Depres

General characteristics. Structure:

Active ingredient: 22,36 mg of fluoxetine of a hydrochloride that is equivalent to fluoxetine of 20 mg.

Excipients: starch corn, magnesium stearate.

Structure of a cover: quinolinic yellow (E104), titanium dioxide (E171), yellow "sunset" (E110), gelatin.

Pharmacological properties:

Pharmacodynamics. Depres - antidepressant, derivative propylamine, chemically differs from tricyclic and tetracyclic antidepressants. Action of a depres is connected with its inhibition of the return neyronalny serotonin reuptake in the central nervous system. Fluoxetine blocks serotonin reuptake, but does not influence noradrenaline. Promotes improvement of mood, reduces sensation of fear and tension, eliminates a dysphoria. Does not cause sedation. At reception in average therapeutic doses also other systems practically do not influence functions cardiovascular.

Pharmacokinetics. After reception of a single dose of 40 mg, peak plasma concentration of fluoxetine it is reached within 6 - 8 hours and makes 15 - 55 nanograms/ml. Meal does not influence bioavailability of fluoxetine though its absorption can be delayed. Linkng with plasma proteins makes 94,5%.

Fluoxetine is quickly metabolized in a liver on норфлуоксетин and other inactive metabolites. After metabolism in a liver fluoxetine is removed by kidneys. The elimination half-life of fluoxetine makes 2 - 3 days, and an active metabolite - a norfluoksetin of 7 - 9 days. The elimination half-life of fluoxetine and a norfluoksetin lasts at patients with a liver failure. Long therapy with fluoxetine at patients with a heavy renal failure can bring to drug cumulation.

Indications to use:

- depression;

- concern;

- obsessivno - compulsive neurosis;

- psychogenic bulimia.

Route of administration and doses:

Adults. The recommended daily dose for treatment of a depression and obsessivno-compulsive neurosis - 20 mg, in the morning. If necessary the dose can be increased to 80 mg/day. Doses over 20 mg/day is accepted twice a day, in the morning and in the evening.

The recommended dose for treatment of psychogenic bulimia makes - 60 mg/day. The maximum daily dose should not exceed 80 mg.

Because of a long elimination half-life of drug (2 - 3 days) and its active metabolite (7 - 9 days) concentration of drug in a blood plasma remains within several weeks.

Elderly patients. The recommended daily dose should not exceed 60 mg.

Patients with a renal and/or liver failure. At a renal failure of average and moderate weight (level of glomerular filtering <15 - 50 ml/min.) and a liver failure it is necessary to reduce a dose or to appoint drug every other day, especially at the elderly patients with associated diseases receiving at the same time several drugs.

Features of use:

Depres it is possible to apply not earlier than in 14 days after cancellation of monoamine oxidase inhibitors. The period after cancellation of fluoxetine prior to therapy by monoamine oxidase inhibitors has to make not less than 5 weeks. At use of monoamine oxidase inhibitors later a short period after cancellation of fluoxetine the lethal outcome is possible.

In the presence in the anamnesis a heart disease, respect for care at fluoxetine use is necessary. Electrocardiograms of the patients receiving fluoxetine were retrospectively checked and no disturbances of conductivity which could lead to a heart block were revealed.

Depres can cause weight reduction.

At patients with a diabetes mellitus change of level of glucose in blood is possible that demands correction of the mode of dosing of hypoglycemic drugs. In the course of treatment the hypoglycemia, and after its termination - a hyperglycemia can develop.

Features of influence of medicine on ability to manage the vehicle or potentially dangerous mechanisms. Depres can break thought processes therefore patients are recommended to refrain from the driving of the car and other types of activity demanding the increased concentration of attention.

Side effects:

- adynamy, fever;

- nausea, diarrhea, vomiting, dryness in a mouth, appetite loss, dyspepsia;

- headache, dizziness, nervousness, sleeplessness, drowsiness, concern, weakness, tremor, spasms;

- asthma;

- perspiration, rash, skin itch, small tortoiseshell;

- sexual dysfunction, decrease in a libido.

Interaction with other medicines:

At simultaneous use Depres with:

- with the drugs exerting the oppressing impact on the central nervous system and also with ethanol, perhaps considerable strengthening of the oppressing action on the central nervous system, and also increase in probability of development of spasms;

- with the drugs possessing high extent of linkng with proteins, especially with anticoagulants or with digitoxin increase in concentration in a blood plasma of free (untied) drugs and increase in risk of development of adverse effects is possible;

- with drugs of lithium increase in concentration of lithium and development of toxic effects is possible;

- with Phenytoinum, increase in its concentration in a blood plasma and development of toxic effects;

- with tryptophane, strengthening of motive concern, disturbances from digestive tract is possible;

- with other antidepressants, there is an increase in their levels in plasma;

 - with benzodiazepines, at some patients the diazepam elimination half-life can increase;

- to monoamine oxidase inhibitors (including selegiliny or moklobemidy), owing to increase in content of serotonin and suppression of its return capture, there is a substantial increase of amount of serotonin in a synapse - "a serotoninovy syndrome" at which the hyperthermia, muscular rigidity, a myoclonus, and also manifestations of instability of a mental and physiological condition of an organism are observed, up to a lethal outcome.

Contraindications:

- hypersensitivity to fluoxetine;

- heavy renal failure (level of glomerular filtering   less than 10 ml/min.);

- concomitant use of inhibitors of a monoaminooxidase (MAO);

- epilepsy, convulsive symptom;

- pregnancy and period of a lactation;

- children's age and teenagers up to 18 years.

Overdose:

Symptoms: nausea, vomiting, excitement of the central nervous system.

Treatment: there is no specific antidote. Symptomatic therapy. Use of absorbent carbon with sorbitol or a gastric lavage. The artificial diuresis, dialysis are inefficient.

Storage conditions:

To store at a temperature not above 25 °C in the dry, protected from light place. To store in the place, unavailable to children!  Period of storage 2 years. Not to apply after a period of storage.

Issue conditions:

According to the recipe

Packaging:

On 8 capsules in a blister strip packaging from a film of polyvinyl chloride and printing aluminum foil.

On 2 planimetric packagings together with the instruction on a medical use in the state and Russian languages place in a pack cardboard with the hologram of firm - producer.