Banamine® Injectable Solution

Banamine® Injectable Solution



Pharmaceutical Name
Flunixin meglumine


Overview
Banamine brand of flunixin meglumine is the pioneer injectable non-steroidal anti-inflammatory drug approved for cattle and horses in the United States!

Banamine rapidly reduces the fever and lung inflammation that typically accompany bovine respiratory disease (BRD). With Banamine as part of a BRD treatment program, cattle feel better fast, and studies show they eat better sooner and have fewer lung lesions than cattle treated with conventional therapies.

Each milliliter of BANAMINE Injectable Solution contains flunixinmeglumine equivalent to 50 mg flunixin, 0.1 mg edetate disodium, 2.5 mg sodium formaldehyde sulfoxylate, 4.0 mg diethanolamine, 207.2mg propylene glycol; 5.0mg phenol as preservative, hydrochloric acid,water for injection qs

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.

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Description
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 q.s.

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, endotoxemia and acute bovine mastitis. BANAMINE Injectable Solution is also indicated for the control of inflammation in endotoxemia.

Administration and Dosage
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 cattle 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: 2 mL per 100 lbs) of body weight given once by intravenous administration.

Caution
As a class, cyclo-oxygenase inhibitory NSAID's 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 NSAID's 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 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.

Supply Information
BANAMINE Injectable Solution, 50 mg/mL is available in 50-mL (NDC 0061-0851-02), 100-mL (NDC 0061-0851-03), and 250-mL (NDC 0061-0851-04) multi-dose vials.
Store between 2° and 30° C (36° and 86° F).

Contact information
US only:
Merck Animal Health
livestocktechsrvc@merck-animal-health.com
1-800-211-3574

Website
www.banamine.com

Product Label(s) and MSDS
Product Label