flavocoxid/citrated zinc bisglycinate (Rx)

Brand and Other Names:Limbrel
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Dosing & Uses

AdultPediatric

Dosage Forms & 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

Safety and efficacy not established

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Interactions

Interaction Checker

and flavocoxid/citrated zinc bisglycinate

No Results

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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                  Minor (0)

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                    Adverse Effects

                    Frequency Not Defined

                    Nausea

                    Diarrhea

                    Flatulence

                    Hypertension

                    Psoriasis

                    Jaundice

                    Liver injury

                    Fluid on the knee

                    Occult stools

                    Psoriasis

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                    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

                    Cases of serious adverse events, including drug-induced liver injury and hypersensitivity pneumonitis, involving flavocoxid/citrated zinc bisglycinate; advise patients to immediately discontinue treatment; if patients experience any symptoms or other health problems while taking flavocoxid/citrated zinc bisglycinate, the FDA encourages you to work with them to provide clinical information through MedWatch

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                    Pregnancy & 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.

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                    Pharmacology

                    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

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                    Images

                    No images available for this drug.
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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                    Formulary

                    FormularyPatient Discounts

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                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    Tier Description
                    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
                    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                    ST Step Therapy
                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                    OR Other Restrictions
                    Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.