# Luvox ### (fluvoxamine) **[Luvox](https://wiki.joshnp.com/link/152)** (fluvoxamine); not controlled; brand discontinued, generic only
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7ecd83ec-88f5-4f85-9cc2-9068375d8820&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ecd83ec-88f5-4f85-9cc2-9068375d8820)
--- ### **Summary** Luvox is a selective serotonin reuptake inhibitor whose only approved use is obsessive-compulsive disorder, indicated down to 8 years of age. The brand is discontinued, and the two generic forms are not interchangeable: the immediate-release tablet holds the pediatric indication, while the extended-release capsule has never been evaluated in children. Potent CYP1A2 inhibition gives it the largest interaction burden of any SSRI here. Not controlled; generic only. --- ### **Forms & Strengths** - **Immediate-release tablets** (pediatric-indicated, from 8 years): 25 mg, 50 mg, 100 mg - **Extended-release capsules** (never evaluated in children, adults only): 100 mg, 150 mg - No oral liquid or chewable form --- ### **Dosing** - **Age:** - Immediate-release tablets, OCD: 8 y/o and older, and adults - Extended-release capsules: adults only; never evaluated in pediatric patients - Not approved below 8 y/o, or for any indication other than OCD - **Onset:** 1 to 2 weeks for early effect; 10 weeks for full response - **Duration:** continuous with daily dosing; half-life 15.6 hours - **Initial Dose:** - 8 to 17 y/o: 25 mg once daily at bedtime - Adults: 50 mg once daily at bedtime - **Titration:** - 8 to 17 y/o: 25 mg every 4 to 7 days as tolerated - Adults: 50 mg every 4 to 7 days as tolerated - **Max Dose:** - 8 to 11 y/o: 200 mg/day - 12 to 17 y/o: 300 mg/day, the adult maximum - Adults: 300 mg/day - **Considerations:** These are immediate-release tablet doses; the extended-release capsule is not pediatric and starts at 100 mg. Split pediatric totals above 50 mg, adult totals above 100 mg, larger dose at bedtime. Titrate a girl more slowly than a boy. --- ### **Pharmacology** - **Mechanism:** potent serotonin reuptake inhibitor with no significant histaminergic, adrenergic, muscarinic or dopaminergic affinity - **Delivery / Release:** immediate-release tablet; bioavailability 53%, unaffected by food; half-life 15.6 hours, shortest of the youth SSRIs - **Metabolism:** hepatic to inactive metabolites; NONLINEAR kinetics over 100 to 300 mg/day. Clearance falls 30% in hepatic dysfunction, rises 25% in smokers. - **Class Positioning:** enzyme inhibition, not receptor pharmacology, separates it from every other SSRI. A POTENT CYP1A2 inhibitor, it also inhibits CYP2C9, CYP3A4 and CYP2C19. - **Versus siblings:** four outright drug contraindications no other SSRI carries --- ### **Indications** - **Obsessive-compulsive disorder** (ICD-10: F42.x): immediate-release tablets, 8 y/o and older, plus adults - **Obsessive-compulsive disorder, adults only** (ICD-10: F42.x): extended-release capsules, never evaluated in children - **No other approved indication at any age**; not approved for depression in the United States --- ### **Off-Label Uses** - **Pediatric anxiety disorders** (ICD-10: F93.0, F40.1, F41.1): CLASS-level support only; AHRQ graded SSRIs moderate to high. (AHRQ 2017) - **Depression in youth** (ICD-10: F32.x, F33.x), **autism repetitive behaviours** (F84.0), **ADHD** (F90.x), and pediatric use of the extended-release capsule: all insufficient - **Choosing among pediatric OCD agents:** AACAP makes CBT first line, adding medication for moderate to severe illness, with little evidence separating SSRIs. (AACAP 2011) --- ### **Contraindications & Warnings** - **Boxed Warning:** Suicidal thoughts and behaviors. Antidepressants increased this risk in children, adolescents and young adults. Observe closely for clinical worsening and suicidality, especially early and at dose changes; the label's stated interval is DAILY family observation