FLUOXETINE

Can J Psychiatry. 2005 Jan;50(1):31-8
International dosage differences in fluoxetine clinical trials.
Patten S, Cipriani A, Brambilla P, Nose M, Barbui C
Department of Community Health Sciences, University of Calgary, Alberta

OBJECTIVE: International differences are thought to exist in dosages used by clinicians treating mood disorders. This study examined international dosage differences in antidepressant clinical trials, using a database formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine. METHODS: This systematic review included 132 studies. A detailed set of methodological features and results were abstracted from the original publications and entered into an electronic database. Mean and maximum fluoxetine dosages were compared across countries. To evaluate the dosages of comparison medications, a defined daily dosage (DDD) ratio was calculated as the trial mean dosage divided by the DDD for that drug. RESULTS: Both the maximum and mean dosages for fluoxetine and comparison medications were higher in trials conducted in the US (fluoxetine weighted mean dosage 49.18 mg; 95% CI, 41.30 to 57.05), compared with trials conducted in Europe (fluoxetine weighted mean dosage 29.98 mg; 95% CI, 25.28 to 34.68). Since most clinical trials were conducted in Europe or the US, we could not determine whether different dosages tended to be used in other regions. CONCLUSIONS: International differences in prescriber behaviour may influence, and in turn be influenced by, the conduct of clinical trials. It is difficult to reconcile such differences with the principles of evidence-based medicine.

J Am Acad Child Adolesc Psychiatry 2002 Oct;41(10):1205-15
Fluoxetine for acute treatment of depression in children and adolescents: a placebo-controlled, randomized clinical trial.
Emslie GJ, Heiligenstein JH, Wagner KD, Hoog SL, Ernest DE, Brown E, Nilsson M, Jacobson JG
Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, USA

BACKGROUND: This report presents results from the acute treatment phase of a clinical trial designed to confirm efficacy of a fixed dose of 20 mg of fluoxetine in children and adolescents with major depressive disorder (MDD). METHOD: After a 3-week screening period, 122 children and 97 adolescents with MDD ( ) were randomly assigned to placebo or fluoxetine. After a 1-week placebo lead-in, fluoxetine-treated patients received fluoxetine 10 mg/day for 1 week, then fluoxetine 20 mg/day for 8 weeks. RESULTS: Fluoxetine was associated with greater mean improvement in Children's Depression Rating Scale-Revised (CDRS-R) score than placebo after 1 week ( <.05) and throughout the study period. Significantly more fluoxetine-treated patients (41%) met the prospectively defined criteria for remission than did placebo-treated patients (20%) ( <.01). More fluoxetine- (65%) than placebo-treated (53%) patients met the prospectively defined response criterion of > or =30% decrease in CDRS-R score, but this difference was not significant ( =.093). Significantly more fluoxetine-than placebo-treated patients completed acute treatment ( =.001). There were no significant differences between treatment groups in discontinuations due to adverse events ( =.408). CONCLUSION: Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients. Fluoxetine is the only antidepressant that has demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatric depression.

GENERIC NAME: fluoxetine
BRAND NAME: Prozac

DRUG CLASS AND MECHANISM: Fluoxetine is in a new class of antidepressant medications that affects chemical messengers within the brain. These chemical messengers are called neurotransmitters. Many experts believe that an imbalance in these neurotransmitters is the cause of depression. Fluoxetine is believed to work by inhibiting the release or affects the action of serotonin. Fluoxetine does not have MAO activity.

PREPARATIONS: Capsules (Pulvules) are available in 10mg and 20mg sizes. Fluoxetine also is available in liquid oral suspension of 20mg/5ml by Dista labs.

STORAGE: Store in a dry place at 20-25 degrees C (68-77 F).

PRESCRIBED FOR: Depression and has been approved for obsessive compulsive disorders.

DOSING: Fluoxetine is used in the treatment of depression and obsessive-compulsive disorders. It usually is taken once or twice daily; however, it also has been taken once weekly. Fluoxetine should be taken with food at doses specifically directed by your physician. Individual doses vary greatly between individuals. If discontinued you should gradually withdraw from this medication as directed by your doctor.

DRUG INTERACTIONS: Do not take with MAO inhibitors or for at least two weeks after their discontinuation. MAO inhibitors medications should not be taken for at least five weeks after discontinuing fluoxetine (Prozac). The same is true for Haldol. Most medications affecting the brain have the potential to slow reflexes or impair judgment and caution is advised. This medication has not been studied extensively in the US and re-evaluation periodically by your physician is advised. This medication should not be taken with tryptophan. Caution when taking this medication with the heart drug lanoxin and the anticoagulant coumadin. Check with you pharmacist when taking with other medications.

NURSING MOTHERS: The manufacturer of fluoxetine recommends that women taking fluoxetine not nurse their infants.

SIDE EFFECTS: Fluoxetine as with most antidepressants can cause nausea, headaches, anxiety, insomnia, drowsiness, and loss of appetite. Fluoxetine has been implicated in serious skin rashes and vasculitis. Increased blood pressure can occur and should be monitored. Seizures have been reported. Life-threatening interactions can occur in combination with MAO inhibitors, such as nardil and parnate. MAO inhibitors and fluoxetine should not be taken together and a waiting period of 14 days between taking these two classes of medications is strongly advised.

"If antidepressants are discontinued abruptly, symptoms may occur such as dizziness, headache, nausea, changes in mood, or changes in the sense of smell, taste, etc. (Such symptoms even may occur when even a few doses of antidepressant are missed.) Therefore, it is recommended that the dose of antidepressant be reduced gradually when therapy is discontinued."

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.
Also, you should read carefully important health information about this drug given here:

my.webmd.com