Fluoxetine (Fluoxetine )

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceFluoxetineFluoxetine
Similar drugsTo uncover
  • Apo-Fluoxetine
    capsules inwards 
    Apothec Inc.     Canada
  • Prozac®
    capsules inwards 
    Eli Lilly East SA     Switzerland
  • Fluval
    capsules inwards 
    KRKA, dd, Novo mesto, AO    
  • Flunisan
    pills inwards 
    Hemofarm AD     Serbia
  • Fluoxetine
    capsules inwards 
    MEDISORB, CJSC     Russia
  • Fluoxetine
    capsules inwards 
    ZIO-HEALTH, JSC     Russia
  • Fluoxetine
    capsules
    BIOKOM, CJSC     Russia
  • Fluoxetine
    capsules inwards 
    ALSI Pharma, ZAO     Russia
  • Fluoxetine
    capsules
    OZONE, LLC     Russia
  • Fluoxetine
    capsules inwards 
    PRODUCTION OF MEDICINES, LTD.     Russia
  • Fluoxetine Lannacher
    capsules inwards 
    VALEANT, LLC     Russia
  • Fluoxetine-OBL
    capsules inwards 
    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
  • Fluoxetine-canon
    capsules inwards 
    CANONFARMA PRODUCTION, CJSC     Russia
    • Dosage form: & nbspcapsules
    Composition:
    1 capsule contains:
    active ingredient: fluoxetine hydrochloride-11.18 mg or 22.36 mg, calculated as fluoxetine 10.00 mg or 20.00 mg.
    Auxiliary substances: lactose monohydrate (sugar milk) - 82.42 mg or 71.24 mg, potato starch - 24.00 mg or 24.00 mg, magnesium stearate - 1.20 mg or 1.20 mg, silicon dioxide colloid ( aerosil) - 1.20 mg or 1.20 mg.
    Capsule composition: for dosage of 10 mg - body: gelatin, titanium dioxide E 171; lid: gelatin, titanium dioxide E 171, dye quinoline yellow E 104; for dosage of 20 mg - body: gelatin, titanium dioxide E 171; lid: gelatin, titanium dioxide E 171.

    Description:Hard gelatin capsules No. 3 are opaque white with a yellow lid (for a dosage of 10 mg) or opaque white with a white lid (for a dosage of 20 mg). The contents of the capsules are white or white powder with a yellow tint of color.
    Pharmacotherapeutic group:antidepressant
    ATX: & nbsp

    N.06.A.B.03   Fluoxetine

    Pharmacodynamics:
    Antidepressant group selective serotonin reuptake inhibitors. Has a timoanaleptic and stimulating effect.
    Selectively blocks the reverse neuronal capture of serotonin (5HT) in the synapses of neurons of the central nervous system. Inhibition of reuptake of serotonin leads to an increase in the concentration of this neurotransmitter in the synaptic cleft, enhances and prolongs its effect on postsynaptic receptor sites. In therapeutic doses fluoxetine blocking the seizure of serotonin by human platelets. Is a weak antagonist of muscarinic, histamine HI, adrenergic alpha 1 and alpha 2 receptors, has little effect on re-uptake of dopamine. It causes a reduction in obsessive-compulsive disorders, as well as a decrease in appetite, which can lead to a decrease in body weight.Does not cause sedation! When taken in moderate therapeutic doses, it practically does not affect the function of the cardiovascular and other systems.

    Pharmacokinetics:
    When taking the drug, the drug is well absorbed from the gastrointestinal tract (up to 95% of the dose taken), application with food slightly inhibits the absorption of fluoxetine. The maximum concentration in the blood plasma is reached in 6-8 hours. Bioavailability of fluoxetine after ingestion is more than 60%. The drug is well accumulated in tissues, easily penetrates the blood-brain barrier, binding to plasma proteins is more than 90%. Metabolised in the liver by demethylation to the active metabolite of norfluoxetine and a number of unidentified metabolites. It is excreted by the kidneys, the amount of clearance of fluoxetine is 94-704 ml / min, norfluoxetine 60-336 ml / min. Kidney deficiency has no significant effect on the rate of fluoxetine removal. About 12% of the drug is released through the gastrointestinal tract. The half-life of fluoxetine is about 2-3 days, norfluoxetine is 7-9 days. In patients with liver failure, the half-life of fluoxetine and norfluoxetine is prolonged.The drug is excreted in breast milk (up to 25% of the concentration in the blood serum).

    Indications:
    Depression of various genesis.
    Obsessive-compulsive disorder. .
    Bulimic neurosis.

    Contraindications:
    Children and adolescents under 18 years.
    Hypersensitivity to the drug.
    Simultaneous reception with monoamine oxidase inhibitors (MAO).
    Severe renal function impairment (creatinine clearance less than 10 ml / min) and liver.
    Breastfeeding period.
    Pregnancy.

    Carefully:
    Diabetes mellitus, convulsive syndrome of various genesis and epilepsy (including in the anamnesis), Parkinson's disease, compensated renal and / or liver failure, excessive weight loss, suicidal mood.