with communication to the prescriber. Write the smallest quantity of tablets consistent with good patient management. - **Contraindicated:** - **Tizanidine:** AUC rose about 33-fold, dropping systolic pressure a mean 35 mm Hg. - **Thioridazine:** concentrations triple, causing QTc prolongation, torsades and sudden death. - **Alosetron:** AUC rose 6-fold. **Pimozide:** QT prolongation and fatal torsades. - **MAOIs**, including linezolid and methylene blue: current use or within 14 days, either direction. - **Use with caution:** - Known or suspected bipolar disorder; manic reactions hit 4% in the pediatric OCD trial. - Any seizure disorder; avoid in unstable epilepsy, stop if seizures increase. - Hyponatremia risk with diuretics; bleeding risk with aspirin, NSAIDs or anticoagulants; untreated narrow angles. - Hepatic impairment: lower the start, lengthen the interval. - Any narrow-window substrate: warfarin, theophylline, omeprazole, phenytoin. - **Screen before starting:** - The medication list against CYP1A2, CYP3A4, CYP2C9 and CYP2C19 substrates; four agents are contraindicated. - Bipolar and seizure history, baseline suicidality, height and weight, and smoking status. - Confirmation the prescription reads immediate-release TABLETS, not capsules. --- ### **Drug Interactions** - **Contraindicated:** tizanidine, thioridazine, alosetron, pimozide, and MAOIs within 14 days. Choose another agent. - **Potent CYP1A2 inhibition is the defining hazard.** Review the medication list for substrates before writing it and at every visit. - **Viloxazine** ([Qelbree](https://wiki.joshnp.com/link/36)): the likeliest collision in an ADHD practice; itself a strong CYP1A2 inhibitor, so combining stacks two potent inhibitors. - **Ramelteon** AUC rose 190-fold; do not combine. **Theophylline:** cut to one third, monitor levels. - **Warfarin** rose 98%; **tricyclics**, **carbamazepine**, **clozapine**, **propranolol** and **methadone** rise. Monitor levels; adjust methadone when fluvoxamine starts AND stops. - **Benzodiazepines:** halve the alprazolam start, avoid diazepam; lorazepam and oxazepam are unaffected. - **Other serotonergic drugs** (SNRIs, triptans, opioids, lithium, amphetamines): additive serotonin syndrome risk. Quitting smoking raises levels. --- ### **Administration** - Give at bedtime as one dose while the total is 50 mg or less in a child, 100 mg or less in an adult. - Above those thresholds divide into two doses, the larger at bedtime. Give with or without food. - Tablets must be swallowed; the 25 mg is unscored, thinly stocked. - Never substitute extended-release capsules under 18: never evaluated in children, and its lowest strength, 100 mg, is four times the pediatric start. - Titrate a girl more slowly than a boy the same age; girls reach benefit at lower doses. - Missed dose: same day only, never doubled. Never stop abruptly. --- ### **Side Effects** - **Common:** nausea at about 40%, the commonest reason a child stops early, plus headache, somnolence, insomnia, dry mouth, nervousness, diarrhea and tremor; in children also emotional lability, hyperkinesia, ecchymosis and epistaxis - **Serious:** - Suicidal thoughts and behavior: the boxed warning. Reassess early and at each dose change. - Serotonin syndrome: stop fluvoxamine and every serotonergic drug immediately. - Manic or hypomanic switch, 4% in the pediatric OCD trial: stop rather than titrating through. - Seizures, hyponatremia as SIADH, bleeding up to life-threatening haemorrhage. - Angle closure glaucoma, priapism, sexual dysfunction, weight loss. Ask directly and plot growth. --- ### **Monitoring & Labs** - **Suicidality:** daily family observation, plus clinician assessment of ideation and behaviour at every contact for 3 months and at every dose change. - **Medication reconciliation:** recheck the full list at EVERY visit against CYP1A2, CYP3A4, CYP2C9 and CYP2C19 substrates. The highest-yield