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PMS-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: pms-FLUOXETINE (fluoxetine) is indicated in adults for: • Depression: pms-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 pms-FLUOXETINE. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping pms-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 pms-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 Clinical Trial by Indication 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 Adverse Reaction Overview Commonly Observed Adverse Events In clinical trials, the most commonly observed adverse events associated with the use of fluoxetine and not seen at an equivalent incidence among placebo-treated patients were: central nervous system complaints, including headache, nervousness, insomnia, drowsiness, fatigue or asthenia, anxiety, tremor, and dizziness or lightheadedness; gastrointestinal complaints, including nausea, diarrhea, dry mouth and anorexia; and excessive sweating.
Adverse Events Leading to Discontinuation of Treatment Fifteen percent of approximately 4,000 patients who received fluoxetine in North American clinical trials discontinued treatment due to an adverse event. The more common events causing discontinuation pms-FLUOXETINE (fluoxetine hydrochloride) Page 20 of 48 from depression trials in adults and elderly, included: psychiatric, primarily nervousness, anxiety, and insomnia; digestive, primarily nausea; nervous system, primarily dizziness, asthenia, and headaches; skin, primarily rash and pruritus.
1% of fluoxetine treated patients discontinued treatment early because of adverse events. Anxiety and rash, at incidences of less than 2%, were the most frequently reported events. 2% of fluoxetine treated patients discontinued treatment early because of adverse events.
Insomnia, anxiety and rash, at incidences of less than 2%, were the most frequently reported events. , headache, insomnia, paresthesias, nervousness, anxiety, nausea, sweating, numbness, dizziness, jitteriness, asthenia, or other symptoms which may be of clinical significance).
The majority of these are mild and self–limiting. Fluoxetine has been only rarely associated with such symptoms. Plasma fluoxetine and norfluoxetine concentrations decrease gradually at the conclusion of therapy, which makes dose tapering unnecessary in most patients.
, Neurologic 08/2024 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS .....................................................................................................................
1 Pediatrics ..................................................................................................................... 2 Geriatrics .....................................................................................................................
4 2 CONTRAINDICATIONS ........................................................................................................ 4 3 SERIOUS WARNING AND PRECAUTIONS BOX .....................................................................
5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration............................................................................................................. 5 Missed Dose ................................................................................................................
7 5 OVERDOSAGE .................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING...................................... 10 7 WARNINGS AND PRECAUTIONS .......................................................................................
• Hypersensitivity - pms-FLUOXETINE 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 section.
pms-FLUOXETINE (fluoxetine hydrochloride) Page 5 of 48 • 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). pms-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 pms-FLUOXETINE before starting an MAOI. Limited reports suggest that intravenously administered dantrolene or orally administered cyproheptadine may benefit patients experiencing such reactions.
4 Drug-Drug Interactions, Monoamine Oxidase Inhibitors section. • Thioridazine - Thioridazine should not be administered concomitantly with pms-FLUOXETINE or within a minimum of 5 weeks after pms-FLUOXETINE has been discontinued, nor should pms-FLUOXETINE be administered within 2 weeks after thioridazine has been discontinued.
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 pms-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 pms-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 pms-FLUOXETINE during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment.
The health professional may consider tapering pms-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, Psychiatric, POTENTIAL ASSOCIATION WITH BEHAVIOURAL 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 pms-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.
1 Dosing Considerations, Discontinuation of Treatment; and 7 WARNINGS AND PRECAUTIONS, General. Serious Adverse Reactions Suicidal thoughts and acts are far more common among depressed patients than in the general population. It is estimated that suicide is 22 to 36 times more prevalent in depressed persons than in the general population.
A comprehensive meta-analysis of pooled data from 17 double blind clinical trials in patients with major depressive disorder compared fluoxetine (n = 1765) with a tricyclic antidepressant (n = 731) or placebo (n = 569), or both. 6% for tricyclic antidepressants.
In countries where the drug has already been marketed, the following potentially serious adverse reactions have been reported; interactions with MAO inhibitors and possibly other drugs, allergic reactions, cardiovascular reactions, syndrome of inappropriate ADH secretion, and grand mal seizure.
Death and life-threatening events have been associated with some of these reactions, although causal relationship to fluoxetine has not necessarily been established. Post-marketing experience also confirms the profile of adverse reactions commonly reported during clinical trials with fluoxetine including allergic skin reactions.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse drug 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 drug reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Multiple doses of fluoxetine had been administered to 10,782 patients with various diagnoses in US clinical trials as of May 8, 1995.
Adverse events were recorded by clinical investigators using descriptive terminology of their own choosing. , reduced) number of standardized event categories. pms-FLUOXETINE (fluoxetine hydrochloride) Page 21 of 48 Adults: In the tables and tabulations that follow, COSTART Dictionary terminology has been used to classify reported adverse events.
The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
It is important to emphasize that events reported during therapy were not necessarily caused by it. The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing health professional with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.
Table 2:
Treatment-Emergent Adverse Events Incidence in Fluoxetine versus Placebo Trials Listed by Indication Percentage of Patients Reporting Event Body System/ Adverse Event DEPRESSION* (Adults) DEPRESSION (Elderly) OCD* BULIMIA* Fluoxetine (N=1728) Placebo (N=975) Fluoxetine (N=335) Placebo (N=336) Fluoxetine (N=266) Placebo (N=89) […]
1 Special Populations ................................................................................................... 1 Pregnant Women ....................................................................................................................
2 Breast-feeding ......................................................................................................................... 3 Pediatrics .................................................................................................................................
4 Geriatrics ................................................................................................................................. 19 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 ................................................................................ 27 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 ............................................................................ 32 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action................................................................................................. 2 Pharmacodynamics ...................................................................................................
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 Trial by Indication .......................................................................................... 2 Comparative Bioavailability Studies […]
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, pms-FLUOXETINE should not be used in combination with thioridazine.
4 Drug-Drug Interactions, Thioridazine section. 3 SERIOUS WARNING AND PRECAUTIONS BOX 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 behaviours (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM).