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Fluoxetine DR

Class
Antidepressants
Subclass
Selective serotonin reuptake inhibitors
Substance name
FLUoxetine hydrochloride DR
Common formulations
Capsule
See also
Fluoxetine (Prozac®)
Dosage and administration
Adults patients
Major depressive disorder
•
90 mg PO weekly, starting 7 days after the last daily dose of fluoxetine IR 20 mg
Premenstrual dysphoric disorder • Off-label
•
90 mg PO weekly on days 7 and 14 of each menstrual cycle
Indications for use
Labeled indications
Adults
•
Treatment of major depressive disorder
Off-label indications
Adults
•
Treatment of premenstrual dysphoric disorder
Safety risks
Boxed warnings
Suicidal ideation
•
Use extreme caution in patients with major depressive disorder or other psychiatric disorders, particularly in children, adolescents, and young adults. Monitor closely for suicidality and unusual changes in behavior.
Contraindications
Hypersensitivity to fluoxetine or its components
Concomitant use of MAOIs
•
Do not use fluoxetine with or within 14 days of stopping MAOIs. Do not use MAOIs within 5 weeks of stopping fluoxetine.
Concomitant use of pimozide or thioridazine
•
Do not use fluoxetine with pimozide or pimozide because of the risk of QT prolongation. Do not initiate thioridazine until 5 weeks after fluoxetine has been discontinued.
Warnings and precautions
Acute angle-closure glaucoma
•
Use caution in patients with untreated anatomically narrow angles.
Allergic skin reaction, urticaria, anaphylactoid reactions
•
Maintain a high level of suspicion, as fluoxetine may cause allergic reactions and rash.
Antidepressant discontinuation syndrome
•
Do not discontinue abruptly in any patient.
Anxiety, nervousness, insomnia
•
Maintain a high level of suspicion, as fluoxetine has been associated with these adverse events.
Bleeding
•
Use caution in patients taking aspirin, NSAIDs, antiplatelet or anticoagulant therapy.
Cognitive difficulties, motor impairment
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Decreased blood glucose
•
Use caution in patients with diabetes mellitus.
Hyponatremia, SIADH
•
Use caution in all patients, especially in the elderly and in patients with volume depletion or taking diuretics.
Increased serum drug levels, prolonged QT interval
•
Use caution in patients taking drugs metabolized by CYP2D6.
Loss of appetite, weight loss
•
Use caution in patients with underweight or bulimia.
Mania
•
Use caution in patients with bipolar disorder. Screen patients for any personal or family history of bipolar disorder before initiating fluoxetine.
Seizure
•
Use caution in patients with seizure disorder.
Serotonin syndrome
•
Use caution in patients taking other serotonergic drugs (including triptans, TCAs, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John's Wort).
Sexual dysfunction
•
Maintain a high level of suspicion, as SSRIs have been associated with decreased libido, erectile dysfunction, and ejaculatory delay or failure in males, and decreased libido and delayed or absent orgasm in females.
Torsades de pointes, ventricular arrhythmias
•
Use extreme caution in patients with congenital long QT syndrome, bradycardia, hypokalemia, hypomagnesemia, recent acute myocardial infarction, uncompensated HF, or taking other QT-prolonging drugs.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
Reduce dose. Reduce frequency.
Pregnancy and breastfeeding
Pregnancy
First and second trimesters • Australia Category: C
•
Use only if benefits outweigh potential risks.
Third trimester • Australia Category: C
•
Consider safer alternatives. Monitor neonates for direct toxic effects of the drug, serotonin syndrome and discontinuation syndrome. The use of SSRIs in late pregnancy is associated with an increased risk of postpartum hemorrhage, persistent pulmonary hypertension of the newborn, and symptoms of poor adaptation in the neonate.
Breastfeeding
Consider alternative agents that may be safer.
•
Monitor breastfed infants exposed to fluoxetine for agitation, irritability, poor feeding, and poor weight gain.
Low excretion in breastmilk (5-25%).
Low levels in breastfed infants (5-25%).
May potentially cause adverse effects in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Anxiety, asthenia, diarrhea, headache, insomnia, loss of appetite, nausea, nervousness, somnolence
Common 1-10%
•
Antidepressant discontinuation syndrome, pharyngitis, chills, palpitations, ↑QT interval, emotional lability, change in taste, constipation, ↓ libido, dizziness, dry mouth, dyspepsia, erectile dysfunction, fever, flatulence, vomiting, itching, flu-like symptoms, mania, nightmares, skin rash, sweating, weight loss, visual disturbances, yawning, sinusitis, tremor
Uncommon < 1%
•
Gastritis, gastroenteritis, peptic ulcer disease, suicidal ideation, hypotension, dysphagia, melena, ecchymosis, akathisia, ataxia, loss of balance, bruxism, euphoria, ↑ libido, hypertonia, myoclonus, paranoid ideation, hair loss, mydriasis, dysuria, vaginal bleeding
Rare < 0.1%
•
Hepatitis, photosensitivity of skin, hematochezia, gastrointestinal bleeding, hematemesis, petechiae, purpura, delusions, laryngeal edema
Unknown frequency
•
Aplastic anemia, atrial fibrillation, stroke, cataract, DRESS syndrome, toxic epidermal necrolysis, eosinophilic pneumonia, erythema multiforme, erythema nodosum, exfoliative dermatitis, heart failure, cardiac arrest, hemolytic anemia, renal failure, acute pancreatitis, optic neuritis, pulmonary embolism, Stevens-Johnson syndrome, pulmonary hypertension, ventricular tachycardia, torsades de pointes, serotonin syndrome, acute angle-closure glaucoma, anosmia, jaundice, dyskinesia, galactorrhea, gynecomastia, ↓ blood glucose, hyperprolactinemia, memory impairment, pancytopenia, ↓ platelet count, hostility, seizure, motor impairment, exacerbation of tremor, sexual dysfunction, priapism
Interactions
Drug(s)
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