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Flavocoxid

Pronunciation

(fla vo KOKS id)

Index Terms

  • Flavan

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

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.

  • Limbrel
  • Limbrel250
  • Limbrel500

Pharmacologic Category

  • Anti-inflammatory Agent
  • Medical Food

Pharmacology

Exerts anti-inflammatory properties through nonspecific inhibition of cyclooxygenase (COX) and lipoxygenase (5-LOX) pathways; may also possess general analgesic and antioxidant/anticytokine properties

Absorption

Effect of food: May increase absorption.

Metabolism

Primarily via glucuronidation and sulfation

Time to Peak

Plasma: 5.8 hours (baicalin); 1.5 hours (catechin)

Half-Life Elimination

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).

Contraindications

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.

Dosing: Adult

Osteoarthritis: Oral: 250 to 500 mg (with or without zinc) every 12 hours

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Administration

Oral: Administer with or without meals.

Storage

Store at 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Drug Interactions

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

Adverse Reactions

≥2%:

Cardiovascular: Hypertension, varicose veins

Dermatologic: Psoriasis

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

Warnings/Precautions

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).

Disease-related concerns:

• 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.

Pregnancy Considerations

Flavocoxid has not been studied in pregnant women; use during pregnancy is not recommended.

Patient Education

• 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, nausea, or flatulence. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), or cough (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 health care 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.

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