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For: Horses, Beef and Dairy Cattle.
DESCRIPTION:
Banamine Injectable A sterile solution of flunixin meglumine used for alleviation of pain and inflammation associated with colic and musculoskeletal disorders in horses. Banamine Injectable now approved for cattle in the U.S.
Banamine comes in an injectable form for intravenous or intramuscular use. It can also be given orally in the paste or granule forms. Banamine is in the same category of drugs as aspirin and phenylbutazone (bute). They are all nonsteroidal anti-inflammatory drugs.
Banamine is a prescription drug, many horse owners keep it on hand because it is an effective medication for colic. It relieves pain, and in some of the more serious cases of colic, fights some of the dangerous toxins that may be released from the intestinal system into the bloodstream.
INGREDIENT(S):
Each milliliter of BANAMINE Injectable Solution contains flunixin meglumine equivalent to 50 mg flunixin, 0.1 mg edetate disodium, 2.5 mg sodium formaldehyde sulfoxylate, 4.0 mg diethanolamine, 207.2 mg propylene glycol; 5.0 mg phenol as preservative, hydrochloric acid, water for injection qs.
CLINICAL 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%). 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.7 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 phase (V?). This discrepancy appears to be attributable to extended drug elimination from a deep compartment.8The terminal half-life has been shown to vary from 3.14 to 8.12 hours.
Flunixin persists in inflammatory tissues and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentrations. These observations account for the counterclockwise hysteresis associated with flunixin's pharmacokinetic/pharmacodynamic relationships.
Therefore, prediction of drug concentrations based upon the estimated plasma terminal elimination half-life will likely underestimate both the duration of drug action and the concentration of drug remaining at the site of activity.
USES AND INDICATIONS:
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.
CONTRAINDICATIONS AND PRECAUTION:
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.
s 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.
ADVERSE EFFECTS AND 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.
For animal use only. Keep out of the reach of children and other animals.
DOSAGE 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.
STORAGE:
Store between 2° and 30°C (36° and 86°F).
MANUFACTURER: INTERVET/SCHERING-PLOUGH ANIMAL HEALTH
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