Zoetis
(ketoprofen)
Sterile Solution, 100 mg/mL
For intravenous use in horses only.
NADA 140-269, Approved by FDA
CAUTION
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION
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.
PHARMACOLOGY
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.
MAXIMUM FLEXION (intravenous ketoprofen, mean ± sem, n = 4)*
*sem = standard error of the mean
n = number of animals
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.
MAXIMUM FLEXION (mean ± sem, n = 6)*
*sem = standard error of the mean
n = number of animals
INDICATION
KETOFEN® (ketoprofen) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
ADMINISTRATION AND DOSAGE
The recommended dosage is 1 mg/lb (1 mL/100 lbs) of body weight once daily. Treatment is administered by intravenous injection and may be repeated for up to five days. Onset of activity is within two hours with peak response by 12 hours.
CONTRAINDICATIONS
There are no known contraindications to this drug when used as directed. Intra-arterial injection should be avoided. Do not use in a horse if it has previously shown hypersensitivity to ketoprofen.
CAUTION
This product should not be used in breeding animals since the effects of KETOFEN on fertility, pregnancy or fetal health in horses have not been determined.
PRECAUTIONS
Studies to determine activity of KETOFEN when administered concomitantly with other drugs have not been conducted. Drug compatibility should be monitored closely in patients requiring adjunctive therapy.
WARNING
Do not use in horses intended for human consumption.
SIDE EFFECTS
During investigational studies, no significant side effects were reported.
HOW SUPPLIED
KETOFEN (ketoprofen) Solution 100 mg/mL is available in 50 mL and 100 mL multidose bottles.
Store at controlled room temperature 20° to 25°C (68° to 77°F).