Fluoxetine-Canon capsules 20mg, 30pcs

Composition

1 capsule contains:

Active substances – fluoxetine hydrochloride 22.36 mg in terms of fluoxetine 20.00 mg;

Excipients-corn starch,

lactose monohydrate (milk sugar),

magnesium stearate;

Solid gelatin capsule No. 3, including:

gelatin, titanium dioxide, indigo carmine.

Pharmacological action

An antidepressant. Selectively inhibits the reuptake of serotonin, which leads to an increase in its concentration in the synaptic cleft, strengthening and prolonging the action on postsynaptic receptors.

By increasing serotonergic transmission, fluoxetine inhibits neurotransmitter exchange by a negative feedback mechanism. With prolonged use, fluoxetine inhibits the activity of 5-HT1 receptors.

Weakly affects 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-adrenergic receptors.

It is effective for endogenous depression and obsessive-compulsive disorders. Improves mood, reduces tension, anxiety and feelings of fear, eliminates dysphoria.

It has an anorexic effect, may cause weight loss. It does not cause orthostatic hypotension, sedation, and is non-cardiotoxic. A persistent clinical effect occurs after 1-2 weeks of treatment.

Indications

-depression of various etiologies;

– bulimia nervosa;

– obsessive-compulsive disorder.

Contraindications

– hypersensitivity;

– concomitant use of monoamine oxidase inhibitors (MAOIS) and for 14 days after their cancellation;

– simultaneous reception of thioridazine (and within 5 weeks of stopping fluoxetine), pimozide;

– liver failure;

– renal failure (creatinine clearance less than 10 ml/min);

– atonic bladder;

– closure glaucoma;

– hyperplasia of the prostate;

– pregnancy;

– lactation period;

– lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

– age up to 18 years.

With caution

Suicidal risk: with depression, there is a possibility of suicide attempts, which may persist until the onset of persistent remission. Individual cases of suicidal thoughts and suicidal behavior have been reported during or shortly after fluoxetine therapy, similar to other drugs with similar pharmacological effects (antidepressants). Patients at risk should be carefully monitored. Doctors should encourage patients to immediately report any thoughts or feelings that cause anxiety.

Epileptic seizures: As with other antidepressants, fluoxetine should be used with caution in patients who have previously experienced epileptic seizures.

Hyponatremia: there were cases of hyponatremia (in some cases, the level of sodium in the blood serum was less than mmol / l). Most of these cases were observed in elderly patients and in patients who received diuretics due to a decrease in the volume of circulating blood.

Glycemic control: diabetic patients experienced hypoglycemia during treatment with fluoxetine, and hyperglycemia developed after discontinuation of the drug. At the beginning or after the end of treatment with fluoxetine, it may be necessary to adjust the doses of insulin and/or hypoglycemic drugs for oral use.

Hepatic / renal insufficiency: fluoxetine undergoes intensive metabolism in the liver and is excreted by the kidneys. Patients with severe hepatic impairment are recommended to take lower doses of fluoxetine, or take the drug every other day. When taking fluoxetine at a dose of 20 mg / day for two months in patients with severe renal impairment (creatinine clearance

Side effects

The body as a whole: autonomous symptoms (dry mouth, sweating, vasodilation, chills), hypersensitivity (pruritus, skin rashes, urticaria, anaphylactic reaction, vasculitis, serum-like reaction, angioedema), serotonin syndrome (characterized by a complex of clinical manifestations of changes in mental state and neuromuscular activity in combination with disorders of the autonomous nervous system), photosensitivity, erythema multiforme exudative).

Cardiovascular system: palpitations, arrhythmias.

Digestive system: gastrointestinal disorders (diarrhea, nausea, vomiting, dysphagia, dyspepsia, perversion of taste), very rarely idiosyncratic hepatitis.

Endocrine system: abnormal secretion of antidiuretic hormone.

Hematopoietic and lymphatic system: ecchymosis.

Metabolic and nutritional disorders: weight loss.

Musculoskeletal system: arthritis, bone pain, bursitis, leg cramps, osteoarthritis, myasthenia gravis, myopathy, osteomyelitis, osteoporosis, rheumatoid arthritis.

Nervous system: abnormal movement / tremor (twitching, ataxia, bucco-glosal syndrome, myoclonus, tremor), anorexia, anxiety and its manifestations (palpitation, restlessness, nervousness, agitation), dizziness, fatigue (drowsiness, asthenia), impaired concentration and thinking (including depersonalization), manic disorders, sleep disorders (unusual dreams, insomnia), seizures.

Respiratory system: yawning.

Skin: Alopecia.

Sensory organs: visual disturbances (blurred vision, mydriasis).

Genitourinary system: urinary disorders (including changes in the frequency of urination), priapism/prolonged erection, sexual dysfunction (decreased libido, delayed or absent ejaculation, anorgasmia, impotence).

