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RIVA-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: RIVA-SERTRALINE (sertraline hydrochloride capsules) is indicated for: Adults • Depression RIVA-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…
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 RIVA- SERTRALINE. In addition, at least 14 days should be allowed after stopping RIVA-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 50-200 mg/day, a dose of 50 mg/day is recommended as the initial dose.
Panic Disorder RIVA-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.
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, RIVA-SERTRALINE should be used with caution in patients 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 of age): Health Canada has not authorized an indication for pediatric use. (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association With Behavioral 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 hydrochloride 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 hydrochloride 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 hydrochloride patients who participated in controlled trials comparing titrated sertraline hydrochloride with placebo for depression in adults.
6 Centr. & Periph. Nerv. 5 * Events reported by at least 1% of patients treated with sertraline hydrochloride are included. RIVA-SERTRALINE (Sertraline Hydrochloride Capsules) Page 18 of 56 (1) %based on male patients only: 271 sertraline hydrochloride and 271 placebo patients.
1 Pregnant Women 06/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 7 5 OVERDOSAGE...............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations..............................................................................................
• RIVA-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, RIVA-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 RIVA-SERTRALINE treatment before starting an MAOI.
• Pimozide The concomitant use of RIVA-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.
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When treating a pregnant woman with RIVA-SERTRALINE during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment. The health professional may consider tapering RIVA-SERTRALINE in the third trimester.
RIVA-SERTRALINE (Sertraline Hydrochloride Capsules) Page 7 of 56 Discontinuation of RIVA-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 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 RIVA-SERTRALINE should be administered with food once daily preferably with the evening meal, or, if administration in the morning is desired, with breakfast.
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 hydrochloride 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.
(2) % based on female patient only: 590 sertraline hydrochloride and 582 placebo patients. Panic Disorder In placebo-controlled clinical trials, 430 patients with panic disorder were treated with sertraline hydrochloride in doses of 25 - 200 mg/day.
During treatment, most patients received doses of 50 - 200 mg/day. Adverse events observed at an incidence of at least 5% for sertraline hydrochloride 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 hydrochloride 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 hydrochloride discontinued treatment due to an adverse event. 1%). 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 hydrochloride who […]
1 Pregnant Women ............................................................................................ 2 Breast-feeding ................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ......................................................................................................... 15 8 ADVERSE REACTIONS .................................................................................................
2 Clinical Trial Adverse Reactions ........................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings ..........................................................................
5 Post-Market Adverse Reactions .......................................................................... 23 9 DRUG INTERACTIONS ................................................................................................. 1 Serious Drug Interactions ....................................................................................
3 Drug-Behavioural Interactions............................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions........................................................................................
6 Drug-Herb Interactions St. John’s Wort ............................................................... 7 Drug-Laboratory Test Interactions....................................................................... 32 10 CLINICAL PHARMACOLOGY ........................................................................................
1 Mechanism of Action........................................................................................... 3 Pharmacokinetics ................................................................................................ 33 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
34 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 34 PART II: SCIENTIFIC INFORMATION ........................................................................................
35 13 PHARMACEUTICAL INFORMATION ............................................................................. 35 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication .................................................................................. 3 Comparative Bioavailability Studies..................................................................... 37 15 MICROBIOLOGY .........................................................................................................
38 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 38 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 48 PATIENT MEDICATION INFORMATION ...................................................................................
49 RIVA-SERTRALINE (Sertraline Hydrochloride Capsules) Page 4 of 56 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS RIVA-SERTRALINE (sertraline hydrochloride capsules) is indicated for: Adults • Depression RIVA-SERTRALINE is indicated for the symptomatic relief of depressive illness.
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