Fluoxetine (fluoxetine HCl)

Dosage of fluoxetine hydrochloride is expressed in terms of fluoxetine.

Consider prolonged elimination half-life of fluoxetine and norfluoxetine (active metabolite) when titrating dosage or discontinuing therapy. Several weeks will be required before the full effect of such alterations is realized.

Fluoxetine hydrochloride is administered orally without regard to meals.

Fluoxetine hydrochloride conventional capsules, tablets, and oral solution are administered once or twice daily; the delayed-release capsules are administered once weekly.

For the initial management of depression, obsessive-compulsive disorder (OCD), premenstrual dysphoric disorder (PMDD), or bulimia nervosa, fluoxetine conventional preparations generally are administered once daily in the morning. If the dosage exceeds 20 mg daily, the manufacturer states that the medication can be administered once in the morning or in 2 divided doses daily (preferably in the morning and at noon). Fluoxetine delayed-release capsules are administered once weekly as maintenance therapy for major depressive disorder.

Fluoxetine is also commercially available in fixed-combination with olanzapine for the treatment of acute depressive episodes associated with bipolar I disorder and treatment-resistant depression. See full prescribing information for dosage and administration.

Fluoxetine hydrochloride conventional capsules should be stored at 15-30degreesC and protected from light. Fluoxetine hydrochloride tablets, delayed-release capsules and oral solution should be stored at 20-25degreesC and protected from light.

No dosing information is available for this tab.

No dosing information is available for this tab.

Fluoxetine is extensively metabolized; it is known to inhibit cytochrome P-450 (CYP) 2D6 and to a lesser extent CYP3A4.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Concurrent or recent (i.e., within 2 weeks) therapy with a monoamine oxidase inhibitor (MAOI). MAOIs are contraindicated within 5 weeks after fluoxetine discontinuation.

*Concurrent pimozide therapy.

*Concurrent thioridazine therapy. Thioridazine is contraindicated within 5 weeks after fluoxetine discontinuation.

*Known hypersensitivity to fluoxetine.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse effects reported in at least 5% of patients in clinical studies receiving fluoxetine for major depressive disorder, OCD, bulimia nervosa, or panic disorder include abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, decreased libido, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of fluoxetine in pediatric patients have not been established in children <8 years of age for major depressive disorder or in children <7 years of age for obsessive-compulsive disorder (OCD).

FDA warns that antidepressants may increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders. The risk of suicidality for these medications was identified in a pooled analysis of data from short-term, placebo-controlled studies of 9 antidepressants (i.e., fluoxetine, bupropion, citalopram, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, venlafaxine) in over 4400 children and adolescents with major depressive disorder, OCD, or other psychiatric disorders. The analysis revealed a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in pediatric patients receiving antidepressants than in those receiving placebo. However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs, including fluoxetine, and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation. No suicides occurred in these pediatric trials.

The risk of suicidality in FDA's pooled analysis differed across the different psychiatric indications, with the highest incidence observed in the major depressive disorder studies. In addition, although there was considerable variation in risk among the antidepressants, a tendency toward an increase in suicidality risk in younger patients was found for almost all medications studied. It is currently unknown whether the suicidality risk in pediatric patients extends to longer-term use (i.e., beyond several months). Anyone considering the use of fluoxetine in a child or adolescent for any clinical use must balance the potential risks of therapy with the clinical need.

As with other SSRIs, decreased weight gain has been observed in association with fluoxetine in children and adolescents. In one clinical trial in pediatric patients, height gain averaged about 1.1 cm less and weight gain averaged about 1.1 kg less after 19 weeks of fluoxetine therapy relative to placebo-treated patients. Because the safety of fluoxetine in pediatric patients has not been systematically assessed for chronic therapy longer than several months in duration and studies that directly evaluate the long-term effects of fluoxetine on the growth, development, and maturation of children and adolescents are lacking, height and weight should be monitored routinely in pediatric patients receiving fluoxetine.

A pregnancy registry is available that monitors pregnancy outcomes in females exposed to antidepressants during pregnancy. Healthcare providers can register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

Published observational data have shown exposure to SSRIs, particularly during the month before delivery, is associated with a <2-fold increased risk of postpartum hemorrhage.

Some neonates exposed to fluoxetine and other SSRIs or SNRIs late in the third trimester of pregnancy have developed complications that have sometimes been severe and required prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Clinical findings reported in neonates include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These clinical features appear to be consistent with either a direct toxic effect of the SSRI or SNRI or, possibly, a drug withdrawal syndrome. It should be noted, in some cases, the clinical picture was consistent with serotonin syndrome.

Infants exposed to SSRIs in late pregnancy may have an increased risk of persistent pulmonary hypertension of the newborn (PPHN). PPHN is a rare heart and lung condition occurring in an estimated 1-2 infants per 1000 births in the general population. Several recent epidemiologic studies suggest an association between SSRI use during pregnancy and PPHN, although others do not.

When treating a pregnant patient with fluoxetine, the clinician should carefully consider the potential risks and benefits of such therapy. Clinicians should consider that in a prospective longitudinal study of 201 females with a history of recurrent major depression who were either on antidepressant therapy or had received antidepressants <12 weeks prior to their last menstrual period and were in remission at the beginning of pregnancy, those who discontinued their antidepressant medication (SSRIs, TCAs, or others) during pregnancy were found to be substantially more likely to have a relapse of depression than females who continued to receive their antidepressant therapy while pregnant.

The effect of fluoxetine on labor and delivery is not known.

Fluoxetine and its metabolites distribute into human milk. Crying, sleep disturbance, vomiting, and watery stools developed in an infant who was breastfed from a female receiving fluoxetine; plasma fluoxetine and norfluoxetine concentrations in the infant on the second day of feeding were 340 and 208 ng/mL, respectively. Some manufacturers state fluoxetine should not be used in nursing females and patients should notify their physician if they plan to breast-feed.

Breast-fed infants who are exposed to fluoxetine should be monitored for agitation, irritability, poor feeding, and poor weight gain, and should seek medical care if these signs are observed.

A lower dosage of fluoxetine should be considered for geriatric patients.

Although no overall differences in efficacy or safety were observed between geriatric and younger patients, the possibility that some older patients may exhibit increased sensitivity to the medication cannot be ruled out.

In pooled data analyses, a reduced risk of suicidality was observed in adults >=65 years of age with antidepressant therapy compared with placebo.

SNRIs and SSRIs, including fluoxetine, have been associated with clinically significant hyponatremia in geriatric patients, who may be at an increased risk for this adverse effect due to volume depletion or use of diuretics.