Instructions for use Prozac
Prozac is a selective serotonin reuptake inhibitor; antidepressant.
Release form and composition
Dosage form – capsules: size No. 3, gelatin, hard, green / cream, opaque, with the identification code “3105” and the logo “LILLY”; contents – white powder (in blisters of 14 pcs., in a pack of cardboard 2 blisters).
Active substance: fluoxetine (in the form of hydrochloride) – 20 mg in 1 capsule.
Auxiliary components: dimethicone and starch.
The composition of the capsule shell: gelatin, titanium dioxide, yellow iron dye, patent blue dye (patent dye blue V), food ink (used for identification printing).
Indications for use
- Obsessive-compulsive disorder;
- Depression of various etiologies;
- Premenstrual dysphoric disorder;
- Bulimia nervosa.
Prozac is contraindicated in case of hypersensitivity to any component included in its composition.
There is no data on the safety and effectiveness of the drug in pediatrics.
No-mood-problems.com should be used with caution in patients with a history of epileptic seizures.
In experimental animal studies, the negative effect of fluoxetine on the development of the embryo / fetus was not detected, in vitro studies evidence of impaired fertility and mutagenicity was not obtained. However, animal reproduction studies do not always allow predicting a human reaction, therefore, during pregnancy, Prozac can be prescribed only in case of emergency.
Since fluoxetine is excreted in milk, the drug should be used with caution during lactation.
Dosage and administration
Prozac should be taken orally, regardless of meals.
Recommended daily doses for adult patients:
- Obsessive-compulsive disorders – 20-60 mg;
- Depression – 20 mg;
- Premenstrual dysphoric disorder – 20 mg;
- Bulimia Nervous – 60 mg.
Depending on the clinical situation, the dose can be reduced or increased. The maximum daily dose is 80 mg; the use of higher doses has not been studied.
Patients who take other drugs at the same time, have concomitant diseases or impaired liver function, it is necessary to reduce the dose of fluoxetine or increase the interval between doses.
- From the side of the central and peripheral nervous system: buccal gloss syndrome, anorexia, myoclonus, ataxia, tremor, fatigue (asthenia, drowsiness), impaired thinking and concentration, dizziness, blurred vision (blurred vision, mydriasis), sleep disturbances (insomnia , unusual dreams), manic reaction, convulsions, anxiety (accompanied by anxiety, agitation, palpitations, nervousness), disorders of the autonomic nervous system (increased sweating, chills, dry mouth, vasodilation), serotonin syndrome;
- From the digestive system: taste perversion, dysphagia, nausea, vomiting, diarrhea, dyspepsia; in isolated cases – idiosyncratic hepatitis;
- From the endocrine system: impaired secretion of antidiuretic hormone;
- From the genitourinary system: urination disorders (including frequent urination), sexual disorders (absence or delayed ejaculation, decreased libido, lack of orgasm, impotence), priapism / prolonged erection;
- Allergic and dermatological reactions: skin rash, itching, urticaria, vasculitis, anaphylactic reactions, alopecia, photosensitivity, reactions similar to manifestations of serum sickness;
- Other: ecchymoses, yawning.
There are reports of occurrence in patients taking fluoxetine, skin rash, anaphylactic reactions and progressive systemic disorders involving the kidneys, liver, lungs and skin in the pathological process. Therefore, in the event of a rash or other allergic reactions, the cause of which cannot be established, Prozac should be discontinued.
During treatment with fluoxetine, hyponatremia may develop (there are isolated cases where the sodium level in the blood decreased below 110 mmol / L), more often in older people and patients taking diuretics (due to a decrease in the volume of circulating blood).
In patients with diabetes mellitus during therapy, hypoglycemia may develop, after discontinuation of the drug – hyperglycemia. For this reason, at the beginning of taking the drug and after the end of Prozac treatment, a dose adjustment of the oral hypoglycemic drug or insulin may be required.
In connection with the effect of the drug on mental activity at the beginning of treatment, it is worthwhile to refrain from driving and performing potentially dangerous work until the patient determines the degree of influence of fluoxetine on his ability to engage in these types of activities.
Prozac should not be used simultaneously with monoamine oxidase inhibitors (MAOs) and within 14 days after their withdrawal. If MAO inhibitors are prescribed after Prozac, then the interval between doses should be at least 5 weeks. If fluoxetine has been used for a long time or in high doses, then this interval should be increased. This is due to the fact that serious cases of the development of serotonin syndrome, including death, are known.
When prescribing to a patient who receives fluoxetine or has been taking it for the previous 5 weeks, drugs metabolized with the participation of the CYP2D6 isoenzyme and having a narrow therapeutic index should be prescribed with minimal doses. If Prozac is prescribed to a patient who is taking such a drug, the dose of fluoxetine should be reviewed. This is due to the fact that fluoxetine has the ability to inhibit the CYP2D6 isoenzyme.
Prozac affects the blood concentration of diazepam, clozapine, alprazolam, haloperidol, lithium, carbamazepine, imipramine, desipramine, phenytoin. In some cases, a toxic effect was noted. If you need to use fluoxetine in combination with any of these drugs, you must carefully select the dose and monitor the patient’s condition.
With the simultaneous use of fluoxetine with another agent that firmly binds to plasma proteins, a mutual change in plasma concentrations is possible.
When using Prozac in combination with warfarin, an increase in bleeding time is noted, therefore, during treatment and after discontinuation of fluoxetine, blood coagulation parameters must be carefully monitored.
Separate cases of increasing the duration of seizures during electroshock therapy in patients receiving fluoxetine are known.
When prescribing any drug after the withdrawal of Prozac, it is necessary to take into account the long half-life of fluoxetine and norfluoxetine (its active metabolite) and the associated risk of drug interaction.
Terms and conditions of storage
Store at a temperature of 15-30 ° C in a dark place, out of reach of children.
Shelf life is 3 years.