Luvox CR
Drug - Luvox CR (fluvoxamine maleate) extended release capsules [Jazz Pharmaceuticals]
June 2011
FDA approved indication
Luvox CR is indicated for the treatment of obsessive compulsive disorder (OCD) in adults.
The indication for Social Anxiety Disorder (SAD) was removed from the product label May 2011. Luvox CR will not be approved for use for SAD after June 2011.
Criteria
- Patient is an adult with OCD AND
- Patient has demonstrated clinical benefit but has not tolerated immediate release (IR) fluvoxamine when dosed at bedtime AND
- Patient is not concurrently taking tizanidine, thioridazine, or pimozide, which are contraindicated for use with fluvoxamine
Rationale
- Both the original IR fluvoxamine and CR products allow for once daily dosing, and both are to be administered at bedtime.
- The half-life of Luvox CR (16.3 hours) does not appear to offer a clinical advantage to generic fluvoxamine (15 hours). Both achieve steady state concentrations within a week of dosing.
- Luvox CR has not been shown to be superior in clinical efficacy or severity of adverse events to fluvoxamine immediate release.
- Luvox CR is about $5.00 to $5.50 per tablet and may be dosed up to 3 tablets daily.
- Luvox CR Capsules are available in 100 mg and 150 mg strengths for oral administration. The approved dosage range for Luvox CR is 100 mg/day to 300 mg/day once daily.
- Luvox CR does not eliminate multiple tablet dosing, and any dose ≥200 mg requires multiple tablets.
- Safety and effectiveness of Luvox CR has not been evaluated in pediatric patients. However, fluvoxamine exhibits non-linear pharmacokinetics in children, as in adults, and fluvoxamine concentrations were 2 fold and 3 fold higher in children than in adolescents at steady state.
Questions?
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