline and 582 placebo patients. Panic Disorder In placebo-controlled clinical trials, 430 patients with panic disorder were treated with sertraline in doses of 25 to 200 mg/day. During treatment, most patients received doses of 50 to 200 mg/day.
Adverse events observed at an incidence of at least 5% for sertraline and at an incidence that was twice or more the incidence among placebo-treated patients included: diarrhea, ejaculation failure (primarily ejaculatory delay), anorexia, constipation, libido decreased, agitation, and tremor.
In the total safety data base for panic disorder, 14% of patients discontinued treatment due to an adverse event. 1%). Obsessive-Compulsive Disorder In placebo-controlled clinical trials for OCD, adverse events observed at an incidence of at least 5% for sertraline and at an incidence that was twice or more the incidence among placebo- treated patients included: nausea, insomnia, diarrhea, decreased libido, anorexia, dyspepsia, ejaculation failure (primarily ejaculatory delay), tremor, and increased sweating.
In placebo-controlled clinical trials for OCD, 10% of patients treated with sertraline discontinued treatment due to an adverse event. 1%). PRO-SERTRALINE (Sertraline hydrochloride Capsules) Page 22 of 70 Incidence in Controlled Clinical Trials for Panic and Obsessive-compulsive disorder in adults Table 3 enumerates adverse events that occurred at a frequency of 2% or more among patients on sertraline who participated in […]
PRO-SERTRALINE (Sertraline hydrochloride Capsules) Page 6 of 70 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Increased risk of self-harm, harm to others, suicidal thinking and behavior with antidepressants use.
Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviors (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, Including Self-Harm).
1 Dosing Considerations 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 PRO-SERTRALINE. In addition, at least 14 days should be allowed after stopping PRO-SERTRALINE before starting an MAOI (see 2 CONTRAINDICATIONS).
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 to 200 mg/day, a dose of 50 mg/ day is recommended as the initial dose.
Panic Disorder PRO-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 to 200 mg/day.
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 PRO-SERTRALINE (Sertraline hydrochloride Capsules) Page 7 of 70 effective dose and patients should be periodically reassessed to determine the need for continued treatment.
Special Populations • Hepatic Impairment:
As with many other medications, PRO-SERTRALINE should be used with caution in patients with hepatic impairment (see 7 WARNINGS AND PRECAUTIONS). The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied.
• Pediatrics (< 18 years of age): Health Canada has not authorized an indication for pediatric use. (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, Including Self-Harm). 1 Pregnant Women).
When treating a pregnant woman with PRO-SERTRALINE during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment. The health professional may consider tapering PRO-SERTRALINE in the third trimester.
Discontinuation of Sertraline Treatment Symptoms associated with the discontinuation or dosage reduction of sertraline have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction.
A gradual reduction in the dose over several weeks rather than abrupt […]
PRO-SERTRALINE (Sertraline hydrochloride Capsules) Page 6 of 70