    Dosing and Administration:
    The drug is taken orally.
    The initial dose is 20 mg once a day in the morning, regardless of food intake. If necessary, the dose can be increased to 40-60 mg / day, divided into 2-3 receptions. The maximum daily dose is 80 mg.
    The clinical effect develops 1-4 weeks after the start of treatment, in some patients it can be achieved later.
    Obsessive-compulsive disorder: the recommended dose is 20-60 mg per day.
    With bulimic neurosis, the drug is used in a daily dose of 60 mg divided into 2-3 doses.
    In elderly patients, the recommended daily dose is 20 mg. In patients with impaired liver and kidney function, as well as with low body weight, the use of lower doses and lengthening of the interval between doses is recommended.
    Duration of admission is determined by the attending physician and can last for several years.

    Side effects:
    On the part of the central nervous system: hypomania or mania, increased suicidal tendencies, anxiety, irritability, agitation, dizziness, headache, tremor, sleepiness or insomnia, asthenic disorders.
    On the part of the gastrointestinal tract: decreased appetite, impaired taste, nausea, vomiting, dry mouth or hypersalivation, diarrhea.
    From the genitourinary system: urinary incontinence or retention; dysmenorrhea, vaginitis, decreased libido, sexual dysfunction in men (delayed ejaculation).
    When developing, against the background of taking fluoxetine, seizures, the drug should be discarded.
    Rarely occur: allergic reactions in the form of skin rashes, hives, itching, chills,increased body temperature, pain in the muscles and joints (possible use of antihistamines and steroid drugs); increased sweating, hyponatremia, tachycardia, visual acuity, vasculitis.
    Perhaps the development of anorexia and weight loss.
    These side effects often occur at the beginning of fluoxetine therapy or with an increase in the dose of the drug.

    Overdose:
    Symptoms: psychomotor agitation, convulsive seizures, heart rhythm disturbances, tachycardia, nausea, vomiting.
    Treatment: specific antagonists to fluoxetine have not been found. Symptomatic therapy, gastric lavage with the appointment of activated charcoal, with convulsions - diazepam, maintaining breathing, cardiac activity, body temperature.

    Interaction:
    It is impossible to apply the drug simultaneously with MAO inhibitors, including antidepressants - MAO inhibitors; furozolidone, procarbazine, selegiline, as well as tryptophan (a precursor of serotonin), since it is possible to develop a serotonergic syndrome manifested in confusion, hypomaniacal state, psychomotor agitation, convulsions, dysarthria, hypertensive crises, chills, tremor, nausea, vomiting, diarrhea.The interval between the end of therapy with MAO inhibitors and the initiation of treatment with fluoxetine should be at least 14 days; between the end of fluoxetine treatment and the initiation of therapy with MAO inhibitors - at least 5 weeks.
    Simultaneous reception of fluoxetine with alcohol or with drugs of central action, which cause depression of the central nervous system, enhances their effect.
    Fluoxetine blocks the metabolism of tricyclic and tetracyclic antidepressants, trazodone, carbamazepine, diazepam, metoprolol, terfenadine, phenytoin (diphenine), which leads to an increase in serum concentrations, increasing their effect and increasing the incidence of complications.
    The combined use of fluoxetine and lithium salts requires careful monitoring of the concentration of lithium in the blood, since it is possible to increase it.
    Fluoxetine enhances the action of hypoglycemic drugs. When used simultaneously with drugs that have a high degree of binding to proteins, especially with anticoagulants and digitoxin, it is possible to increase plasma concentrations of free (unbound) drugs and increase the risk of developing adverse effects.

    Special instructions:
    There are reports of skin rash, anaphylactic reactions and progressive systemic disorders involving the skin, lungs, liver, kidneys in the pathological process in patients taking fluoxetine. When there is a skin rash or other possible allergic reactions, the etiology of which can not be determined, fluoxetine should be withdrawn.
    In studies in vitro and in animals, evidence of carcinogenicity has not been obtained. - - Safety and efficacy of fluoxetine in children have not been established.
    When using fluoxetine in elderly patients, the dose of the drug should be reduced by a factor of 2. Also, the dose should be reduced 2-fold with impaired liver and kidney function.
    Patients with diabetes mellitus may develop hypoglycemia during fluoxetine and hyperglycaemia therapy after withdrawal. At the beginning and after the end of treatment with fluoxetine, a correction of insulin doses and / or hypoglycemic drugs for oral administration may be required. .
    Against the background of electroconvulsive therapy, it is possible to develop long-term epileptic seizures.
    In the treatment of patients with body weight deficiency, anorexigenic effects should be considered (a progressive loss of body weight is possible).
    After the drug is withdrawn, its therapeutic concentration in the blood serum may persist for several weeks.
    During the treatment with fluoxetine, alcoholic beverages are not allowed.
    It requires careful monitoring of patients with suicidal tendencies, especially at the beginning of treatment. To a greater extent, the risk of suicide affects people under 24 years of age.

    Effect on the ability to drive transp. cf. and fur:
    During the treatment with Fluoxetine, one should refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:
    Capsules 10 mg and 20 mg.

    Packaging:
    10 capsules per contour cell package.
    By 2, 3 or 5 contour mesh packages together with instructions for use in a pack of cardboard.

    Storage conditions:
    In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:
    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000530
    Date of registration:27.04.2010
    The owner of the registration certificate:BIOKOM, CJSC BIOKOM, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOKOM, CJSCBIOKOM, CJSC
    Information update date: & nbsp20.10.2015
    Illustrated instructions
      Instructions
      Up