Prozac, capsules 20 mg, 14 pcs

fluoxetine (in the form of hydrochloride) 20 mg

Excipients:

starch,

dimeticon.

Composition of the capsule shell:

patented blue dye (patent blue V dye), yellow iron oxide dye, titanium dioxide, gelatin, food ink (for identification printing).

Antidepressant. It is a selective serotonin reuptake inhibitor, which determines the mechanism of its action. Fluoxetine has almost no affinity for other receptors, such as α1-, α2- and β-adrenergic receptors, serotonin receptors, dopamine receptors, histamine H1 receptors, m-choline receptors and GABA receptors.

Pharmacokinetics

Suction

After ingestion, it is well absorbed from the gastrointestinal tract. Cmax is achieved in 6-8 hours.

Bioavailability when taken orally - more than 60%. Dosage forms of fluoxetine for oral administration are bioequivalent.

Distribution

Binding to blood plasma proteins - more than 90%. Distributed throughout the body. Css in plasma is achieved after taking the drug for several weeks. Css after prolonged use of the drug is similar to the concentrations observed at 4-5 weeks of taking the drug.

Metabolism

Intensively metabolized in the liver to norfluoxetine and a number of other unidentified metabolites.

Withdignment

It is excreted in the urine as metabolites. T1/2 fluoxetine is 4-6 days, and its main active metabolite is 4-16 days.

- depression of various etiology;

- nervous bulimia;

- obsessive-compulsive disorder;

- premenstrual dysphoric disorder.

Experimental animal studies have not revealed a direct or indirect negative effect of fluoxetine on the development of an embryo or fetus or on pregnancy.

In vitro and animal studies, no evidence of mutagenicity and fertility disorders has been obtained. Since animal reproduction studies do not always allow predicting human reactions, Prozac should be used during pregnancy only in cases of emergency.

Fluoxetine is secreted with breast milk, so the drug should be carefully prescribed to nursing mothers.

The effect of fluoxetine on the birth process in humans is unknown.

- established hypersensitivity to fluoxetine.

From the digestive system: diarrhea, nausea, vomiting, dysphagia, dyspepsia, taste perversion; in isolated cases - idiosyncrasic hepatitis.

From the CNS and peripheral nervous system: seizures, ataxia, bucco-glossal syndrome, myoclonus, tremors, anorexia (up to weight loss of body weight), anxiety accompanied by heartbeat, anxiety, nervousness, agitation, dizziness, fatigue (drowsiness, asthenia), concentration and

On the part of the genitourinary system: urination disorders (including rapid urination), priapism/longed erection, sexual disorders (reduction of libido, delay or absence of ejaculation, lack of orgasm, impotence).

From the endocrine system: ADH secretion disorders.

Allergic reactions: itching, skin rash, hives, anaphylactic reactions, vasculitis, reactions similar to serum disease manifestations.

Dermatological reactions: photosensitivity, alopecia.

Others: yawning, ecchymosis.

Prozac should not be prescribed simultaneously with MAO inhibitors and within at least 14 days after termination of treatment with MAO inhibitors. After the abolition of fluoxetine and the beginning of treatment with MAO inhibitors, there should be an interval of at least 5 weeks. If long-term treatment with fluoxetine was carried out and/or the drug was used at high doses, this interval should be increased. Among patients who had previously taken fluoxetine and began to take MAO inhibitors at a shorter interval, there were serious cases of serotonin syndrome (the manifestations of which may be similar to ZNS), up to death.

Fluoxetine has the ability to inhibit the isoenzyme CYP2D6. Therefore, treatment with drugs that are metabolized by this system and that have a narrow therapeutic index should begin at the lowest doses if the patient simultaneously receives fluoxetine or took it within the previous 5 weeks. If fluoxetine is included in the treatment regimen of a patient who is already taking such a drug, a decrease in the dose of the first drug should be provided.

Simultaneous use with Prozac shows a change in blood concentrations of phenytoin, carbamazepine, haloperidol, clozapine, diazepam, alprazolam, lithium, imipramine and desipramine, and in some cases there have been manifestations of toxic effects. When taking fluoxetine in combination with these drugs, conservative dose selection of the drug should be provided and the patient's condition should be monitored.

Fluoxetine binds firmly to plasma proteins. Therefore, when prescribing fluoxetine against the background of another drug that binds firmly to plasma proteins, there may be changes in plasma concentrations of both drugs.

When fluoxetine and warfarin were used simultaneously, there was an increase in bleeding time. Changes in anticoagulant action (laboratory indicators and/or clinical signs and symptoms) were unstable. As with warfarin treatment in combination with many other drugs at the beginning of use or in the event of termination of fluoxetine treatment against the background of warfarin therapy, careful monitoring of blood clotting rates should be carried out.

If it is necessary to prescribe other drugs after Prozac's abolition, the long half-life of fluoxetine and its active metabolite norfluoxetine should be taken into account and, in this regard, the possibility of developing drug interaction.

Rarely have there been cases of increased seizure duration in patients taking fluoxetine during electroshock therapy.

In case of depression, the initial recommended dose is 20 mg/day.

In case of nerve bulimia, the recommended dose is 60 mg/day.

In obsessive-compulsive disorders, the recommended dose is 20-60 mg/day.

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

The recommended doses can be increased or decreased, but the use of the drug at a dose of more than 80 mg/day has not been studied.

The drug can be taken regardless of food intake.

There is no data on the need to change the dose depending on age.

In patients with liver disorders, concomitant diseases or taking other drugs, doses should be reduced and the frequency of administration should be reduced.

Symptoms: nausea, vomiting, seizures, cardiovascular disorders (from asymptomatic arrhythmias to cardiac arrest), respiratory system disorders and signs of CNS changes from arousal to coma.

Cases of overdose of only one fluoxetine usually proceed softly, death was extremely rare.

Treatment: control of general condition and cardiac activity along with general symptomatic and supportive therapy. A specific antidote is unknown. The effectiveness of forced diuresis, dialysis, hemoperfusion, cross-transfusion is unlikely.

When treating an overdose, the possibility of using several drugs should be taken into account.

There are reports of skin rash, anaphylactic reactions and progressive systemic disorders involving skin, lungs, liver and kidneys in patients taking fluoxetine in the pathological process. In case of skin rash or other possible allergic reactions, the etiology of which cannot be determined, Prozac's intake should be canceled.

As with other antidepressants, Prozac should be carefully prescribed to patients who have had epileptic seizures in their history.

When using fluoxetine, there were cases of hyponatremia (in some cases, sodium levels in the blood were less than 110 mmol/l). Basically, similar cases were observed in elderly patients and patients treated with diuretics due to the decrease in BCC.

Diabetes patients had hypoglycemia during Prozac treatment, and hyperglycemia after the withdrawal of the drug. At the beginning and after the end of fluoxetine treatment, correction of doses of insulin and/or hypoglycemic drugs for oral administration may be required.

Results of experimental studies

There is no evidence of carcinogenicity in vitro and animal studies.

Use in pediatrics

The safety and effectiveness of Prozac in children have not been established.

Impact on the ability to drive vehicles and drive mechanisms

Drugs that affect mental activity can affect decision-making skills and driving skills. Patients should be advised to avoid driving a car or driving dangerous mechanisms until it is established that there is no effect of the drug on the ability to carry these activities.

Capsules are solid gelatinous, size 3, opaque, green/cream, with the logo "LILLY" and identification code "3105""; the contents of the capsules are white powder.