task. - **Activation and mania:** ask during titration and every 3 months once stable about reduced sleep need, pressured speech and hyperactivity. - **Growth:** height and weight charted at baseline, quarterly for a year, then twice yearly. - **Sodium, bleeding, seizures:** check sodium for new headache or confusion; ask about bruising, nosebleeds and convulsions. - **Interacting-drug levels:** check any narrow-window co-drug at baseline and 1 week post-change. - **Response:** reassess with the same instrument at 10 weeks. --- ### **Discontinuation & Taper** - Do not stop abruptly; reduce gradually and monitor for discontinuation symptoms. - Discontinuation syndrome: dysphoric mood, irritability, agitation, dizziness, electric shock sensations, headache, insomnia. - Taper matters more here than for most SSRIs. Slow it as the dose gets small. - If intolerable symptoms follow a decrease, resume the previous dose and go slower. Exception: emergent suicidality, where the label directs tapering as fast as feasible. - Adjust methadone when fluvoxamine comes off. No drug holidays. --- ### **Pregnancy & Lactation** - **Pregnancy:** observational data show no clear risk of major birth defects or miscarriage. Risks: persistent pulmonary hypertension of the newborn, poor neonatal adaptation, a less than 2-fold rise in postpartum hemorrhage. - **Fertility:** animal findings suggest impaired fertility on treatment. Weigh risk against relapse. - **Lactation:** relative infant dose roughly 1%; maternal doses up to 300 mg daily are not expected to cause adverse effects, and not a reason to stop nursing. (LactMed 2026) - **Infant monitoring:** watch for diarrhea, vomiting, poor sleep and agitation. (LactMed 2026) - **Exposure Registry:** National Pregnancy Registry for Antidepressants, 1-844-405-6185, [womensmentalhealth.org](https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/) --- ### **Counseling Points** - **Counsel the family on:** - The tablet and the capsule not being the same medicine. If the pharmacy hands over capsules, call first. - Nausea being the commonest problem, worst in the first two weeks; food and slower titration, not stopping. - Bedtime dosing at 50 mg or less, splitting above that with the larger half at bedtime. - Bringing every new medicine to you first, over-the-counter included; this one changes how the body handles others. - Watching daily, early and after dose changes, for agitation, emotional swings or self-harm talk; never stopping abruptly; 10 weeks being the decision point. - **Advise them to call for:** - New or worsening self-harm talk, or a sudden mood or behaviour change. - Several nights of almost no sleep, or pressured speech. - Agitation with fever, shivering, twitching or stiffness; same-day call. - Nosebleeds that will not stop, unusual bruising, or blood in vomit or stool. - Headache with confusion or unsteadiness, which can be low sodium. - A seizure, an erection over 4 hours, or sudden eye pain. --- ### **References** 1. DailyMed. Fluvoxamine maleate tablets, ANI Pharmaceuticals; the pediatric-indicated IR product. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ecd83ec-88f5-4f85-9cc2-9068375d8820 2. DailyMed. Fluvoxamine maleate extended-release capsules, Actavis Pharma; source of the never-evaluated-in-children statement. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bbd7e39-b9ab-4716-9522-aa8c4b92210e 3. LactMed. Fluvoxamine. Drugs and Lactation Database, NICHD. https://www.ncbi.nlm.nih.gov/books/NBK501187/ 4. AHRQ. Anxiety in Children. Comparative Effectiveness Review 192. https://www.ncbi.nlm.nih.gov/books/NBK476277/ 5. AACAP. Practice Parameter for Obsessive-Compulsive Disorder in Youth. https://psychiatryonline.org/doi/10.1176/appi.focus.10.3.360 6. FDA. National Drug Code Directory, openFDA; generic name fluvoxamine. https://api.fda.gov/drug/ndc.json?search=generic\_name:%22fluvoxamine%22&limit=1000