Luvox CR (fluvoxamine maleate) - Drug SummaryJazz Pharmaceuticals, Inc.
Luvox CR
(fluvoxamine maleate)
 BOXED WARNING
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Monitor and observe closely for clinical worsening, suicidality, or unusual changes in behavior.
THERAPEUTIC CLASS
Selective serotonin reuptake inhibitor (SSRI)
DEA CLASS
RX
ADULT DOSAGE & INDICATIONS
Obsessive Compulsive Disorder
Initial: 100mg qhs
Titrate: Increase by 50mg every week, as tolerated, until max therapeutic benefit is achieved
Max: 300mg/day
Maint/Continuation of Extended Treatment:
Adjust to lowest effective dose; periodically reassess need for continued treatment
Dosing Considerations with MAOIs
Switching to/from an MAOI for Psychiatric Disorders:
Allow at least 14 days between discontinuation of an MAOI and initiation of treatment, and allow at least 14 days between discontinuation of treatment and initiation of an MAOI
W/ Other MAOIs (eg, Linezolid, IV Methylene Blue):
Do not start fluvoxamine in patients being treated w/ linezolid or IV methylene blue
In patients already receiving fluvoxamine, if acceptable alternatives are not available and benefits outweigh risks, d/c fluvoxamine and administer linezolid or IV methylene blue; monitor for serotonin syndrome for 2 weeks or until 24 hrs after the last dose of linezolid or IV methylene blue, whichever comes 1st. May resume fluvoxamine therapy 24 hrs after the last dose of linezolid or IV methylene blue
DOSING CONSIDERATIONS
Hepatic Impairment
Titrate slowly
Elderly
Titrate slowly
Discontinuation
Gradually reduce dose whenever possible
If intolerable symptoms occur following a decrease in dose or upon discontinuation of treatment, may resume the previously prescribed dose; subsequently, may continue decreasing dose but at a more gradual rate
ADMINISTRATION
Oral route
Do not crush or chew caps
HOW SUPPLIED
Cap, Extended-Release: 100mg, 150mg
CONTRAINDICATIONS
Use of an MAOI for psychiatric disorders either concomitantly or within 14 days of stopping treatment. Treatment within 14 days of stopping an MAOI for psychiatric disorders. Starting treatment in patients being treated with MAOIs (eg, linezolid, IV methylene blue). Concomitant use of thioridazine, tizanidine, pimozide, alosetron, or ramelteon.
WARNINGS/PRECAUTIONS
Not approved for the treatment of bipolar depression. May precipitate mixed/manic episode in patients at risk for bipolar disorder; screen for risk of bipolar disorder prior to initiating therapy. Serotonin syndrome reported; d/c immediately and initiate supportive symptomatic treatment. Pupillary dilation that occurs following use may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Adverse events reported upon discontinuation; gradually reduce dose. May increase risk of bleeding events. Activation of mania/hypomania reported. Avoid with unstable epilepsy and monitor patients with controlled epilepsy; d/c if seizures occur or seizure frequency increases. Hyponatremia may occur; caution in the elderly, volume-depleted patients, and patients taking a diuretic. Consider discontinuation in patients with symptomatic hyponatremia and institute appropriate medical intervention. Caution with diseases/conditions that affect metabolism or hemodynamic responses, and in pregnancy (3rd trimester).
ADVERSE REACTIONS
Insomnia, N/V, headache, somnolence, asthenia, diarrhea, anorexia, dizziness, abnormal ejaculation, dry mouth, dyspepsia, sweating, anxiety, tremor, decreased libido.
DRUG INTERACTIONS
See Contraindications. Inhibits several CYP450 enzymes that are known to be involved in metabolism of other drugs, such as CYP1A2 (eg, theophylline, propranolol, tizanidine), CYP3A4 (eg, alprazolam), CYP2C9 (eg, warfarin), and CYP2C19 (eg, omeprazole). Caution with CYP450 inhibitors (eg, quinidine), and in patients with reduced levels of CYP2D6 activity. Clinically significant interactions possible with drugs that have a narrow therapeutic ratio (eg, pimozide, omeprazole, phenytoin). Avoid with alcohol and diazepam. May increase levels of TCAs, carbamazepine, warfarin, clozapine, methadone, tacrine, propranolol, amitriptyline, clomipramine, or imipramine. Bradycardia reported with diltiazem. Orthostatic hypotension, hypotension, and bradycardia reported with metoprolol. May reduce clearance of mexiletine, theophylline, and benzodiazepines metabolized by hepatic oxidation (eg, alprazolam, midazolam, triazolam). Increased risk of bleeding with aspirin, NSAIDs, and other drugs that affect coagulation. May increase PT with warfarin; monitor PT and adjust dose of oral anticoagulants. Caution with lithium; may enhance serotonergic effects and cause seizures. May cause serotonin syndrome with other serotonergic drugs (eg, triptans, TCAs, fentanyl, tryptophan) and with drugs that impair metabolism of serotonin; d/c immediately if this occurs. Smoking increases metabolism. Refer to PI for dosing modifications when used with certain concomitant therapies.
PREGNANCY AND LACTATION
Category C, not for use in nursing.
MECHANISM OF ACTION
SSRI; presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
PHARMACOKINETICS
Absorption: Cmax (at doses 100mg, 200mg, 300mg) =47ng/mL, 161ng/mL, 319ng/mL. Distribution: Vd=25L/kg; plasma protein binding (80%); found in breast milk. Metabolism: Liver (extensive) via oxidative demethylation and deamination. Elimination: Urine (2% unchanged); T1/2 =16.3 hrs.
ASSESSMENT
Assess for susceptibility to angle-closure glaucoma, risk/presence of bipolar disorder, volume depletion, history of mania, seizures, history of drug abuse, disease/condition that affects metabolism or hemodynamic response, hepatic impairment, pregnancy/nursing status, and possible drug interactions.
MONITORING
Monitor for signs/symptoms of clinical worsening, suicidality, unusual changes in behavior, serotonin syndrome, angle-closure glaucoma, bleeding events, hyponatremia, seizures, activation of mania/hypomania, discontinuation symptoms, hepatic dysfunction, and other adverse reactions. Monitor height and weight periodically in children. Monitor PT with warfarin and other oral anticoagulants. Periodically reassess the need for continued treatment.
PATIENT COUNSELING
Inform of risks, benefits, and appropriate use of therapy. Counsel to be alert for the emergence of suicidality, unusual changes in behavior, or worsening of depression, especially early during treatment and when the dose is adjusted up or down; instruct to report such symptoms especially if severe, abrupt in onset, or not part of presenting symptoms. Advise to inform physician if taking or planning to take any prescription or OTC drugs. Advise that drug may increase the risk of bleeding events. Inform that drug may cause mild pupillary dilation, which in susceptible individuals, may lead to an episode of angle-closure glaucoma. Caution about operating hazardous machinery. Instruct to notify physician if pregnant, intending to become pregnant, or breastfeeding. Instruct to avoid alcohol. Advise to notify physician if allergic reactions develop during therapy.
STORAGE
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Avoid exposure to >30°C (86°F). Protect from high humidity.