Fluoxetine-Canon, 20 mg, capsules, 30 pcs.
When treating patients with underweight, the anorexigenic effects of fluoxetine should be taken into account (progressive weight loss is possible).
In patients with diabetes mellitus, the administration of fluoxetine increases the risk of hypoglycemia; when it is discontinued, hyperglycemia occurs. In this regard, the dose of insulin and/or any other hypoglycemic drugs used orally should be adjusted. Patients should be under medical supervision.
The interval between the end of therapy with MAO inhibitors and the start of treatment with fluoxetine should be at least 14 days; between the end of treatment with fluoxetine and the start of therapy with MAO inhibitors - at least 5 weeks.
Careful monitoring of patients with suicidal tendencies is required, especially at the beginning of treatment. The risk of suicide is highest in patients who have previously taken other antidepressants and in patients who experience excessive fatigue, hypersomnia, or restlessness during treatment with fluoxetine.
When carrying out electroconvulsive therapy while taking fluoxetine, prolonged epileptic seizures are possible.
During treatment, you should refrain from drinking alcohol and engaging in potentially hazardous activities that require increased attention and speed of mental and motor reactions.
In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and behavior. Therefore, when prescribing Fluoxetine or any other antidepressants in children, adolescents and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. In short-term studies, the risk of suicide did not increase in people over 24 years of age, but the risk of suicide decreased slightly in people over 65 years of age. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment with antidepressants, all patients should be monitored for early detection of disturbances or changes in behavior, as well as suicidality.
The occurrence of skin rash, anaphylactic reactions and progressive systemic disorders, sometimes serious involving the skin, kidneys, liver and lungs in the pathological process, has been reported in patients taking fluoxetine. If a skin rash or other possible allergic reactions occur, the etiology of which cannot be determined, fluoxetine should be discontinued.
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 caps. 20mg 30 pcs canonpharma
Fluoxetine and its main metabolite, norfluoxetine, have long half-lives, which must be taken into account when combining fluoxetine with other drugs, as well as when replacing it with another antidepressant. Phenytoin. Changes in the concentration of phenytoin in the blood were detected when it was combined with fluoxetine. In some cases, manifestations of intoxication were noted. Increasing the dose of phenytoin or fluoxetine when administered simultaneously should be done with caution and under the supervision of the clinical dynamics of the condition.
Serotonergic drugs. Concomitant use of serotonergic drugs (for example, tramadol and triptans) increases the likelihood of developing serotonin syndrome. Concomitant use of triptans also increases the likelihood of developing coronary vasoconstriction and arterial hypertension.
Benzodiazepines. With the simultaneous use of fluoxetine and benzodiazepines, the half-life of the latter may increase. When alprazolam and fluoxetine were taken together, an increase in the concentration of alprazolam in the blood and an increase in its sedative effect were observed.
Lithium and tryptophan. There are known cases of the development of serotonin syndrome while taking selective serotonin reuptake inhibitors (SSRIs) and lithium or tryptophan, and therefore the simultaneous administration of fluoxetine with these drugs should be carried out with caution. When fluoxetine and lithium are taken concomitantly, more frequent and careful monitoring of the clinical condition is necessary.
Medicines metabolized with the participation of the CYP2D6 isoenzyme (propafenone, carbamazepine, tricyclic antidepressants). It should be taken into account that the metabolism of fluoxetine (as well as tricyclic antidepressants, as well as selective serotonergic antidepressants) is carried out with the participation of the CYP2D6 isoenzyme of the liver cytochrome system. Simultaneous use of drugs, the main route of biotransformation of which is metabolism with the participation of the CYP2D6 isoenzyme, and having a small range of therapeutic doses (such as propafenone, carbamazepine, tricyclic antidepressants) should be carried out using minimal therapeutic doses. The above also applies if less than 5 weeks have passed since stopping fluoxetine.