Interaction

Fluoxetine and its main metabolite norfluoxetine have long half-lives, which should 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 combined with fluoxetine. In some cases, there were manifestations of intoxication. Increasing the dose of phenytoin or fluoxetine with their simultaneous use should be carried out with caution and under the control of clinical dynamics of the condition.

Serotonergic drugs. Concomitant use of serotonergic drugs (for example, tramadol and triptans) increases the likelihood of developing serotonin syndrome. Simultaneous use of triptans also increases the likelihood of developing narrowing of coronary vessels and arterial hypertension.

Benzodiazepines. With the simultaneous use of fluoxetine and benzodiazepines, it is possible to increase the half-life of the latter. 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 serotonin syndrome when taking selective serotonin reuptake inhibitors(SSRIs)at the same time and lithium, or tryptophan, and therefore the simultaneous use of fluoxetine with these drugs should be carried out with caution. When taking fluoxetine and lithium at the same time, more frequent and careful monitoring of the clinical condition is necessary.

Drugs that are 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. Concomitant use of drugs whose main biotransformation pathway is metabolism with the participation of the CYP2D6 isoenzyme, and having a small therapeutic dose interval (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 the withdrawal of fluoxetine.

Indirect anticoagulants and other drugs that affect the blood coagulation system (Nonsteroidal anti-inflammatory drugs, acetylsalicylic acid). Changes in the anticoagulant effect (according to laboratory parameters and/or clinical manifestations) are known without any general characteristic trend, but with a probability of increased bleeding with simultaneous use of fluoxetine and oral anticoagulants. 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 are rare reports of increased duration of seizures in patients taking fluoxetine and receiving ECT, so caution is recommended.

Alcohol. In experimental studies, fluoxetine did not increase the concentration of alcohol in the blood, nor did it increase the effects of alcohol. However, concomitant use of SSRIs and alcohol is not recommended.

Products based on the Hypericum perforatum plant. As with other SSRIs, there may be a pharmacodynamic interaction between fluoxetine and agents based on the Hypericum perforatum plant, which may lead to an increase in the undesirable effect.

How to take it, course of use and dosage

Depression. The initial recommended dose is 20 mg / day 1 time. If necessary, the dose is increased by 20 mg/day weekly. The maximum daily dose is 80 mg in 2-3 divided doses.

Bulimia.The recommended dose is 60 mg / day in 3 divided doses.

Obsessive-compulsive disorders. The recommended dose is 20-60 mg / day.

All indications. The recommended dose may be reduced or increased. Doses greater than 80 mg / day have not been systematically studied.

Age. There is no data on the need to change doses depending on age.

Food intake. Fluoxetine can be taken at any time, regardless of food intake.

Concomitant diseases and / or concomitant treatment. In patients with impaired liver function, concomitant diseases, or taking other medications, the dose should be reduced and the frequency of use should be reduced.

Overdose

The main manifestations of overdose included increased side effects, seizures, drowsiness, nausea, tachycardia, and vomiting.

Other serious symptoms reported with fluoxetine overdose (either isolated or in combination with other medications) included coma, delirium, QT prolongation, and ventricular tachyarrhythmia, including ventricular flutter and cardiac arrest, decreased blood pressure, syncope, mania, pyrexia, stupor, and a condition similar to neuroleptic malignant syndrome.

Special instructions

When treating patients with a body mass deficit, the anorexic effects of fluoxetine should be taken into account (progressive weight loss is possible).

In patients with diabetes mellitus, the use of fluoxetine increases the risk of hypoglycemia; if it is discontinued, hyperglycemia occurs. In this regard, the dose of insulin and/or any other hypoglycemic drugs administered orally should be adjusted. Patients should be supervised by a doctor.

The interval between the end of therapy with MAO monoamine oxidase 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 highest risk of suicide is in patients who have previously taken other antidepressants, and patients who experience excessive fatigue, hypersomnia, or motor restlessness during treatment with fluoxetine.

Prolonged epileptic seizures may occur during electroconvulsive therapy while taking fluoxetine.

During treatment, you should refrain from taking alcohol and engaging in potentially dangerous 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 psychiatric disorders, antidepressants increase the risk of suicidal thoughts and behavior compared to placebo. Therefore, when prescribing Fluoxetine or any other antidepressants in children, adolescents and young adults (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 did not increase in people over 24 years of age, and people over 65 years of age slightly decreased. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment with antidepressants, all patients should be monitored for early detection of behavioral disorders or changes, as well as suicidal tendencies.

Skin rash, anaphylactic reactions, and progressive systemic disorders, sometimes serious involving the skin, kidneys, liver, and lungs, have been reported in patients treated with fluoxetine. If skin rash or other possible allergic reactions occur, the etiology of which cannot be determined, fluoxetine should be discontinued.

Form of production

Capsules No. 3 are blue in color. The contents of the capsules are a mixture of granules and powder of white or white with a yellowish tinge of color. Individual lumps are allowed.

Storage conditions

Store in a dry place protected from light at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Fluoxetine

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For adults as directed by your doctor

Indications

Obsessive-compulsive Disorder, Depression, Mental disorders