Each tablet contains: Fluoxetine Hydrochloride USP Equivalent to Fluoxetine 20 mg.
Pharmacology: Pharmacokinetics: Fluoxetine is readily absorbed from the gastrointestinal tract with peak plasma concentrations appearing about 6 to 8 hours after oral doses. Systemic bioavailability does not appear to be affected by food. Fluoxetine is extensively metabolised, by demethylation, in the liver to its primary active metabolite norfluoxetine. Excretion is mainly via the urine. Protein binding is reported to be about 95%. Fluoxetine is widely distributed throughout the body. Fluoxetine has a relatively long elimination half-life of about 1 to 3 days after acute use and 4 to 6 days after long-term use; that of its metabolite, norfluoxetine, is even longer, being about 4 to 16 days. These long half lives have clinical implications. Steady-state plasma concentrations will only be attained after several weeks.
For the treatment of depression; management of generalized anxiety disorder, obsessive-compulsive disorder, panic disorder with or without agoraphobia, social phobia, and post-traumatic stress disorder, and as part of the management of bulimia nervosa; treatment of premenstrual dysphoric disorder.
In the treatment of Depression: 20 mg once daily.
Bulimia nervosa: 60 mg once daily.
Obsessive compulsive disorder: Initial dose of 20 mg once daily up to 60-80 mg daily.
Panic disorder: Initial dose of 10 mg once daily up to 20-60 mg daily.
Premenstrual Dysphoric disorder: 20 mg once daily.
Or as prescribed by the physician.
Known hypersensitivity to the active substance or to any of the excipients.
Antidepressants increase the risk of suicidal thinking and behavior (suicidality), in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders and those considering use of these agents "must balance risk with the clinical need".
Because of epileptogenic effect Fluoxetine should be used with caution in patient with history of epilepsy. Used with caution in patients with cardiac disease or a history of bleeding disorder, diabetes, angle-closure glaucoma, impaired hepatic function. SSRIs may impair performance of skilled tasks and, if affected, patients should not drive or operate machinery.
Adverse effects include dry mouth and gastrointestinal disturbances such as nausea, vomiting, dyspepsia, constipation and diarrhea. Anorexia and weight loss may occur.
Neurological side effects have included anxiety, restlessness, nervousness, and insomnia and drowsiness and fatigue, headache, tremor, agitation and extra pyramidal effects, depersonalisation, mania, panic attacks, sexual dysfunction and symptoms suggestive of a serotonin syndrome have also occurred.
Store at temperatures not exceeding 30°C.
N06AB03 - fluoxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.