flavocoxid/citrated zinc bisglycinate (Limbrel)

Dosing and uses of Limbrel (flavocoxid/citrated zinc bisglycinate)

• Adult
• Pediatric

 

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