Label: KETOFEN- ketoprofen injection, solution
- NDC Code(s): 54771-4396-1, 54771-4396-2
- Packager: Zoetis Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated March 26, 2020
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Ketoprofen is a non-steroidal anti-inflammatory agent of the propionic acid class that includes ibuprofen, naproxen and fenoprofen. Each mL of KETOFEN (ketoprofen) contains 100 mg of ketoprofen in an aqueous formulation containing: L-Arginine, 70 mg; citric acid (to adjust pH); benzyl alcohol, 0.025 g (as preservative).
It is packaged in a multiple dose bottle.
KETOFEN is a non-narcotic, non-steroidal anti-inflammatory agent with analgesic and antipyretic properties.
In horses, intravenous dosages of ketoprofen ranging from 0.5 to 1.5 mg/lb resulted in dosage dependent anti-inflammatory effects in the chronic adjuvant carpitis model as depicted in the following graph.
n = number of animals
- sem = standard error of the mean
MAXIMUM FLEXION (intravenous ketoprofen, mean ± sem, n = 4)*
Additional studies using the same model in horses have shown that the effects of ketoprofen are maximal by 12 hours and still measurable at 24 hours after each dosage as depicted in the following graph.
Horses were found to tolerate ketoprofen given intravenously at dosages of 0, 1, 3 and 5 mg/lb once daily for 15 consecutive days (up to five times the recommended dosage for three times the usual duration) with no evidence of toxic effects. In clinical studies, intravenous injection of 1 mg/lb/day for five days resulted in no injection site irritation or other side effects.
At 15-fold overdose (15 mg/lb/day) for five days one of two horses developed severe laminitis, but no gross lesions or histologic changes were observed. The toxic effects observed in the horses given a 25-fold overdose (25 mg/ lb/day) for five days included inappetence, depression, icterus, abdominal swelling and postmortem findings of gastritis, nephritis and hepatitis.
- ADMINISTRATION AND DOSAGE
- SIDE EFFECTS
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
INGREDIENTS AND APPEARANCE
ketoprofen injection, solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-4396 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K) KETOPROFEN 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength ARGININE (UNII: 94ZLA3W45F) 70 mg in 1 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-4396-1 1 in 1 CARTON 1 50 mL in 1 BOTTLE 2 NDC:54771-4396-2 1 in 1 CARTON 2 100 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140269 09/26/1990 Labeler - Zoetis Inc. (828851555)