INDICATIONS
No infromation provided.
DOSAGE AND ADMINISTRATION
Dosage for Adults
The recommended starting dose for LUVOX Tablets in adult
patients is 50 mg, administered as a single daily dose
at bed time. In the controlled clinical trials establishing
the effectiveness of LUVOX Tablets in OCD, patients were
titrated with in a dose range of 100 to 300 mg/day. Consequently,
the dose should be increased in 50 mg increments every
4 to 7 days, as tolerated, until maximum therapeutic benefit
is achieved, not to exceed 300 mg per day. It is advisable
that a total daily dose of more than 100 mg should be
given in two divided doses. If the doses are not equal,
the larger dose should be given at bedtime.
Dosage for Pediatric Population (children
and adolescents)
The recommended starting dose for LUVOX Tablets in pediatric
populations (ages 8-17 years) is 25 mg, administered as
a single daily dose at bedtime. In a controlled clinical
trial establishing the effectiveness of LUVOX Tablets
in O.D. pediatric patients (ages 8-17) were started within
a dose range of 50 to 200 mg/day. The dose should be increased
in 25 mg increments every 4 to 7 days, as tolerated, until
maximum therapeutic benefit is achieved, not to exceed
200 mg per day. It is advisable that a total daily dose
of more then 50 mg should be given in two divided doses.
If the two divided doses are not equal, the larger dose
should be given at bedtime.
Dosage for Elderly or Hepatically Impaired Patients
Elderly patients and those with hepatic impairment have
been observed to have a decreased clearance of fluvoxamine
maleate. Consequently, it may be appropriate to modify
the initial dose and the subsequent dose titration for
those patient groups.
Maintenance/Continuation Extended Treatment
Although the efficacy of LUVOX Tablets beyond 10 weeks
of dosing for OCD has not been documented in controlled
trials, OCD is a chronic condition, and it is reasonable
to consider continuation for a responding patient. Dosage
adjustments should be made to maintain the patient on
the lowest effective dosage, and patients should be periodically
reassessed to determine the need for continued treatment.
HOW SUPPLIED
Tablets 25 mg: unscored, white, elliptical, film-coated
(debossed "SOLVAY" and "4202" on one
side)
Bottles of 100 .......................... NDC 0032-4202-01
Unit dose pack of 100 .............. NDC 0032-4202-11
Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed
“SOLVAY" and "4205" on side and scored
on the other)
Bottles of 100 .......................... NDC 0032-4205-01
Bottles of 1000 ........................ NDC 0032-4205-10
Unit dose pack of 100 .............. NDC 0032-4205-11
Tablets 100 mg; scored, beige, elliptical, film-coated (debossed
"SOLVAY" and "4210" on one side and
scored on the other)
Bottles of 100 ........................... NDC 0032-4210-01
Bottles of 1000 .........:............... NDC 0032-4210-10
Unit dose pack of 100 ............... NDC 0032-4210-11
LUVOX Tablets should be protected from high humidity
and stored at controlled room temperature, 15-30°
C (59-86° F) Dispense in tight containers.
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