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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Limbrel: 250 mg
Limbrel: 500 mg [contains brilliant blue fcf (fd&c blue #1)]
Limbrel250: Flavocoxid 250 mg and citrated zinc bisglycinate 50 mg [contains brilliant blue fcf (fd&c blue #1)]
Limbrel500: Flavocoxid 500 mg and citrated zinc bisglycinate 50 mg [contains brilliant blue fcf (fd&c blue #1)]
Brand Names: U.S.
- Anti-inflammatory Agent
- Medical Food
Exerts anti-inflammatory properties through nonspecific inhibition of cyclooxygenase (COX) and lipoxygenase (5-LOX) pathways; may also possess general analgesic and antioxidant/anticytokine properties
Effect of food: May increase absorption.
Primarily via glucuronidation and sulfation
Time to Peak
Plasma: 5.8 hours (baicalin); 1.5 hours (catechin)
11 to 12 hours (baicalin); 3 to 4 hours (catechin)
Use: Labeled Indications
Osteoarthritis: A medical food for dietary management of the metabolic processes of osteoarthritis
Note: A medical food is formulated to be administered enterally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods are not drugs and, therefore, are not subject to any FDA regulatory requirements that specifically apply to drugs (eg, requirement for written/oral prescription prior to dispensing, premarket review or approval, proof of safety and efficacy).
Hypersensitivity to flavocoxid, flavonoids, or any component of the formulation; foods rich in flavonoid include colored fruits and vegetables, dark chocolate, tea (especially green tea), red wine, and Brazil nuts.
Osteoarthritis: Adults: Oral: 250 to 500 mg (with or without zinc) every 12 hours
Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Oral: Administer with or without meals.
Store at 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy
TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use cannot be avoided, initiate tizanidine at an adult dose of 2 mg and increase in 2-4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification
Cardiovascular: Hypertension, varicose veins
Gastrointestinal: Occult stools (statistically similar to placebo)
Neuromuscular & skeletal: Fluid on the knee
Postmarketing and/or case reports (Limited to important or life-threatening): Hepatotoxicity (idiosyncratic) (Chalasani, 2014), jaundice, liver injury
Concerns related to adverse effects:
• Hepatic effects: Notable elevations of ALT and AST (approximately >3 to 5 times ULN) occurred in clinical trials in <2% of subjects; rare cases of severe hepatic reactions accompanied by jaundice or eosinophilia have been reported (cases resolved within 2 to 4 weeks after discontinuation). Discontinue immediately if abnormal liver function tests persist or worsen, if clinical signs/symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, abdominal pain, diarrhea, dark urine).
• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disorders.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Flavocoxid has not been studied in pregnant women; use during pregnancy is not recommended.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience diarrhea or flatulence. Have patient report immediately to prescriber severe dyspepsia, edema of hands or feet, excessive weight gain, melena, hematuria, ecchymosis, hemorrhaging, or considerable headache (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.