Veterinary Product Information

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Ketoprofen Sterile Solution

This page contains information on Ketoprofen Sterile Solution for veterinary use.
The information provided typically includes the following:

Ketoprofen Sterile Solution Indications
Warnings and cautions for Ketoprofen Sterile Solution
Direction and dosage information for Ketoprofen Sterile Solution

Ketoprofen Sterile Solution

This treatment applies to the following species:

Horses

Manufacturer: Clipper (Phoenix Pharm.)

100 mg/mL

For Intravenous Use In Horses Only.

ANADA 200-392, Approved by FDA

Ketoprofen Sterile Solution 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 Ketoprofen Sterile Solution 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

Ketoprofen Sterile Solution is a non-narcotic, non-steroidal anti-inflammatory agent with analgesic and antipyretic properties.

In horses, intravenous doses 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

Toxicity

Horses 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.

Ketoprofen Sterile Solution Indication

Ketoprofen Sterile Solution 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.

Precautions

This product should not be used in breeding animals since the effects of Ketoprofen Sterile Solution on fertility, pregnancy or fetal health in horses have not been determined.

Studies to determine activity of Ketoprofen Sterile Solution when administered concomitantly with other drugs have not been conducted. Drug compatibility should be monitored closely in patients requiring adjunctive therapy.

Residue Warning

Not for use in horses intended for human consumption.

Side Effects

During investigational studies, no significant side effects were reported.

How Supplied

Ketoprofen Sterile Solution 100 mg/mL is available in 100 mL multidose bottles.

Store between 15° to 30°C (59° to 86°F).

Keep Out Of Reach Of Children

Manufactured by IVX Animal Health, Inc., St. Joseph, MO 64503

Phoenix™ Pharmaceutical, Inc.

Manufactured For: Clipper Distributing Company, Llc, St. Joseph, Mo 64507

Trademarks are property of Clipper Distributing Company, LLC.

Net Contents:	NDC
100 mL	57319-522-05	600106 Iss1206

Nac No.

12561431

CLIPPER DISTRIBUTING CO., LLC
PHOENIX PHARMACEUTICAL INC.
1302 SOUTH 59 STREET, ST. JOSEPH, MO, 64507

Telephone:		816-364-5777
Order Desk:		800-759-3644
Fax:		816-364-4969
Website:		www.clipperdist.net

Every effort has been made to ensure the accuracy of the Ketoprofen Sterile Solution information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

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