EQUIOXX- firocoxib injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

firocoxib (UNII: Y6V2W4S4WT) (firocoxib - UNII:Y6V2W4S4WT)

Available from:

Merial, Inc.

INN (International Name):

firocoxib

Composition:

firocoxib 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Indications: EQUIOXX Injection is administered for up to 5 days for the control of pain and inflammation associated with osteoarthritis in horses. Contraindications: Horses with hypersensitivity to firocoxib should not receive EQUIOXX Injection.

Product summary:

How Supplied: EQUIOXX (firocoxib) Injection for Horses will be supplied in sterile, 25 mL amber glass vials for multi-dose use.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

EQUIOXX- FIROCOXIB INJECTION, SOLUTION
MERIAL, INC.
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EQUIOXX
INJECTION (FIROCOXIB)
Non-steroidal anti-inflammatory drug for intravenous use in horses
only.
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A LICENSED VETERINARIAN.
DESCRIPTION: EQUIOXX (firocoxib) belongs to the coxib class of
non-narcotic, non-steroidal anti-
inflammatory drugs (NSAID). Firocoxib is a white crystalline compound
described chemically as 3-
(cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)-5,
5-dimethylfuranone. The empirical formula is
C
H O S, and the molecular weight is 336.4. The structural formula is
shown below:
EQUIOXX Injection is a colorless to pale yellow solution. Each mL of
EQUIOXX Injection for
Horses contains 20 mg of firocoxib as a free base, 550 mg of
polyethylene glycol (PEG 400) and 600
mg of glycerol formal.
INDICATIONS: EQUIOXX Injection is administered for up to 5 days for
the control of pain and
inflammation associated with osteoarthritis in horses.
DOSAGE AND ADMINISTRATION: Always provide the Client Information Sheet
with the prescription. The
recommended dosage of EQUIOXX Injection for intravenous administration
in horses is 0.04 mg/lb
(0.09 mg/kg) of body weight once daily for up to 5 days. If further
treatment is needed, EQUIOXX
(firocoxib) Oral Paste for horses can be used at a dosage of 0.045
mg/lb (0.1 mg/kg) body weight for
up to an additional 9 days of treatment. The overall duration of
treatment with EQUIOXX Injection and
EQUIOXX Oral Paste will be dependent on the response observed, but
should not exceed 14 days. See
EQUIOXX Oral Paste for horses package insert for dosage and
administration. EQUIOXX Injection is a
non-aqueous solution and should not be mixed with aqueous solutions
(Do not flush through intravenous
lines using aqueous flush solutions).
CONTRAINDICATIONS: Horses with hypersensitivity to firocoxib should
not receive EQUIOXX Injection.
WARNINGS: FOR INTRAVENOUS USE IN HORSES ONLY. DO NOT USE IN HORSES
INTENDED FOR HUMAN
CONS UMPTION.
HUMAN WARNINGS: Not for