Composition, form of production and packaging
Hard gelatin capsules, size 3, opaque, green / cream, with the logo "LILLY" and the identification code "3105" printed on them, and the contents of the capsules are white powder.
fluoxetine (in the form of hydrochloride) 20 mg
Excipients: starch, dimethicone.
The composition of the capsule shell: blue dye patented dye (patent V blue patent), iron oxide yellow oxide, titanium dioxide, gelatin, food grade inks (for identification printing).
14 pcs. - blisters (1) - packs of cardboard.
14 pcs. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The description of the drug was approved by the manufacturer for the 2006 print edition.
Antidepressant. It is a selective inhibitor of serotonin reuptake, which determines the mechanism of its action. Fluoxetine has practically no affinity for other receptors, for example, to? 1 -,? 2 - and? -adrenoceptors, serotonin receptors, dopamine receptors, histamine H 1 -receptors, m-cholinergic receptors and GABA-receptors.
After oral administration, it is well absorbed from the digestive tract. C max is achieved in 6-8 hours.
Bioavailability when ingested - more than 60%. Medicinal forms of fluoxetine for oral administration are bioequivalent.
Binding to blood plasma proteins - more than 90%. It is distributed throughout the body. C ss in plasma is achieved after taking the drug for several weeks. C ss after a long reception of the drug is similar to the concentrations observed at the 4-5 week of taking the drug.
Intensively metabolized in the liver to norfluoxetine and a number of other unidentified metabolites.
It is excreted in the urine in the form of metabolites. T 1/2 fluoxetine is 4-6 days, and its main active metabolite is 4-16 days.
- Depression of various etiologies;
- Bulimia nervosa;
- obsessive-compulsive disorder;
premenstrual dysphoric disorder.
With depression, the initial recommended dose is 20 mg / day.
With bulimia nervosa, 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 in 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 impaired hepatic function, concomitant diseases or taking other drugs , the dose should be reduced and the frequency of administration reduced.
From the digestive system: diarrhea, nausea, vomiting, dysphagia, dyspepsia, taste perversion; in isolated cases - idiosyncratic hepatitis.
From the side of the central nervous system and the peripheral nervous system: convulsions, ataxia, bucco-glossal syndrome, myoclonus, tremor, anorexia (up to loss of body weight), anxiety accompanied by palpitation, anxiety, nervousness, agitation, dizziness, fatigue (drowsiness, asthenia), violation of the process of concentration and thinking, manic reaction, sleep disturbances (unusual dreams, insomnia); visual impairment (mydriasis, blurred vision); disorders of the autonomic nervous system (dry mouth, increased sweating, vasodilation, chills), serotonin syndrome (a complex of clinical manifestations of changes in mental status and neuromuscular activity in combination with autonomic disorders of the nervous system).
On the part of the genitourinary system: urination disorders (including frequent urination), priapism / prolonged erections, sexual disorders (decreased libido, delay or lack of ejaculation, lack of orgasm, impotence).
On the part of the endocrine system: violation of ADH secretion.
Allergic reactions: itching, skin rash, urticaria, anaphylactic reactions, vasculitis, reactions similar to manifestations of serum sickness.
Dermatological reactions: photosensitivity, alopecia.
Other: yawning, ecchymosis.
- established hypersensitivity to fluoxetine.
PREGNANCY AND LACTATION
In experimental animal studies, no direct or indirect adverse effect of fluoxetine on the development of the embryo or fetus or on the course of pregnancy has been detected. In studies in vitro and in animals, evidence of mutagenicity and impaired fertility has not been obtained. Since animal reproduction studies do not always allow predicting a person's reaction, Prozac should be used during pregnancy only in cases of extreme necessity.
Fluoxetine is excreted in breast milk, so the drug should be administered with caution to nursing mothers.
The effect of fluoxetine on the process of childbirth in humans is unknown.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with impaired liver function , doses should be reduced and the frequency of administration reduced.
APPLICATION FOR CHILDREN
Prozac's safety and effectiveness in children are not established.
