- SPL UNCLASSIFIED SECTION
- WARNINGS
- DESCRIPTION
- VETERINARY INDICATIONS
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SPL UNCLASSIFIED SECTION
ACTIVITY Flunixin meglumine is a potent, nonnarcotic, 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. Oral studies in the horse show onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.
- CONTRAINDICATIONS
- FOOD SAFETY WARNING
- PRECAUTIONS
- SPL UNCLASSIFIED SECTION
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DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION The recommended dose of flunixin is 0.5 mg per lb of body weight once daily. The BANAMINE Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time.
DOSAGE TABLE Syringe Mark* Horse Weight (lbs) BANAMINE Paste Delivered (g) Mg Flunixin Delivered - *
- Use dial edge nearest syringe barrel to mark dose.
0 — — — 250 250 2.5 125 500 500 5.0 250 750 750 7.5 375 1000 1000 10.0 500 The paste is orally administered by inserting the nozzle of the syringe through the interdental space, and depositing the required amount of paste on the back of the tongue by depressing the plunger.
Treatment may be given initially by intravenous or intramuscular injection of BANAMINE Solution, followed by BANAMINE Granules or BANAMINE Paste on Days 2 to 5. BANAMINE treatment should not exceed 5 consecutive days.
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SPL UNCLASSIFIED SECTION
TOXICITY No toxic effects were observed in rats given oral flunixin 2 mg/kg per day for 42 days. Higher doses produced ulceration of the gastrointestinal tract. The emetic dose in dogs is between 150 and 250 mg/kg. Flunixin was well tolerated in monkeys dosed daily with 4 mg/kg for 56 days. No adverse effects occurred in horses dosed orally with 1.0 or 1.5 mg/lb for fifteen consecutive days.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label
Syringe contains flunixin
meglumine equivalent to1500 mg
FLUNIXIN
Net Wt 30 gNDC 0061-0214-02
Banamine®
(flunixin meglumine paste)
PasteFor oral use in horses only.
Warning: Do not use in horses intended
for human consumption.
Caution: Federal law restricts this drug to
use by or on the order
of a licensed veterinarian.
Approved by FDA under NADA # 137-409MERCK
Animal Health -
INGREDIENTS AND APPEARANCE
BANAMINE
flunixin meglumine pasteProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0061-0214 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Flunixin Meglumine (UNII: 8Y3JK0JW3U) (Flunixin - UNII:356IB1O400) Flunixin 1500 mg in 1 g Inactive Ingredients Ingredient Name Strength Starch, Corn (UNII: O8232NY3SJ) Propylene Glycol (UNII: 6DC9Q167V3) Carboxymethylcellulose (UNII: 05JZI7B19X) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0061-0214-02 30 g in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA137409 11/11/2011 Labeler - Merck Sharp & Dohme Corp. (001317601)