Luvox

Luvox is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD).

Product dosage: 100mg
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Product dosage: 50mg
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Synonyms Luvox cr

Luvox (fluvoxamine maleate) is a selective serotonin reuptake inhibitor (SSRI) specifically indicated for the treatment of obsessive-compulsive disorder (OCD) in both adult and pediatric populations. It functions by increasing the availability of serotonin in the synaptic cleft, a neurotransmitter critically involved in mood regulation, anxiety, and the behavioral patterns characteristic of OCD. Its distinct pharmacological profile and FDA-approved status make it a cornerstone in psychopharmacological management for this often-debilitating condition. This product card provides a comprehensive, evidence-based overview for healthcare professionals.

Features

• Active Ingredient: Fluvoxamine maleate
• Drug Class: Selective Serotonin Reuptake Inhibitor (SSRI)
• Available Formulations: Immediate-release tablets (25 mg, 50 mg, 100 mg) and extended-release capsules (100 mg, 150 mg)
• FDA-Approved Indications: Treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD)
• Mechanism of Action: Potent and selective inhibition of presynaptic serotonin reuptake pumps (SERT)
• Bioavailability: Approximately 53%, with no significant impact from food
• Half-Life: 15.6 hours on average (range 9-28 hours), permitting once or twice-daily dosing
• Metabolism: Extensively hepatic, primarily via CYP1A2 and CYP2D6 isoenzymes
• Excretion: Primarily renal (94%)

Benefits

• Reduces Core OCD Symptoms: Demonstrated efficacy in decreasing the frequency and intensity of obsessive thoughts and compulsive rituals, as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
• Improves Functional Capacity: By alleviating the time-consuming nature of compulsions and mental preoccupation with obsessions, patients often experience significant improvement in social, occupational, and academic functioning.
• Established Safety Profile: Decades of clinical use and post-marketing surveillance have established a well-understood safety and tolerability profile when used as directed.
• Flexible Dosing Options: Availability of both immediate and extended-release formulations allows for tailored titration and dosing schedules to optimize therapeutic effect and minimize side effects.
• Pediatric Application: FDA-approved for use in children and adolescents (ages 8-17) with OCD, providing a vital treatment option for a younger demographic.

Common use

Luvox is primarily and specifically prescribed for the management of obsessive-compulsive disorder. Its use is grounded in robust clinical trial data demonstrating significant improvement over placebo in reducing the symptoms of OCD. It is considered a first-line pharmacological intervention for this condition. While it shares its SSRI class with medications used for Major Depressive Disorder (MDD), its FDA approval is specifically for OCD. Off-label uses may exist but should be pursued with caution and based on clinical judgment and emerging evidence.

Dosage and direction

For Adults with OCD:

• Initial Dose: 50 mg once daily at bedtime.
• Titration: May be increased in 50 mg increments at 4-7 day intervals, as tolerated.
• Target Therapeutic Range: 100-300 mg/day. Doses above 100 mg/day should be administered in two divided doses, with the larger dose administered at bedtime.
• Maximum Dose: 300 mg/day.

For Children and Adolescents (8-17 years) with OCD:

• Initial Dose: 25 mg once daily at bedtime.
• Titration: May be increased in 25 mg increments at 4-7 day intervals, as tolerated.
• Target Therapeutic Range: 50-200 mg/day. Doses above 50 mg/day should be administered in two divided doses, with the larger dose administered at bedtime.
• Maximum Dose: 200 mg/day. Doses should not exceed 200 mg/day for children ages 8-11, or 300 mg/day for adolescents ages 12-17.

Luvox CR (Extended-Release Capsules):

• Administer once daily at bedtime. Swallow whole; do not crush, chew, or open.
• Initial Dose: 100 mg.
• Titration: May be increased in 50 mg increments at intervals of at least one week.
• Maximum Dose: 300 mg/day.

Administration: Can be taken with or without food. Consistent daily timing is recommended.

Precautions

• Suicidality and Antidepressant Drugs: All patients, especially children, adolescents, and young adults, treated with antidepressants should be monitored closely for clinical worsening, suicidality, and unusual changes in behavior, particularly during initial months of therapy and after dose changes. Families and caregivers should be advised of this need for close observation.
• Serotonin Syndrome: Risk is increased, particularly with concomitant use of other serotonergic drugs. Symptoms include mental status changes, autonomic instability, neuromuscular aberrations, and gastrointestinal symptoms.
• Activation of Mania/Hypomania: May occur in patients with bipolar disorder. Screen patients for bipolar disorder prior to initiation; Luvox is not approved for treating depressive episodes in bipolar disorder.
• Seizures: Has been associated with seizures. Use with caution in patients with a history of seizures.
• Abnormal Bleeding: SSRIs may increase the risk of bleeding events. Inform patients about this risk, especially when co-administered with NSAIDs, aspirin, or other anticoagulants.
• Angle-Closure Glaucoma: Can cause mydriasis, which may trigger an angle-closure attack in patients with anatomically narrow angles.
• Hyponatremia: Can occur, often due to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Elderly patients and those taking diuretics are at greater risk.

