Flunixin Meglumine
Banamine Injectable Solution (flunixin meglumine) is an injectable non-steroidal anti-inflammatory drug for horses and cattle. Banamine rapidly reduces fever, and alleviates pain and inflammation associated with musculoskeletal disorders, mastitis, visceral pain and respiratory disease.
Horse: BANAMINE Injectable Solution 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:
BANAMINE Injectable Solution is indicated for the control of pyrexia
associated with bovine respiratory disease and endotoxemia and acute bovine
mastitis. BANAMINE Injectable Solution is also indicated for the control of
inflammation in endotoxemia.
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.
Dose and Administration:
Horse: The recommended dose for
musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight
once daily. Treatment may be given by intravenous or intramuscular injection
and repeated for up to 5 days. Studies show onset of activity is within 2
hours. Peak response occurs between 12 and 16 hours and duration of activity
is 24-36 hours.
The recommended dose for the
alleviation of pain associated with equine colic is 0.5 mg per pound of body
weight. Intravenous administration is recommended for prompt relief.
Clinical studies show pain is alleviated in less than 15 minutes in many
cases. Treatment may be repeated when signs of colic recur. During clinical
studies approximately 10% of the horses required one or two additional
treatments. The cause of colic should be determined and treated with
concomitant therapy.
Cattle:
The recommended dose for control of pyrexia associated with bovine
respiratory disease and endotoxemia and control of inflammation in
endotoxemia, is 1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) of
body weight given by slow intravenous administration either once a day as a
single dose or divided into two doses administered at 12-hour intervals for
up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb)
of body weight. Avoid rapid intravenous administration of the drug.
The recommended dose for acute
bovine mastitis is 2.2 mg/kg (1 mg/lb; 2mL per 100 lbs) of body weight given
once by intravenous administration.
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:
There are no known contraindications to this drug in cattle when used as
directed. Do not use in animals showing hypersensitivity to flunixin
meglumine. Use judiciously when renal impairment or gastric ulceration are
suspected.
Residue Warnings: Cattle must not be slaughtered for human
consumption within 4 days of the last treatment. Milk that has been
taken during treatment and for 36 hours after the last treatment
must not be used for food. Not for use in dry dairy cows. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
Not for use in horses intended for food.
PRECAUTIONS:
As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with
gastrointestinal and renal toxicity. Sensitivity to drug-associated adverse
effects varies with the individual patient. Patients at greatest risk for
renal toxicity are those that are dehydrated, on concomitant diuretic
therapy, or those with renal, cardiovascular, and/or hepatic dysfunction.
Since many NSAIDs possess the
potential to induce gastrointestinal ulceration, concomitant use of BANAMINE
Injectable Solution with other anti-inflammatory drugs, such as other NSAIDs
and corticosteroids, should be avoided or closely monitored.
Horse:
The effect of BANAMINE Injectable Solution on pregnancy has not been
determined. Studies to determine the activity of BANAMINE Injectable
Solution when administered concomitantly with other drugs have not been
conducted. Drug compatibility should be monitored closely in patients
requiring adjunctive therapy.
Cattle:
Do not use in bulls intended for breeding, as reproductive effects of
BANAMINE Injectable Solution in these classes of cattle have not been
investigated. NSAIDs are known to have potential effects on both parturition
and the estrous cycle. There may be a delay in the onset of estrus if
flunixin is administered during the prostaglandin phase of the estrous
cycle. The effects of flunixin on imminent parturition have not been
evaluated in a controlled study. NSAIDs are known to have the potential to
delay parturition through a tocolytic effect. Do not exceed the recommended
dose.
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.
Adverse Reactions: In horses, isolated reports of local reactions following
intramuscular injection, particularly in the neck, have been received. These
include localized swelling, sweating, induration, and stiffness. In rare
instances in horses, fatal or nonfatal clostridial infections or other
infections have been reported in association with intramuscular use of
BANAMINE Injectable Solution. In horses and cattle, rare instances of
anaphylactic-like reactions, some of which have been fatal, have been
reported, primarily following intravenous use.
How Supplied:
BANAMINE Injectable Solution, 50 mg/mL, is available in 50-mL, 100-mL,
and 250-mL multi-dose vials.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian
Store between
2° and 30°C (36° and 86°F)
Intervet/Schering-Plough
Animal Health
