Fluoxetine tablets 10mg №20

Description for Fluoxetine tablets 10mg №20

Pharmacological action

Antidepressant derived propylamine. The mechanism of action is associated with selective blockade of the inverse of neuronal serotonin reuptake in the CNS. Fluoxetine is a weak antagonist holino-, adrenergic and histamine receptors. Unlike most antidepressants, fluoxetine, apparently, does not cause reduction of functional activity of postsynaptic beta-adrenergic receptors. Improves mood, reduces anxiety and stress, eliminates dysphoria. Does not cause sedation. When you receive a medium therapeutic doses does not affect the function of cardiovascular and other systems.

Pharmacokinetics

Absorbed from the gastrointestinal tract. Poorly metabolized in the "first pass" through the liver. Food intake did not affect the extent of absorption, although it may slow its speed. The maximum plasma concentration is achieved in 6-8 h. The equilibrium concentration in plasma is achieved only after continuous reception in a few weeks. Protein binding 94.5%. Easily penetrates through the BBB. Metabolized in the liver by demethylation to form the main active metabolite norfluoksetina.
The half-life of fluoxetine is 2-3 days, norfluoksetina - 7-9 days. Excreted by the kidneys and 80% through the intestine - about 15%.

Statement

Depressions of various origins, obsessive-compulsive disorders, bulimic neurosis.

Dosing regimen

Initial dose - 20 mg 1 time per day during the first half of the day, if necessary, the dose may be increased in 3-4 weeks. Frequency of admission - 2-3 times / day.
Maximum dose: at intake for adults - 80 mg / day.

Side effect

CNS: possible state of anxiety, tremors, nervousness, drowsiness, headache, sleep disturbances.
From the digestive system: possible diarrhea, nausea.
From a metabolism: possible increased sweating, hypoglycemia, hyponatremia (especially in elderly patients and hypovolemia).
From the reproductive system: decreased libido.
Allergic reactions: possible skin rash, itching.
Other: pain in joints and muscles, shortness of breath, increased body temperature.

Contraindications

Glaucoma, bladder atony, severe renal dysfunction, benign prostatic hyperplasia, co-administration of MAO inhibitors, convulsions of various origins, epilepsy, pregnancy, lactation, hypersensitivity to fluoxetine.

Pregnancy and lactation

Contraindicated during pregnancy and lactation.

Cautions

With caution used in patients with impaired liver and kidney, with a history of epileptic seizures, cardio-vascular diseases.
Patients with diabetes may change in blood glucose levels that require correction dosing regimen hypoglycemic drugs. When applied in debilitated patients with fluoxetine increases the risk of epileptic seizures.
With the simultaneous application of fluoxetine and electroconvulsive therapy may develop prolonged seizures.
Fluoxetine can be applied not earlier than 14 days after discontinuation of MAO inhibitors. Period after the abolition of fluoxetine before therapy MAO inhibitors should not be less than 5 weeks.
Elderly patients need correction dosing regimen.
Safety of fluoxetine in children has not been established.
During the period of treatment to avoid alcohol.
Effects on ability to drive vehicles and management mechanisms
During the period of treatment should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions.
Fluoxetine in the form of tablets and capsules is included in the list ZHNVLS.

Drug Interactions

With the simultaneous application of fluoxetine with drugs that provide a depressing effect on the CNS, as well as possibly a significant increase in ethanol inhibitory actions on the CNS, as well as increasing the likelihood of developing seizures.
In an application with drugs with a high degree of protein binding, especially with antikoakulyantami or digitoxin, may increase the plasma concentrations of free (unbound) drugs and increased risk of adverse effects, with medication lithium - may increase the concentration of lithium, and development of toxic effects; with phenytoin - increasing its concentration in blood plasma and the development of toxic effects, with tryptophan - may increase agitation, restlessness, disorders of the gastrointestinal tract.
In an application with MAO inhibitors (including seligilinom or moclobemide), due to the increase of serotonin and suppress its reuptake, there was a significant increase in the amount of serotonin in the synapse - "serotonin syndrome" in which there are hyperthermia, muscle rigidity, myoclonus, as well as the manifestations of mental instability and physiological state of the body, until death.

Conditions and terms of

The drug should be stored in a dry, dark place.

Shelf life - 2 years.