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ACH-FLUOXETINE is a brand name for Fluoxetine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ACH-Fluoxetine (fluoxetine) is indicated in adults for: • Depression: ACH-Fluoxetine is indicated for the symptomatic relief of Major Depressive Disorder (MDD). • Bulimia Nervosa: Fluoxetine has been shown to significantly decrease binge-eating and purging activity when compared with placebo treatment. •…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations General: During maintenance therapy, the dosage should be kept at the lowest effective level. 4 Drug-Drug Interactions, Tricyclic Antidepressants section).
Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI):
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with ACH-Fluoxetine. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping ACH-Fluoxetine before starting MAOI (see 2 CONTRAINDICATIONS section).
Discontinuation of Treatment:
When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in mind when starting or stopping treatment. Dosage tapering is unnecessary in most patients. Despite its long-half life, symptoms associated with the discontinuation of fluoxetine have been reported in clinical trials and post–marketing.
Patients should be monitored for these and other symptoms when discontinuing treatment, regardless of the indication for which ACH-Fluoxetine is being prescribed. Fluoxetine has been only rarely associated with such symptoms. 1 Adverse Reaction Overview).
2 Recommended Dose and Dosage Adjustment Depression: Initial Adult Dosage: The usual initial dosage is 20 mg administered once daily in the morning. A gradual dose increase should be considered only after a trial period of several weeks if the expected clinical improvement does not occur.
Dosage should not exceed a maximum of 60 mg per day.
Long Term:
The efficacy of fluoxetine in maintaining an antidepressant response for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial. 1 Trial Design and Study Demographics section).
Bulimia Nervosa:
Adult Dosage: The recommended dosage is 60 mg per day, although studies show that lower doses may also be efficacious. Electrolyte levels should be assessed prior to initiation of treatment.
Obsessive-Compulsive Disorder:
1. Clinical Trial Adverse Reactions – Pediatrics. 2. 4 Geriatrics). 2 CONTRAINDICATIONS • Hypersensitivity – ACH-Fluoxetine is contraindicated in patients who are hypersensitive to ACH-Fluoxetine (Fluoxetine Capsules BP) Page 5 of 57 Serious Warnings and Precautions Increased risk of self-harm, harm to others, suicidal thinking and behaviour with antidepressant use.
Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviour (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, including Self-Harm).
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 section. • Monoamine Oxidase Inhibitors - In patients receiving serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma).
These reactions have also been reported in patients who have recently discontinued SSRI treatment and then started treatment on an MAOI. , serotonin syndrome). ACH-Fluoxetine should not be used in combination with an MAOI (including the antibiotic linezolid and the thiazine dye methylthioninium chloride (methylene blue) which are less well-known examples of MAOIs) or within 14 days of discontinuing therapy with an MAOI.
Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should elapse after discontinuing treatment with ACH-Fluoxetine before starting an MAOI. Limited reports suggest that intravenously administered dantrolene or orally administered cyproheptadine may benefit patients experiencing such reactions.
1 Pregnant Women 04/2022 7 WARNINGS AND PRECAUTIONS, Neurologic 07/2024 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 07/2024 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 ..................................................................... 3 1 INDICATIONS ..............................................................................................................
1 Pediatrics ............................................................................................................. 2 Geriatrics .............................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................ 1 Dosing Considerations .........................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................... 4 Administration ..................................................................................................... 5 Missed Dose .........................................................................................................
8 5 OVERDOSAGE ............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 10 7 WARNINGS AND PRECAUTIONS ................................................................................
• Hypersensitivity – ACH-Fluoxetine is contraindicated in patients who are hypersensitive to ACH-Fluoxetine (Fluoxetine Capsules BP) Page 5 of 57 Serious Warnings and Precautions Increased risk of self-harm, harm to others, suicidal thinking and behaviour with antidepressant use.
Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviour (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, including Self-Harm).
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 section. • Monoamine Oxidase Inhibitors - In patients receiving serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma).
These reactions have also been reported in patients who have recently discontinued SSRI treatment and then started treatment on an MAOI. , serotonin syndrome). ACH-Fluoxetine should not be used in combination with an MAOI (including the antibiotic linezolid and the thiazine dye methylthioninium chloride (methylene blue) which are less well-known examples of MAOIs) or within 14 days of discontinuing therapy with an MAOI.
Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should elapse after discontinuing treatment with ACH-Fluoxetine before starting an MAOI. Limited reports suggest that intravenously administered dantrolene or orally administered cyproheptadine may benefit patients experiencing such reactions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fluoxetine 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.
A dose range of 20 mg / day to 60 mg / day is recommended for the treatment of obsessive- compulsive disorder.
Dose Adjustment:
Since it may take up to four or five weeks to reach steady-state plasma levels of fluoxetine, sufficient time should be allowed to elapse before dosage is gradually increased. Higher dosages are usually associated with an increased incidence of adverse reactions.
, ventricular and septal defects) associated with use of fluoxetine. The mechanism is unknown. The use of ACH- Fluoxetine during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus taking into account the risks associated with untreated depression.
1 Pregnant Women, Complications following late third trimester exposure to SSRIs). When treating pregnant women with ACH-Fluoxetine during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment.
The health professional may consider tapering ACH-Fluoxetine in the third trimester. • Geriatrics (≥ 60 years of age): Fluoxetine was evaluated in depressed elderly patients only at a dosage of 20 mg / day. A lower or less frequent dosage may be effective and should be considered in elderly patients with concurrent disease or on multiple medications.
