Laboratorios Silesia


JF Draf
Full Prescribing Info
Fluoxetine hydrochloride.
1 capsule contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine.
Pharmacology: The anti-depressant, antiobsessional, and antibulimic actions of fluoxetine are presumed to be linked to its ability to inhibit the neuronal reuptake of serotonin. It selectively inhibits serotonin reuptake in synaptic nerve terminals.
Pharmacokinetics: Fluoxetine is well absorbed after oral administration (85%). Peak concentrations in the plasma are achieved within approximately 6 hours after the administration. Food does not affect the amount of fluoxetine absorbed, but the peak concentration is obtained slightly later. Norfluoxetine is the main metabolite being the result of demethylisation and is also a selective serotonin reuptake inhibitor. The half-live of fluoxetine and norfluoxetine vary individually from 2-3 days and 7-9 days, respectively. Owing to the long half-life steady state is achieved within 2-3 weeks. The plasma clearance in patients is reported to be 20 L/hour for fluoxetine and 9 L/hour for norfluoxetine. The drug is totally excreted 3-5 weeks after discontinuation of the therapy. The volume distribution for fluoxetine and norfluoxetine is about 20-45 L/kg and binding to plasma proteins is about 94%.
Fluoxetine undergoes extensive metabolism and it metabolites are excreted mainly renally and only to a small amount biliary.
Depression: Indicated for the treatment of depressions due to various origins, e.g. endogenous, neurotic and reactive depressions.
Bulimia Nervosa: To decrease the incidence of bulimic attacks as well as for the treatment of associated symptoms such as weight loss (self-induced vomiting, abuse of laxatives).
Obsessive-Compulsive Disorder: Indicated for the treatment of obsessive-compulsive disorders which are identified by persisting obsession, thoughts, perception, and/or repeated intentional marked compulsive behaviour.
Dosage/Direction for Use
Adults: Depression: The usual dose is 20 mg daily. A dose increase may be considered by the physician after several weeks if no clinical improvement is observed up to a maximum of 80 mg daily. Doses above 20 mg a day should be administered in 2 divided doses (e.g. in the morning and in the evening).
Obsessive-compuslive disorder: Initial dose is 20 mg daily increased to 60 mg daily after several weeks if there is no clinical response.
Bulimia nervosa: The recommended dose is 60 mg daily.
In elderly patients and patients with low body weight fluoxetine dose should not exceed 60 mg. In patients with severe liver disease due to impaired metabolism a lower dosage of fluoxetine should be used.
Children: The safety and effectiveness of fluoxetine in children have not been established.
Symptoms: The most common symptoms are dizziness, nausea, vomiting, tachycardia, disturbance of accomodation, agitation, restlessness, and hypomania. Severe arrhythmias have not been reported.
Treatment: Primary detoxification by gastric lavage and administration of activated charcoal in combination with sorbitol is recommended on the day of intake. Dialysis, haemoperfusion, and diuretics are not beneficial due to the large distribution volume of fluoxetine. In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of an overdosage.
Hypersensitivity against fluoxetine.
MAO inhibitors: Concomitant use of fluoxetine and MAOI should be avoided. Due to experience with the simultaneous administration of MAO-inhibitors and tricyclic antidepressants a period of at least 14 days should be chosen after the discontinuation of the MAOI and the onset of the fluoxetine therapy. Due to the long half-life of fluoxetine and the active metabolite norfluoxetine a period of at least 5 weeks (about 5 half-lives of norfluoxetine) should be chosen after the discontinuation of fluoxetine and the onset of the therapy with MAOI. The administration of MAOI within 5 weeks after the discontinuation of fluoxetine may increase the risk of severe adverse events.
'Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolscents with major depressive disorder (MDD) and other psychiatric disorders' and those considering use of these agents "must balance risk with the clinical need".
Rash and Possibly Allergic Events: Various types of rashes and/or urticaria have been reported. Upon appearance of these symptoms, fluoxetine should be discontinued.
Patients should be cautioned against driving an automobile or performing hazardous tasks when taking fluoxetine.
Special Precautions
Anxiety or marked sleeping difficulties at the start of therapy should be treated with tranquilizers or soporifics.
Because of its epileptogenic effect it should be used with caution in patients with epilepsy or a history of such disorders.
Fluoxetine should be discontinued in patients who develop a rash since systemic effects, possibly related to vasculitis, have occurred in such patients.
Depressed patients with suicidal tendencies should be carefully supervised during treatment. If fluoxetine is given for the depressive component of bipolar disorder, mania may be precipitated.
Treatment with fluoxetine may cause significant weight loss which may be undesirable especially in underweight depressed or bulimic patients.
In patients with severe hepatic or renal disorders metabolism or elimination of fluoxetine is prolonged therefore the dosage or the dosaging interval has to be adjusted.
Dosaging should be done carefully in patients taking drugs acting on the CNS. In patients with diabetes treatment with fluoxetine caused hypoglycaemia and after discontinuation of the antidepressant hyperglycaemia. Therefore dosage adjustment of insulin and/or the oral antidiabetic has to be considered in patients with diabetes.
Use In Pregnancy & Lactation
Although there was no evidence of teratogenicity, the use of fluoxetine during pregnancy, especially during the first three months, should be avoided unless it is considered absolutely necessary and the potential benefit outweighs the potential hazards to the fetus.
The use of fluoxetine during breast feeding is not recommended.
Small amounts of fluoxetine are excreted in breast milk; a concentration of 70.4 ng/ml of fluoxetine and norfluoxetine in breast milk was reported. Maternal plasma concentration was 295.0 ng/ml. Although no adverse events were recorded in the child.
Adverse Reactions
Body as a whole: Chills and fever, fatigue, asthenia, face edema.
Gastrointestinal: Nausea and vomiting, disturbances of appetite, diarrhea.
Nervous System: Headache, nervousness, agitation, visual disturbances, insomnia, anxiety, dizziness.
Urogenital System: Urinary tract infection, sexual dysfunction, painful menstruation.
Respiratory System: Dyspnea, bronchitis. Infrequent: Asthma, hiccup, hyperventilation.
Dermatologic: Acne, alopecia, dry skin, eczema.
Musculoskeletal: Back pain, joint pain, muscle pain.
It is important to emphasize that all those undesirable effects may also be symptoms of the depression itself and therefore may often decrease during the course of therapy.
Mania/hypomania have been reported in about 1% of patients. Additionally there are reports regarding the activation of mania or hypomania in patients with severe affective disorders treated with other tricyclic antidepressants.
There are few reports about poor concentration, dyspnoea, decreased libido, micturition difficulties.
Leukopaenia or an increase of liver enzymes has been rarely observed.
Hyperprolactinaemia or thrombocytopaenia have been reported in frequently. No casual relationship with fluoxetine therapy has been proven.
Drug Interactions
Drugs that may interfere with MAOIs, Tryptophan, TCAs, Carbamazepine, Haloperidol, Phenothiazine and other CNS active drugs like Lithium.
Store at temperatures not exceeding 30°C.
Protected from light.
MIMS Class
ATC Classification
N06AB03 - fluoxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Cap 20 mg x 20's.
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