Fluoxetine capsules 10mg, 20pcs

Composition

Each capsule contains: The Active ingredient of fluoxetine hydrochloride is 11.2 mg in terms of fluoxetine 10 mg. Excipients: microcrystalline cellulose-153.0 mg, pregelatinized starch-14.3 mg, magnesium stearate-1.5 mg. Composition of the 10 mg capsule: titanium dioxide, indigo carmine, iron oxide yellow dye, gelatin.

Pharmacological action

Pharmacotherapeutic group

antidepressant

ATX Code: N06AB03

Pharmacodynamics :

Selectively blocks reverse neuronal uptake of serotonin (5 HT) in synapses of central nervous system neurons. Inhibition of serotonin reuptake leads to an increase in the concentration of this neurotransmitter in the synaptic cleft and enhances and prolongs its effect on postsynaptic receptor sites. In therapeutic doses, fluoxetine blocks the uptake of serotonin by human platelets. It is a weak antagonist of muscarinic histamine H1 adrenergic a1 and a2 receptors and has little effect on the reuptake of dopamine. Causes a reduction in obsessive-compulsive disorders as well as a decrease in appetite, which can lead to weight loss. Does not cause sedation. When taken in medium therapeutic doses, it practically does not affect the functions of the cardiovascular and other systems. Pharmacokinetics: When taken orally, the drug is well absorbed from the gastrointestinal tract (up to 95% of the dose taken). Use with food slightly inhibits the absorption of fluoxetine. Maximum plasma concentrations are reached in 6-8 hours. The bioavailability of fluoxetine after oral use is more than 60%. The drug accumulates well in the tissues easily penetrates the blood-brain barrier binding to plasma proteins is more than 90%. It is metabolized in the liver by demethylation to the active metabolite of norfluoxetine and a number of unidentified metabolites. Excreted by the kidneys the clearance of fluoxetine is 94-704 ml/min norfluoxetine 60-336 ml/min. About 12% of the drug is excreted through the gastrointestinal tract. The half-life of fluoxetine is about 2-3 days, norfluoxetine-7-9 days. In patients with hepatic insufficiency, the half-life of fluoxetine and norfluoxetine is prolonged. The drug is excreted in breast milk (up to 25% of the serum concentration).

Indications

-Depressions of various etiologies. – Obsessive-compulsive disorders. – Bulimic neurosis. – Premenstrual dysphoric disorder.

Contraindications

Hypersensitivity concomitant use of MAO inhibitors (and for 14 days after their withdrawal) thioridazine (and within 5 weeks after discontinuation of fluoxetine) pimozide severe renal impairment (creatinine clearance less than 10 ml / min) and liver pregnancy lactation age up to 18 years.

With caution:

Diabetes mellitus epilepsy convulsive disorders (including in the anamnesis) suicidal mood.

Side effects

From the central nervous system: increased suicidal tendencies anxiety headache tremor agitation increased irritability sleep disorders dizziness drowsiness asthenic disorders decreased libido manic and convulsive disorders. From the gastrointestinal tract: decreased appetite impaired taste nausea vomiting dry mouth or hypersalivation diarrhea. From the genitourinary system: incontinence or urinary retention dysmenorrhea vaginitis decreased libido sexual dysfunction in men (delayed ejaculation). Rarely there are allergic reactions in the form of skin rash itching chills urticaria fever muscle and joint pain (possible use of antihistamines and steroid medications) hyponatremia orthostatic hypotension tachycardia visual acuity disorders. Other: increased sweating tachycardia systemic disorders of the lungs kidneys or liver vasculitis. Possible development of anorexia and weight loss. These side effects are more likely to occur at the beginning of fluoxetine therapy or when increasing the dose of the drug.

Interaction

Increases the effects of alprazolam diazepam ethyl alcohol and hypoglycemic drugs. Increases the plasma concentration of phenytoin tricyclic antidepressants maprotilin trazodone 2 times (it is necessary to reduce the dose of tricyclic antidepressants by 50% when used simultaneously). It is possible to increase the concentration of lithium – the risk of developing toxic effects of lithium. These drugs should be used simultaneously with caution, frequent determination of the concentration of lithium in the blood serum is recommended. Against the background of electroconvulsive therapy, prolonged epileptic seizures may develop. Tryptophan enhances the serotonergic properties of fluoxetine (increased agitation of motor anxiety disorders of the gastrointestinal tract). MAO inhibitors increase the risk of developing serotonin syndrome (hyperthermia chills increased sweating myoclonus hyperreflexia tremor diarrhea coordination disorders autonomic lability psychomotor agitation delusional disorders depression of consciousness up to coma). Drugs that have a depressing effect on the central nervous system increase the risk of side effects and increase the depressive effect on the central nervous system. When used concomitantly with drugs with a high degree of protein binding, especially with anticoagulants and digitoxin, it is possible to increase the plasma concentration of free (unbound) drugs and increase the risk of adverse effects. Fluoxetine enhances the effect of hypoglycemic drugs and anticoagulants.

How to take, course of use and dosage

The drug is taken orally. Depression. The initial dose is 20 mg once a day in the morning, regardless of food intake. If necessary and tolerable, the dose can be increased to 40-60 mg per day (20 mg per week) divided into 2-3 doses. The maximum daily dose is 80 mg. The therapeutic effect of the drug is established 1-4 weeks after the start of treatment in some patients, it can be achieved later. Obsessive-compulsive disorders-the recommended dose is 20-60 mg per day. For bulimia nervosa, the recommended dose is 60 mg per day divided into 2-3 doses. Premenstrual dysphoric disorders: The recommended dose is 20 mg per day In elderly patients, the recommended initial daily dose is 20 mg. In patients with impaired liver and kidney function, it is recommended to use lower doses and lengthen the interval between doses.

Overdose

Symptoms: agitation manic and convulsive disorders cardiac arrhythmias tachycardia nausea vomiting. Treatment: no specific fluoxetine antagonists were found. Symptomatic therapy is performed gastric lavage with the appointment of activated charcoal for convulsions-diazepam maintenance of respiration heart activity body temperature.

Special instructions

When treating patients with a body mass deficit, anorexic effects should be taken into account (progressive weight loss is possible). In patients with diabetes mellitus, the use of fluoxetine increases the risk of hypoglycemia and hyperglycemia-if it is discontinued. In this regard, the dose of insulin and / or any other hypoglycemic drugs used orally should be adjusted. Patients should be monitored by a doctor until there is a significant improvement in treatment. During treatment, you should refrain from taking alcohol and engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions. After the use of MAO inhibitors, the appointment of fluoxetine is allowed no earlier than 14 days. Do not use MAO inhibitors and/or thioridazine earlier than 5 weeks after discontinuation of fluoxetine. If you develop seizures while taking fluoxetine, the drug should be discontinued. In patients with liver diseases and in the elderly, treatment should begin with minimal doses.

Storage conditions

List B. Store in a dry place protected from light at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Fluoxetine

Conditions of release from pharmacies

By prescription

Dosage form

Capsules