Flunisan - instructions for use, dose, side effects, contraindications

1 tablet contains the active substance: fluoxetine (in the form of fluoxetine hydrochloride 22.40 mg) 20 mg; auxiliary substances: silicate microcrystalline cellulose, pregelatinized starch, magnesium stearate, dye Indigocarmine (indigotine) E 132.

Description:

Round biconvex tablets are bluish-white in color with a risk on one side.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.03 Fluoxetine

Pharmacodynamics:Selectively blocks the reverse neuronal capture of serotonin in the 5HT receptors 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 postsynaptic receptor sites. In therapeutic doses fluoxetine blocking the seizure of serotonin by human platelets. It is a weak antagonist of muscarinic, H1-histamine, adrenergic alpha1 and alpha2 receptors, May influences the reuptake 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 system.

Pharmacokinetics:

Absorption: if taken internally fluoxetine well absorbed from the gastrointestinal tract (GIT), the intake of food does not affect its bioavailability. The time to reach the maximum concentration in the blood plasma after ingestion is 6-8 hours.

Distribution: fluoxetine (about 95%) and is well distributed in the body (the volume of distribution reaches 20-40 l / kg), the maximum concentration (Cmax) value is 15-55 ng / ml , the drug easily penetrates the BBB.

Equilibrium concentrations in the plasma are achieved after several weeks of application of the drug, while it is characteristic that the concentrations achieved with prolonged use do not differ from those that were achieved after 4-5 weeks of fluoxetine.

Metabolism: fluoxetine has a nonlinear pharmacokinetic profile with the effect of "first passage" through the liver. In the liver, it is metabolized by the polymorphic enzyme CYP2D6 to the active metabolite of norfluoxetine and a number of other unidentified metabolites.

Excretion: the half-life (T1 / 2) of fluoxetine is from 4 to 6 days, and its active metabolite is from 4 to 16 days. In patients with cirrhosis of the liver, T1 / 2 is 3-4 times longer. Metabolites are excreted by the kidneys (80%) and with fecal masses (15%), mainly in the form of glucuronides. The drug is excreted in breast milk (up to 25% of the concentration in the blood serum).

In the body, the therapeutic concentration of fluoxetine is maintained 5 to 6 weeks after discontinuation of therapy.

Indications:

Depression of various etiologies;

Bulimia nervosa;

Obsessive-compulsive disorder.

Contraindications:

Hypersensitivity to fluoxetine or other components of the drug;

Simultaneous administration of MAO inhibitors (and within 14 days after their cancellation);

Simultaneous administration of thioridazine and a period of up to 5 weeks after its withdrawal;

Simultaneous administration of pimozide;

Age to 18 years;

Pregnancy and lactation.

Carefully:suicidal mood, diabetes mellitus, epileptic syndrome of various genesis and epilepsy (including in the anamnesis), renal and / or hepatic insufficiency.

Pregnancy and lactation:

Application in pregnancy and lactation - is contraindicated.

Dosing and Administration:

The drug Flunisan is taken orally, at any time, regardless of the meal.

Depression of different etiology

The initial dose is 20 mg / day (1 tablet) in the morning; if necessary weekly dose is increased by 20 mg / day for 1-4 weeks, up to 40-60 mg per day, divided into 2-3 doses.

The maximum daily dose is 80 mg.

Nervous bulimia

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

Obsessive-compulsive disorder

The initial dose is 20 mg per day, with insufficient effectiveness, the dose is increased to 60 mg per day in 3 divided doses.

Elderly patients are recommended an initial daily dose of 20 mg, the maximum daily dose of the drug is 60 mg in 3 divided doses. The course of treatment is 3-4 weeks.

In patients with impaired liver and kidney function, lower doses and lengthening of the interval between doses are recommended.

Side effects:

From the central nervous system: increased suicidal tendencies, anxiety, headache, tremor, agitation, increased irritability, violation

sleep, dizziness, drowsiness, asthenic disorders, mania or hypomania, seizures.

On the part of the digestive system: disorders of the gastrointestinal tract of the digestive tract (nausea, diarrhea, vomiting, taste change), decreased appetite, dry mouth or hypersalivation.

Allergic reactions: skin rash, hives, myalgia, arthralgia, fever.

From the genitourinary system: urinary incontinence or retention, dysmenorrhea, vaginitis, decreased libido, impaired sexual function in men (slowing of ejaculation).

Other; increased sweating, tachycardia, visual acuity, weight loss, systemic disorders of the lungs, kidneys or liver, vasculitis.

Overdose:

Symptoms, nausea, vomiting, arousal, convulsions, tachycardia.

Treatment: gastric lavage, the appointment of activated charcoal, with cramps, the use of anxiolytic drugs (tranquilizer - diazepam), symptomatic therapy.

Interaction:

Strengthens the effects of alprazolam, diazepam, ethanol and hypoglycemic drugs (LS).

Increases in the plasma concentration of phenytoin, tricyclic antidepressants, maprotylipa, trazodone in 2 times (it is necessary to reduce the dose of tricyclic antidepressants by 50% with simultaneous application).

Against the background of electroconvulsive therapy, it is possible to develop long-term epileptic seizures.

Perhaps an increase in the concentration of lithium - the risk of toxic effects of lithium. These drugs should be used simultaneously with caution, it is recommended that the serum concentration of lithium be measured frequently.

Tryptophan enhances the serotoninergic properties of fluoxetine (agitation, motor anxiety, gastrointestinal disorders).

MAO inhibitors increase the risk of developing serotonin syndrome (hyperthermia, chills, increased sweating, myoclonus, hyperreflexia, tremor, diarrhea, movement coordination disorders, autonomic lability, agitation, delirium and coma). Drugs that exert a depressing effect on the central nervous system (CNS), increase the risk of side effects and increased oppressive effects on the central nervous system. When used simultaneously with drugs that have a high degree of binding to proteins, especially with anticoagulants and digitoxin, an increase in the concentration of free (unbound) drugs in the plasma and an increased risk of developing adverse effects are possible.

Special instructions:

In the treatment of patients with body weight deficiency, anorexigenic effects should be considered (a progressive loss of body weight is possible).

In patients with diabetes, the administration of fluoxetine increases the risk of developing hypoglycemia and hyperglycemia - when it is withdrawn. In this regard, the dose of insulin and / or any other hypoglycemic drugs used inward, should be adjusted.Before the onset of significant improvement in treatment, patients should be under the supervision of a physician.

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 treatment with fluoxetine and the onset of therapy with MAO inhibitors - at least 5 weeks.

With liver diseases and in old age, treatment should be started with 1/2 dose.

During treatment, one should refrain from taking ethanol and practicing potentially dangerous activities that require increased attention and speed of mental and motor reactions.

Effect on the ability to drive transp. cf. and fur:

Form release / dosage:

Tablets of 20 mg.

Packaging:For 10 tablets in a blister of PVC / Al. For 3 blisters, together with instructions for use, put in a pack of cardboard.

Storage conditions:

List B.

Store at a temperature of 15 to 25 ° C, in a dry place protected from light.

Keep out of the reach of children's day.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LSR-000283/10

Date of registration:25.01.2010

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Information update date: & nbsp20.10.2015

Illustrated instructions

Instructions

Flunisan (Flunisan)