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Indications and usage:
Prozac (Fluoxetine Hydrochloride) is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of major depressive disorder (MDD).
Acute and maintenance treatment of obsessive compulsive disorder (OCD).
Acute and maintenance treatment of bulimia nervosa.
Acute treatment of panic disorder, with or without agoraphobia.
Prozac and olanzapine in combination for treatment of:
Acute depressive episodes associated with bipolar I disorder.
Treatment resistant depression.
Dosage and administration:
Take Prozac exactly as prescribed. Your healthcare provider may need to change the dose of this medication until it is the right dose for you.
Fluoxetine capsules may be taken with or without food.
If you miss a dose of Prozac, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluoxetine at the same time.
If you take too much of this drug, call your healthcare provider or poison control center right away, or get emergency treatment.
A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications.
Dosage forms and strengths:
Prozac (Fluoxetine Hydrochloride) capsules or pulvules: 10 mg, 20 mg, 40 mg, 60 mg.
Sarafem (Fluoxetine Hydrochloride) tablets: 10 mg, 15 mg, 20 mg.
For current information on the management of Prozac overdose, contact your local certified poison control center. Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multi-drug overdose.
Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use general supportive and symptomatic measures. Induction of emesis is not recommended.
Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for fluoxetine are known.
A specific caution involves patients who are taking or have recently taken fluoxetine and might ingest excessive quantities of a TCA. In such a case, accumulation of the parent tricyclic and/or an active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation.
Serotonin Syndrome and MAOIs: do not use MAOIs intended to treat psychiatric disorders with Prozac or within 5 weeks of stopping treatment with Fluoxetine. Do not use this medicines within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Prozac in a patient who is being treated with linezolid or intravenous methylene blue.
Pimozide: do not use. Risk of QT prolongation and drug interaction.
Thioridazine: do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing Fluoxetine HCl. Do not use thioridazine within 5 weeks of discontinuing Prozac.
Warnings and precautions:
Suicidal thoughts and behaviors in children, adolescents, and young adults: monitor for clinical worsening and suicidal thinking and behavior.
Serotonin syndrome: serotonin syndrome has been reported with SSRIs and SNRIs, including Prozac, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). If such symptoms occur, discontinue Prozac and initiate supportive treatment. If concomitant use of Fluoxetine capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Allergic reactions and rash: discontinue upon appearance of rash or allergic phenomena.
Activation of mania/hypomania: screen for bipolar disorder and monitor for mania/hypomania.
Seizures: use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
Altered appetite and weight: significant weight loss has occurred.
Abnormal bleeding: may increase the risk of bleeding. Use with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding.
Angle-closure glaucoma: angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
Hyponatremia: has been reported with Prozac in association with syndrome of inappropriate antidiuretic hormone (SIADH). Consider discontinuing if symptomatic hyponatremia occurs.
Anxiety and Insomnia: may occur.
QT prolongation: QT prolongation and ventricular arrhythmia including Torsades de Pointes have been reported with Prozac use. Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure. Use cautiously in patientswith risk factors for QT prolongation.
Potential for cognitive and motor impairment: has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery.
Long half-life: changes in dose will not be fullyreflected in plasma for several weeks.
Side effects, adverse reactions:
Most common adverse reactions ( >= 5% and at least twice that for placebo) of fluoxetine associated with major depressive disorder, obsessive compulsive disorder, bulimia, and panic disorder: 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.
To report suspected adverse reactions of Prozac and Sarafem (Fluoxetine Hydrochloride) pills, contact Eli Lilly pharmaceutical company or your local FDA.
Monoamine Oxidase Inhibitors (MAOIs).
Drugs metabolized by CYP2D6: fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway.
Tricyclic antidepressants (TCAs): monitor TCA levels during coadministration with Prozac or when Fluoxetine HCl has been recently discontinued.
CNS acting drugs: caution should be used when taken in combination with other centrally acting drugs.
Benzodiazepines: diazepam - increased T1/2, alprazolam - further psychomotor performance decrement due to increased levels.
Antipsychotics: potential for elevation of haloperidol and clozapine levels.
Anticonvulsants: potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity.
Drugs that interfere with hemostasis (e.g. NSAIDs, aspirin, warfarin): may potentiate the risk of bleeding.
Drugs tightly bound to plasma proteins: may cause a shift in plasma concentrations.
Olanzapine: when used in combination with Prozac, also refer to the Drug Interactions section of the package insert for Symbyax.
Drugs that prolong the QT interval: do not use Prozac with thioridazine or pimozide. Use with caution in combination with other drugs that prolong the QT interval.
Amitriptyline (Elavil, Endep)
Use in specific populations:
SSRI use, particularlylater in pregnancy, may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate.
Safety and effectiveness of Prozac pills in patients < 8 years of age with Major Depressive Disorder and < 7 years of age with OCD have not been established. Safety and effectiveness of Prozac and olanzapine in combination in patients < 10 years of age for depressive episodes associated with Bipolar I Disorder have not been established.
Lower or less frequent dosing may be appropriate in patients with cirrhosis.
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