Flavocoxid Flavocoxid Citrated Zinc Bisglycinate

Flavocoxid Flavocoxid Citrated Zinc Bisglycinate Brand Names

Limbrel | LIMBREL250 | LIMBREL500 | LIMBREL525

What is Flavocoxid Flavocoxid Citrated Zinc Bisglycinate

Flavocoxid and flavocoxid citrated zinc bisglycinate (Limbrel) is a proprietary blend of flavonoids and flavans from various phytochemicals found in food plant sources.

Each capsule contains approximately 10 mg of elemental zinc, an essential mineral with physiological functions related to bone and cartilage metabolism. This nutritional supplement is marketed as a medical food for the clinical dietary management of osteoarthritis (OA); however, use is not currently recommended due to serious adverse events reported to the FDA. Advise patients taking this product to immediately stop use.

If a patient has experienced serious adverse events (e.g., drug-induced liver injury, hypersensitivity pneumonitis) or other health problems while taking this product, health care providers should help them report clinical information to the FDA through MedWatch.

A medical food is a prescription-only item, prescribed when a patient has special nutrient needs associated with a disease or health condition. The FDA does not currently have specific safety or efficacy evaluation standards for medical foods, which are not regulated as drugs.

The combination of phytochemicals found in flavocoxid is reported to non-selectively dampen arachidonic acid (AA) metabolism via the modest inhibition of both cyclooxygenase pathways (COX-1 and COX-2) and the 5-Lipoxygenase pathway (5-LOX).

Clinically, the benefit for OA patients may include a decrease in the damaging metabolic inflammatory processes in the joint leading to improved functional mobility, reduced stiffness, and decreased joint discomfort.

In a 4 week double-blind study involving 103 patients, flavocoxid 500 mg twice daily demonstrated similar reductions in signs and symptoms of knee OA when compared with naproxen 500 mg twice daily.

Patients in both treatment groups had improvements in the Visual Analogue Scale (VAS) for discomfort and global disease activity, as well as a reduction in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) over the 1 month assessment period. Adverse events were similar in both study groups, 46% for flavocoxid and 51% for naproxen.

Flavocoxid has not been evaluated for safety or efficacy in the treatment of pain or for other inflammatory musculoskeletal or arthritic conditions.

Indications

  • osteoarthritis

For dietary management of patients with osteoarthritis (OA)

Side Effects

  1. abdominal pain
  2. cough
  3. diarrhea
  4. dizziness
  5. drowsiness
  6. dyspepsia
  7. edema
  8. elevated hepatic enzymes
  9. eosinophilia
  10. fever
  11. flatulence
  12. GI bleeding
  13. hypertension
  14. jaundice
  15. musculoskeletal pain
  16. nausea
  17. pneumonitis
  18. pruritus
  19. pyrosis (heartburn)
  20. rash
  21. urticaria
  22. vomiting

Monitoring Parameters

  • laboratory monitoring not necessary

Contraindications

  • acute myocardial infarction
  • angina
  • breast-feeding
  • cardiac arrhythmias
  • cardiac disease
  • cardiomyopathy
  • cerebrovascular disease
  • children
  • coronary artery disease
  • corticosteroid therapy
  • geriatric
  • GI bleeding
  • GI disease
  • GI perforation
  • heart failure
  • hepatic disease
  • hepatotoxicity
  • hypertension
  • infants
  • jaundice
  • myocardial infarction
  • neonates
  • pain
  • peptic ulcer disease
  • peripheral edema
  • peripheral vascular disease
  • pneumonitis
  • pregnancy
  • renal disease
  • renal failure
  • renal impairment
  • rheumatoid arthritis
  • stroke
  • tachycardia

Interactions

  • Acetaminophen; Aspirin, ASA; Caffeine
  • Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
  • Amlodipine; Celecoxib
  • Aspirin, ASA
  • Aspirin, ASA; Butalbital; Caffeine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Aspirin, ASA; Caffeine; Dihydrocodeine
  • Aspirin, ASA; Caffeine; Orphenadrine
  • Aspirin, ASA; Carisoprodol
  • Aspirin, ASA; Carisoprodol; Codeine
  • Aspirin, ASA; Citric Acid; Sodium Bicarbonate
  • Aspirin, ASA; Dipyridamole
  • Aspirin, ASA; Omeprazole
  • Aspirin, ASA; Oxycodone
  • Aspirin, ASA; Pravastatin
  • Celecoxib
  • Choline Salicylate; Magnesium Salicylate
  • Diclofenac
  • Diclofenac; Misoprostol
  • Diflunisal
  • Diphenhydramine; Ibuprofen
  • Diphenhydramine; Naproxen
  • Esomeprazole; Naproxen
  • Etodolac
  • Famotidine; Ibuprofen
  • Fenoprofen
  • Flurbiprofen
  • Hydrocodone; Ibuprofen
  • Ibuprofen
  • Ibuprofen; Oxycodone
  • Ibuprofen; Pseudoephedrine
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lansoprazole; Naproxen
  • Magnesium Salicylate
  • Meclofenamate Sodium
  • Mefenamic Acid
  • Meloxicam
  • Nabumetone
  • Naproxen
  • Naproxen; Pseudoephedrine
  • Naproxen; Sumatriptan
  • Nonsteroidal antiinflammatory drugs
  • Oxaprozin
  • Piroxicam
  • Rofecoxib
  • Salsalate
  • Sulindac
  • Tolmetin
  • Valdecoxib
  • Warfarin
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