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Prozac 20 Tablet contains Fluoxetine Hydrochloride
Prozac 20 Tablet side effects
Gastrointestinal: Nausea, vomiting, dyspepsia, dry mouth, and diarrhoea.
Neurological: Anxiety, nervousness, insomnia/ drowsiness and fatigue.
Others: Excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement. It has therefore been advised that Fluoxetine therapy should be discontinued in any patient who develops a skin rash.
As Fluoxetine undergoes hepatic metabolism and renal excretion, it should be used with caution and in reduced doses in patients with impaired hepatic or renal function. Because of its epileptogenic effect, it should be used with caution in patients with epilepsy or a history of such disorders. Fluoxetine may alter glycaemic control and therefore caution is also warranted in diabetic subjects. Depressed patients with suicidal tendencies should be carefully supervised during treatment. Fluoxetine is not usually considered a suitable form of therapy for the depressive component of bipolar (manic depressive) illness as mania may be precipitated.
May lead to serotonin syndrome with serotonergic drugs (e.g. triptans, TCAs, fentanyl, tramadol, lithium, buspirone, tryptophan). May increase risk of bleeding with aspirin, NSAIDs, warfarin and other anticoagulants. May increase plasma levels of phenytoin.
Potentially Fatal: May increase risk of serotonin syndrome with concomitant admin or within 14 days of MAOIs withdrawal. May increase the QTc prolonging effect of pimozide and thioridazine.
Pregnancy: In animal studies, no teratogenicity or harmful effect was found. Because animal reproductive studies are not always predictive of human responses, Fluoxetine should be used in pregnancy only if clearly needed.
Lactation: As Fluoxetine is excreted in human milk, caution should be exercised when Fluoxetine is administered to nursing women.
Fluoxetine Hydrochloride is contraindicated in patients known to be hypersensitive to it.
Monoamine oxidase inhibitors: There have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and changes of mental status that include extreme agitation progressing to delirium and coma) in patients receiving Fluoxetine in combination with monoamine oxidase inhibitors (MAOIs), and in patients who have recently discontinued Fluoxetine and are then started on MAOIs. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine should not be used in combination with MAOI, or within 14 days of discontinuing therapy with MAOI. Since Fluoxetine and its major metabolites have very long elimination half-lives, at least 5 weeks should be allowed after stopping Fluoxetine and before starting MAOI.
Use in children: The use of Fluoxetine in children is not recommended as safety and efficacy have not been established.
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