Fluoxetine Lannacher - instructions for use, dose, side effects, contraindications

Composition:One capsule contains: active substance - fluoxetine hydrochloride 22.36 mg (corresponding to fluoxetine 20.00 mg); auxiliary substances: corn starch pregelatinized starch -185.64 mg, dimethicone 2.0 mg; shell capsule: body: gelatin - 30.0 mg, titanium dioxide - 0.509 mg, iron oxide oxide yellow - 0.013 mg; lid: dye patented blue V - 0.003 mg, titanium dioxide 0.291 mg, iron dye oxide yellow 0.054 mg, gelatin 20.0 mg

Description:

Hard gelatin capsules No. 3, body: beige, opaque, lid: light green, opaque.

Contents of capsules, white powder.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.03 Fluoxetine

Pharmacodynamics:

Selectively blocks the reverse neuronal capture of serotonin (5-hydroxytryptamine) 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. Has a low affinity for a1 a2 and betta adrenergic, serotonin, dopaminergic, H1-histamine, muscarinic and GABAergic receptors. Promotes mood improvement, reduces tension, anxiety and fear, eliminates dysphoria, causes a decrease in appetite. It causes a reduction in obsessive-compulsive disorders. Does not cause orthostatic hypotension, sedation, not cardiotoxic.

A persistent clinical effect occurs after 1-2 weeks of treatment.

Pharmacokinetics:

When ingested, the drug is well absorbed from the gastrointestinal tract. Eating does not affect the bioavailability of the drug. The maximum concentration in the blood plasma is achieved in 6-8 hours. The drug binds well to plasma proteins - about 95% (including albumin and alpha 1-acid glycoprotein), a well accumulates in the tissues. The volume of distribution of the drug - a high, readily penetrates the blood-brain barrier, excreted in breast milk (up to 25% of plasma concentration). Metabolized in the liver by the CYP2D6 isoenzyme by demygylation to the active metabolite of norfluoxetine. Metabolites are excreted by the kidneys (80%) and the intestine (15%) mainly in the form of glucuronides. Period

fluoxetine half-life after reaching equilibrium concentration in plasma is 4-6 days, single dose - 1-4 days, half-life of norfluoxetine - 4-16 days, which causes significant cumulation active forms and prolonged presence in the body (5-6 weeks) after withdrawal of the drug.

In patients with cirrhosis of the liver, the half-life period is 3-4 times longer.

Indications:

Depression of various genesis; obsessive-compulsive disorder; bulimic neurosis; premenstrual dysphoria.

Contraindications:

hypersensitivity to the drug;
simultaneous administration of MAO inhibitors (monoamine oxidase) and within 14 days after their withdrawal, thioridazine, pimozide;
lactation period; pregnancy;
severe violations of kidney function (creatinine clearance less than 10 ml / min) and liver; atony of the bladder;
children under 18 years of age (effectiveness and safety not established);

Carefully:

diabetes, epilepsy (including in the anamnesis), excessive weight loss, Parkinson's disease, suicidal mood.

Pregnancy and lactation:

The use of the drug during pregnancy and during breast-feeding is contraindicated.

Dosing and Administration:

Inside.

With depression, the initial dose is 20 mg I 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 doses. The maximum daily dose is 80 mg. Obsessive-compulsive disorder: the recommended dose is 20-60 mg per day.

With bulimic neurosis and for elderly patients, the drug is used in a daily dose of 60 mg divided into 2-3 doses.

In premenstrual dysphoric disorders, the recommended dose is 20 mg / day.

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

In patients with impaired renal function should reduce the dose and increase the interval between taking the drug.

Course of treatment 3-4 weeks.

Side effects:

From the side of the central nervous system: dizziness, headache, sleep disturbances, fatigue, asthenia, tremor, agitation, motor agitation, increased suicidal tendencies, anxiety, mania or hypomania

On the part of the gastrointestinal tract, decreased appetite, impaired taste, nausea, vomiting, dry mouth or hypersalivation, diarrhea

Allergic reactions in the form of skin rashes, itching, urticaria, myalgia, arthralgia, fever.

On the part of 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, motor anxiety, convulsive disorders, dysfunction of the cardiovascular system.

Treatment: specific antagonists to fluoxegine have not been found. Symptomatic therapy, gastric lavage, the appointment of activated carbon, with convulsions, the appointment of tranquilizers, the maintenance of breathing, cardiac activity.

Interaction:

It is impossible to apply the drug simultaneously with MAO inhibitors (monoamine oxidase), since it is possible to develop serotonin syndrome (hyperthermia, chills, increased sweating, myoclonus, hyperreflexia, tremor, diarrhea, movement coordination disorder, vegetative lability, agitation, delirium and coma).

Tryptophan enhances the serotonergic properties of the drug (agitation, motor anxiety, gastrointestinal disorders).

When used with preparations containing St. John's Wort (Hypericum perforatum), there may be an increase in the serotonergic effect, an increase in undesirable effects.

Increases in the plasma concentration of phenytoin, tricyclic antidepressants, maprotiline, trazodone by half (it is necessary to reduce the dose of these drugs by 50% with simultaneous use with fluoxetine).

Strengthens the effects of alprazolam, diazepam, ethanol, hypoglycemic drugs.

Simultaneous reception of fluoxetine with alcohol or with drugs of central action, which cause depression of the central nervous system, increases their effect and increases the risk of side effects.

Medicines containing lithium (Li +) should be used with caution because of the possible increase in the concentration of lithium (Li +) and the risk of toxic effects.

Against the background of electroconvulsive therapy, it is possible to develop prolonged convulsive seizures.

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:

In patients with concomitant diabetes, hypoglycemia may develop during fluoxetine therapy and hyperglycemia after its withdrawal. Therefore, the dose of insulin and / or any other hypoglycemic agents should be adjusted.Before the significant improvement in the treatment of diabetes, patients should be under the supervision of a doctor.

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

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 disease and in old age, treatment should be started with a Vi dose.

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, in the appointment of fluoxetine or any antidepressant in children, adolescents and young people (under 24 years old), the risk of suicide and the benefits of their use should be correlated. In short-term studies in people over 24 years of age, the risk of suicide did not increase, but in people older than 65 years, it declined slightly. Any depressive disorder in itself increases the risk of suicide.Therefore, during treatment with antidepressants, all patients should be monitored for early detection of abnormalities or behavioral changes, as well as suicidal tendencies.

During treatment with fluoxetine, you should refrain from drinking alcohol and practicing potentially dangerous activities that require increased attention and speed of mental and motor reactions.

Form release / dosage:Capsules 20 mg.

Packaging:

10 capsules per blister of PVC / A1.

2 blisters together with instructions for use in a cardboard box.

Storage conditions:Keep in 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:П N015843 / 01

Date of registration:29.05.2009

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

G.L.PHARMA, GmbH Austria

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp20.10.2015

Illustrated instructions

Instructions

Fluoxetine Lannacher (Fluoxetine Lannacher)