Ketofen: Product Information (Page 2 of 3)

INDICATIONS

KETOFEN® (ketoprofen) is indicated for the control of pyrexia associated with Bovine Respiratory Disease (BRD) in beef heifers, beef steers, beef calves 2 months of age and older, beef bulls, replacement dairy heifers, and dairy bulls. Not for use in reproducing animals over one year of age, dairy calves, or veal calves. Not for use in lactating dairy cattle or calves <2 months old.

DOSAGE AND ADMINISTRATION

Cattle: The recommended dosage is 3 mg/kg (1 mL/33.3 kg) or 1.36 mg/lb (1 mL/74 lb) of body weight. Treatment is administered by subcutaneous injection once daily and may be repeated for up to three days if pyrexia persists.
Use contents within 4 months of first vial puncture.Cattle Dosing Guide:

Animal Weight (lb) Dose Volume (mL) Animal Weight (lb) Dose Volume (mL)
150 2.1 600 8.4
200 2.8 650 9.1
250 3.5 700 9.8
300 4.2 750 10.5
350 4.9 800 11.2
400 5.6 850 11.9
450 6.3 900 12.6
500 7.0 950 13.3
550 7.7 1000 14.0

CONTRAINDICATIONS

Do not use in animals showing hypersensitivity to ketoprofen.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

Cattle must not be slaughtered for human consumption within 48-hours following last treatment with this drug product. Not for use in female dairy cattle 1 year of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

USER SAFETY WARNINGS

Not for human use. Keep this and all drugs out of the reach of children.
The Safety Data Sheet (SDS) provides more detailed occupational safety information. To obtain a Safety Data Sheet contact Zoetis Inc. at 1-888-963-8471.

ANIMAL SAFETY WARNINGS

Do not use in cattle that are dehydrated or with known renal disease.

PRECAUTIONS

As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, hepatic 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 KETOFEN® with other antiinflammatory drugs, such as other NSAIDs and corticosteroids, should be avoided or closely monitored. Discontinue use if fecal blood is observed.
The effects of KETOFEN® on bovine reproductive performance, pregnancy, lactation, or on animals of reproductive age intended for breeding has not been investigated.
KETOFEN® may cause injection site swelling that appears 1 to 3 days post-treatment and typically resolves by 28 days post-injection. These reactions may result in trim loss of edible tissue at slaughter.

ADVERSE REACTIONS

Repeated administration of NSAIDs can result in gastric or renal toxicity. Sensitivity to drug-associated adverse effects varies with the individual patient. Patients at greatest risk for toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with pre-existing gastric ulcers, renal, cardiovascular, and/or hepatic dysfunction.

CONTACT INFORMATION

For a copy of the Safety Data Sheet or to report suspected adverse drug experiences, call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

CLINICAL PHARMACOLOGY

KETOFEN is a non-narcotic, non-steroidal anti-inflammatory agent. The primary mechanism of action for ketoprofen is inhibition of the cyclooxygenase (COX) pathway leading to decreased production of prostaglandins[1]. Ketoprofen is a relatively nonselective inhibitor of the COX isozymes. After subcutaneous administration of a single dose of 3 mg/kg ketoprofen in fourteen calves, the mean and range (minimum and maximum) for the maximum plasma concentration (Cmax ) was 9.40 μg/mL (7.06 – 15.8), the area under the curve to the last quantifiable point AUC(last) was 67.4 μg•h/mL (48.4 – 96.9), the time to maximum plasma concentration (Tmax ) was 1.54 hours (0.67-2.0), and the half-life (t1/2 ) was 3.03 hours (2.48-3.88). Ketoprofen has shown linear pharmacokinetics across a 1 to 15 mg/kg dose range and has shown little to no accumulation on multiple dosing with a 24-hour dose interval.

EFFECTIVENESS

The control of pyrexia associated with bovine respiratory disease (BRD) was demonstrated in a single multisite study. Cattle exhibiting clinical signs of BRD and having a rectal temperature of at least 104.5°F were enrolled. A total of 202 cattle were administered either a single subcutaneous injection of KETOFEN® (3.0 mg/kg BW) or a single subcutaneous injection of saline (0.028 mL/kg BW) on day 0. Six hours after treatment, rectal temperatures were measured. The treatment success rate of the KETOFEN® -treated group was compared to the treatment success rate in the saline-treated group. A treatment success was defined as a decrease in rectal temperature of ≥ 2°F in an individual animal. The percent of animals with a ≥ 2 degree decrease in rectal temperature at 6 hours post-treatment was significantly different and higher (P=0.0215) in the KETOFEN® group (74.3%) vs. the saline treated group (5.9%).

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