• Pediatrics (˂ 18 years of age): Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, General, Potential Association with Behavioural ACH-Fluoxetine (Fluoxetine Capsules BP) Page 8 of 57 and Emotional Changes, including Self-Harm).
• Renal/Hepatic Impairment or Otherwise Debilitated Patients: A lower or less frequent dosage should be used in patients with renal and/or hepatic impairment and in those on multiple medications. 4 Administration ACH-Fluoxetine may be taken with or without food.
The capsules should not be opened or chewed, and they must be swallowed whole. 5 Missed Dose In the event that a patient misses a dose, they should be instructed to take their dose as soon as they can. The next dose should be taken at the next scheduled time.
4 Drug-Drug Interactions, Monoamine-Oxidase Inhibitors section. • Thioridazine - Thioridazine should not be administered concomitantly with ACH-Fluoxetine or within a minimum of 5 weeks after ACH-Fluoxetine has been discontinued, nor should ACH-Fluoxetine be administered within 2 weeks after thioridazine has been discontinued.
Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsades de pointes-type arrhythmias, and sudden death. This effect appears to be dose-related.
An in vivo study suggests that drugs which inhibit P4502D6, including certain SSRI’s such as paroxetine, fluoxetine and fluvoxamine, will elevate plasma levels of thioridazine. Therefore, ACH-Fluoxetine should not be used in combination with thioridazine.
4 Drug-Drug Interactions, Thioridazine section. 1 Dosing Considerations General: During maintenance therapy, the dosage should be kept at the lowest effective level. 4 Drug-Drug Interactions, Tricyclic Antidepressants section).
Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI):
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with ACH-Fluoxetine. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping ACH-Fluoxetine before starting MAOI (see 2 CONTRAINDICATIONS section).
Discontinuation of Treatment:
When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in mind when starting or stopping treatment. Dosage tapering is unnecessary in most patients. Despite its long-half life, symptoms associated with the discontinuation of fluoxetine have been reported in clinical trials and post–marketing.
Patients should be monitored for these and other symptoms when discontinuing treatment, regardless of the indication for which ACH-Fluoxetine is being prescribed. Fluoxetine has been only rarely associated with such symptoms. 1 Adverse Reaction Overview).
2 Recommended Dose and Dosage Adjustment Depression: Initial Adult Dosage: The usual initial dosage is 20 mg administered once daily in the morning. A gradual dose increase should be considered only after a trial period of several weeks if the expected clinical improvement does not occur.
Dosage should not exceed a maximum of 60 mg per day.
Long Term:
The efficacy of fluoxetine in maintaining an antidepressant response for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial. 1 Trial Design and Study Demographics section).
Bulimia Nervosa:
Adult Dosage: The recommended dosage is 60 mg per day, although studies show that lower doses may also be efficacious. Electrolyte levels […]
1 Special Populations ............................................................................................ 1 Pregnant Women ............................................................................................... 2 Breast-feeding ...................................................................................................
3 Pediatrics ........................................................................................................... 4 Geriatrics ...........................................................................................................
21 8 ADVERSE REACTIONS ................................................................................................ 1 Adverse Reaction Overview ............................................................................... 2 Clinical Trial Adverse Reactions..........................................................................
1 Clinical Trial Adverse Reactions – Pediatrics ...................................................... 3 Less Common Clinical Trial Adverse Reactions................................................... 4 Abnormal laboratory findings ............................................................................
5 Post-Market Adverse Reactions ......................................................................... 31 9 DRUG INTERACTIONS ............................................................................................... 1 Serious Drug Interactions...................................................................................
2 Drug Interactions Overview ............................................................................... 3 Drug-Behavioural Interactions ........................................................................... 4 Drug-Drug Interactions ......................................................................................
5 Drug-Food Interactions ...................................................................................... 6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions .....................................................................
37 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ......................................................................................... 2 Pharmacodynamics ............................................................................................
3 Pharmacokinetics ............................................................................................... 38 11 STORAGE, STABILITY AND DISPOSAL......................................................................... 39 12 SPECIAL HANDLING INSTRUCTIONS ..........................................................................
39 PART II: SCIENTIFIC INFORMATION ...................................................................................... 40 13 PHARMACEUTICAL INFORMATION ........................................................................... 40 14 CLINICAL TRIALS .......................................................................................................
1 Trial Design and Study Demographics ................................................................ 3 Comparative Bioavailability Studies ................................................................... 41 15 MICROBIOLOGY ........................................................................................................
42 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 42 17 SUPPORTING PRODUCT MONOGRAPHS […]
4 Drug-Drug Interactions, Monoamine-Oxidase Inhibitors section. • Thioridazine - Thioridazine should not be administered concomitantly with ACH-Fluoxetine or within a minimum of 5 weeks after ACH-Fluoxetine has been discontinued, nor should ACH-Fluoxetine be administered within 2 weeks after thioridazine has been discontinued.
Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsades de pointes-type arrhythmias, and sudden death. This effect appears to be dose-related.
An in vivo study suggests that drugs which inhibit P4502D6, including certain SSRI’s such as paroxetine, fluoxetine and fluvoxamine, will elevate plasma levels of thioridazine. Therefore, ACH-Fluoxetine should not be used in combination with thioridazine.
4 Drug-Drug Interactions, Thioridazine section. 3 SERIOUS WARNING AND PRECAUTIONS BOX ACH-Fluoxetine (Fluoxetine Capsules BP) Page 6 of 57