Prozac

Prozac – drug of antidepressive action, selective serotonin reuptake inhibitor.

Form of release and structure

Dosage form of drug – the capsule: the size No. 3, opaque, firm gelatinous, color green/cream, the name and a dosage - "Prozac 20 mg", and an identification code – "3105", contents of capsules – white color powder is applied on the case (on 14 pieces in blisters, 1 or 2 blisters in a cardboard pack).

Contains in 1 capsule:

• Active ingredient: fluoxetine (in the form of a hydrochloride) – 20 mg;
• Auxiliary components: диметикон, starch;
• Capsule cover: dye blue patent, dye ferrous oxide yellow, food ink for drawing the identification press, gelatin, titanium dioxide.

Indications to use

• Depressive frustration of various etiology;
• Obsessivno-kompulsivnoye frustration;
• Nervous bulimia;
• Premenstrual dysphoric frustration (PMDR).

Contraindications

Absolute:

• Children's and teenage age up to 18 years (there are no data of clinical observations);
• The established hypersensitivity to fluoxetine and other components of drug.

At pregnancy and during breastfeeding (lactation) Prozac is allowed to be applied only in urgent cases and under observation of the doctor.

Route of administration and dosage

The Prozac capsules accept inside, irrespective of meal.

The recommended daily doses of fluoxetine:

• Depressions of various etiology – 20 mg (an initial dose);
• Nervous bulimia – 60 mg;
• Obsessivno-kompulsivnye frustration – from 20 to 60 mg;
• PMDR – 20 mg.

The recommended doses are allowed to be reduced or increased, but surely considering the fact that reception of fluoxetine in a daily dose more than 80 mg was not studied.

Dose adjustment of drug depending on age is not required.

To patients with a liver failure, the accompanying diseases or accepting other medicines reduce doses of Prozac and reduce reception frequency.

Side effects

• Alimentary system: dysphagy, dyspepsia, nausea, vomiting, diarrhea, food faddism; in isolated cases – idiosyncratic hepatitis;
• Central and peripheral nervous system: an ataxy, spasms, a bukkoglossalny syndrome, a tremor, a myoclonus, fatigue (with an adynamy, drowsiness), anorexia (up to loss of weight), alarm (with concern, agitation, heartbeat, nervousness), dizziness, maniacal reaction, disturbance of process of concentration of attention and thinking, an insomniya, unusual dreams, a mydriasis, an illegibility of sight, disturbance from the autonomic nervous system (a hyperhidrosis, dryness in a mouth, a fever, a vazodilatation), a serotoninovy syndrome;
• Urinogenital system: a dysuria (including the speeded-up urination), sexual pathologies (a delay or lack of an ejaculation, decrease a libido, impotence, lack of an orgasm), a priapism / a long erection;
• Endocrine system: disturbances of secretion of antidiuretic hormone (ADG);
• Hypersensitivity reactions: skin rash, itch, small tortoiseshell, anaphylaxis, vasculitis, morbid conditions, similar to symptoms of a serum disease;
• Dermatological answers: alopecia, photosensitivity;
• Others: yawning, ecchymoma.

Symptoms of overdose are: attacks, nausea, vomiting, disturbance of work of cardiovascular system (from symptomless arrhythmia to a cardiac standstill), breath disturbance, change of a condition of the central nervous system (from excitement to a coma). The overdose at monotherapy by fluoxetine usually proceeds softly, cases with a lethal outcome were extremely seldom fixed.

Therapy assumes monitoring of cordial activity and the general condition of the patient against the background of carrying out the supporting and symptomatic treatment which should be seen off with the obligatory accounting of a possibility of use by the patient at the same time of several medicines.

For today fluoxetine has no specific antidote. Efficiency of dialysis, an artificial diuresis, cross transfusion, hemoperfusion, hemoperfusion is also improbable.

Special instructions

It was reported about anaphylactic reactions, skin rash, the progressing system frustration with involvement in pathological process of integuments, a liver, kidneys, lungs at the patients undergoing treatment by fluoxetine. It is necessary to stop therapy at emergence of any possible reactions of hypersensitivity of the obscure etiology.

Prozac, as well as other antidepressants, it is required to appoint with care in the presence in the anamnesis of data on epileptic seizures.

Owing to reception of fluoxetine the hyponatremia with decrease in sodium level blood sometimes lower than 110 mmol/l was observed (generally at patients of advanced age and at the patients with the reduced volume of the circulating blood (VCB) receiving diuretics).

At a diabetes mellitus therapy can be followed by a hypoglycemia, and drug withdrawal – a hyperglycemia therefore before treatment by fluoxetine correction of a dose of insulin and/or hypoglycemic medicines for intake perhaps will be required.

Prozac, as well as all drugs exerting impact on mental activity can affect speed of psychomotor reactions and concentration of attention in this connection it is recommended to avoid driving of motor transport and control of difficult mechanisms, lack of such influence will not be authentically established yet.

Medicinal interaction

• Monoamine oxidase inhibitors (MAO) – the probability of development of a serotoninovy syndrome which signs are similar to symptoms of the malignant antipsychotic syndrome (MAS) is high, including a lethal outcome (simultaneous use is forbidden, it is possible to accept fluoxetine not less than in 2 weeks after therapy by MAO inhibitors, between the termination of reception of Prozac and the beginning of therapy by MAO inhibitors there have to pass not less than 5 weeks (in case of fluoxetine reception long time and/or in high doses this interval is required to be increased));
• The substances/drugs which are metabolized CYP2D6 isoenzyme – fluoxetine has ability to inhibit this enzyme therefore treatment with such drugs having a narrow therapeutic index is begun with the smallest effective doses at a concomitant use with fluoxetine or within 5 weeks after its cancellation; inclusion of fluoxetine in structure of complex therapy of the patient who is already accepting similar drug also begins with the reduced doses;
• Alprazolam, Phenytoinum, a haloperidol, clozapine, carbamazepine, diazepam, lithium, Imipraminum, desipramine – fluoxetine changes their concentration in blood, increasing probability of manifestation of toxic effects (at these combinations it is recommended to practice conservative selection of a dose of medicines and to carry out monitoring of a condition of the patient);
• Warfarin – increases a bleeding time, change of anticoagulating effect (clinical signs and/or laboratory indicators) of non-constant character (at the beginning of therapy and at its termination careful control of indicators of a blood coagulation is necessary) is noted;
• The drugs which are strongly contacting proteins of plasma – their concentration in a blood plasma and/or concentration of fluoxetine can change.

Increase in duration of attacks at the patients accepting fluoxetine along with electroconvulsive therapy was in rare instances observed.

After Prozac cancellation, in case of need uses of other medicines, it is necessary to consider that the fluoxetine elimination half-life, and also its active metabolite of a norfluoksetin is rather long in this connection development of medicinal interaction is possible.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 15-30 °C.

Period of validity – 3 years.