PREVAIL- flunixin meglumine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

flunixin meglumine (UNII: 8Y3JK0JW3U) (flunixin - UNII:356IB1O400)

Available from:

MWI Veterinary Supply Co

INN (International Name):

flunixin meglumine

Composition:

flunixin meglumine 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Horse: Prevail® is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. Cattle: Prevail® is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Prevail® is also indicated for the control of inflammation in endotoxemia. Horse: There are no known contraindications to this drug when used as directed. Intra-arterial injection should be avoided. Horses inadvertently injected intra-arterially can show adverse reactions. Signs can be ataxia, incoordination, hyperventilation, hysteria and muscle weakness. Signs are transient and disappear without antidotal medication within a few minutes. Do not use in horses showing hypersensitivity to flunixin meglumine. Cattle: NSAIDs inhibit production of prostaglandins which are important in signaling the initiation of parturition. The use of flu

Product summary:

Prevail® (flunixin meglumine injection) 50 mg/mL, is available in 100 mL and 250 mL multiple dose vials. Approved by FDA under ANADA # 200-308 Made in the UK Distributed by: MWI Boise, ID 83705 www.VetOne.net Rev. 10/23 VETone ® Store between 2° and 30°C (36° and 86°F). Use within 60 days of first puncture. When using a draw-off spike or needle with a bore diameter larger than 16-gauge, discard any product remaining in the vial immediately after use.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

PREVAIL- FLUNIXIN MEGLUMINE INJECTION, SOLUTION
MWI VETERINARY SUPPLY CO
----------
VETONE
PREVAIL
(FLUNIXIN MEGLUMINE INJECTION)
INJECTABLE SOLUTION
50 MG/ML
ONLY FOR INTRAVENOUS USE IN BEEF AND DAIRY CATTLE.
NOT FOR USE IN DRY DAIRY COWS AND VEAL CALVES.
FOR INTRAVENOUS AND INTRAMUSCULAR USE IN HORSES.
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Each milliliter of Prevail
contains 50 mg flunixin (equivalent to 83 mg flunixin
meglumine), 0.1 mg edetate disodium, 2.5 mg sodium formaldehyde
sulphoxylate, 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, non-steroidal, analgesic
agent with anti-
inflammatory and anti-pyretic 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 post injection.
_Cattle:_ Flunixin meglumine is a weak acid (pKa=5.82) which exhibits
a high degree of
plasma protein binding (approximately 99%) . However, free (unbound)
drug appears to
readily partition into body tissues (VSS predictions range from 297 to
782 mL/kg
.
Total body water is approximately equal to 570 mL/kg) . In cattle,
elimination occurs
primarily through biliary excretion . This may, at least in part,
explain the presence of
multiple peaks in the blood concentration/time profile following IV
administration .
In healthy cattle, total body clearance has been reported to range
from 90 to 151
mL/kg/hr
. 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 p