Fluoxetine Canon (20mg)
Suicidal risk
Depression is associated with an increased risk of suicidal ideation, self-harm (self-harm), and suicidal events. This risk persists until stable remission occurs. Since improvement may not occur during the first few weeks of treatment, careful monitoring by the attending physician is necessary until the patient's condition improves. Clinical practice shows that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which Fluoxetine Canon is prescribed may also be associated with an increased risk of suicidal events. In addition, these diseases can accompany major depressive disorder. Therefore, the same caution should be exercised when treating patients with other psychiatric illnesses as when treating patients with major depressive disorder.
Patients with a history of suicidal behavior who clearly exhibit suicidal ideation before treatment are at increased risk for suicidal ideation or behavior. These patients should be closely monitored during therapy.
A meta-analysis of placebo-controlled clinical trials of antidepressants used to treat psychiatric conditions in adult patients found that among patients younger than 25 years, antidepressant use is associated with an increased risk of suicidal behavior compared with patients receiving placebo.
Patients, particularly those at high risk of developing suicidal behavior, should be closely monitored, especially during the early stages of treatment and during subsequent dose changes. Patients (and their caregivers) should be warned to monitor for any clinical deterioration, monitor for the occurrence of suicidal behavior or thoughts, and unusual changes in behavior, and should contact their healthcare provider immediately if these symptoms occur.
Cardiovascular effects
QT prolongation may occur with fluoxetine, and ventricular arrhythmias or torsade de pointes (TdP) have been reported during post-marketing studies of fluoxetine. Fluoxetine should be used with caution in patients with congenital long QT syndrome, acquired long QT syndrome (for example, while taking fluoxetine with drugs that prolong the QT interval), if there is a history of indications of an increase in the duration of the QT interval in the patient's relatives, with other clinical conditions predisposing to the development of arrhythmia (for example, with hypokalemia, hypomagnesemia, bradycardia, acute myocardial infarction, decompensated heart failure) and with increased exposure to fluoxetine (for example, with reduced liver function). Patients with stable heart disease should undergo electrocardiography (ECG) before starting fluoxetine therapy. If signs of arrhythmia develop during therapy, fluoxetine should be discontinued and an ECG study performed.
Skin rash
In patients taking fluoxetine, skin rash, anaphylactic reactions and progressive systemic disorders, sometimes serious involving the skin, kidneys, liver and lungs, have been reported. If a skin rash or other possible allergic reactions occur, the etiology of which cannot be determined, fluoxetine should be discontinued.
Epileptic seizures
As with other antidepressants, fluoxetine should be used with caution in patients with a history of seizures. Fluoxetine therapy should be discontinued if epileptic seizures develop in any patient. Also, fluoxetine therapy should not be prescribed to patients with unstable epilepsy; patients with controlled epilepsy require careful monitoring.
Electroconvulsive therapy
In patients receiving electroconvulsive therapy, prolonged seizures have been reported in rare cases while receiving fluoxetine. Caution is recommended when administering fluoxetine to these patients.
Mania
Antidepressants should be used with caution in patients with a history of mania/hypomania. Fluoxetine, like any antidepressant, must be discontinued if the patient is in a manic state.
Akathisia/ psychomotor restlessness
The use of fluoxetine leads to the development of akathisia, which is manifested by subjectively unpleasant sensations or restlessness, the need for constant movement, often without the ability to sit or stand still. Most often, such phenomena are observed during the first few weeks of treatment. In patients with these symptoms, increasing the dose of fluoxetine may have negative consequences.
Withdrawal symptoms
Withdrawal symptoms were common when fluoxetine therapy was stopped, especially when discontinued abruptly. In clinical studies, approximately 60% of patients developed various adverse events when therapy was discontinued, both in the fluoxetine group and in the placebo group. In the fluoxetine group, 17% of these events were severe, and in the placebo group - 12%.
The risk of developing withdrawal symptoms depends on several factors, including duration of therapy, dose, and rate of dose reduction. The most commonly reported symptoms were dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and vivid dreams), asthenia, anxiety or agitation, nausea and/or vomiting, tremor and headache. Typically these episodes were mild to moderate in severity, but in some patients they could be more severe. In most cases, these phenomena resolve on their own within two weeks, but sometimes they can last longer (2-3 months or more). Therefore, withdrawal of fluoxetine therapy should be done gradually over one or two weeks, depending on the patient's needs.
Tamoxifen
Fluoxetine, as a potent inhibitor of the CYP2D6 isoenzyme, can lead to a decrease in the concentration of endoxifen, one of the most important active metabolites of tamoxifen. Therefore, fluoxetine should be avoided during tamoxifen therapy.
Weight loss
When using fluoxetine, patients may experience a decrease in body weight, however, this is usually proportional to the initial average body weight.
Hyponatremia
There have been cases of hyponatremia (in some cases, serum sodium levels were less than 110 mmol/l). Mostly, such cases were observed in elderly patients, in patients receiving diuretics and in patients with a decrease in circulating blood volume.
Diabetes
In patients with diabetes mellitus, hypoglycemia was observed during treatment with fluoxetine, and hyperglycemia developed after discontinuation of the drug. At the beginning or after the end of treatment with fluoxetine, dose adjustment of insulin and/or oral hypoglycemic drugs may be required.
Liver/renal failure
Fluoxetine undergoes extensive metabolism in the liver and is excreted by the kidneys. For patients with severe liver dysfunction, it is recommended to prescribe lower doses of fluoxetine, or prescribe the drug every other day. When taking fluoxetine at a dose of 20 mg/day for two months in patients with severe renal failure (creatinine clearance < 10 ml/min) requiring hemodialysis, there were no differences in the concentrations of fluoxetine and norfluoxetine in the blood plasma when compared with patients from control group with normal renal function.
