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An antidepressant group of selective serotonin reuptake inhibitors. It has thymoanaleptic and stimulating effects.
Selectively blocks the reverse neuronal seizure of serotonin (5HT) in the synapses of the neurons of the central nervous system. Inhibition of serotonin reuptake leads to an increase in the concentration of this neurotransmitter in the synaptic cleft, enhances and prolongs its effect on the postsynaptic receptive regions. By increasing serotonergic transmission, fluoxetine inhibits the neurotransmitter metabolism by the mechanism of negative membrane communication. With prolonged use, fluoxetine inhibits the activity of 5-HT1 receptors. It has little effect on the reuptake of norepinephrine and dopamine. It has no direct effect on serotonin, m-cholinergic, H1-histamine and alpha-adrenergic receptors. Unlike most antidepressants, it does not cause a decrease in the activity of postsynaptic beta-adrenoreceptors.
It is effective in endogenous depressions and obsessive-compulsive disorders. It has anorexigenic effects and may cause weight loss. Does not cause orthostatic hypotension, sedation, non-cardiotoxic. Persistent clinical effect occurs after 1-2 weeks of treatment.
- depression of various origins;
- obsessive compulsive disorder;
- bulimic neurosis.
Excipients: lactose monohydrate (milk sugar) - 30.8 mg, microcrystalline cellulose - 16.1 mg, colloidal silicon dioxide (aerosil) - 150 μg, magnesium stearate - 600 μg, talc - 1.15 mg.
The composition of the capsule shell: gelatin - 36.44 mg, titanium dioxide - 1.52 mg, indigo carmine - 40 mcg.
Fluoxetine is marketed under different brands and generic names, and comes in different dosage forms:
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Dosage and Administration
The drug is taken orally, at any time, regardless of the meal.
The initial dose is 20 mg 1 time / day in the first half of the day, regardless of the meal. If necessary, the dose can be increased to 40-60 mg / day, divided into 2-3 doses (20 mg / day weekly). The maximum daily dose is 80 mg in 2-3 doses.
The clinical effect develops within 1-2 weeks after the start of treatment, in some patients it can be achieved later.
Obsessive Compulsive Disorders
The recommended dose is 20-60 mg / day.
The drug is used in a daily dose of 60 mg, divided into 2-3 doses.
Use of the drug by patients of different ages
There are no data on dose changes depending on age. Older patients should begin treatment with a dose of 20 mg / day.
Fluoxetine should be prescribed to patients with impaired liver function or kidney problems with the use of low doses and prolongation of the interval between doses.
When fluoxetine is used, as in the case of using drugs of the group of selective serotonin reuptake inhibitors, the following undesirable effects are noted.
Since the cardiovascular system: often (≥ 1% - ≤10%) - atrial flutter, hot flashes; infrequently (≥ 0.1% - ≤1%) - hypotension; rarely (≤ 0.1%) - vasculitis, vazolidation.
On the part of the digestive system: very often (≥ 10%) - diarrhea, nausea; often (≥ 1% - ≤10%) - dry mouth, dyspepsia, vomiting; infrequently (≥ 0.1% - ≤1%) - dysphagia, taste perversion; rarely (≤ 0.1%) - pain along the esophagus.
Hepatobiliary system: rarely (≤ 0.1%) - idiosyncratic hepatitis.
On the part of the immune system: very rarely (≤ 0.1%) - anaphylactic reactions, serum sickness.
Metabolic and nutritional disorders: often (≥ 1% - ≤10%) - anorexia (including weight loss) of the body.
From the musculoskeletal system: infrequently (≥ 0.1% - ≤1%) - muscular twitching.
CNS: very often (≥ 10%) - headache; often (≥ 1% - ≤10%) - impaired attention, dizziness, lethargy, drowsiness (including hypersensitivity, sedation), tremor; infrequently (≥ 0.1% - ≤1%) - psychomotor agitation, hyperactivity, ataxia, incoordination, bruxism, dyskinesia, myoclonus; rarely (≤ 0.1%) - bukko-global syndrome, convulsions, serotonin syndrome.