Indirect anticoagulants and other drugs that affect the blood coagulation system (Non-steroidal anti-inflammatory drugs, acetylsalicylic acid). There is a known change in the anticoagulant effect (according to laboratory parameters and/or clinical manifestations) without any general characteristic trend, but with the likelihood of increased bleeding when taking fluoxetine and oral anticoagulants simultaneously. The functional state of the blood coagulation system in patients receiving warfarin should be carefully monitored when prescribing and discontinuing fluoxetine.
Electroconvulsive therapy (ECT). There have been rare reports of increased seizure duration in patients taking fluoxetine and receiving ECT, and caution is advised.
Alcohol. In experimental studies, fluoxetine did not increase blood alcohol concentrations or enhance the effects of alcohol. However, concomitant use of SSRIs and alcohol is not recommended.
Products based on the plant Hypericum perforatum. As with other SSRIs, a pharmacodynamic interaction may develop between fluoxetine and products based on the Hypericum perforatum plant, which may lead to increased undesirable effects.
Fluoxetine-Canon capsules 20mg bl N10x3 Canonpharma
Fluoxetine and its main metabolite, norfluoxetine, have long half-lives, which must be taken into account when combining fluoxetine with other drugs, as well as when replacing it with another antidepressant. Phenytoin. Changes in the concentration of phenytoin in the blood were detected when it was combined with fluoxetine. In some cases, manifestations of intoxication were noted. Increasing the dose of phenytoin or fluoxetine when administered simultaneously should be done with caution and under the supervision of the clinical dynamics of the condition. Serotonergic drugs. Concomitant use of serotonergic drugs (for example, tramadol and triptans) increases the likelihood of developing serotonin syndrome. Concomitant use of triptans also increases the likelihood of developing coronary vasoconstriction and arterial hypertension. Benzodiazepines. With the simultaneous use of fluoxetine and benzodiazepines, the half-life of the latter may increase. When alprazolam and fluoxetine were taken together, an increase in the concentration of alprazolam in the blood and an increase in its sedative effect were observed. Lithium and tryptophan. There are known cases of the development of serotonin syndrome while taking selective serotonin reuptake inhibitors (SSRIs) and lithium or tryptophan, and therefore the simultaneous administration of fluoxetine with these drugs should be carried out with caution. When fluoxetine and lithium are taken concomitantly, more frequent and careful monitoring of the clinical condition is necessary. Medicines metabolized with the participation of the CYP2D6 isoenzyme (propafenone, carbamazepine, tricyclic antidepressants). It should be taken into account that the metabolism of fluoxetine (as well as tricyclic antidepressants, as well as selective serotonergic antidepressants) is carried out with the participation of the CYP2D6 isoenzyme of the liver cytochrome system. Simultaneous use of drugs, the main route of biotransformation of which is metabolism with the participation of the CYP2D6 isoenzyme, and having a small range of therapeutic doses (such as propafenone, carbamazepine, tricyclic antidepressants) should be carried out using minimal therapeutic doses. The above also applies if less than 5 weeks have passed since stopping fluoxetine. Indirect anticoagulants and other drugs that affect the blood coagulation system (Non-steroidal anti-inflammatory drugs, acetylsalicylic acid). There is a known change in the anticoagulant effect (according to laboratory parameters and/or clinical manifestations) without any general characteristic trend, but with the likelihood of increased bleeding when taking fluoxetine and oral anticoagulants simultaneously. The functional state of the blood coagulation system in patients receiving warfarin should be carefully monitored when prescribing and discontinuing fluoxetine. Electroconvulsive therapy (ECT). There have been rare reports of increased seizure duration in patients taking fluoxetine and receiving ECT, and caution is advised. Alcohol. In experimental studies, fluoxetine did not increase blood alcohol concentrations or enhance the effects of alcohol. However, concomitant use of SSRIs and alcohol is not recommended. Products based on the plant Hypericum perforatum. As with other SSRIs, a pharmacodynamic interaction may develop between fluoxetine and products based on the Hypericum perforatum plant, which may lead to increased undesirable effects.
