Fluoxetine LANNAHER

Active material: Fluoxetine
When ATH: N06AB03
CCF: Antidepressant
When CSF: 02.02.04
Manufacturer: LANNACHER HEILMITTEL Ges.m.b.H. (Austria)

Pharmaceutical form, composition and packaging

Excipients: Dimethicone, corn starch.

Composition of the capsule wall: gelatin, indogotin, quinoline yellow (E 104), sodium lauryl, Titanium dioxide

10 PC. – blisters (2) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

Antidepressant, propylamine derivative. The mechanism of action is associated with the selective blockade of the reverse neuronal uptake of serotonin in the central nervous system. Fluoxetine is a weak antagonist of choline, adreno- and histamine receptors. Unlike most antidepressants, fluoxetine, apparently, does not cause a decrease in the functional activity of postsynaptic β-adrenergic receptors. Promotes Mood Improvement, reduces feelings of fear and tension, eliminates dysphoria. Does not cause sedation. When taken in medium therapeutic doses, it practically does not affect the functions of the cardiovascular and other systems.

Pharmacokinetics

Absorbed from the gastrointestinal tract. Poorly metabolized when “first pass” through the liver. Eating does not affect the degree of suction, although it may slow down its speed. C_max plasma achieved through 6-8 no. C_ss in plasma is achieved only after continuous administration for several weeks. Protein binding 94.5%. Easily penetrates the BBB. Metabolized in the liver by demethylation to form the main active metabolite, norfluoxetine.

T_1/2 fluoxetine is 2-3 day, norfluoxetine – 7-9 days. Report the news 80% and through the intestine – about 15%.

Testimony

Depression of various origins, obsessive compulsive disorder, bulimic neurosis.

Dosage regimen

The initial dose – 20 mg 1 times / day in the morning; if necessary, the dose can be increased through 3-4 Sun. Reception frequency – 2-3 times / day.

The maximum dose: ingestion for adults – 80 mg / day.

Side effect

CNS: possible alarms, tremor, nervousness, drowsiness, headache, sleep disorders.

From the digestive system: possible diarrhea, nausea.

Metabolism: There may be increased sweating, gipoglikemiâ, giponatriemiya (especially in elderly patients and with hypovolemia).

Reproductive system: decreased libido.

Allergic reactions: possible skin rash, itch.

Other: pain in joints and muscles, labored breathing, fever.

Contraindications

Glaucoma, atonic bladder, severe renal dysfunction, benign prostatic hyperplasia, simultaneous administration of MAO inhibitors, convulsive syndrome of various origins, epilepsy, pregnancy, lactation, hypersensitivity to fluoxetine.

Pregnancy and lactation

Contraindicated during pregnancy and lactation.

Cautions

Use with extreme caution in patients with impaired liver and kidney function., When seizures pripadkah in history, cardiovascular diseases.

In patients with diabetes mellitus, changes in blood glucose levels are possible, which requires correction of the dosage regimen of hypoglycemic drugs. When used in debilitated patients with fluoxetine, the likelihood of developing epileptic seizures increases.

With the simultaneous use of fluoxetine and electroconvulsive therapy, the development of prolonged epileptic seizures is possible.

Fluoxetine can be used no earlier than after 14 days after discontinuation of MAO inhibitors. The period after discontinuation of fluoxetine before starting therapy with MAO inhibitors should be at least 5 Sun.

Elderly patients require dosage adjustment.

The safety of fluoxetine in children has not been established..

During treatment, avoid alcohol.

Effects on ability to drive vehicles and management mechanisms

During the period of treatment should refrain from potentially hazardous activities, requiring attention and quick emotional reactions.

Drug Interactions

In an application with drugs, have a depressing effect on the central nervous system, with ethanol, a significant increase in the inhibitory effect on the central nervous system is possible, as well as an increased likelihood of developing seizures.

Together with the use of MAO inhibitors, furazolidonom, procarbazine, tryptophan, the development of serotonin syndrome is possible (confusion, elated state, restlessness, ažitaciâ, convulsions, dysarthria, hypertensive crisis, chills, tremor, nausea, vomiting, diarrhea).

With the simultaneous use of fluoxetine inhibits the metabolism of tricyclic and tetracyclic antidepressants, trazodona, karʙamazepina, diazepama, metoprolol, Terfenadine, phenytoin, which leads to an increase in their concentration in serum, enhancing their therapeutic and side effects.

With simultaneous use, it is possible to inhibit the biotransformation of drugs, metabolized with the participation of the CYP2D6 isoenzyme.

With simultaneous use with hypoglycemic agents, it is possible to enhance their action.

There are reports of increased effects of warfarin when used simultaneously with fluoxetine.

When used simultaneously with haloperidol, fluphenazine, Maprotiline, metoklopramidom, perphenazine, periciazine, pimozidom, risperidone, sulpiride, trifluoperazine described cases of extrapyramidal symptoms and dystonia; with dextromethorphan – described a case of the development of hallucinations; with digoxin – a case of an increase in the concentration of digoxin in blood plasma.

With simultaneous use with lithium salts, an increase or decrease in the concentration of lithium in the blood plasma is possible.

With simultaneous use, it is possible to increase the concentration of imipramine or desipramine in blood plasma in 2-10 time (can persist for 3 weeks after discontinuation of fluoxetine).

With simultaneous use with propofol, a case is described, in which spontaneous movements were observed; with phenylpropanolamine – described case, in which dizziness was observed, weight loss, hyperactivity.

With simultaneous use, it is possible to enhance the effects of flecainide, mexiletine, propafenone, tioridazina, zuclopenthixol.