onsior™ (robenacoxib)

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

robenacoxib (UNII: Z588009C7C) (robenacoxib - UNII:Z588009C7C)

Available from:

Elanco US Inc.

INN (International Name):

robenacoxib

Composition:

robenacoxib 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

ONSIOR should not be used in dogs that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs.

Product summary:

ONSIOR tablets are available as 10, 20 and 40 mg round flavored tablets in perforated blisters and are supplied in cards containing 6 tablets. Each carton holds 10 blister cards (60 tablets per carton). The appropriate number of tablets per patient is to be dispensed in an ONSIOR dispensing envelope containing an Information for Dog Owners Sheet.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ONSIOR- ROBENACOXIB TABLET
ELANCO US INC.
----------
ONSIOR™
(ROBENACOXIB)
10 MG, 20 MG AND 40 MG TABLETS FOR DOGS
FOR ORAL USE IN DOGS ONLY
DO NOT USE IN CATS. Cats cannot be accurately dosed with the tablet
sizes intended to
be used in dogs.
CAUTION:
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
ONSIOR (robenacoxib) is a non-narcotic, non-steroidal
anti-inflammatory drug (NSAID)
of the coxib class. Tablets are round, beige to brown in color, not
scored, flavored and
contain robenacoxib. The molecular weight of robenacoxib is 327.28.
The empirical
formula is C
-H
- F -NO . Robenacoxib is [5-Ethyl-2-(2,3,5,6-tetrafluoro-phenylamino)-
phenyl]-acetic acid. The structural formula is:
INDICATION:
ONSIOR tablets are indicated for the control of postoperative pain and
inflammation
associated with soft tissue surgery in dogs ≥ 5.5 lbs (2.5 kg) AND
≥ 4 months of age;
for up to a MAXIMUM OF 3 DAYS.
DOSAGE AND ADMINISTRATION:
ALWAYS PROVIDE “INFORMATION FOR DOG OWNERS” SHEET WITH
PRESCRIPTION.
CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISK OF ONSIOR TABLETS
AND
OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE ONSIOR TABLETS. Use the
lowest effective dose for the shortest duration consistent with
individual response.
The dose of ONSIOR tablets is 0.91 mg/lb (2 mg/kg) orally once daily,
for a MAXIMUM OF
3 DAYS. (SEE WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS).
16
13
4
2
DOSAGE DIRECTIONS: For oral use in dogs ≥ 5.5 lbs AND ≥ 4 months
of age; for up to a
MAXIMUM OF 3 DAYS. Tablets are not scored and should not be broken.
The calculated
dosage should be provided using a combination of whole tablet sizes.
Do not use in dogs weighing less than 5.5 lbs (2.5 kg), as dogs less
than 5.5 lbs (2.5 kg)
cannot be accurately dosed. DO NOT USE IN CATS. CATS CANNOT BE
ACCURATELY
DOSED WITH THE TABLET SIZES INTENDED TO BE USED IN DOGS.
The first dose should be administered approximately 45 minutes prior
to surgery, at the
same time as the pre-anesthetic agents are g