Mental disorders: very often (≥ 10%) - insomnia (including early morning awakening, primary and secondary insomnia); often (≥ 1% - ≤ 10%) - unusual dreams (including nightmares), nervousness, tension, decreased libido (including lack of libido), euphoria, sleep disturbance; infrequently (≥ 0.1% - ≤1%) - depersonalization, hyperthymia, impaired orgasm (including anorgasmia), impaired thinking; rarely (≤ 0.1%) - manic disorders.
On the part of the skin: often (≥ 1% - ≤10%) - hyperhidrosis, pruritus, polymorphic skin rash, urticaria; infrequently (≥ 0.1% - ≤1%) - ecchymosis, tendency to bruise, alopecia, cold sweat; rarely (≤ 0.1%) - angioedema, photosensitivity reactions.
From the senses: often (≥ 1% - ≤10%) - blurred vision; infrequently (≥ 0.1% - ≤1%) - mydriasis.
From the genitourinary system: often (≥ 1% - ≤10%) - frequent urination (including pollakiuria), impaired ejaculation (including lack of ejaculation, dysfunctional ejaculation, early ejaculation, delayed ejaculation, retrograde ejaculation), erectile dysfunction, gynecological bleeding (including bleeding from the cervix of the uterus, dysfunctional uterine bleeding, bleeding from the genital tract, menometer, menorrhagia, metrorrhagia, polymenorrhea, postmenopausal bleeding, uterine bleeding, vaginal bleeding); infrequently (≥ 0.1% - ≤1%) - dysuria; rarely (≤ 0.1%) - sexual dysfunction, priapism.
Post marketing messages
On the part of the endocrine system, there were cases of insufficiency of antidiuretic hormone.
These side effects often occur at the beginning of fluoxetine therapy or with an increase in the dose of the drug.
- simultaneous prim with MAO inhibitors (and within 14 days after their cancellation);
- simultaneous administration of thioridazine (and within 5 weeks after discontinuation of fluoxetine), pimozide;
- breastfeeding period;
- severe renal dysfunction (creatinine clearance less than 10 ml / min);
- liver failure;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- age up to 18 years;
- Hypersensitivity to the drug.
Suicidal risk: with depressions, there is a likelihood of suicidal attempts that may persist until the onset of persistent remission. Selected cases of suicidal thoughts and suicidal behavior are described against the background of therapy or shortly after its completion, similar to the effect of other drugs of similar pharmacological action (antidepressants). Careful observation of patients at risk is needed. Doctors should convince patients to immediately report any thoughts or feelings that are disturbing.
Epileptic fiddles: fluucetine should be used with caution in patients who have had epileptic seizures.
Hyponatremia: there have been cases of hyponatremia. Mostly similar cases were observed in elderly patients and in patients taking diuretics, due to a decrease in circulating blood volume.
Diabetes mellitus: glycemic control in patients with diabetes during treatment with fluoxetine showed hypoglycemia, after discontinuation of the drug hyperglycemia developed. At the beginning or after treatment with fluoxetine, it may be necessary to adjust the doses of insulin and / or hypoglycemic drugs for oral administration.
Renal / hepatic impairment: Fluoxetine is metabolized in the liver and excreted by the kidneys and through the gastrointestinal tract. Patients with severely impaired liver function are advised to prescribe lower doses of fluoxetine, or prescribe the drug every other day. When fluoxetine was taken at a dose of 20 mg / day for two months, there were no differences in fluoxetine and norfluoxetine concentrations in the blood plasma of healthy individuals with normal renal function and patients with severe impaired renal function (creatinine clearance 10 ml / min) in need of hemodialysis
Fluoxetine and its main metabolite, norfluoxetine, have long half-life, which must be considered when combining fluoxetine with other drugs, as well as when replacing it with another antidepressant.
