Instruction for use: Fluoxetine Nycomed

Dosage form: capsules

Active substance: Fluoxetine*

ATX

N06AB03 Fluoxetin

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F50.2 Nervous Bulimia: Bulimic Neurosis; Bulimia; Wolf hunger; Kinorexia

Composition

1 capsule contains fluoxetine (as hydrochloride) 20 mg; in a blister 10 pcs., in a cardboard box 1, 2, 3, 6 and 10 blisters.

Pharmachologic effect

Pharmacological action - antidepressant, timoleptic.

Selectively inhibits reverse neuronal capture of serotonin in the brain, increases its content in the synaptic cleft, and enhances the excitation of serotonergic postsynaptic receptors.

Pharmacokinetics

Well absorbed. Eating does not affect systemic bioavailability. Cmax in blood plasma is reached after 4-8 hours. The degree of binding to proteins is about 95%. It is converted in the liver into an active metabolite, norfluoxetine, which is then transformed into inactive metabolites (excreted by the kidneys). T1 / 2 fluoxetine - 4-6 days, norfluoxetine - 4-16 days. With liver cirrhosis or with cytochrome deficiency, P450 T1 / 2 may increase, leading to cumulation (with prolonged admission). The distribution kinetics is nonlinear for fluoxetine; linear - for norfluoxetine.

Clinical Pharmacology

Promotes better mood, reduces feelings of fear, eliminates dysphoria. Does not cause sedation. Anticholinergic properties are poorly expressed in contrast to anorexigenic. The pronounced therapeutic effect develops after 1-4 weeks.

Indications Fluoxetine Nycomed

Depression of various genesis (including accompanied by fear), bulimic neurosis.

Contraindications

Hypersensitivity, atony of the bladder, severe disorders of the excretory function of the kidneys, glaucoma, prostate adenoma, decompensated epilepsy.

Application in pregnancy and lactation

Contraindicated (no data on use during pregnancy and breastfeeding).

Side effects

Nausea (at the beginning of treatment), headache, sleep disturbance, sweating, dry mouth.

Interaction

With simultaneous use with inhibitors, MAO can cause an increase in blood pressure and a state of excitation, with lithium preparations - anxiety and ataxia (manifestations of serotonergic syndrome), with other antidepressants, haloperidol and carbamazepine - increasing their concentration in the blood plasma. Enhances the effect of hypoglycemic drugs.

Dosing and Administration

Inside, the capsules are swallowed whole, washed down with a glass of water (regardless of food intake). With depression - 20 mg once a day (in the morning), if necessary, increase the dose to a maximum - 80 mg / day; with severe violations of the liver - 20 mg every other day; the duration of therapy is determined individually, on average - a course of 1-2 weeks, if necessary - 90 days. With neurotic bulimia - 60 mg daily.

Overdose

Symptoms - nausea, vomiting, anxiety, hypomania. Treatment is symptomatic.

Precautionary measures

It is not recommended to apply simultaneously with MAO inhibitors or less than 2 weeks after stopping their intake; MAO inhibitors should be prescribed no earlier than 5 weeks after discontinuation of fluoxetine treatment. When diabetes is required to change the scheme of therapy, hypoglycemic agents.

Storage conditions for Fluoxetine Nycomed

At room temperature.

Keep out of the reach of children.

Shelf life of Fluoxetine Nycomed

3 years.

Do not use after the expiry date printed on the package.