Midriaz
Mydriasis has been reported in association with fluoxetine. Caution should be exercised when prescribing fluoxetine to patients with elevated intraocular pressure or patients at risk of developing acute angle-closure glaucoma.
Hemorrhages
Ecchymosis, purpura and other similar disorders associated with increased bleeding have been reported with the use of SSRIs. Ecchymosis has been rarely reported. Other hemorrhagic phenomena (gynecological bleeding, gastrointestinal bleeding, etc.) were observed rarely. Caution should be exercised when treating fluoxetine, in particular in patients with concomitant therapy with oral anticoagulants and other drugs that affect platelet function (for example, with atypical antipsychotics such as clozapine, with phenothiazines, with most tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs) , as well as with concomitant therapy with drugs that may increase the tendency to bleeding, and in patients with a history of bleeding.
Phenomena similar in symptoms to serotonin syndrome or neuroleptic malignant syndrome
In rare cases, the development of serotonin syndrome or neuroleptic malignant syndrome associated with fluoxetine has been reported, especially when used together with other serotonergic drugs (including those containing L-tryptophan) and/or antipsychotics. Because these syndromes can lead to life-threatening conditions, fluoxetine therapy should be discontinued if a combination of symptoms such as pyrexia, rigidity, myoclonus, autonomic nervous system disorders, mental status changes including confusion, irritability, extreme agitation with possible development of delirium and coma occur. , and prescribe the necessary symptomatic therapy.
All patients taking antidepressants for any indication should be closely monitored for signs of clinical worsening, suicidal ideation, and unusual behavioral changes, especially during the first months of therapy or during dose changes (increases or decreases).
Impact on the ability to drive vehicles,
mechanisms
The drug Fluoxetine Canon has no or minimal effect on the ability to drive vehicles and operate machinery. Treatment with any psychoactive drug may affect judgment, thinking, or motor skills. Patients should be advised to avoid driving or operating dangerous machinery until they are confident enough to do so. that the drug has no effect on them.
Fluoxetine Canon capsules 20 mg 30 pcs. in Moscow
For oral administration.
Fluoxetine can be taken once a day or several times a day in divided doses - during or between meals (regardless of meals).
Major depressive episodes
Adult and elderly patients: The recommended daily dose is 20 mg. If necessary, within 3-4 weeks after the start of therapy and subsequently, if clinically indicated, the dose can be reviewed and adjusted. Despite the potential risk of increased adverse effects as the dose is increased, in some patients who have an insufficient response to therapy at a dose of 20 mg, the dose may be gradually increased to 60 mg (maximum dose). Dose adjustments should be made carefully based on the needs of each individual patient so that the patient continues to receive the minimum effective dose.
To achieve stable remission, the duration of therapy in patients suffering from depression should be at least 6 months.
Bulimia nervosa
Adult and elderly patients: recommended daily dose
is 60 mg. For bulimia nervosa, long-term effectiveness (more than 3 months) has not been demonstrated.
Obsessive-compulsive disorder
Adult and elderly patients: recommended daily dose
is 20 mg. In some patients who do not respond sufficiently to a 20 mg dose for two weeks, the dose may be gradually increased to a maximum of 60 mg.
If there is no improvement within 10 weeks, fluoxetine therapy should be reconsidered. If a good therapeutic response is achieved, therapy can be extended using a dose adjusted based on the individual needs of the patient. Although there are no systematic studies addressing the question of the duration of fluoxetine therapy, it should be noted that obsessive-compulsive disorder (OCD) is a chronic disease, and in patients who respond to therapy, it is reasonable to continue treatment for more than 10 weeks. Dose adjustments should be made carefully, based on the patient's individual needs, so that the patient continues to receive the minimum effective dosage. The need for therapy should be reassessed periodically. For patients who respond well to pharmacotherapy, some physicians recommend concomitant behavioral therapy. The effectiveness of fluoxetine in the long term (more than 24 weeks) in the treatment of OCD has not been demonstrated.
All readings
The recommended dose may be reduced or increased. Doses exceeding 80 mg/day have not been systematically studied.
Patients, particularly those at high risk of developing suicidal behavior, should be closely monitored, especially during the early stages of treatment and during subsequent dose changes. Patients (and their caregivers) should be warned to monitor for any clinical deterioration, monitor for the occurrence of suicidal behavior or thoughts, and unusual changes in behavior, and should contact their healthcare provider immediately if these symptoms occur.
Elderly patients
Increasing the dose should be done with caution; in general, daily doses should not exceed 40 mg. The maximum recommended dose is 60 mg/day.
Liver failure
In patients with liver failure, the drug is prescribed in a reduced dose or with a reduced frequency (for example, 20 mg every other day). These recommendations also apply to patients taking concomitant medications that potentially interact with Fluoxetine Canon.
Withdrawal symptoms noted when stopping therapy with Fluoxetine Canon
Abrupt discontinuation of the drug should be avoided. To reduce the risk of developing “withdrawal syndrome,” when stopping therapy with Fluoxetine Canon, the dose should be reduced gradually, over at least one to two weeks. If intolerable symptoms develop after reducing the dose or after stopping treatment, you should resume taking the drug at the previously prescribed dose. In the future, the doctor may prescribe a more gradual dose reduction.
When you stop taking the drug, the active substance remains in the body for several weeks. This fact should be taken into account when prescribing or completing therapy.