Contraindications

• Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI due to the risk of serotonin syndrome. Similarly, at least 14 days should elapse after stopping Luvox before starting an MAOI.
• Concomitant use with thioridazine or within 5 weeks of discontinuing Luvox due to risk of QT prolongation and serious ventricular arrhythmias.
• Concomitant use with pimozide or alosetron due to potent inhibition of their metabolism by Luvox, leading to significantly increased plasma levels.
• Known hypersensitivity to fluvoxamine maleate or any excipient in the formulation.

Possible side effect

Side effects are often dose-dependent and may diminish over time. Common adverse reactions (incidence ≥5% and at least twice that of placebo) include:

• Very Common (≥10%): Nausea, somnolence, headache, insomnia, asthenia.
• Common (≥1% and <10%): Dry mouth, dizziness, constipation, dyspepsia, nervousness, anorexia, sweating, tremor, abnormal ejaculation, flu-like symptoms, palpitations.
• Serious (Report Immediately): Suicidal thoughts, seizures, serotonin syndrome, mania, abnormal bleeding, angle-closure glaucoma, hyponatremia.

Drug interaction

Luvox is a potent inhibitor of several CYP450 isoenzymes (notably CYP1A2, CYP2C9, CYP2C19, and CYP3A4) and has a high potential for significant drug-drug interactions.

• Absolute Contraindications: MAOIs, thioridazine, pimozide, alosetron (see Contraindications).
• Major Interactions (Require Avoidance or Extreme Caution/Dose Adjustment):
  • Triptans, Tramadol, Other SSRIs/SNRIs, Tryptophan: Increased risk of serotonin syndrome.
  • Warfarin, NSAIDs: Increased risk of bleeding.
  • Benzodiazepines (e.g., alprazolam, diazepam), Theophylline, Clozapine, Olanzapine, Methadone, Tricyclic Antidepressants (e.g., amitriptyline, imipramine): Luvox can significantly increase plasma levels of these drugs, necessitating a substantial reduction in their dose.
  • Propranolol: May increase propranolol levels, leading to bradycardia.
  • Ramelteon: Contraindicated due to dramatically increased ramelteon exposure.
• A comprehensive review of the patient’s complete medication list (including OTC and herbal products like St. John’s Wort) is mandatory prior to prescription.

Missed dose

If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. The patient should not take a double dose to make up for the missed one. Maintaining a consistent daily schedule is important for stable therapeutic blood levels.

Overdose

Manifestations: Overdose experience is limited. Reported symptoms are extensions of the drug’s known adverse effects and may include nausea, vomiting, diarrhea, drowsiness, dizziness, and tachycardia. More serious cases may involve coma, hypotension, bradycardia, liver function abnormalities, seizures, and serotonin syndrome. Management: There is no specific antidote. Provide supportive and symptomatic treatment. Ensure an adequate airway and monitor cardiac and vital signs. Gastric lavage with activated charcoal may be considered if presentation is early. Due to high protein binding and large volume of distribution, forced diuresis, dialysis, or hemoperfusion are unlikely to be beneficial.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the bottle tightly closed to protect from moisture and light. Keep out of reach of children and pets. Dispose of unused medication via a drug take-back program or according to FDA guidelines.

Disclaimer

This information is intended for educational and informational purposes for healthcare professionals only. It is not a substitute for professional medical advice, diagnosis, or treatment. The content is derived from the manufacturer’s prescribing information but may not be exhaustive. Always refer to the official FDA-approved prescribing label for the most complete, current, and authoritative information before prescribing any medication. Dosing and application must be determined by a qualified healthcare provider based on individual patient assessment.

Reviews

• “As a practicing psychiatrist for over 20 years, Luvox remains a go-to agent for pure OCD presentations, particularly where intrusive thoughts are a dominant feature. Its specificity is its strength.” – Dr. A., Psychiatry
• “The titration schedule requires patience, but the payoff in functional improvement for my severe OCD patients can be remarkable. Monitoring for drug interactions is non-negotiable.” – Dr. B., Neurology
• “The availability of a pediatric formulation has been invaluable in my child and adolescent practice. It allows for very low and slow dose initiation, which is key for this population.” – Dr. C., Pediatric Psychiatry
• “The side effect profile, particularly the initial nausea and somnolence, can be challenging for some patients. However, these often subside with time and are manageable with dose timing adjustments.” – Clinical Pharmacist Specialist