ALLOXATE- meloxicam injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

meloxicam (UNII: VG2QF83CGL) (meloxicam - UNII:VG2QF83CGL)

Available from:

Patterson Veterinary

INN (International Name):

meloxicam

Composition:

meloxicam 5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Dogs: Alloxate™ (meloxicam) 5 mg/mL Solution for Injection is indicated in dogs for the control of pain and inflammation associated with osteoarthritis. Dogs with known hypersensitivity to meloxicam should not receive Alloxate 5 mg/mL Solution for Injection. Cats: For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery. Cats with known hypersensitivity to meloxicam should not receive Alloxate 5 mg/mL Solution for Injection. Additional doses of meloxicam or other NSAIDs in cats are contraindicated, as no safe dosage for repeated NSAID administration has been established (See Animal Safety). Do not use meloxicam in cats with pre-existing renal dysfunction.

Product summary:

Alloxate 5 mg/mL Solution for Injection: 10 mL and 20 mL vial Made in the UK. Manufactured For: Patterson Veterinary. 137 Barnum Road, Devens, MA 01434 www.pattersonvet.com Manufactured By: Norbrook Laboratories Limited, Newry, BT35 6PU, Co. Down, Northern Ireland. Alloxate is a trademark of Patterson Veterinary 023974I01 Alloxate 5 mg/mL Solution for Injection: 10 mL and 20 mL vial

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ALLOXATE- MELOXICAM INJECTION, SOLUTION
PATTERSON VETERINARY
----------
PACKAGE INSERT FOR DOGS
ANADA 200-491, Approved by FDA
ALLOXATE™
(MELOXICAM)
5 MG/ML SOLUTION FOR INJECTION
Non-steroidal anti-inflammatory drug for use in dogs and cats only.
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
WARNING: REPEATED USE OF MELOXICAM IN CATS HAS BEEN ASSOCIATED WITH
ACUTE RENAL FAILURE
AND DEATH. DO NOT ADMINISTER ADDITIONAL INJECTABLE OR ORAL MELOXICAM
TO CATS. SEE
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS FOR DETAILED INFORMATION.
DES CRIPTION:
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the
oxicam class. Each mL of this
sterile product for injection contains meloxicam 5.0 mg, alcohol 15%,
glycofurol 10%, poloxamer 188
5%, sodium chloride 0.6%, glycine 0.5% and meglumine 0.3%, in water
for injection, pH adjusted with
sodium hydroxide and hydrochloric acid.
INDICATIONS :
DOGS: Alloxate™ (meloxicam) 5 mg/mL Solution for Injection is
indicated in dogs for the control of
pain and inflammation associated with osteoarthritis.
DOSAGE AND ADMINISTRATION:
Carefully consider the potential benefits and risk of Alloxate and
other treatment options before
deciding to use Alloxate. Use the lowest effective dose for the
shortest duration consistent with
individual response.
DOGS: Alloxate 5 mg/mL Solution for Injection should be administered
initially as a single dose at 0.09
mg/lb (0.2 mg/kg) body weight intravenously (IV) or subcutaneously
(SQ), followed, after 24 hours, by
Meloxicam Oral Suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg)
body weight, either mixed
with food or placed directly in the mouth.
CONTRAINDICATIONS :
Dogs with known hypersensitivity to meloxicam should not receive
Alloxate 5 mg/mL Solution for
Injection.
WARNINGS :
Not for use in humans. Keep this and all medications out of reach of
children. Consult a physician in
case of accidental ingestion by humans. For IV or SQ injectable use in
dogs. All dogs should undergo a
thorough h