Flumeglumine Injection

Generic name: flunixin meglumine injection
Dosage form: FOR ANIMAL USE ONLY

FluMeglumine

50 mg/mL

(FLUNIXIN MEGLUMINE)

Injectable

Solution

Veterinary

For Intravenous or Intramuscular Use in Horses and for Intravenous Use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION: Each milliliter of FluMeglumine Injectable Solution contains flunixin meglumine equivalent to 50 mg flunixin, 0.1 mg edetate disodium, 2.2 mg sodium formaldehyde sulfoxylate, 4.0 mg diethanolamine, 207.2 mg propylene glycol, 5.0 mg phenol as preservative, hydrochloric acid, water for injection q.s.

PHARMACOLOGY

Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test.

Horse: Flunixin is four times as potent on a mg-per-mg basis as phenylbutazone as measured by the reduction in lameness and swelling in the horse. Plasma half-life in horse serum is 1.6 hours following a single dose of 1.1 mg/kg. Measurable amounts are detectable in horse plasma at 8 hours postinjection.

Cattle: Flunixin meglumine is a weak acid (pKa=5.82)1 which exhbits a high degree of plasma protein binding (approximately 99%).2 However, free (unbound) drug appears to readily partition into body tissues (Vss predictions range from 297 to 782 mL/kg.2-5 Total body water is approximately equal to 570 mL/kg).6 In cattle, elimination occurs primarily through biliary excretion.7 This may, at least in part, explain the presence of multiple peaks in the blood concentration/time profile following IV administration.2

In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr.2-5 These studies also report a large discrepancy between the volume of distribution at steady state (Vss) and the volume of distribution associated with the terminal elimination phase (VB). This discrepancy appears to be attributable to extended drug elimination from a deep compartment.8 The terminal half-life has been shown to vary from 3.14 to 8.12 hours.2-5 Flunixin persists in inflammatory tissues9 and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma ...