After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed. In the short-term (8- to 9-week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of MDD, patients were administered fluoxetine doses of 10 to 20 mg/day see CLINICAL STUDIES (14.1).
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Fluoxetine was shown to be significantly more effective than placebo as measured by the Hamilton Depression Rating Scale (HAM-D). Fluoxetine was also significantly more effective than placebo on the HAM-D subscores for depressed mood, sleep disturbance, and the anxiety subfactor. Higher average steady-state fluoxetine and norfluoxetine concentrations were fluoxetine: side effects, dosage, uses, and more observed in children relative to adults; however, these concentrations were within the range of concentrations observed in the adult population.
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Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with fluoxetine. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. Prozac (fluoxetine) and Xanax (alprazolam) are both prescription medications used to treat mental health conditions, but they work in different ways. Drowsiness is more common from taking Xanax, while Prozac tends to cause insomnia and nausea as side effects.
10 Anxiety and Insomnia
There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications.
Fluoxetine Dosage and Administration
It is important that your doctor check your progress at regular visits, to make sure this medicine is working properly. When using fluoxetine hydrochloride and olanzapine in combination, also refer to the Boxed Warning section of the package insert for fluoxetine hydrochloride/olanzapine. Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with fluoxetine may cause you to bruise or bleed easily. Do not stop using fluoxetine suddenly, or you could have unpleasant withdrawal symptoms. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking fluoxetine tablets. The dietary administration of fluoxetine to rats and mice for 2 years at doses of up to 10 and 12 mg/kg/day, respectively (approximately 1.2 and 0.7 times, respectively, the MRHD of 80 mg on a mg/m2 basis), produced no evidence of carcinogenicity. Fluoxetine is approved for use in pediatric patients with MDD and OCD see BOXED WARNING AND WARNINGS AND PRECAUTIONS (5.1). Anyone considering the use of fluoxetine in a child or adolescent must balance the potential risks with the clinical need.
- Clinical studies of pimozide with other antidepressants demonstrate an increase in drug interaction or QT prolongation.
- Rat exposures to the major metabolite, norfluoxetine, were approximately 0.3 to 0.8, 1 to 8, and 3 to 20 times, respectively, the pediatric exposure at the MRHD.
- This list is not complete and many other drugs may affect fluoxetine.
- The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications.
Older adults may be more sensitive to the effects of this medication. FLUoxetine (Eqv-PROzac) may also be used for purposes not listed in this medication guide. Browse discussions, ask questions, and share experiences across hundreds of health topics. Take them to your local pharmacy which will dispose of them for you. Never give it to other people even if their condition appears to be the same as yours. Tell your doctor if you feel that you are not getting any better, or if you experience any troublesome side-effects.
- Thioridazine should not be administered with fluoxetine or within a minimum of 5 weeks after fluoxetine has been discontinued, because of the risk of QT prolongation see CONTRAINDICATIONS (4.2), WARNINGS AND PRECAUTIONS (5.11), and DRUG INTERACTIONS (7.7).
- However, you may have a relapse of depression if you stop taking your antidepressant.
- Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
- Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
- If you think there has been an overdose, call your poison control center or get medical care right away.
These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1. The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated see DOSAGE AND ADMINISTRATION (2.6) and WARNINGS AND PRECAUTIONS (5.2). Multiple doses of fluoxetine have been administered to 10,782 patients with various diagnoses in US clinical trials. In addition, there have been 425 patients administered fluoxetine in panic clinical trials.
This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Because of the long elimination half-lives of the parent drug and its major active metabolite, changes in dose will not be fully reflected in plasma for several weeks, affecting both strategies for titration to final dose and withdrawal from treatment. This is of potential consequence when drug discontinuation is required or when drugs are prescribed that might interact with fluoxetine and norfluoxetine following the discontinuation of fluoxetine see CLINICAL PHARMACOLOGY (12.3).
Usual Adult Dose for Premenstrual Dysphoric Disorder
In US fluoxetine clinical trials, 0.7% of 10,782 patients reported mania/hypomania see USE IN SPECIFIC POPULATIONS (8.4). Postmarketing cases of QT interval prolongation and ventricular arrhythmia including Torsades de Pointes have been reported in patients treated with fluoxetine. Fluoxetine should be used with caution in patients with congenital long QT syndrome; a previous history of QT prolongation; a family history of long QT syndrome or sudden cardiac death; and other conditions that predispose to QT prolongation and ventricular arrhythmia.