Product Description.:
LIMBREL, 52001
capsule , blue , oblong oblong
White ink
A specially formulated medical food product, consisting primarily of a proprietary blend of flavonoid (polyphenol) ingredients, for the clinical dietary management of the metabolic processes of osteoarthritis (OA). Must be administered under physician supervision.
INDICATIONS
Recommended Use
LIMBREL is intended for the clinical dietary management of the metabolic processes of osteoarthritis (OA).
Disclaimed Use
LIMBREL has not been investigated for use in the clinical dietary management of rheumatoid arthritis (RA), acute pain or primary dysmenorrhea.
DOSAGE AND ADMINISTRATION
Recommended Administration
For the clinical dietary management of the metabolic processes of OA, take either one 250 mg or one 500 mg capsule every 12 hours for 500 mg to 1,000 mg total daily consumption as directed by a physician. LIMBREL is safe taken with or without other foods. If patients forget to take the prescribed amount, take it as soon as they remember and then resume the normal schedule as directed by a physician.
SIDE EFFECTS
In a randomized, double-blind placebo-controlled safety study of 60 days, subjects ingested either 125 mg of LIMBREL or placebo. Rates of symptomatic adverse events were low and did not differ between the LIMBREL and placebo arms. There were also no usage-related changes in routine hematological or biochemical safety parameters.
In a controlled clinical trial of 90 days duration, the incidence of clinical side effects and changes in routine hematological and biochemical parameters and incidence of fecal occult blood positivity were identical for the LIMBREL and placebo groups. Adverse events reported included increased varicose veins, elevated hypertension, fluid accumulation in the knee, psoriasis in the LIMBREL 125 mg BID arm, psoriasis in the LIMBREL 250 mg BID arm, and reduced flexibility in the placebo arm.
Adverse reactions were also collected in a double-blind, randomized clinical trial of 30 days, although this study was not designed to specifically assess usage-related differences in adverse events. Overall, no serious adverse events were reported for LIMBREL. There was a non-significant trend toward more frequent edema and nonspecific musculoskeletal events in the naproxen arm. No significant changes were observed within or between arms for weight, systolic blood pressure, or diastolic blood pressure. As expected in a trial of this duration, no fecal occult blood was detected in study subjects, including those taking naproxen.
