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There were suicides in fluoxetine the women adult trials, but the for number was women not sufficient to women reach any conclusion about drug effect on suicide. Your healthcare provider may need to change the dose of fluoxetine your diabetes medicines when you start or stop taking fluoxetine. These data indicate that fluoxetines extent of inhibition of CYP3A4 activity is not likely women to be of clinical significance. Initial Treatment Administer fluoxetine 60 mg/day in the morning. Make dosage adjustments, if indicated, according to efficacy and tolerability. Call your doctor for medical advice about side effects. When using Fluoxetine and olanzapine in combination, also refer fluoxetine to Boxed Warning section of the package insert for Symbyax. Obsessive Compulsive Disorder Adult for The effectiveness of prozac women for the treatment of Obsessive Compulsive Disorder (OCD) was demonstrated in two 13-week, multicenter, parallel group studies (Studies 1 and 2) of adult outpatients who received fixed prozac doses. Animal Data Significant toxicity on muscle tissue, neurobehavior, reproductive organs, and bone development has been observed following exposure of juvenile rats women to fluoxetine from weaning through maturity. However, in rat reproduction studies, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths during the first 7 days postpartum occurred following maternal exposure to 12 mg/kg/day (1.5 times the mrhd. Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients for women with Panic Disorder. Patients receiving continued fluoxetine 60 mg/day experienced a significantly longer time to relapse over the subsequent 52 weeks compared with those receiving placebo. This effect is reversible after cessation of fluoxetine treatment. Other important adverse reactions reported with fluoxetine overdose (single or multiple drugs) include coma, delirium, ECG abnormalities (such as QT interval prolongation and ventricul ararrhythmias, including Torsades de Pointes-type arrhythmias hypotension, mania, neuroleptic malignant women syndrome-like reactions, pyrexia, stupor, and syncope. Patients should be advised that they should not alter their dosing regimen, or stop taking fluoxetine without consulting their physician see Warnings and Precautions (5.15). Fluoxetine and Olanzapine in Combination When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for olanzapine and fluoxetine hydrochloride capsules. Overall, however, a causal relationship has not been established. For more information, ask your healthcare provider or pharmacist. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for olanzapine and fluoxetine hydrochloride capsules. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. While a specific study with pimozide and fluoxetine has not been conducted, the potential for drug interactions or QT prolongation warrants restricting the concurrent use of pimozide and prozac see contraindications, warnings AND precautions, and Drugs That Prolong The QT Interval. Stone has has published high-profile articles on the molecular mechanisms of cardiovascular disease and cancer in journals such as Blood and the Journal of the American Heart Association. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. However, only rarely have patients discontinued treatment with fluoxetine because of anorexia or weight loss see Use in Specific Populations (8.4). Prozac (fluoxetine)." Dista Products Company, Indianapolis,. CNS Acting Drugs Caution is advised if the concomitant administration of prozac and such drugs is required. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases see Clinical Studies. Anxiety and Insomnia In fluoxetine US placebo-controlled clinical trials for Major Depressive Disorder, 12 to 16 of patients treated with fluoxetine and 7 to 9 of patients treated with placebo reported anxiety, nervousness, or insomnia. Use fluoxetine with caution in combination with other drugs that cause QT prolongation. Human Experience Worldwide exposure to fluoxetine hydrochloride is estimated to be over 38 million patients (circa 1999). Prozac should also not be started in a patient who is being treated with maois such as linezolid or intravenous methylene blue. Treatment of Pregnant Women during the First Trimester - There are no adequate and well -controlled clinical studies on the use of fluoxetine in pregnant women. Among the most common adverse reactions associated with discontinuation (incidence at least twice that for placebo and at least 1 for fluoxetine in clinical trials collecting only a primary reaction associated with discontinuation) in US placebo-controlled fluoxetine clinical. If satisfactory response is not maintained with prozac Weekly, consider reestablishing a daily dosing regimen see Clinical Studies. No adverse effects on the infant were reported. Pediatric (children and adolescents) The efficacy of prozac 20 mg/day in children and adolescents (N315 randomized; 170 children ages for 8 to 13, 145 adolescents ages 13 to 18) was studied in two 8-to 9-week placebo-controlled clinical trials in depressed outpatients. Manic reaction, including mania and hypomania, was reported in 6 fluoxetine (1 mania, 5 hypomania) out of 228 (2.6) fluoxetine-treated patients and in 0 out of 190 (0) placebo-treated patients. Keep prozac away from light. Fluoxetine was also significantly more effective than placebo on the HAM-D subscores for depressed mood, sleep disturbance, and the anxiety subfactor. USE IN specific populations When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for olanzapine and fluoxetine hydrochloride capsules. Prozac should not be taken with monoamine oxidase inhibitors ( maoi ) (for example, isocarboxazid Marplan). This condition can be life threatening. Suicidal Thoughts And Behaviors In Children, Adolescents, And Young Adults Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness hypomania, mania. See Warnings and Precautions (5.6) and Use in Specific Populations (8.4).

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