Important drug warning

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Use another fluoxetine product for initial doses of 10 mg to 20 mg/day or for doses other than 30 mg or 60 mg.

Important safety information for fluoxetine tablets, 60 mg

Contraindications

• Do not use monoamine oxidase inhibitors (MAOIs) intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine due to risk of serotonin syndrome. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue due to risk of serotonin syndrome.
• Do not use fluoxetine with pimozide due to risk of QT interval prolongation and drug interaction.
• Do not use fluoxetine with thioridazine due to risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine.
• Do not use this fluoxetine product in patients with known hypersensitivity to fluoxetine due to risk of anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria.

Warnings and precautions

• All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.
• The development of a potentially life-threatening serotonin syndrome has been reported with serotonin-norepinephrine or selective serotonin reuptake inhibitors (SNRIs or SSRIs), including fluoxetine, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Patients should be monitored for emergence of serotonin syndrome. The concomitant use of fluoxetine with MAOIs intended to treat psychiatric disorders is contraindicated. Fluoxetine should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. Treatment with fluoxetine and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur, and supportive symptomatic treatment should be initiated.
• Systemic reactions with rash, possibly related to vasculitis and including lupus-like syndrome, have developed in patients treated with fluoxetine. Although these reactions are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic reactions. Anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria alone and in combination, have been reported. Pulmonary reactions, including inflammatory processes of varying histopathology and/or fibrosis, have been reported rarely. These reactions have occurred with dyspnea as the only preceding symptom. Upon the appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified, fluoxetine should be discontinued.
• A major depressive episode may be the initial presentation of Bipolar Disorder. Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disorder and monitored for mania/hypomania. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
• The percentage of patients experiencing convulsions in all US fluoxetine clinical trials appears to be similar to that associated with other marketed drugs effective in the treatment of MDD. Fluoxetine should be introduced with care in patients with a history of seizures. There have been rare reports of prolonged seizures in patients taking fluoxetine who are also receiving electroconvulsive therapy treatment.
• Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with fluoxetine. Rarely have patients discontinued treatment with fluoxetine because of anorexia or weight loss. Weight change should be monitored during therapy.
• SNRIs and SSRIs, including fluoxetine, may increase the risk of bleeding reactions. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk.
• The pupillary dilation that occurs following use of many antidepressant drugs including fluoxetine may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
• Hyponatremia has been reported during treatment with SNRIs and SSRIs, including fluoxetine. Elderly patients and patients taking diuretics or who are otherwise volume-depleted may be at greater risk. Discontinuation of fluoxetine should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.
• In US placebo-controlled clinical trials, among the most common adverse reactions associated with discontinuation (incidence at least twice that for placebo and at least 1% for fluoxetine in trials collecting only a primary reaction associated with discontinuation) were anxiety (2% in OCD), insomnia (1% in combined indications and 2% in BN), and nervousness (1% in MDD).
• 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. Such conditions include concomitant use of drugs that prolong the QT interval; hypokalemia or hypomagnesemia; recent myocardial infarction, uncompensated heart failure, bradyarrhythmias, and other significant arrhythmias; and conditions that predispose to increased fluoxetine exposure. Consider ECG assessment and periodic ECG monitoring if initiating treatment with fluoxetine in patients with risk factors for QT prolongation and ventricular arrhythmia. Consider discontinuing fluoxetine and obtaining a cardiac evaluation if patients develop signs or symptoms consistent with ventricular arrhythmia.
• In patients with diabetes, hypoglycemia has occurred during therapy with fluoxetine, and hyperglycemia has developed following discontinuation of the drug. As is true with many other types of medication when taken concurrently by patients with diabetes, insulin and/or oral hypoglycemic, dosage may need to be adjusted when therapy with fluoxetine is instituted or discontinued.
• Fluoxetine has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.
• 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.
• During marketing of fluoxetine, SNRIs, and SSRIs, there have been spontaneous reports of adverse reactions occurring, some of which have been serious, upon discontinuation of these drugs, particularly when abrupt. Patients should be monitored for these symptoms when discontinuing treatment with fluoxetine. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.

Adverse reactions

• Most common adverse reactions associated with the use of fluoxetine (incidence of at least 5% and at least twice that for placebo, within at least 1 of the indications) for the treatment of MDD, OCD, and BN in US controlled clinical trials and Panic Disorder in US plus non-US controlled trials: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn.

You are encouraged to report negative side effects of prescription drugs to Almatica at 1-877-447-7979 or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

FORFIVO XL is a registered trademark of IntelGenx Corporation.

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