flavocoxid/citrated zinc bisglycinate (Limbrel)
Classes: Nutritionals, Other; Anti-Inflammatory Agents
Dosing and uses of Limbrel (flavocoxid/citrated zinc bisglycinate)
Adult dosage forms and strengths
flavocoxid
capsule
- 250mg
- 500mg
Osteoarthritis
Medical food product indicated for the clinical dietary management of the metabolic processes of osteoarthritis
250-500 mg PO q12hr
Administration
May take with or without food
Increased absorption if taken 1 hr before or after meals
Taking with food does not affect metabolism and may buffer effects of slight indigestion
Pediatric dosage forms and strengths
Safety and efficacy not established
Limbrel (flavocoxid/citrated zinc bisglycinate) adverse (side) effects
Frequency not defined
Nausea
Diarrhea
Flatulence
Hypertension
Psoriasis
Jaundice
Liver injury
Fluid on the knee
Occult stools
Psoriasis
Warnings
Contraindications
Hypersensitivity to any component of flavocoxid or to flavonoids; foods rich in flavonoid contents include colored fruits and vegetables, dark chocolate, tea (especially green tea), red wine, and Brazil nuts
Cautions
Borderline elevations (1.2-3x ULN) of 1 or more liver tests without other signs or symptoms occurred in controlled clinical trials in <10% of subjects; notable elevations of ALT and AST (approximately >3 to 5x ULN) occurred in controlled clinical trials in <2% of subjects
Hypersensitivity pneumonitis (rare reports)
Use caution in patients with history of GI disorders
Use only under close supervision of a healthcare professionaL
Pregnancy and lactation
Pregnancy category: Not studied; not recommended
Lactation: Unknown if excreted in breast milk; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Limbrel (flavocoxid/citrated zinc bisglycinate)
Mechanism of action
Flavocoxid: Blend of 2 flavonoids, Free-B-Ring flavonoids (eg, baicalin) and flavans (eg, catechin), from Scutellaria baicalensis and Acacia catechu respectively
Reduces arachidonic acid (AA) metabolism by weakly inhibiting COX-1 and COX-2 enzymes, as well as the 5-lipoxygenase enzyme; restores and maintains balance of AA metabolites at approximately equal levels to maintain physiologic function in osteoarthritis
Elicits strong antioxidant activity to limit oxidative conversion of AA to damaging fatty acid products
Pharmacokinetics
Bound primarily to albumin
<10% metabolized via glucuronidation and sulfation by hepatic metabolism involving cytochrome P450 isoenzymes
Onset of action: 1-2 hr
