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Animal NDC 61133-4007-1 Ketomed

Ketoprofen

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-4007-1
Proprietary Name Ketomed What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Ketoprofen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Bimeda, Inc.
Product Type Prescription Animal Drug
Usage Information
    INDICATIONKetoMed(ketoprofen) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Active Ingredient(s)
  • Ketoprofen
Inactive Ingredient(s)
  • ARGININE (94ZLA3W45F)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • BENZYL ALCOHOL (LKG8494WBH)
  • ARGININE (94ZLA3W45F)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • BENZYL ALCOHOL (LKG8494WBH)
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200625 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

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Ketomed Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



KetoMedTM
(ketoprofen)

Sterile Solution, 100 mg/mL

For intravenous use in horses only.

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CAUTION

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

SIDE EFFECTS

During investigational studies, no significant side effects were reported.

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

Approved by FDA under ANADA # 200-625

Manufactured for:
Bimeda, Inc.

Le Sueur, MN 56058

www.bimeda.com


12/20


Description



DESCRIPTION

Ketoprofen is a non-steroidal anti-inflammatory agent of the propionic acid class that includes ibuprofen, naproxen, and fenoprofen.  Each mL of KetoMed (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.


Animal Pharmacology & Or Toxicology



PHARMACOLOGY

KetoMed 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

TOXICITY

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.


Indications & Usage



INDICATION

KetoMed(ketoprofen) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.


Dosage & Administration



DOSAGE AND ADMINISTRATION

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



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



PRECAUTIONS

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


Warnings



WARNING

Do not use in horses intended for human consumption.


How Supplied



HOW SUPPLIED

KetoMed (ketoprofen) Solution 100 mg/mL is available in 50 mL and 100 mL multidose bottles.


Storage And Handling



Store at 20°C - 25°C (68°F- 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F). Do not freeze.

Use within 28 days of first puncture.


Package Label.Principal Display Panel




* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.