MELOXICAM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

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 meloxicam injection 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. Dogs with known hypersensitivity to meloxicam should not receive meloxicam injection 5 mg/mL solution for injection.

Product summary:

Meloxicam injection 5 mg/mL solution for injection: 10 mL and 20 mL vial Meloxicam injection 5 mg/mL solution for injection: 10 mL and 20 mL vial Distributed by: Covetrus North America 400 Metro Place North Dublin, OH 43017 covetrus.com Made in the UK AH-Meloxicam injection-04 REV: 0821 731845I03

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

MELOXICAM- MELOXICAM INJECTION, SOLUTION
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
----------
COVETRUS
PACKAGE INSERT FOR CATS
Approved by FDA under ANADA # 200-491
MELOXICAM
INJECTION
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.
DESCRIPTION:
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:
CATS: For the control of postoperative pain and inflammation
associated with orthopedic
surgery, ovariohysterectomy and castration when administered prior to
surgery.
DOSAGE AND ADMINISTRATION:
Carefully consider the potential benefits and risk of meloxicam
injection and other
treatment options before deciding to use meloxicam injection. Use the
lowest effective
dose for the shortest duration consistent with individual response.
CATS: Administer A SINGLE, ONE-TIME SUBCUTANEOUS DOSE of meloxicam
injection 5
mg/mL solution for injection to cats at a dose of 0.14 mg/lb (0.3
mg/kg) body weight.
®
USE OF ADDITIONAL MELOXICAM OR OTHER NSAIDS IS CONTRAINDICATED. (SEE
CONTRAINDICATIONS). To ensure accuracy of dosing, the use of a 1 mL
graduated
syringe is recommended.
CONTRAINDICATIONS:
Cats with known hypersensitivity to meloxicam should not receive
meloxicam injection 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
est