PREVAIL- flunixin meglumine paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUNIXIN MEGLUMINE (UNII: 8Y3JK0JW3U) (FLUNIXIN - UNII:356IB1O400)

Available from:

MWI

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Prevail Equine Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. ACTIVITY: Flunixin meglumine is a potent, nonnarcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show 1 onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

PREVAIL- FLUNIXIN MEGLUMINE PASTE
MWI
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PREVAIL
(FLUNIXIN MEGLUMINE PASTE)
EQUINE PASTE
APPLE FLAVORED
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION: Each 30-g syringe of Flunazine Equine Paste contains
flunixin
meglumine equivalent to 1500 mg flunixin.
INDICATIONS: Prevail Equine Paste is recommended for the alleviation
of inflammation
and pain associated with musculoskeletal disorders in the horse.
ACTIVITY: Flunixin meglumine is a potent, nonnarcotic, nonsteroidal,
analgesic agent
with anti-inflammatory and antipyretic activity. It is significantly
more potent than
pentazocine, meperidine, and codeine as an analgesic in the rat yeast
paw test. Oral
studies in the horse show 1 onset of flunixin activity occurs within 2
hours of
administration. Peak response occurs between 12 and 16 hours and
duration of activity
is 24 to 36 hours.
FOR ORAL USE IN HORSES ONLY
CONTRAINDICATIONS: THERE ARE NO KNOWN CONTRAINDICATIONS TO THIS DRUG
WHEN USED AS DIRECTED.
WARNING: DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUMPTION.
PRECAUTIONS: The effect of flunixin meglumine on pregnancy has not
been
determined. Studies to date show there is no detrimental effect on
stallion
spermatogenesis with or following the recommended dose of flunixin
meglumine.
SIDE EFFECTS: During field studies with flunixin meglumine, 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-VET or online at www.fda.gov/reportanimalaeduration of
activity is 24 to 36
hours.
DOSAGE AND ADMINISTRATION: The recommended dose of flunixin is 0.5 mg
per lb
of body weight once daily. The Prevail Equine Paste syringe,
calibrated in twelve 250-lb
weight increments, delivers 125 mg of flunixin for each 250 lbs (see
dosage table). One
syringe will t