Do not use the drug simultaneously with MAO inhibitors, incl. antidepressants - MAO inhibitors; furazolidone, procarbazine, selegiline, and tryptophan (a precursor of serotonin), since it is possible to develop a serotonergic syndrome, manifested in mental confusion, hypomania, psychomotor agitation, convulsions, dysarthria, hypertensive crises, tremors, tremors, convulsions, dysarthria, hypertensive crises, tremors, tremor, seizures, dysarthria, hypertensive crises, tremor, tremors, cramps, dysarthria, hypertensive crises, tremors, tremor, spasms, dysarthria, hypertensive crises, tremor, tremors, cramps, dysarthria, hypertensive crises, tremors, tremor
After the use of MAO inhibitors, fluoxetine can be prescribed not earlier than 14 days. MAO inhibitors should not be used earlier than 5 weeks after discontinuation of fluoxetine.
Simultaneous administration of drugs metabolized with the participation of CYP2D6 isoenzyme (carbamazepine, diazepam, propafenone) with fluoxetine should be carried out with the use of minimal therapeutic doses. Fluoxetine blocks the metabolism of tricyclic and tetracyclic antidepressants of trazodone, metoprolol, terfenadine, which leads to an increase in their concentration in blood serum, increasing their effect and increasing the frequency of complications.
In patients who consistently took maintenance doses of phenytoin, plasma phenytoin concentrations increased significantly and symptoms of phenytoin intoxication (nystagmus, diplopia, ataxia and CNS depression) appeared after the start of concurrent treatment with fluoxetine.
The combined use of fluoxetine and lithium salts, requires careful monitoring of the concentration of lithium in the blood, because its increase is possible.
Fluoxetine enhances the effect of hypoglycemic drugs.
With simultaneous use with drugs with a high degree of protein binding, especially with anticoagulants and digitoxin, it is possible to increase the plasma concentration of free (unbound) drugs and increase the risk of adverse effects.
Pregnancy and Lactation
Contraindicated in pregnancy and lactation.
Careful observation 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 have excessive fatigue, hypersomnia or motor restlessness during treatment with fluoxetine. Before the onset of a significant improvement in treatment, such patients should be under the supervision of a physician.
In children, adolescents and young people (under 24 years) with depression, other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing fluoxetine or any other antidepressants in children, adolescents and young people (under 24 years of age), the risk of suicide and the benefits of their use should be correlated. In short-term studies, the risk of suicide was not increased in people over 24 years of age, while in people over 65 years of age it somewhat decreased. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment with antidepressants, all patients should be monitored for the purpose of early detection of abnormalities or behavioral changes, as well as suicidal tendencies.
On the background of electroconvulsive therapy, the development of long-term epileptic seizures is possible.
The interval between the end of treatment 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.
After discontinuation of the drug, its therapeutic serum concentration may persist for several weeks.
In patients with diabetes mellitus, hypoglycemia may develop during therapy with fluoxetine and hyperglycemia after its withdrawal. At the beginning or after treatment with fluoxetine, it may be necessary to adjust the doses of insulin and / or hypoglycemic drugs for oral administration.
When treating patients with a body mass deficiency, anorexigenic effects should be taken into account (progressive loss of body weight is possible).
While taking fluoxetine, you should refrain from taking alcohol, because The drug enhances the effect of alcohol.
Influence on ability to drive motor transport and control mechanisms
Fluoxetine may adversely affect the performance of work that requires a high rate of mental and physical reactions.
Symptoms: psychomotor agitation, convulsive seizures, drowsiness, cardiac arrhythmias, tachycardia, nausea, vomiting.
Other serious symptoms of fluoxetine overdose (both when taking fluoxetine alone and when taken with other drugs) included coma, delirium, prolongation of the QT interval and ventricular tachyarrhythmia, including flicker - ventricular flutter and cardiac arrest, decreased blood pressure, fainting, mania, pyrexia, stupor, and a condition similar to neuroleptic malignant syndrome
Treatment: no specific antagonists for fluoxetine were found. Symptomatic therapy, gastric lavage with the appointment of activated carbon, with convulsions - diazepam, maintaining breathing, cardiac activity, body temperature.
- Brand name: Fluoxetine-Canon
- Active ingredient: Fluoxetine
- Dosage form: Capsules 20 mg
- Manufacturer: Canonpharma
- Country of Origin: Russia
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