There are reports of skin rash, anaphylactic reactions and progressive systemic disorders involving the skin, lungs, liver, and kidneys in the pathological process in patients taking fluoxetine. When skin rashes or other possible allergic reactions occur, the etiology of which can not be determined, Prozac's intake should be discarded.
As with other antidepressants, Prozac should be administered with caution to patients who have a history of epileptic seizures.
When fluoxetine was used, there were cases of development of hyponatremia (in some cases, the sodium level in the blood was less than 110 mmol / l). Basically, similar cases were observed in elderly patients and in patients receiving diuretics, due to a decrease in BCC.
In patients with diabetes mellitus, during treatment with Prozac, hypoglycemia was noted, and after discontinuation of the drug - hyperglycemia. At the beginning and after the end of treatment with fluoxetine, a correction of insulin doses and / or hypoglycemic drugs for oral administration may be required.
Results of experimental studies
In studies in vitro and in animals, evidence of carcinogenicity has not been obtained.
Use in Pediatrics
Prozac's safety and effectiveness in children are not established.
Impact on the ability to drive vehicles and manage mechanisms
Drugs that affect mental activity can affect the ability to make decisions and the driving skills of a car. Patients should be advised to avoid driving the car or managing dangerous mechanisms until it is determined that the drug has no effect on the ability to perform these activities.
Symptoms: nausea, vomiting, seizures, dysfunction of the cardiovascular system (from asymptomatic arrhythmias to cardiac arrest), impaired function of the respiratory system and signs of changes in the CNS state from excitation to coma.
Cases of overdose of only one fluoxetine usually proceed mildly, the lethal outcome was extremely rare.
Treatment: control of general condition and cardiac activity along with general symptomatic and maintenance therapy. The specific antidote is unknown. The effectiveness of forced diuresis, dialysis, hemoperfusion, cross-transfusion is unlikely.
In the treatment of overdose, the possibility of using several drugs should be considered.
Prozac should not be administered simultaneously with MAO inhibitors and for at least 14 days after discontinuation of treatment with MAO inhibitors. After the abolition of fluoxetine and the onset of treatment with MAO inhibitors, there should be an interval of at least 5 weeks. If long-term fluoxetine treatment was used and / or the drug was used in high doses, then this interval should be increased. Among patients who had previously taken fluoxetine, and started taking MAO inhibitors through a shorter interval, there were serious cases of the development of serotonin syndrome (manifestations of which may be similar to ZNS), up to a lethal outcome.
Fluoxetine has the ability to inhibit the isoenzyme CYP2D6. Therefore, treatment with drugs that are metabolized by this system and which have a narrow therapeutic index should start with the lowest doses if the patient simultaneously receives fluoxetine or has taken it within the previous 5 weeks. If fluoxetine is included in the treatment regimen of a patient already taking such a drug, a dose reduction of the first drug should be provided.
With simultaneous use with Prozac, the changes in blood concentrations of phenytoin, carbamazepine, haloperidol, clozapine, diazepam, alprazolam, lithium, imipramine and desipramine are noted, and in some cases toxic effects have been observed. When taking fluoxetine in combination with these drugs should provide for a conservative dose selection and monitor the patient.
Fluoxetine binds strongly to plasma proteins. Therefore, with the appointment of fluoxetine against the background of the use of another drug that binds firmly to plasma proteins, changes in the plasma concentrations of both drugs are possible.
With the simultaneous use of fluoxetine with warfarin, there was an increase in bleeding time. Changes in anticoagulant activity (laboratory indicators and / or clinical signs and symptoms) were unstable. As in the case of treatment with warfarin in combination with many other drugs at the beginning of the application or in the event of discontinuation of fluoxetine treatment with warfarin therapy, careful monitoring of blood coagulation should be carried out.
If it is necessary to prescribe other drugs after Prozac's withdrawal, a long half-life of fluoxetine and its active metabolite of norfluoxetine should be taken into account and, in this connection, the possibility of drug interaction development.
Rarely have there been cases of prolonged seizures in patients taking fluoxetine during electroconvulsive therapy.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at room temperature (15 В° to 30 В° C), out of the reach of children.