Instruction for use: Floxet

Dosage form: capsules

Active substance: Fluoxetine*

ATX

N06AB03 Fluoxetin

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F10.2 Syndrome of alcohol dependence: Dipsomania; Drunken drunkenness; Dependence on alcohol; Psycho-organic syndrome in chronic alcoholism; Alcoholism; Alcohol addiction; Drunken state; Alcohol abuse; Ideator disorder in alcoholism; Obsessive attraction to alcohol; Neurotic symptoms with alcoholism; Pathological attraction to alcohol; Chronic alcoholism; Quarterly drinking; Decreased desire for alcohol

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F42 Obsessive-compulsive disorder: Obsessive-compulsive syndrome; Obsessive compulsive states; Obsessive-compulsive syndrome; The Obsession Syndrome; The obsession neurosis; Obsessive-compulsive neurosis; Obsessions

F50.0 Anorexia nervosa: Anorexia nervosa syndrome; Anorexia nervosa; Anorexia nervously-psychical; Cachexia nervy; Psychogenic anorexia

F50.2 Nervous Bulimia: Bulimic Neurosis; Bulimia; Wolf hunger; Kinorexia

Composition and release form

1 capsule contains fluoxetine hydrochloride 20 mg; in blister 14 pcs., in the box 1 or 2 blisters.

Pharmachologic effect

Pharmacological action - antidepressant.

Selectively and reversibly inhibits reverse neuronal seizure of serotonin, enhances and prolongs its effect on postsynaptic receptors, blocks muscarinic, histamine and alpha-adrenergic receptors of the central nervous system.

Pharmacokinetics

Sufficiently absorbed. After a single dose (before meals), Cmax is reached after 6-8 hours. It is characterized by a high degree of binding to plasma proteins, a large volume of distribution and intensive diffusion into the tissue. T1 / 2 1-4 days. Metabolites (mainly glucuronides) are excreted in urine and feces. T1 / 2 of the main metabolite (norfluoxetine) - 7-9 days.

Indications of the drug Floxet

Depression (all types and any degree of severity), obsessive-compulsive states, bulimia, anorexia, alcoholism.

Contraindications

Hypersensitivity, atony of the bladder, severe disorders of kidney and liver function, glaucoma, prostate adenoma, decompensated epilepsy, convulsive syndrome of various genesis, use of MAO inhibitors (in the previous 2 weeks), children's age.

Application in pregnancy and lactation

Not recommended.

Side effects

From the nervous system and sense organs: anxiety, nervousness, manifestation of suicidal tendencies (against the background of depression), mania or hypomania, headache, irritability, sleep disturbance, increased fatigue, dizziness, tremor, decreased libido.

On the part of the digestive tract: loss of appetite, taste disorders, nausea, vomiting, dry mouth, diarrhea.

On the part of the genitourinary system: urinary incontinence or retention, dysmenorrhea, vaginitis, sexual dysfunction in men (delayed ejaculation).

Allergic reactions: skin rashes, itching.

Other: chills, fever, pain in the muscles and joints, rarely - hyponatremia, orthostatic hypotension, tachycardia, visual acuity.

Interaction

Serotonergic effects enhance tryptophan. Can change the level of lithium in the plasma. Increases the effect of alprazolam, diazepam, alcohol, hypoglycemic drugs and anticoagulants. Incompatible with MAO inhibitors (with simultaneous or earlier than 5 weeks after Floxet's abolition, administration of MAO inhibitors may lead to changes in vital functions, fatal reactions, hyperthermia, myoclonus, vegetative lability, agitation, nonsense, coma). It blocks metabolism, increases the concentration in the blood, increases the activity (and the risk of complications) of tricyclic and tetracyclic antidepressants, trazodone, carbamazepine, diazepam, metoprolol, terfenadine and phenytoin.

Dosing and Administration

Inside, regardless of food intake, at an initial dose of 20 mg / day in the morning, if necessary, the dose can be increased to 40-60 mg / day, divided into 2-3 doses. The maximum daily dose is 80 mg. With bulimia nervosa - 60 mg / day in 2-3 divided doses. In elderly patients, the recommended daily dose is 20 mg; against the background of violations of the liver and kidneys recommended the use of lower doses and lengthening the interval between doses. The clinical effect develops within 1-4 weeks.

Precautionary measures

When developing convulsive seizures, the drug should be discarded. In patients with a small body weight, anorexigenic action (probably progressive weight loss of the body) should be taken into account. Patients with diabetes mellitus may develop hypoglycemia during the appointment of Floxet and hyperglycemia after its withdrawal. With caution should be used in patients with cardiovascular diseases (only under strict medical supervision). Do not use during work drivers of vehicles and people whose profession is associated with increased concentration of attention.

Storage conditions for Floxet

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Floxet

2 years.

Do not use after the expiry date printed on the package.