FLUNIXIN MEGLUMINE INJECTABLE SOLUTION- flunixin meglumine injection

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

FLUNIXIN MEGLUMINE (UNII: 8Y3JK0JW3U) (FLUNIXIN - UNII:356IB1O400)

Verfügbar ab:

COVETRUS

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION

Anwendungsgebiete:

Horse:  Flunixin meglumine injectable solution is recommended for the alleviation of inflammation and pain associated with muscoskeletall disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. Cattle: Flunixin meglumine injectable solution is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flunixin meglumine injectable solution is also indicated for the control of inflammation in endotoxemia. CONTRAINDICATIONS 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 flunixin can delay parturition and prolong labor which may increase the risk of stillbirth. Do not use flunixin meglumine injectable solution within 48 hours of expected parturition. Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal impairment or gastric ulceration are suspected. SAFETY Horse: A 3-fold intramuscular dose of 1.5 mg/lb of body weight daily for 10 consecutive days was safe. No changes were observed in hematology, serum chemistry, or urinalysis values. Intravenous dosages of 0.5 mg/lb daily for 15 days; 1.5 mg/lb daily for 10 days; and 2.5 mg/lb daily for 5 days produced no changes in blood or urine parameters. No injection site irritation was observed following intramuscular injection of the 0.5 mg/lb recommended dose. Some irritation was observed following a 3-fold dose administered intramuscularly. Cattle: No flunixin-related changes (adverse reactions) were noted in cattle administered a 1X (2.2 mg/kg; 1.0 mg/lb) dose for 9 days (three times the maximum clinical duration). Minimal toxicity manifested itself at moderately elevated doses (3X and 5X) when flunixin was administered daily for 9 days, with occasional findings of blood in the feces and/or urine. Discontinue use if hematuria or fecal blood are observed.

Produktbesonderheiten:

HOW SUPPLIED Flunixin meglumine injectable solution, 50 mg/mL, is available in 100 mL and 250 mL multi-dose vials.

Berechtigungsstatus:

Abbreviated New Animal Drug Application

Fachinformation

FLUNIXIN MEGLUMINE INJECTABLE SOLUTION- FLUNIXIN MEGLUMINE INJECTION
COVETRUS
----------
ANADA #200-387, APPROVED BY FDA
FLUNIXIN MEGLUMINE
INJECTABLE SOLUTION
50 MG/ML
STERILE SOLUTION, MULTI-DOSE VIAL, VETERINARY
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
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 flunixin meglumine 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)  which
exhibits a high degree of
plasma protein binding (approximately 99 percent).
However, free (unbound) drug
appears to readily partition into body tissues (V
prediction 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