Prozac, 20 mg capsules 14 pcs

An antidepressant. It is a selective serotonin reuptake inhibitor, which determines its mechanism of action. Fluoxetine has practically no affinity for other receptors, such as α1-, α2- and β-adrenoreceptors, serotonin receptors, dopamine receptors, histamine H1-receptors, m-cholinoreceptors and GABA-receptors.

Pharmacokinetics

Intake

After oral administration is well absorbed from the gastrointestinal tract. Cmax is reached after 6-8 hours.

Bioavailability when taken orally is more than 60%. Oral dosage forms of fluoxetine are bioequivalent.

Distribution

The binding to plasma proteins is more than 90%. It is distributed throughout the body. Css in plasma is reached after several weeks of taking the drug. Css after prolonged use of the drug is similar to the concentrations observed at 4-5 weeks of the drug.

Metabolism

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

Elimination

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

Indications

– Depression of various etiologies;

p> – bulimia nervosa;

– obsessive-compulsive disorder;

– premenstrual dysphoric disorder.

Active ingredient

Composition

fluoxetine (in the form of hydrochloride)20 mg

Excipients:

Starch,

Dimethicone.

Capsule shell composition:

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

How to take, the dosage

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

In 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 more than 80 mg/day has not been studied.

The drug can be taken regardless of meals.

There are no data on the need to change the dose according to age.

In patients with hepatic impairment, comorbidities, or who are taking other medications, doses should be reduced and the frequency of administration should be reduced.

Interaction

Prozac should not be administered concomitantly with MAO inhibitors and for at least 14 days after stopping treatment with MAO inhibitors. There should be an interval of at least 5 weeks after withdrawal of fluoxetine and initiation of treatment with MAO inhibitors. If long-term treatment with fluoxetine and/or the drug was used in high doses, this interval should be extended. Serious cases of serotonin syndrome (which may be similar to MNS), up to and including death, have been reported among patients who previously took fluoxetine and started taking MAO inhibitors at shorter intervals.

Fluoxetine has the ability to inhibit the CYP2D6 isoenzyme. Therefore, treatment with drugs that are metabolized by this system and that have a narrow therapeutic index should be started with the lowest dose 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 a similar drug, consideration should be given to reducing the dose of the first drug.

In concomitant use with Prozac, changes in blood concentrations of phenytoin, carbamazepine, haloperidol, clozapine, diazepam, alprazolam, lithium, imipramine and desipramine have been observed, and in some cases toxic effects have been observed. When fluoxetine is taken in combination with these medications, conservative dosing of the drug and monitoring of the patient should be provided.

Fluoxetine binds strongly to plasma proteins. Therefore, when fluoxetine is prescribed with another drug that binds firmly to plasma proteins, there may be changes in plasma concentrations of both drugs.

In concomitant use of fluoxetine with warfarin, an increase in bleeding time has been noted. Changes in anticoagulant action (laboratory values and/or clinical signs and symptoms) were inconstant. As in the case of treatment with warfarin in combination with many other drugs, careful monitoring of clotting parameters should be performed at the beginning of use or in case of discontinuation of treatment with fluoxetine against the background of warfarin therapy.

If other medications must be prescribed after discontinuation of Prozac, the long elimination half-life of fluoxetine and its active metabolite norfluoxetine should be considered, and this may lead to drug interactions.

Rarely, there have been cases of increased seizure duration in patients taking fluoxetine with electroconvulsive therapy.

Special Instructions

There have been reports of skin rash, anaphylactic reactions, and progressive systemic disorders with involvement of the skin, lungs, liver, and kidneys in patients taking fluoxetine. If a skin rash or other possible allergic reactions occur, the etiology of which cannot be determined, Prozac should be stopped.

As with other antidepressants, Prozac should be prescribed with caution in patients who have a history of epileptic seizures.

When using fluoxetine, there have been cases of hyponatremia (in some cases blood sodium levels have been less than 110 mmol/l). Mostly these cases were observed in elderly patients and in patients receiving diuretics due to decreased blood pressure.

Hypoglycemia has been observed in diabetic patients during treatment with Prozac, and hyperglycemia after discontinuation of the drug. Doses of insulin and/or oral hypoglycemic medications may need to be adjusted at the beginning and after treatment with fluoxetine has ended.

The results of experimental studies

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

Pediatric use

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

Impact on driving and operating machinery

Mental medications can affect decision-making ability and driving skills. Patients should be advised to avoid driving or operating dangerous machinery until it is determined that the drug has no effect on the ability to do these activities.

Contraindications

– established hypersensitivity to fluoxetine.

Side effects

Digestive system disorders: diarrhea, nausea, vomiting, dysphagia, dyspepsia, perversion of taste; in single cases – idiosyncratic hepatitis.

CNS and peripheral nervous system disorders: seizures, ataxia, bucco-glossal syndrome, myoclonus, tremor, anorexia (up to weight loss), anxiety accompanied by palpitations, anxiety, nervousness, agitation, dizziness, fatigue (drowsiness, asthenia), impaired concentration and thinking process, manic reaction, sleep disorders (unusual dreams, insomnia); visual disturbances (mydriasis, blurred vision); disorders of the autonomic nervous system (dry mouth, increased sweating, vasodilation, chills), serotonin syndrome (complex of clinical manifestations of changes in mental state and neuromuscular activity in combination with autonomic nervous system disorders).

Urogenital system disorders: urinary disorders (including frequent urination), priapism/ prolonged erection, sexual disorders (decreased libido, delayed or absent ejaculation, absence of orgasm, impotence).

Endocrine system: disorders of ADH secretion.

Allergic reactions: itching, skin rash, urticaria, anaphylactic reactions, vasculitis, reactions similar to the manifestations of serum sickness.

Dermatological reactions: photosensitivity, alopecia.

Others: yawning, ecchymosis.

Overdose

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

In cases of fluoxetine overdose alone, overdoses are usually mild, and deaths have been extremely rare.

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

The treatment of overdose should consider the possibility of multiple medications.

Pregnancy use

There have been no direct or indirect negative effects of fluoxetine on embryonic or fetal development or pregnancy in experimental animal studies.

There is no evidence of mutagenicity or impaired fertility in in vitro or animal studies. Because animal studies of reproduction do not always predict human response, Prozac should only be used in pregnancy when absolutely necessary.

Fluoxetine is excreted with breast milk, so the drug should be administered with caution to nursing mothers.

The effect of fluoxetine on childbirth in humans is unknown.

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