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

the capsule contains the active substance fluoxetine hydrochloride 11.2 mg in terms of fluoxetine 10 mg. Excipients: microcrystalline cellulose - 153.0 mg, pregelatinized starch 14.3 mg, magnesium stearate 1.5 mg.

Composition of the capsule 10 mg: titanium dioxide, indigocarmine, iron oxide, yellow oxide, gelatin.

Capsules 20 mg. Each capsule contains the active substance fluoxetine hydrochloride 22.4 mg in terms of fluoxetine 20 mg.Auxiliary substances of cellulose microcrystalline - 141.8 mg, pregelatinized starch - 14.3 mg, magnesium stearate - 1.5 mg.

Composition of the capsule 20 mg: titanium dioxide, indigocarmine, iron oxide yellow oxide, quinoline yellow dye, azorubin dye, blue patented dye, diamond black dye, gelatin.

Description:

hard gelatin capsules number 2.

Capsules 10 mg - capsule body olive green, cap capsule - olive green.

Capsules 20 mg - capsule body olive green, cap capsule - green. The contents of the capsules are white or almost white in color.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.03 Fluoxetine

Pharmacodynamics:

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.It is a weak antagonist of muscarinic, histamine H1, adrenergic a1 and a2 receptors, has little effect on the reuptake of dopamine. It causes a reduction in obsessive-comedic 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 ingested, the drug is well absorbed from the gastrointestinal tract (up to 95% of the dose taken), use with food slightly inhibits the absorption of fluoxetine. The maximum concentration in the blood plasma is reached after 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 norfluxetine 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.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 hepatic insufficiency, 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 etiologies.

-Obsessivno-compulsive disorders.

-Bulichic neurosis.

- Premenstrual dysphoric disorder.

Contraindications:

Hypersensitivity, simultaneous administration of MAO inhibitors (and within 14 days after their withdrawal), thioridazine (and within 5 weeks after the abolition of fluoxetine), pimozide, severe renal dysfunction (creatinine clearance less than 10 ml / min) and liver, pregnancy, period lactation, age to 18 years.

Carefully:

Diabetes mellitus, epilepsy, convulsive disorders (including in the anamnesis), suicidal mood.

Dosing and Administration:

The drug is taken orally.

Depression. The initial dose is 20 mg once a day in the morning, regardless of food intake. If necessary, and tolerability, the dose may be increased to 40-60 mg per day (20 mg per week), divided into 2-3 doses. The maximum daily dose is 80 mg.The therapeutic effect of the drug is established 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 bulimia nervosa, the recommended dose is 60 mg per day, divided into 2-3 doses.

Premenstrual dysphoric disorder: the recommended dose is 20 mg per day. In elderly patients, the recommended initial daily dose is 20 mg.

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, sleep disturbance, dizziness, drowsiness, asthenic disorders, decreased libido, manic and convulsive 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).

Rarely allergic reactions occur in the form of skin rash, itching, chills, hives, fever, pain in the muscles and joints (possible application

antihistamine and steroid drugs), hyponatremia, orthostatic hypotension, tachycardia, visual acuity.

Other: increased sweating, tachycardia, systemic disorders of the lungs, kidneys or liver, 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: agitation, manic and convulsive disorders, heart rhythm disturbances, tachycardia, nausea, vomiting.

Treatment: specific antagonists to fluoxetine have not been found. Symptomatic therapy is carried out, gastric lavage with the appointment of activated charcoal, with navigators - diazepam, maintaining breathing, cardiac activity, body temperature.

Interaction:

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

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

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 frequent determination of the concentration of lithium in the serum.

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

Tryptophan enhances the serotonergic properties of fluoxetine (increased agitation, motor anxiety, disorders of the gastrointestinal tract).

MAO inhibitors increase the risk of developing serotonin syndrome (hyperthermia, chills, increased sweating, myoclonus, hyperreflexia, tremor, diarrhea, movement coordination disorders, autonomic lability, psychomotor agitation, delusional disorders, depression of consciousness down to coma).

Drugs that exert a depressing effect on the central nervous system, increase the risk of side effects and increase the inhibitory effect on the central nervous system.

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. Fluoxetine enhances the effect of hypoglycemic drugs and anticoagulants.

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.

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

After using MAO inhibitors, administration of fluoxetine is allowed no earlier than 14 days. Do not use MAO inhibitors and / or thioridazine earlier than 5 weeks after the abolition of fluoxetine.

When developing, against the background of taking fluoxetine, seizures, the drug should be discarded. With liver diseases and in old age, treatment should begin with minimal doses.

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

Packaging:

For 7, 10, 14 capsules in a contour cell package of. polyvinyl chloride film and aluminum foil printed lacquered.

By 7, 10, 14, 20, 28, 30, 40, 50 or 100 capsules into the polymer container for medicines.

One container or 1, 2, 3, 4, 5, 6, 8 or 10 out-of-round cell packs, together with the instructions, are placed in a pack of cardboard.

Storage conditions:

List B. Store in a dry, protected from light 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:LSR-001746/09

Date of registration:10.03.2009

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

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp20.10.2015

Illustrated instructions

Instructions

Fluoxetine (Fluoxetine)