FLUVOXAMINE EXTENDED RELEASE 150MG TABLET
The use of fluvoxamine maleate extended-release capsules and other antidepressants has been associated with an increased risk of suicidal thoughts and behaviors (referred to as suicidality) in children, adolescents, and young adults during short-term studies for conditions like major depressive disorder (MDD) and various psychiatric disorders. Individuals contemplating the use of fluvoxamine maleate extended-release capsules or any other antidepressant in these age groups should carefully consider this risk in relation to their clinical requirements.
It's worth noting that short-term studies did not demonstrate a heightened risk of suicidality with antidepressants compared to placebos in adults under the age of 24; in fact, there was a reduction in risk among adults aged 65 and older. It's essential to recognize that depression and certain psychiatric conditions themselves can elevate the risk of suicide. Consequently, patients of all age groups who initiate antidepressant therapy should be closely monitored and observed for signs of clinical deterioration, suicidality, or unusual behavioral changes. Families and caregivers should also be informed about the importance of close observation and open communication with the prescribing healthcare provider.
Fluvoxamine maleate extended-release capsules are prescribed to address obsessive-compulsive disorder (OCD), as outlined in the DSM-IV criteria. OCD is typified by recurring and enduring intrusive thoughts, urges, or mental images (known as obsessions) that are incongruous with the individual's self-concept. It is coupled with repetitive, deliberate actions (referred to as compulsions) that are acknowledged by the person as excessive or illogical. These obsessions or compulsions result in significant distress, consume a considerable amount of time, or substantially disrupt the person's ability to engage in social or occupational activities.
Fluvoxamine maleate extended-release capsules have shown their effectiveness in various clinical trials. These trials include a 12-week study involving adults using fluvoxamine maleate extended-release capsules, as well as two separate 10-week trials involving adults and an additional 10-week trial in children and adolescents (aged 8 to 17 years). These trials specifically targeted outpatients diagnosed with Obsessive-Compulsive Disorder (OCD) as defined in either the DSM-IV or DSM-III-R criteria.
One study demonstrated the effectiveness of long-term use of fluvoxamine in adults utilizing immediate-release tablets (see Clinical Studies [14.2]). Healthcare professionals considering the prescription of fluvoxamine maleate extended-release capsules for extended durations should regularly assess the continued benefits of the medication for the specific patient (see Dosage and Administration).
2.1 OCD (Obsessive Compulsive Disorder)
The initial prescribed dosage is 100 mg to be taken before bedtime. Subsequently, it can be raised by 50 mg per week as long as it is well-tolerated, up to a maximum therapeutic limit of 300 mg daily.
2.4 Maintenance/Continuation of Extended Treatment
While there is limited data on the effectiveness of fluvoxamine maleate
extended-release capsules beyond a 12-week dosing period in controlled
trials, it's important to recognize that Obsessive-Compulsive Disorder
(OCD) is a chronic condition. Therefore, it is reasonable to contemplate
continued treatment for a patient who has shown a positive response. A
controlled trial, as outlined in Clinical Studies [14.2], illustrated
the advantages of keeping OCD patients on immediate-release fluvoxamine
maleate tablets after achieving a response. This continuation was
maintained for an average duration of approximately 4 weeks within a
10-week single-blind phase, during which patients were titrated to find
the most effective dosage. To ensure the best outcome, dosage
adjustments should be made to maintain the patient on the lowest
effective dose, and periodic assessments should be conducted to
determine the ongoing need for treatment.
Drugs Inhibiting or Metabolized by Cytochrome P450: Fluvoxamine inhibits several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, and CYP2C19) (7.1). Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration (7.2). Sumatriptan: Rare postmarketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan. Monitor appropriately if concomitant treatment is clinically warranted (7.2). Tacrine: Coadministration increased tacrine Cmax and AUC five- and eight-fold and caused nausea, vomiting, sweating, and diarrhea (7.2). Tricyclic Antidepressants (TCAs): Coadministration significantly increased plasma TCA levels. Use caution; monitor plasma TCA levels; reduce TCA dose if indicated (7.2). Tryptophan: Severe vomiting with coadministration (7.2). Diltiazem: Bradycardia with coadministration (7.3). Propranolol or Metoprolol: Reduce dose if coadministered with fluvoxamine and titrate more cautiously (7.3).
